Date/Time of Define-XML document generation: 2021-08-11T00:52:13Z
Define-XML version: 2.0.0
Stylesheet version: 2018-11-21
Analysis Results Metadata - Summary
Table 14.2.2.1.1.2Analysis of Antibody-Mediated Immunogenicity Endpoints
Summary of Neutralizing Antibody Titers Per-Protocol Set for SARS-CoV-2-specific nAb from All Lots
Table 14.2.1.1.12.1Analysis of Antibody-Mediated Immunogenicity Endpoints
Analysis Results Metadata - Detail
| Display | Summary of Neutralizing Antibody Titers Per-Protocol Set for SARS-CoV-2-specific nAb from All Lots Analysis of Antibody-Mediated Immunogenicity Endpoints |
|---|---|
| Analysis Result | Summary of Neutralizing Antibody Titers Per-Protocol Set for SARS-CoV-2-specific nAb from All Lots |
| Analysis Parameter(s) | PARAMCD IN ( "MNET" (MN Endpoint Titer), "MN50" (MN50) ) |
| Analysis Variable(s) | |
| Analysis Reason | SPECIFIED IN SAP |
| Analysis Purpose | Key secondary outcome measure |
| Data References (incl. Selection Criteria) | |
| Documentation | SAP |
| Programming Statements | [SAS version 9.4]SAS program codes could be found from m5\datasets\mRNA-1273-P201 Part A\analysis\adam\programs\t140202010102.txt |
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| Display | Summary of Binding Antibody Levels Specific to SARS-CoV-2 Spike Protein by ELISA Per-Protocol Set for SARS-CoV-2-specific bAb Analysis of Antibody-Mediated Immunogenicity Endpoints |
|---|---|
| Analysis Result | Summary of Binding Antibody Levels Specific to SARS-CoV-2 Spike Protein by ELISA Per-Protocol Set for SARS-CoV-2-specific bAb |
| Analysis Parameter(s) | PARAMCD = "V65IGGS" (VAC65 Spike IgG Antibody (AU/mL)) |
| Analysis Variable(s) | |
| Analysis Reason | SAP |
| Analysis Purpose | Primary outcome measure |
| Data References (incl. Selection Criteria) | |
| Documentation | SAP |
| Programming Statements | [SAS version 9.4]SAS program codes could be found from m5\datasets\mRNA-1273-P201 Part A\analysis\adam\programs\t140201011201.txt |
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Datasets
| Dataset | Description | Class | Structure | Purpose | Keys | Documentation | Location |
|---|---|---|---|---|---|---|---|
| ADSL | Subject-Level Analysis Dataset | SUBJECT LEVEL ANALYSIS DATASET | One record per subject | Analysis | STUDYID, USUBJID | adsl.xpt | |
| ADSLSF | Screen Fail Subj-Level Analysis Dataset | SUBJECT LEVEL ANALYSIS DATASET | One record per screen failed subject | Analysis | USUBJID, SUBJID | adslsf.xpt | |
| ADAR | Solicited AR Analysis Dataset | BASIC DATA STRUCTURE | One or more records per subject per analysis parameter per analysis timepoint | Analysis | USUBJID, PARCAT1, PARAMCD, ATPTREF, ATPTN, ADT, ATM | adar.xpt | |
| ADARP7D | Solicited AR post D7 Analysis Dataset | BASIC DATA STRUCTURE | One or more records per subject per analysis parameter per analysis timepoint | Analysis | USUBJID, PARCAT1, PARAMCD, ATPTREF | adarp7d.xpt | |
| ADARSUM | Solicited AR Summary Analysis Dataset | BASIC DATA STRUCTURE | One or more records per subject per analysis parameter per analysis timepoint | Analysis | USUBJID, PARCAT1, PARAMCD, ATPTREF | adarsum.xpt | |
| ADCOV | COVID-19 Analysis Dataset | BASIC DATA STRUCTURE | One or more records per subject per analysis parameter per analysis timepoint | Analysis | USUBJID, PARCAT1, PARAMCD, VISITNUM, ADT | adcov.xpt | |
| ADIS | Immunogenicity Analysis Dataset | BASIC DATA STRUCTURE | One or more records per subject per analysis parameter per analysis timepoint | Analysis | USUBJID, PARCAT1, PARAMCD, AVISITN, ISDTC | adis.xpt | |
| ADLB | Laboratory Analysis Dataset | BASIC DATA STRUCTURE | One or more records per subject per analysis parameter per analysis timepoint | Analysis | USUBJID, PARAMCD, AVISITN, LBDTC | adlb.xpt | |
| ADMB | Microbiology Analysis Dataset | BASIC DATA STRUCTURE | One or more records per subject per analysis parameter per analysis timepoint | Analysis | USUBJID, PARCAT1, PARAMCD, AVISITN, MBDTC | admb.xpt | |
| ADVS | Vital Signs Analysis Dataset | BASIC DATA STRUCTURE | One or more records per subject per analysis parameter per analysis timepoint | Analysis | USUBJID, PARAMCD, AVISITN, VSDTC | advs.xpt | |
| ADAE | Adverse Event Analysis Dataset | OCCURRENCE DATA STRUCTURE | One record per subject per adverse event | Analysis | AEBODSYS, AEDECOD, AESTDTC, AEENDTC | adae.xpt | |
| ADCM | Concomitant Medication Analysis Dataset | OCCURRENCE DATA STRUCTURE | One record per subject per medication per medication start date | Analysis | USUBJID, CMTRT, CMSTDTC, CMENDTC | adcm.xpt | |
| ADDV | Deviation Analysis Dataset | OCCURRENCE DATA STRUCTURE | One record per subject per deviation | Analysis | USUBJID, DVCAT, DVSCAT, DVSTDTC, DVTERM | addv.xpt | |
| ADEX | Treatment Exposure Analysis Dataset | OCCURRENCE DATA STRUCTURE | One record per subject per administration | Analysis | USUBJID, EXSTDTC | adex.xpt | |
| ADMH | Medical History Analysis Dataset | OCCURRENCE DATA STRUCTURE | One record per subject per medical history | Analysis | USUBJID, MHDECOD | admh.xpt |
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Subject-Level Analysis Dataset (ADSL)
| Variable | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 14 | Study Identifier
| Predecessor: DM.STUDYID |
| USUBJID | Unique Subject Identifier | text | 25 | Predecessor: DM.USUBJID | |
| SUBJID | Subject Identifier for the Study | text | 9 | Predecessor: DM.SUBJID | |
| SITEID | Study Site Identifier | text | 5 | Predecessor: DM.SITEID | |
| COUNTRY | Country | text | 3 | Country
| Predecessor: DM.COUNTRY |
| AGE | Age | integer | 8 | Predecessor: DM.AGE | |
| AGEU | Age Units | text | 5 | Predecessor: DM.AGEU | |
| AGEGR1 | Pooled Age Group 1 | text | 30 | Pooled Age Group 1
| Derived Based on SUPPDM.QVALwhere QNAM='COHORT':
Set to '>=18 and <55 Years' if contains 'COHORT 1'
Set to '>=55 Years' if COHORT contains 'COHORT 2' |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Assigned Based on AGECHRT: Set to 1 if '>=18 and <55 Years' Set to 2 if '>=55 Years' | |
| AGEGR2 | Pooled Age Group 2 | text | 19 | Pooled Age Group 2
| Derived Based on AGE:
Set to '>=18 and <=22 Years' if 18<=AGE<=22';
Set to '>=23 and <=25 Years' if 23<=AGE<=25';
Set to '>25 and <55 Years' if 25<AGE<55';
Set to '>=55 Years' if COHORT contains 'COHORT 2' |
| AGEGR2N | Pooled Age Group 2 (N) | integer | 8 | Assigned | |
| SEX | Sex | text | 1 | Sex
| Predecessor: DM.SEX |
| RACE | Race | text | 41 | Race [8 Terms] | Predecessor: DM.RACE |
| RACESPY | Race Specify | text | 200 | Derived If RACE='OTHER' then set to SUPPDM.QVAL where QNAM is RACEOTH;
If RACE='MULTIPLE' then set to SUPPDM.QVAL where QNAM is MULRACE | |
| ETHNIC | Ethnicity | text | 22 | Ethnicity
| Predecessor: DM.ETHNIC |
| PROTVER | Protocol Version | text | 25 | Derived Set to SUPPDM.QVAL where QNAM is PROTVER | |
| CHILDBP | Childbearing Potential | text | 10 | No Yes Response
| Derived Set to RP.RPORRES where RPTESTCD is CHILDPOT and VISIT=Screening |
| CBNRS | Reason for No Childbearing Potential | text | 200 | Derived Set to SUPPRP.QVAL where QNAM='CBRSN' and VISIT=Screening | |
| RANDFL | Randomized Population Flag | text | 1 | No Yes Response
| Derived Set to 'Y' if USUBJID exists in DS where DSDECOD='RANDOMIZED' and DSSTDTC not missing and DSREFID not missing. Set to 'N' otherwise |
| RANDNUM | Randomization Number | text | 20 | Derived Set to DS.DSREFID | |
| SAFFL | Safety Population Flag | text | 1 | No Yes Response
| Derived Set to "Y" if RANDFL="Y" AND USUBJID exists in EX with non-missing EXSTDTC. Set to "N" otherwise |
| FASBABFL | Full Analysis Set bAb Population Flag | text | 1 | No Yes Response
| Derived Set to 'Y' if
1. SAFFL='Y; and
2. Have at least one non-missing IS.ISSTRESC with ISCAT contains 'Serum SARS-CoV-2 Binding Antibodies' before the first vaccination (DM.RFSTDTC), and
3. Have at least one non-missing IS.ISSTRESC with ISCAT contains 'Serum SARS-CoV-2 Binding Antibodies' post the first vaccination |
| FASNABFL | Full Analysis Set nAb Population Flag | text | 1 | No Yes Response
| Derived Set to 'Y' if
1. SAFFL='Y; and
2. Have at least one non-missing IS.ISSTRESC with ISCAT contains 'Serum SARS-CoV-2 Neutralizing Antibodies' before the first vaccination (DM.RFSTDTC), and
3. Have at least one non-missing IS.ISSTRESC with ISCAT contains 'Serum SARS-CoV-2 Neutralizing Antibodies' post the first vaccination |
| PPBABFL | Per Protocol bAb Population Flag | text | 1 | No Yes Response
| Derived Subjects in FAS for bAb and
1. Complied with the injection schedule as defined in the protocol visit window,
2. don’t have COVID-19 infection at baseline,
3. don't have deviation impact bAb responses.
4. both actual doses are within + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose
set to 'Y' if
1) for #1-3, based on PP_LIST, If a subject has one record with PVSBABFL='Y', and
2) for #4,
a) both TRT01P and TRT01A are 'Placebo', or
b) both TRT01P and TRT01A are 'mRNA-1273 50 ug' and there is no record in EX where EXTRT is 'Placebo' or (EXTRT is 'mRNA-1273' and EXDOSTXT contains '>0-25', '>75-<100' or '>100-125', or '>125 or above'), or
c) both TRT01P and TRT01A are 'mRNA-1273 100 ug' and there is no record in EX where EXTRT is 'Placebo' or (EXTRT is 'mRNA-1273' and EXDOSTXT contains '>0-25', '>25-<50' or >50-75', '>125 or above'),
Set to 'N' otherwise |
| PPNABFL | Per Protocol nAb Population Flag | text | 1 | No Yes Response
| Derived Subjects with FAS for nAb and
1. Complied with the injection schedule as defined in the protocol visit window,
2. don’t have COVID-19 infection at baseline,
3. don't have deviation impact nAb responses.
4. both actual doses are within + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose.
set to 'Y' if
1) for #1-3, based on PP_LIST, If a subject has one record with PVSNABFL='Y', and
2) for #4,
a) both TRT01P and TRT01A are 'Placebo', or
b) both TRT01P and TRT01A are 'mRNA-1273 50 ug' and there is no record in EX where EXTRT is 'Placebo' or (EXTRT is 'mRNA-1273' and EXDOSTXT contains '>0-25', '>75-<100' or '>100-125', or '>125'), or
c) both TRT01P and TRT01A are 'mRNA-1273 100 ug' and there is no record in EX where EXTRT is 'Placebo' or (EXTRT is 'mRNA-1273' and EXDOSTXT contains '>0-25', '>25-<50 ug' or >50-75', '>125'),
Set to 'N' otherwise |
| PPBD29FL | Per Protocol bAb Day 29 Flag | text | 1 | No Yes Response
| Derived Set PP_LIST.PVSBABFL where VISITTPT='Day 29',
Set to 'N' if subject's actual doses is outside + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose (refer to PPBABFL) |
| PPBD57FL | Per Protocol bAb Day 57 Flag | text | 1 | No Yes Response
| Derived Set PP_LIST.PVSBABFL where VISITTPT='Day 57'
Set to 'N' if subject's actual doses is outside + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose (refer to PPBABFL) |
| PBD209FL | Per Protocol bAb Day 209 Flag | text | 1 | No Yes Response
| Derived Set PP_LIST.PVSBABFL where VISITTPT='Day 209'
Set to 'N' if subject's actual doses is outside + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose (refer to PPBABFL) |
| PPND29FL | Per Protocol nAb Day 29 Flag | text | 1 | No Yes Response
| Derived Set PP_LIST.PVSNABFL where VISITTPT='Day 29',
Set to 'N' if subject's actual doses is outside + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose (refer to PPBABFL) |
| PPND57FL | Per Protocol nAb Day 57 Flag | text | 1 | No Yes Response
| Derived Set PP_LIST.PVSNABFL where VISITTPT='Day 57',
Set to 'N' if subject's actual doses is outside + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose (refer to PPBABFL) |
| PND209FL | Per Protocol nAb Day 209 Flag | text | 1 | No Yes Response
| Derived Set PP_LIST.PVSNABFL where VISITTPT='Day 209'
Set to 'N' if subject's actual doses is outside + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose (refer to PPBABFL) |
| SAR1FL | First Solicited Safety Population Flag | text | 1 | No Yes Response
| Derived Set to 'Y' if both criteria met:
1. SAFFL='Y';
2. Have at least one non-missing FAORRES where FATPTREF = 'DOSE 1' in FACE OR have at least one non-missing VSORRES where VSTPTREF = 'DOSE 1' and VSTEST contains "Temperature" where VSCAT contains "REACTOGENICITY" in VS;
Set to 'N' otherwise. |
| SAR2FL | Second Solicited Safety Population Flag | text | 1 | No Yes Response
| Derived Set to 'Y' if all criteria met:
1. SAFFL='Y';
2. Have at least one non-missing FAORRES where FATPTREF = 'DOSE 2' in FACE OR have at least one non-missing VSORRES where VSTPTREF = 'DOSE 2' and VSTEST contains "Temperature" where VSCAT contains "REACTOGENICITY" in VS;
3. DOSE2FL='Y';
Set to 'N' otherwise |
| SARAFL | Solicited Safety Population Flag | text | 1 | No Yes Response
| Derived Set to 'Y' if SAR1FL='Y' or SAR2FL='Y' |
| FASNA2FL | FAS nAb 2 Population Flag | text | 1 | No Yes Response
| Derived Set to 'Y' if
1. SAFFL='Y' and
2. Have at least one non-missing IS.ISSTRESC with ISCAT contains 'Serum SARS-CoV-2 Neutralizing Antibodies' on or before the date of the first vaccination (TR01SDT), and
3. Have at least one non-missing IS.ISSTRESC with ISCAT contains 'Serum SARS-CoV-2 Neutralizing Antibodies' post the date of first vaccination,
Set to 'N' otherwise |
| PPNAB2FL | PP nAb 2 Population Flag | text | 1 | No Yes Response
| Derived Subjects with FAS for nAb and
1. Complied with the injection schedule as defined in the protocol visit window,
2. don’t have COVID-19 infection at baseline,
3. don't have deviation impact nAb responses.
4. both actual doses are within + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose.
set to 'Y' if
1) for #1-3, based on PP_LIST2, If a subject has one record with PVSNABFL='Y', and
2) for #4,
a) both TRT01P and TRT01A are 'Placebo'; or
b) both TRT01P and TRT01A are 'mRNA-1273 50 ug' and there is no record in EX where EXTRT is 'Placebo' or (EXTRT is 'mRNA-1273' and EXDOSTXT contains '>0-25', '>75-<100' or '>100-125', or '>125'); or
c) both TRT01P and TRT01A are 'mRNA-1273 100 ug' and there is no record in EX where EXTRT is 'Placebo' or (EXTRT is 'mRNA-1273' and EXDOSTXT contains '>0-25', '>25-<50 ug' or >50-75', '>125');
'N' otherwise. |
| PN2D29FL | Per Protocol nAb 2 Day 29 Flag | text | 1 | No Yes Response
| Derived Set PP_LIST2.PVSNABFL where VISITTPT='Day 29',
Set to 'N' if subject's actual doses is outside + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose (refer to PPBABFL) |
| PN2D57FL | Per Protocol nAb 2 Day 57 Flag | text | 1 | No Yes Response
| Derived Set PP_LIST2.PVSNABFL where VISITTPT='Day 57',
Set to 'N' if subject's actual doses is outside + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose (refer to PPBABFL) |
| PN2209FL | Per Protocol nAb 2 Day 209 Flag | text | 1 | No Yes Response
| Derived Set PP_LIST2.PVSNABFL where VISITTPT='Day 209'
Set to 'N' if subject's actual doses is outside + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose (refer to PPBABFL) |
| COMPLFL | Completers Population Flag | text | 1 | No Yes Response
| Derived Set to "Y" if USUBJID exists in DS where DSCAT ="DISPOSITION EVENT" and DS.DSSCAT ="END OF STUDY" and DSDECOD = "COMPLETED";
Set to "N" if USUBJID exists in DS where DSCAT = "DISPOSITION EVENT" and DS.DSSCAT = "END OF STUDY" and DSDECOD^= "COMPLETED". |
| DVBABFL | Deviation Impact bAb Flag | text | 1 | No Yes Response
| Derived Based on PP_LISTING, If a subject is excluded from subject-level PP set for bAb and has one record with PBABDVFL='Y', then set to 'Y'.
Set to 'N' otherwise. |
| DVNABFL | Deviation Impact nAb Flag | text | 1 | No Yes Response
| Derived Based on PP_LISTING, If a subject is excluded from subject-level PP set for nAb and has one record with PNABDVFL='Y', then set to 'Y'.
set to 'N' otherwise. |
| DOSE1FL | Vaccination 1 Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if USUBJID exists in EX with non-missing EXSTDTC where EX.VISIT contains 'Day 1'; Set to 'N' otherwise |
| DOSE2FL | Vaccination 2 Flag | text | 1 | No Yes Response
| Derived Set to 'Y' if USUBJID exists in EX with non-missing EXSTDTC where EX.VISIT contains 'Day 29'; Set to 'N' otherwise |
| DOSEROFL | Dosing Error Flag | text | 1 | No Yes Response
| Derived Set to 'Y' if subject received any dose (based on EX.EXTRT, EX.EXDOSE or EX.EXDOSTXT) which is different from the randomized arm (ARM);
'N' otherwise |
| COV19BL | Baseline COVID Infection | text | 20 | Baseline COVID Infection
| Derived Based on MB.MBSTRESC where MBTESTCD='SARSCOV2' and SUPPMB.QVAL is not 'Y' where QNAM is 'LOCALFL' and (MBDTC is before the first vaccination (DM.RFXSTDTC) or on the first vaccination date if time is not available:
Set to 'Not Detected' if 'NOTDETECTED' and 'Detected' if 'DETECTED' |
| ELECSBL | Baseline Elecsys SARS CoV-2 Assay | text | 20 | Derived Based on IS.ISSTRESC where ISTESTCD = 'SARSCOV2' and (date of ISDTC is on or before the date of first vaccination (DM.RFXSTDTC) | |
| HEIGHTBL | Baseline Height (cm) | float | 8 | Derived The last non-missing VS.VSSTRESN where VSTESTCD = “HEIGHT” and (VSDTC is before the first vaccination (DM.RFXSTDTC) or on the first vaccination date with VSTPT contains 'PRE-DOSE'.) | |
| WEIGHTBL | Baseline Weight (kg) | float | 8 | Derived The last non-missing VS.VSSTRESN where VSTESTCD = 'WEIGHT' and (VSDTC is before the first vaccination (DM.RFXSTDTC) or on the first vaccination date with VSTPT contains 'PRE-DOSE') | |
| ARM | Description of Planned Arm | text | 16 | Description of Planned Arm
| Predecessor: DM.ARM |
| ACTARM | Description of Actual Arm | text | 16 | Description of Planned Arm
| Predecessor: DM.ACTARM |
| BMIBL | Baseline BMI (kg/m2) | float | 8 | Derived Set to WEIGHTBL/(HEIGHTBL in meters)^2 | |
| COV19FL | COVID Infection Flag | text | 20 | No Yes Response
| Derived Set to 'Y' if there is one record in MB where MB.MBSTRESC is 'DETECTED' or 'POSITIVE' and MBTESTCD='SARSCOV2' or there is record in AE where AEDECOD is 'COVID-19', 'Asymptomatic COVID-19' or 'SARS-CoV-2 test positive',
Set to 'N', Otherwise |
| SENTLFL | Sentinel Participant Flag | text | 3 | No Yes Response
| Derived Set to SUPPDM.QVAL where QNAM='SENTL' |
| D29W7DFL | Day 29 Out of 7-Day Window Flag | text | 1 | No Yes Response
| Derived Set to 'Y' if DOSE2DT-TR01SDT+1>36;
Otherwise set to 'N' |
| TRT01P | Planned Treatment for Period 01 | text | 25 | Planned Treatment for Period 01
| Derived Set to ARM |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | Assigned 1 if TRT01P=‘Placebo’, 2 if TRT01P=‘mRNA-1273 50 ug’, 3 if TRT01P=‘mRNA-1273 100 ug’" | |
| RFXSTDTC | Date/Time of First Study Treatment | datetime | ISO 8601 | Predecessor: DM.RFXSTDTC | |
| TRT01A | Actual Treatment for Period 01 | text | 25 | Actual Treatment for Period 01
| Derived Set to ACTARM if SAFFL='Y' |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | Assigned 1 if TRT01A=‘Placebo’, 2 if TRT01A=‘mRNA-1273 50 ug’, 3 if TRT01A=‘mRNA-1273 100 ug’" | |
| RFICDT | Date of Informed Consent | integer | DATE9 | Derived Date part of DM.RFICDTC | |
| RANDDT | Date of Randomization | integer | DATE9 | Derived DS.DSSTDTC where DSTERM='RANDOMIZED' and DSCAT='PROTOCOL MILESTONE' | |
| TR01SDT | Date of First Exposure in Period 01 | integer | DATE9 | Derived Set to numeric date part of DM.RFXSTDTC | |
| TR01SDTM | Datetime of First Exposure in Period 01 | integer | DATETIME20 | Derived Set to numeric of DM.RFXSTDTC | |
| TR01EDT | Date of Last Exposure in Period 01 | integer | DATE9 | Derived Set to numeric date part of DM.RFXENDTC | |
| TR01EDTM | Datetime of Last Exposure in Period 01 | integer | DATETIME20 | Derived Set to numeric of DM.RFXENDTC | |
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME20 | Derived Set to numeric of DM.RFXSTDTC | |
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME20 | Derived Set to numeric of DM.RFXENDTC | |
| DOSE2DT | Date of Dose 2 | integer | DATE9 | Derived Set to numeric date part of non-missing EX.EXSTDTC where EX.VISIT contains 'Day 29' | |
| DOS2DTM | Datetime of Dose 2 | integer | DATETIME20 | Derived Set to numeric of non-missing EX.EXSTDTC where EX.VISIT contains 'Day 29' | |
| EOSSTT | End of Study Status | text | 20 | Derived Set to 'COMPLETED' if COMPLFL='Y'
Set to 'DISCONTINUED' if COMPLFL='N'
Set to 'ONGOING', otherwise | |
| EOSDT | End of Study Date | integer | DATE9 | Derived Set to numeric of DS.DSSTDTC where DSCAT='DISPOSITION EVENT' and DSSCAT='END OF STUDY' | |
| EOSDY | End of Study Relative Day | integer | 8 | Derived Set to EOSDT-TR01SDT+1 if EOSDT>=TR01SDT | |
| DCSREAS | Reason for Discontinuation from Study | text | 100 | Reason for Discontinuation of Treatment / Study [11 Terms] | Derived Mixed case of DS.DSTERM where DSCAT='DISPOSITION EVENT' and DSSCAT='END OF STUDY' AND DSDECOD not in ('COMPLETED', 'AE COVID', 'ADVERSE EVENT (OTHER)', 'PHYSICIAN DESICION', 'WITHDRAWAL BY SUBJECT (OTHER)', 'WITHDRAWAL BY SUBJECT (COVID-19 NON-INFECTION RELATED)', 'PROTOCOL DEVIATION', 'OTHER').
Set to 'Adverse Event (COVID-19 Infection)' if DS.DSDECOD is 'AE COVID'
Set to 'Adverse Event (Other)' if DS.DSDECOD is 'ADVERSE EVENT (OTHER)'
Set to 'Physician Decision' if DS.DSDECOD is 'PHYSICIAN DESICION'
Set to 'Withdrawal of Consent (Other)' if DS.DSDECOD is 'WITHDRAWAL BY SUBJECT (OTHER)'
Set to 'Withdrawal of Consent (COVID-19 Non-Infection Related)' if DS.DSDECOD is 'WITHDRAWAL BY SUBJECT (COVID-19 NON-INFECTION RELATED)'
Set to 'Protocol Deviation' if DS.DSDECOD is 'PROTOCOL DEVIATION'
Set to 'Other' if DS.DSDECOD is 'OTHER' |
| DCSREASP | Reason Spec for Discont from Study | text | 200 | Derived DS.DSTERM where DSCAT='DISPOSITION EVENT' and DSSCAT='END OF STUDY' AND DSDECOD in ('ADVERSE EVENT (OTHER)', 'PHYSICIAN DESICION', 'WITHDRAWAL BY SUBJECT (OTHER)', 'WITHDRAWAL BY SUBJECT (COVID-19 NON-INFECTION RELATED)', 'PROTOCOL DEVIATION', 'OTHER') | |
| EOTSTT | End of Treatment Status | text | 20 | Derived Set to 'COMPLETED' if USUBJID exists in DS where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' AND DSDECOD='COMPLETED',
Set to 'DISCONTINUED' if USUBJID exists in DS where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' AND DSDECOD^='COMPLETED',
Set to 'ONGOING', otherwise | |
| EOTDT | End of Treatment Date | integer | DATE9 | Derived Set to numeric of DS.DSSTDTC where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' | |
| EOTDY | End of Treatment Relative Day | integer | 8 | Derived Set to EOTDT-TR01SDT+1 if EOTDT>=TR01SDT | |
| DCTREAS | Reason for Discontinuation of Treatment | text | 100 | Reason for Discontinuation of Treatment / Study [11 Terms] | Derived Mixed case of DS.DSTERM where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' AND DSDECOD not in ('COMPLETED', 'AE COVID', 'ADVERSE EVENT (OTHER)', 'PHYSICIAN DESICION', 'WITHDRAWAL BY SUBJECT (OTHER)', 'WITHDRAWAL BY SUBJECT (COVID-19 NON-INFECTION RELATED)', 'PROTOCOL DEVIATION', 'OTHER'):
Set to 'Adverse Event (COVID-19 Infection)' if DS.DSDECOD is 'AE COVID'
Set to 'Adverse Event (Other)' if DS.DSDECOD is 'ADVERSE EVENT (OTHER)'
Set to 'Physician Decision' if DS.DSDECOD is 'PHYSICIAN DESICION'
Set to 'Withdrawal of Consent (Other)' if DS.DSDECOD is 'WITHDRAWAL BY SUBJECT (OTHER)'
Set to 'Withdrawal of Consent (COVID-19 Non-Infection Related)' if DS.DSDECOD is 'WITHDRAWAL BY SUBJECT (COVID-19 NON-INFECTION RELATED)'
Set to 'Protocol Deviation' if DS.DSDECOD is 'PROTOCOL DEVIATION'
Set to 'Other' if DS.DSDECOD is 'OTHER' |
| DCTREASP | Reason Specify for Discont of Treatment | text | 200 | Derived DS.DSTERM where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' AND DSDECOD in ('ADVERSE EVENT (OTHER)', 'PHYSICIAN DESICION', 'WITHDRAWAL BY SUBJECT (OTHER)', 'WITHDRAWAL BY SUBJECT (COVID-19 NON-INFECTION RELATED)', 'PROTOCOL DEVIATION', 'OTHER') | |
| DTHDT | Date of Death | integer | DATE9 | Derived Set to DM.DTHDTC and convert to numeric | |
| DTHAUTOP | Was autopsy performed? | text | 8 | Derived Set to SUPPDS.QVAL where QNAM='DTHAUTOP' | |
| UNBLND | Unblinded (Y/N) | text | 1 | Derived Set to SUPPDM.QVAL where QNAM = 'UNBLNDYN' | |
| UICF | Updated Informed Consent (Y/N) | text | 1 | Derived Set to 'Y' if there is a record in DS where DSSCAT = 'OPEN LABEL' and DSDECOD = 'INFORMED CONSENT OBTAINED',
Set to 'N' | |
| CUTOFFDT | Data Cutoff Date | integer | DATE9 | Assigned | |
| SAFEREAS | Reason for Safety Set Exclusion | text | 200 | Derived Only for subjects with RANDFL='Y'.
Set to 'Did not receive any vaccination' if SAFFL='N'.
blank otherwise | |
| SAR1ERS | Reason for 1st Solicited Safety Set Exc | text | 200 | Derived Only for subjects with RANDFL='Y'.
If SAFFL='N', set to 'Did not receive any study vaccination';
If SAFFL='Y' and SAR1FL='N', set to 'Did not contribute any solicited AR data for Vaccination #1'.
blank otherwise | |
| SAR2ERS | Reason for 2nd Solicited Safety Set Exc | text | 200 | Derived Only for subjects with RANDFL='Y'.
If SAFFL='N', set to 'Did not receive any study vaccination';
If SAFFL='Y' and DOSE2FL='N', set to 'Did not receive Vaccination #2'.
If SAFFL='Y'and DOSE2FL='Y' and SAR2FL='N', set to 'Did not contribute any solicited AR data for Vaccination #2'.
blank otherwise | |
| FASBABRS | Reason for BAB Full Analysis Set Exc | text | 200 | Derived Only for subjects with RANDFL='Y'.
If SAFFL='N', set to 'Did not receive any study vaccination';
If SAFFL='Y' and FASBABFL='N', set to 'There were no immunogenicity results at baseline and at least one post-vaccination.'.
blank otherwise. | |
| FASNABRS | Reason for NAB Full Analysis Set Exc | text | 200 | Derived Only for subjects with RANDFL='Y'.
If SAFFL='N', set to 'Did not receive any study vaccination';
If SAFFL='Y' and FASNABFL='N', set to 'There were no immunogenicity results at baseline and at least one post-vaccination.'
blank otherwise | |
| PPBABERS | Reason for BAB Per-Protocol Set Exc | text | 200 | Derived Only for subjects with RANDFL='Y' and PPBABFL='N':
if subject is excluded due to dosing error as defined in PPBABFL then set to 'Dosing error' and concatenate the reasons from PP_list if the subject is also excluded due to other reasons,
For exclusion based on PP_list, set to PP_list.PBABREAS and concatenate all unique reasons (Note: merge data by USUBJID) | |
| PPNABERS | Reason for nAb Per-Protocol Set Exc | text | 200 | Derived Only for subjects with RANDFL='Y' and PPNABFL='N',
if subject is excluded due to dosing error as defined in PPNABFL then set to 'Dosing error' and concatenate the reasons from PP_list if the subject is also excluded due to other reasons,
For exclusion based on PP_list, set to PP_list.PNABREAS and concatenate all unique reasons (Note: merge data by USUBJID) | |
| PPBD29ER | Reason for bAb Per-Protocol Day 29 Exc | text | 138 | Derived Only for subjects with RANDFL='Y' and PPBD29FL='N':
Set to PP_list.PBABREAS where VISITTPT='Day 29'
Set to 'Dosing error' and concatenate with the reason from PP_list if subject has dosing error (ADSL.PPBABERS contains 'Dosing error') | |
| PPBD57ER | Reason for bAb Per-Protocol Day 57 Exc | text | 138 | Derived Only for subjects with RANDFL='Y' and PPBD57FL='N':
Set to PP_list.PBABREAS where VISITTPT='Day 57'.
if subject has dosing error (ADSL.PPBABERS contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list if applicable | |
| PBD209ER | Reason for bAb Per-Protocol Day 209 Exc | text | 200 | Derived Only for subjects with RANDFL='Y' and PBD209FL='N':
Set to PP_list.PBABREAS where VISITTPT = 'Day 209'
If subject has dosing error (ADSL.PPBABERS contains 'Dosing error') then Set to 'Dosing error' and concatenate with the reason from PP_list if applicable | |
| PPND29ER | Reason for nAb Per-Protocol Day 29 Exc | text | 138 | Derived Only for subjects with RANDFL='Y' and PPND29FL='N':
Set to PP_list.PNABREAS where VISITTPT='Day 29'.
if subject has dosing error (ADSL.PPNABERS contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list if applicable | |
| PPND57ER | Reason for nAb Per-Protocol Day 57 Exc | text | 138 | Derived Only for subjects with RANDFL='Y' and PPND57FL='N':
Set to PP_list.PNABREAS where VISITTPT='Day 57'.
if subject has dosing error (ADSL.PPNABERS contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list if applicable | |
| PND209ER | Reason for nAb Per-Protocol Day 209 Exc | text | 200 | Derived Only for subjects with RANDFL='Y' and PND209FL='N':
Set to PP_list.PNABREAS where VISITTPT='Day 209'
If subject has dosing error (ADSL.PPNABERS contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list if applicable | |
| PPNAB2ER | Reason for nAb 2 Per-Protocol Set Exc | text | 174 | Derived Only for subjects with RANDFL='Y' and PPNAB2FL='N'.
if subject is excluded due to dosing error as defined in PPNABFL then set to 'Dosing error' and concatenate the reasons from PP_list2 if the subject is also excluded due to other reasons.
For exclusion based on PP_list2, set to PP_list2.PNABREAS and concatenate all unique reasons (Note: merge data by USUBJID) | |
| PN2D29ER | Reason for nAb 2 PP Day 29 Exc | text | 138 | Derived Only for subjects with RANDFL='Y' and PN2D29FL='N':
Set to PP_list2.PNABREAS where VISITTPT='Day 29'.
if subject has dosing error (ADSL.PPNAB2ER contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list2 if applicable | |
| PN2D57ER | Reason for nAb 2 PP Day 57 Exc | text | 138 | Derived Only for subjects with RANDFL='Y' and PN2D57FL='N':
Set to PP_list2.PNABREAS where VISITTPT='Day 57'.
if subject has dosing error (ADSL.PPNAB2ER contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list2 if applicable | |
| PN2209ER | Reason for nAb 2 PP Day 209 Exc | text | 200 | Derived Only for subjects with RANDFL='Y' and PN2209FL='N':
Set to PP_list2.PNABREAS where VISITTPT='Day 209'
If subject has dosing error (ADSL.PPNAB2ER contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list2 if applicable | |
| PREVSCR | Was this participant screened previously | text | 1 | No Yes Response
| Derived Set to SUPPDM.QVAL where QNAM='PREVSCR' per USUBJID |
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Screen Fail Subj-Level Analysis Dataset (ADSLSF)
| Variable | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 14 | Study Identifier
| Predecessor: DM.STUDYID |
| USUBJID | Unique Subject Identifier | text | 25 | Predecessor: DM.USUBJID | |
| SUBJID | Subject Identifier for the Study | text | 9 | Predecessor: DM.SUBJID | |
| SITEID | Study Site Identifier | text | 5 | Predecessor: DM.SITEID | |
| COUNTRY | Country | text | 3 | Country
| Predecessor: DM.COUNTRY |
| AGE | Age | integer | 8 | Predecessor: DM.AGE | |
| AGEU | Age Units | text | 5 | Predecessor: DM.AGEU | |
| SEX | Sex | text | 1 | Sex
| Predecessor: DM.SEX |
| RACE | Race | text | 41 | Race [8 Terms] | Predecessor: DM.RACE |
| RACESPY | Race Specify | text | 200 | Derived Set to SUPPDM.QVAL where QNAM is RACEOTH if RACE='OTHER',
Set to SUPPDM.QVAL where QNAM is MULRACE if RACE='MULTIPLE' | |
| ETHNIC | Ethnicity | text | 22 | Ethnicity
| Predecessor: DM.ETHNIC |
| PROTVER | Protocol Version | text | 25 | Derived Set to SUPPDM.QVAL where QNAM is PROTVER and VISIT=Screening | |
| CHILDBP | Childbearing Potential | text | 10 | No Yes Response
| Derived Set to RP.RPORRES where RPTESTCD is CHILDPOTand VISIT=Screening |
| CBNRS | Reason for No Childbearing Potential | text | 200 | Derived Set to SUPPRP.QVAL where QNAM='CBRSN' | |
| RFICDT | Date of Informed Consent | integer | DATE9 | Derived Set to Date part of DM.RFICDTC | |
| SCFREAS | Screen Failure Reason | text | 200 | Screen Failure Reason
| Derived Set to DS.DSTERM where DSCAT='DISPOSITION EVENT' and DSSCAT='SCREEN FAILURE' and DS.DSDECOD^='OTHER',
Set to 'Other' if DS.DSDECOD='OTHER' where DSCAT = 'DISPOSITION EVENT' and DSSCAT= 'SCREEN FAILURE' |
| SCFREASP | Screen Failure Reason Specify | text | 200 | Derived Set to DS.DSTERM where SCFREAS='OTHER' | |
| PREVSCR | Was this participant screened previously | text | 1 | No Yes Response
| Derived Set to SUPPDM.QVAL where QNAM='PREVSCR' per USUBJID |
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Solicited AR Analysis Dataset (ADAR)
| Variable | Where Condition | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 14 | Study Identifier
| Predecessor: ADSL.STUDYID | |
| USUBJID | Unique Subject Identifier | text | 25 | Predecessor: ADSL.USUBJID | ||
| SUBJID | Subject Identifier for the Study | text | 9 | Predecessor: ADSL.SUBJID | ||
| SITEID | Study Site Identifier | text | 5 | Predecessor: ADSL.SITEID | ||
| COUNTRY | Country | text | 3 | Country
| Predecessor: ADSL.COUNTRY | |
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | ||
| AGEU | Age Units | text | 5 | Predecessor: ADSL.AGEU | ||
| AGEGR1 | Pooled Age Group 1 | text | 30 | Pooled Age Group 1
| Predecessor: ADSL.AGEGR1 | |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Predecessor: ADSL.AGEGR1N | ||
| AGEGR2 | Pooled Age Group 2 | text | 19 | Pooled Age Group 2
| Predecessor: ADSL.AGEGR2 | |
| AGEGR2N | Pooled Age Group 2 (N) | integer | 8 | Predecessor: ADSL.AGEGR2N | ||
| SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX | |
| RACE | Race | text | 41 | Race [8 Terms] | Predecessor: ADSL.RACE | |
| RACESPY | Race Specify | text | 200 | Predecessor: ADSL.RACESPY | ||
| ETHNIC | Ethnicity | text | 22 | Ethnicity
| Predecessor: ADSL.ETHNIC | |
| RANDFL | Randomized Population Flag | text | 1 | No Yes Response (Yes Only)
| Predecessor: ADSL.RANDFL | |
| SAFFL | Safety Population Flag | text | 1 | No Yes Response (Yes Only)
| Predecessor: ADSL.SAFFL | |
| FASBABFL | Full Analysis Set bAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASBABFL | |
| FASNABFL | Full Analysis Set nAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASNABFL | |
| PPBABFL | Per Protocol bAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBABFL | |
| PPNABFL | Per Protocol nAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPNABFL | |
| PPBD29FL | Per Protocol bAb Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBD29FL | |
| PPBD57FL | Per Protocol bAb Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBD57FL | |
| PBD209FL | Per Protocol bAb Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PBD209FL | |
| PPND29FL | Per Protocol nAb Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPND29FL | |
| PPND57FL | Per Protocol nAb Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPND57FL | |
| PND209FL | Per Protocol nAb Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PND209FL | |
| SAR1FL | First Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAR1FL | |
| SAR2FL | Second Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAR2FL | |
| SARAFL | Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SARAFL | |
| FASNA2FL | FAS nAb 2 Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASNA2FL | |
| PPNAB2FL | PP nAb 2 Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPNAB2FL | |
| PN2D29FL | Per Protocol nAb 2 Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2D29FL | |
| PN2D57FL | Per Protocol nAb 2 Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2D57FL | |
| PN2209FL | Per Protocol nAb 2 Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2209FL | |
| DVBABFL | Deviation Impact bAb Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DVBABFL | |
| DVNABFL | Deviation Impact nAb Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DVNABFL | |
| DOSE1FL | Vaccination 1 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSE1FL | |
| DOSE2FL | Vaccination 2 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSE2FL | |
| DOSEROFL | Dosing Error Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSEROFL | |
| COV19BL | Baseline COVID Infection | text | 20 | Baseline COVID Infection
| Predecessor: ADSL.COV19BL | |
| ELECSBL | Baseline Elecsys SARS CoV-2 Assay | text | 20 | Predecessor: ADSL.ELECSBL | ||
| COV19FL | COVID Infection Flag | text | 1 | No Yes Response
| Predecessor: ADSL.COV19FL | |
| SENTLFL | Sentinel Participant Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SENTLFL | |
| D29W7DFL | Day 29 Out of 7-Day Window Flag | text | 1 | No Yes Response
| Predecessor: ADSL.D29W7DFL | |
| TRT01P | Planned Treatment for Period 01 | text | 25 | Planned Treatment for Period 01
| Predecessor: ADSL.TRT01P | |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01PN | ||
| TRT01A | Actual Treatment for Period 01 | text | 25 | Actual Treatment for Period 01
| Predecessor: ADSL.TRT01A | |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01AN | ||
| TR01SDT | Date of First Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01SDT | ||
| TR01SDTM | Datetime of First Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01SDTM | ||
| TR01EDT | Date of Last Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01EDT | ||
| TR01EDTM | Datetime of Last Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01EDTM | ||
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTSDTM | ||
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTEDTM | ||
| DOSE2DT | Date of Dose 2 | integer | DATE9 | Predecessor: ADSL.DOSE2DT | ||
| DOS2DTM | Datetime of Dose 2 | integer | DATETIME20 | Predecessor: ADSL.DOS2DTM | ||
| TRTA | Actual Treatment | text | 50 | Actual Treatment
| Derived Select the last dose record in SDTM.EX before event or assessment Date Time :
Set to 'Placebo' if EX.EXTRT='PLACEBO'
For EX.EXTRT = 'mRNA-1273' :
Set to 'mRNA-1273 50 ug if 0 < EXDOSE <= 75 or EXDOSTXT contains '>0-25', '>25-<50' or '>50-75' ,
Set to 'mRNA-1273 100 ug' if EXDOSE>75 or EXDOSTXT contains '>75-<100' or '>100-125' or '>125'
Note:
Use date only respectively if time part of event or assessment is missing | |
| TRTAN | Actual Treatment (N) | integer | 8 | Assigned 1 if TRT01A=‘Placebo’, 2 if TRT01A=‘mRNA-1273 50 ug’, 3 if TRT01A=‘mRNA-1273 100 ug’" | ||
| ASEQ | Analysis Sequence Number | integer | 8 | Assigned Sort by USUBJID, PARCAT1, PARAMCD, ATPTREF, ATPTN and start from 1, increase by 1 for records within each subject | ||
| ADT | Analysis Date | integer | DATE9 | Derived Set to numeric date part of FACE.FADTC if source data are from FACE
Set to number date part of VS.VSDTC if source data are from VS | ||
| ATM | Analysis Time | integer | TIME5 | Derived Set to numeric time part of FACE.FADTC If source data are from FACE
Set to numeric time part of VS.VSDTC if source data are from VS | ||
| ADTM | Analysis Datetime | integer | DATETIME20 | Derived Set to numeric date time of FACE.FADTC if time part is not missing for data is from FACE
Set to numeric date time of VS.VSDTC if time part is not missing for data is from VS | ||
| ADY | Analysis Relative Day | integer | 8 | Derived Set to FACE.FADY if source data are from FACE
Set to VS.VSDY if source data are from VS | ||
| ATPT | Analysis Timepoint | text | 50 | Derived Set to FACE.FATPT if source data are from FACE
Set to VS.VSTPT if source data are from VS,
Recode 'DAY 1' as 'DAY 1, AFTER VACCINATION (AT HOME)' if FAEVAL='INVESTIGATOR' and PARAMCD is not RASH and LYMPHOCC | ||
| ATPTN | Analysis Timepoint (N) | float | 8 | Assigned 1 if ATPT='DAY 1', 1.1 If ATPT='DAY 1, 1 HOUR AFTER VACCINATION (AT STUDY CLINIC)' , 1.2 if ATPT='DAY 1, AFTER VACCINATION (AT HOME)', 2 if ATPT='DAY 2', 3 if ATPT='DAY 3', 4 if ATPT='DAY 4', 5 if ATPT='DAY 5', 6 if ATPT='DAY 6', 7 if ATPT='DAY 7' | ||
| ATPTREF | Analysis Timepoint Reference | text | 50 | Analysis Timepoint Reference
| Derived If source data are from FACE:
Set to 'Vaccination 1' if FACE.FATPTREF contains 'DOSE 1'
Set to 'Vaccination 2' if FACE.FATPTREF contains 'DOSE 2'
If source data are from VS:
Set to 'Vaccination 1' if VS.VSTPTREF contains 'DOSE 1'
Set to 'Vaccination 2' if VS.VSTPTREF contains 'DOSE 2' | |
| ATPTGR1 | Poolded Analysis Timepoint | text | 50 | Derived Set to 'Day 1' if ATPT contains 'Day 1'
Set to ATPT otherwise | ||
| ATPTGR1N | Poolded Analysis Timepoint (N) | integer | 8 | Assigned 1 if ATPT contains 'Day 1', 2 if ATPT=’DAY 2’, 3 if ATPT=’DAY 3’, 4 if ATPT=’DAY 4’, 5 if ATPT=’DAY 5’, 6 if ATPT=’DAY 6’ 7 if ATPT=’DAY 7’ | ||
| PARCAT1 | Parameter Category 1 | text | 50 | Derived If source data are from FACE:
Set to 'LOCAL' if FASCAT=ADMINISTRATION SITE
Set to FASCAT if FASCAT<>ADMINISTRATION SITE
Set to VSSCAT if source data are from VS
Set to 'SYSTEMIC' if PARAMCD='RASH'
Set to 'LOCAL' if PARAMCD='LYMPHOCC' | ||
| PARCAT1N | Parameter Category 1 (N) | integer | 8 | Solicited AR Category Code
| Assigned | |
| PARAMCD | Parameter Code | text | 8 | Solicited AR Analysis Dataset Parameter Code [17 Terms] | Assigned | |
| PARAM | Parameter | text | 200 | Derived Set to 'Rash Occurrence' if source data are from FACE and FAOBJ='Rash', and FATESTCD ne 'SEV'
Set to 'Rash' if source data are from FACE and FAOBJ='Solicited Rash', and FATESTCD = 'SEV'
Set to 'Underarm Gland Swelling or Tenderness' if source data are from FACE and FAOBJ='Underarm Gland Swelling or Tenderness' and FATESTCD = 'SEV'
Set to 'Lymphadenopathy Occurrence' if source data are from FACE and FAOBJ='Lymphadenopathy'
Set to 'Nausea/Vomiting' if source data are from FACE and FAOBJ='Nausea/Vomiting' and FATESTCD = 'SEV'
Set to 'Fever' || '(' ||VSSTRESU ||')' if source data are from VS and VSTESTCD in ('TEMP' 'VSALL')
Set to FAOBJ ||' Longest Diameter (mm)' if source data are from FACE and FAOBJ in ('Erythema' 'Swelling') and FATEST contains 'Occurrence' and FAORRES='NO'
Set to FAOBJ || ' ' || FATEST|| ' ' || '(' ||FAORRESU || ')' if source data are from FACE and FAOBJ in ('Erythema' 'Swelling') and FATEST='Longest Diameter'
Set to FAOBJ otherwise.
Create one record with PARAM='Prevent Pain or Fever from Occurring' if there is one record in VS where SUPPVS.QNAM='MEDTAKP' and QVAL='Y',
Create one record with PARAM='Treat Pain or Fever already Occurred' if there is one record in VS where SUPPVS.QNAM='MEDTAKT' and QVAL='Y'
Create one record with PARAM='Medication Taken Today for Pain or Fever' if there is one record in VS where SUPPVS.QNAM='MEDTAK' and QVAL='Y'
Note:
Please add space between the VSTEST and VS unit. If the VSSTRESU is missing, use non-missing VSSTRESU)
and assign AVAL=0 (see specs for AVAL) | ||
| AVALVLM | Analysis Value | float | 8 | |||
| PARAMCD = "FEVER" (Fever (C)) | float | 12 | Derived Set to VS.VSSTRESN if source data are from VS | |||
| PARAMCD IN ( "ERYTHDIA SWELLDIA" ) | Erythema Longest Diameter (mm) Swelling Longest Diameter (mm) | float | 5 | Derived Set to 0 If source data are from FACE and FAOBJ = 'Erythema' or 'Swelling' and FATEST='OCCURRENCE' and FAORRES='N'
Set to FACE.FASTRESN, otherwise | ||
| AVALCVLM | Analysis Value (C) | text | 100 | |||
| PARAMCD NOT IN ( "ERYTHDIA SWELLDIA MEDTAK MEDTAKT MEDTAKP" ) | text | 92 | Derived Set to FACE.FASTRESC if source data are from FACE
Set to VS.VSSTRESC if source data are from VS | |||
| PARAMCD IN ( "MEDTAK MEDTAKT MEDTAKP" ) | text | 1 | Derived Set to 'Y' per subject per vaccination (ATPTREF) per timepoint (ATPT) if there is a record in SUPPVS where SUPPVS.QNAM in ('MEDTAK', 'MEDTAKT', 'MEDTAKP') and QVAL='Y' | |||
| PARAMCD IN ( "ERYTHDIA SWELLDIA" ) | Erythema Longest Diameter (mm) Swelling Longest Diameter (mm) | text | 92 | Derived Set to FACE.FASTRESC if source data are from FACE
Set to VS.VSSTRESC if source data are from VS | ||
| ATOXGRVLM | Analysis Toxicity Grade | text | 20 | Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007) | ||
| PARAMCD IN ( "ERYTHDIA SWELLDIA" ) | Erythema Longest Diameter (mm) Swelling Longest Diameter (mm) | text | 10 | Derived Set to 'Grade 0' if .<AVAL < 25 mm or FASTRESC contains 'GRADE 0'
Set to 'Grade 1' if AVAL = 25 - 50 mm or FASTRESC contains 'GRADE 1',
Set to 'Grade 2' if AVAL = 51 - 100 mm or FASTRESC contains 'GRADE 2',
Set to 'Grade 3' if AVAL > 100 mm or FASTRESC contains 'GRADE 3',
Set to 'Grade 4' if FASTRESC contains 'GRADE 4', | ||
| PARAMCD = "FEVER" (Fever (C)) | Fever (C) | text | 11 | Derived Set to 'Grade 0' if .<AVAL < 38.0°C or FASTRESC contains 'GRADE 0'
Set to 'Grade 1' if AVAL = 38.0 – 38.4°C or FASTRESC contains 'GRADE 1'
Set to 'Grade 2' if AVAL = 38.5 – 38.9°C or FASTRESC contains 'GRADE 2'
Set to 'Grade 3' if AVAL = 39.0 – 40.0°C or FASTRESC contains 'GRADE 3'
Set to 'Grade 4' if AVAL > 40.0°C or FASTRESC contains 'GRADE 4' | ||
| PARAMCD = "PAIN" (Pain) | Pain | text | 10 | Derived Set to 'Grade 0' if FASTRESC=’NONE’ or FASTRESC contains 'GRADE 0'
Set to 'Grade 1' if FASTRESC='DOES NOT INTERFERE WITH ACTIVITY' or contains 'GRADE 1';
Set to 'Grade 2' if FASTRESC='REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR INTERFERES WITH ACTIVITY' or contains 'GRADE 2';
Set to 'Grade 3' if FASTRESC='ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY' or contains 'GRADE 3'
Set to 'Grade 4' if FASTRESC contains 'GRADE 4' | ||
| PARAMCD = "LYMPH" (Underarm Gland Swelling or Tenderness) | Lymphadenopathy | text | 10 | Derived Set to 'Grade 0' if FASTRESC='NONE' or FASTRESC contains 'GRADE 0'
Set to 'Grade 1' if FASTRESC='DOES NOT INTERFERE WITH ACTIVITY' or FASTRESC contains 'GRADE 1'
Set to 'Grade 2' if FASTRESC='REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR INTERFERES WITH SOME ACTIVITY' or FASTRESC contains 'GRADE 2'
Set to 'Grade 3' if FASTRESC='ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY' or FASTRESC contains 'GRADE 3'
Set to 'Grade 4' if FASTRESC contains 'GRADE 4' | ||
| PARAMCD = "HEADACHE" (Headache) | Headache | text | 10 | Derived Set to 'Grade 0' if FASTRESC='NONE' or FASTRESC contains 'GRADE 0'
Set to 'Grade 1' if FASTRESC='NO INTERFERENCE WITH ACTIVITY' or FASTRESC contains 'GRADE 1'
Set to 'Grade 2' if FASTRESC='REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR SOME INTERFERENCE WITH ACTIVITY' or FASTRESC contains 'GRADE 2'
Set to 'Grade 3' if FASTRESC='ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY' or FASTRESC contains 'GRADE 3'
Set to 'Grade 4' if FASTRESC contains 'GRADE 4' | ||
| PARAMCD IN ( "FATIGUE" (Fatigue), "MYALGIA" (Myalgia), "ARTHRALG" (Arthralgia) ) | Fatigue, Myalgia, Arthralgia | text | 10 | Derived Set to 'Grade 0' if FASTRESC=NONE' or FASTRESC contains 'GRADE 0'
Set to 'Grade 1' if FASTRESC='NO INTERFERENCE WITH ACTIVITY' or FASTRESC contains 'GRADE 1'
Set to 'Grade 2' if FASTRESC='SOME INTERFERENCE WITH ACTIVITY' or FASTRESC contains 'GRADE 2'
Set to 'Grade 3' if FASTRESC='SIGNIFICANT; PREVENTS DAILY ACTIVITY' or FASTRESC contains 'GRADE 3'
Set to 'Grade 4' if FASTRESC contains 'GRADE 4' | ||
| PARAMCD = "NAUSEA" (Nausea/Vomiting) | Nausea/Vomiting | text | 10 | Derived Set to 'Grade 0' if FASTRESC='NONE' or FASTRESC contains 'GRADE 0'
Set to 'Grade 1' if FASTRESC= ‘NO INTERFERENCE WITH ACTIVITY OR 1-2 EPISODES/24 HOURS' or FASTRESC contains 'GRADE 1'
Set to 'Grade 2' if FASTRESC='SOME INTERFERENCE WITH ACTIVITY OR >2 EPISODES/24 HOURS' or FASTRESC contains 'GRADE 2'
Set to 'Grade 3' if FASTRESC='PREVENTS DAILY ACTIVITY, REQUIRES OUTPATIENT IV HYDRATION' or FASTRESC contains 'GRADE 3'
Set to 'Grade 4' if FASTRESC contains 'GRADE 4' | ||
| PARAMCD = "CHILLS" (Chills) | Chills | text | 10 | Derived Set to 'Grade 0' if FASTRESC='NONE' or FASTRESC contains 'GRADE 0'
Set to 'Grade 1' if FASTRESC= 'NO INTERFERENCE WITH ACTIVITY' or contains 'GRADE 1';
Set to 'Grade 2' if FASTRESC= 'SOME INTERFERENCE WITH ACTIVITY NOT REQUIRING MEDICAL ATTENTION' or contains 'GRADE 2';
Set to 'Grade 3' if FASTRESC= 'PREVENTS DAILY ACTIVITY AND REQUIRES MEDICAL ATTENTION' or contains 'GRADE 3';
Set to 'Grade 4' if FASTRESC contains 'GRADE 4' | ||
| PARAMCD = "RASH" (Rash) | Rash | text | 10 | Derived Set to 'Grade 0' if FASTRESC='GRADE 0 = NO RASH' or contains 'GRADE 0';
Set to 'Grade 1' if FASTRESC='GRADE 1 = LOCALIZED RASH, WITHOUT ASSOCIATED SYMPTOMS' or contains 'GRADE 1';
Set to 'Grade 2' if FASTRESC='GRADE 2 = MACULOPAPULAR RASH, COVERING 50% BODY SURFACE AREA WITH URTICARIA' or contains 'GRADE 2';
Set to 'Grade 3' if FASTRESC='GRADE 3 = GENERALIZED URTICARIAL, COVERING 50% BODY SURFACE AREA' or contains 'GRADE 3';
Set to 'Grade 4' if FASTRESC='GRADE 4 = GENERALIZED EXFOLIATIVE, ULCERATIVE OR BULLOUS DERMATITIS, E.G. STEVENS-JOHNSON SYNDROME OR ERYTHEMA MULTIFORME' or contains 'GRADE 4'; | ||
| ATOXGRN | Analysis Toxicity Grade (N) | integer | 8 | Analysis Toxicity Grade
| Assigned | |
| ANL01FL | Analysis Flag 01 | text | 1 | No Yes Response (Yes Only)
| Derived Set to blank if PARAMCD in (MEDTAK, MEDTAKT And MEDTAKP),
Set to 'Y' by selecting the first record with maximum non-missing AVALC (Y>N) per subject per PARAM per vaccination (ATPTREF) per ATPTGR1 if PARAMCD in (RASHOCC, LYMPHOCC),
Set to 'Y' by selecting the first record with maximum non-missing ATOXGRN per subject per PARAM per vaccination (ATPTREF) per ATPTGR1, otherwise
Note: Please select the one where FAEVAL='STUDY SUBJECT' or missing for FEVER if there are two records per day with different FAEVAL | |
| ANL02FL | Analysis Flag 02 | text | 1 | No Yes Response (Yes Only)
| Derived Set to blank if PARAMCD in (MEDTAK, MEDTAKT And MEDTAKP)
Set to 'Y' by selecting the first record with maximum non-missing AVALC (Y>N) per subject per PARAM per vaccination (ATPTREF) per ATPT if PARAMCD in (RASHOCC, LYMPHOCC)
Set to 'Y' by selecting the first record with maximum non-missing ATOXGRN per subject per PARAM per vaccination (ATPTREF) per ATPT, otherwise
Note: Please select the one where FAEVAL='STUDY SUBJECT' or missing for FEVER if there are two records per day with different FAEVAL | |
| CRIT1 | Analysis Criterion 1 | text | 20 | Derived Set to '> 102.6 degrees F' if CRIT1FL='Y' | ||
| CRIT1FL | Criterion 1 Evaluation Result Flag | text | 1 | Derived Set to 'Y' if PARAMCD='FEVER' and (9*AVAL/5)+32 > 102.6 | ||
| CRIT2 | Analysis Criterion 2 | text | 20 | Derived Set to '> 103.1 degrees F' if CRIT2FL='Y' | ||
| CRIT2FL | Criterion 2 Evaluation Result Flag | text | 1 | Derived Set to 'Y' if PARAMCD='FEVER' and (9*AVAL/5)+32 > 103.1 | ||
| CRIT3 | Analysis Criterion 3 | text | 20 | Derived Set to '> 103.6 degrees F' if CRIT3FL='Y' | ||
| CRIT3FL | Criterion 3 Evaluation Result Flag | text | 1 | Derived Set to 'Y' if PARAMCD='FEVER' and (9*AVAL/5)+32 > 103.6 | ||
| CRIT4 | Analysis Criterion 4 | text | 20 | Derived Set to '> 104.1 degrees F' if CRIT4FL='Y' | ||
| CRIT4FL | Criterion 4 Evaluation Result Flag | text | 1 | Derived Set to 'Y' if PARAMCD='FEVER' and (9*AVAL/5)+32 > 104.1 | ||
| FALOC | Location of the Finding About | text | 34 | Location of the Finding About [15 Terms] | Predecessor: FA.FALOC | |
| FAEVAL | Evaluator | text | 12 | Evaluator
| Predecessor: FA.FAEVAL | |
| LYMPHCOM | Lymphadenopathy Additional information | text | 200 | Derived Set to CO.COVAL where COREF=LYMPHCOM | ||
| LYMPHEVL | Lymphadenopathy evaluated? | text | 1 | No Yes Response (Yes Only)
| Derived Set to SUPPFACE.QVAL where SUPPFACE.QNAME='LYMPHEVL' | |
| SRCOMM | Additional Relevant Rash Information | text | 200 | Derived Set to CO.COVAL where COREF=SRCOMMM | ||
| SREVLFL | Rash evaluated Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to SUPPFACE.QVAL where SUPPFACE.QNAME='SREVL' | |
| SRCDOM | Source Data | text | 20 | Derived Set to FACE.DOMAIN if source data are from FACE
Set to VS.DOMAIN if source data are from VS | ||
| SRCSEQ | Source Sequence Number | integer | 8 | Derived Set to FACE.FASEQ if source data are from FACE
Set to VS.VSSEQ if source data are from VS | ||
| SRCVAR | Source Variable | text | 50 | Derived Set to 'FASTRESC' if source data are from FACE,
Set to 'VSSTRESN' if source data are from VS and PARAMCD = 'FEVER',
Set to 'SUPPVS.QVAL where QNAM='MEDTAK' for PARAMCD='MEDTAK',
Set to 'SUPPVS.QVAL where QNAM='MEDTAKT' for PARAMCD='MEDTAKT',
Set to 'SUPPVS.QVAL where QNAM='MEDTAKP' for PARAMCD='MEDTAKP' | ||
| MAAEFL | Medically Attended Flag | text | 1 | No Yes Response
| Derived SUPPFACE.QVAL where SUPPFACE.QNAME='MAAEFL' |
Go to the top of the Define-XML document
Solicited AR post D7 Analysis Dataset (ADARP7D)
| Variable | Where Condition | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 14 | Study Identifier
| Predecessor: ADSL.STUDYID | |
| USUBJID | Unique Subject Identifier | text | 25 | Predecessor: ADSL.USUBJID | ||
| SUBJID | Subject Identifier for the Study | text | 9 | Predecessor: ADSL.SUBJID | ||
| SITEID | Study Site Identifier | text | 5 | Predecessor: ADSL.SITEID | ||
| COUNTRY | Country | text | 3 | Country
| Predecessor: ADSL.COUNTRY | |
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | ||
| AGEU | Age Units | text | 5 | Predecessor: ADSL.AGEU | ||
| AGEGR1 | Pooled Age Group 1 | text | 30 | Pooled Age Group 1
| Predecessor: ADSL.AGEGR1 | |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Predecessor: ADSL.AGEGR1N | ||
| AGEGR2 | Pooled Age Group 2 | text | 19 | Pooled Age Group 2
| Predecessor: ADSL.AGEGR2 | |
| AGEGR2N | Pooled Age Group 2 (N) | integer | 8 | Predecessor: ADSL.AGEGR2N | ||
| SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX | |
| RACE | Race | text | 41 | Race [8 Terms] | Predecessor: ADSL.RACE | |
| RACESPY | Race Specify | text | 200 | Predecessor: ADSL.RACESPY | ||
| ETHNIC | Ethnicity | text | 22 | Ethnicity
| Predecessor: ADSL.ETHNIC | |
| RANDFL | Randomized Population Flag | text | 1 | No Yes Response (Yes Only)
| Predecessor: ADSL.RANDFL | |
| SAFFL | Safety Population Flag | text | 1 | No Yes Response (Yes Only)
| Predecessor: ADSL.SAFFL | |
| FASBABFL | Full Analysis Set bAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASBABFL | |
| FASNABFL | Full Analysis Set nAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASNABFL | |
| PPBABFL | Per Protocol bAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBABFL | |
| PPNABFL | Per Protocol nAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPNABFL | |
| PPBD29FL | Per Protocol bAb Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBD29FL | |
| PPBD57FL | Per Protocol bAb Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBD57FL | |
| PBD209FL | Per Protocol bAb Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PBD209FL | |
| PPND29FL | Per Protocol nAb Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPND29FL | |
| PPND57FL | Per Protocol nAb Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPND57FL | |
| PND209FL | Per Protocol nAb Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PND209FL | |
| SAR1FL | First Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAR1FL | |
| SAR2FL | Second Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAR2FL | |
| SARAFL | Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SARAFL | |
| FASNA2FL | FAS nAb 2 Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASNA2FL | |
| PPNAB2FL | PP nAb 2 Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPNAB2FL | |
| PN2D29FL | Per Protocol nAb 2 Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2D29FL | |
| PN2D57FL | Per Protocol nAb 2 Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2D57FL | |
| PN2209FL | Per Protocol nAb 2 Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2209FL | |
| DVBABFL | Deviation Impact bAb Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DVBABFL | |
| DVNABFL | Deviation Impact nAb Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DVNABFL | |
| DOSE1FL | Vaccination 1 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSE1FL | |
| DOSE2FL | Vaccination 2 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSE2FL | |
| DOSEROFL | Dosing Error Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSEROFL | |
| COV19BL | Baseline COVID Infection | text | 20 | Baseline COVID Infection
| Predecessor: ADSL.COV19BL | |
| ELECSBL | Baseline Elecsys SARS CoV-2 Assay | text | 20 | Predecessor: ADSL.ELECSBL | ||
| COV19FL | COVID Infection Flag | text | 1 | No Yes Response
| Predecessor: ADSL.COV19FL | |
| SENTLFL | Sentinel Participant Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SENTLFL | |
| D29W7DFL | Day 29 Out of 7-Day Window Flag | text | 1 | No Yes Response
| Predecessor: ADSL.D29W7DFL | |
| TRT01P | Planned Treatment for Period 01 | text | 25 | Planned Treatment for Period 01
| Predecessor: ADSL.TRT01P | |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01PN | ||
| TRT01A | Actual Treatment for Period 01 | text | 25 | Actual Treatment for Period 01
| Predecessor: ADSL.TRT01A | |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01AN | ||
| TR01SDT | Date of First Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01SDT | ||
| TR01SDTM | Datetime of First Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01SDTM | ||
| TR01EDT | Date of Last Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01EDT | ||
| TR01EDTM | Datetime of Last Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01EDTM | ||
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTSDTM | ||
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTEDTM | ||
| DOSE2DT | Date of Dose 2 | integer | DATE9 | Predecessor: ADSL.DOSE2DT | ||
| DOS2DTM | Datetime of Dose 2 | integer | DATETIME20 | Predecessor: ADSL.DOS2DTM | ||
| ASEQ | Analysis Sequence Number | integer | 8 | Assigned Sort by USUBJID, PARCAT1, PARAMCD, ATPTREF and start from 1, increase by 1 for records within each subject | ||
| ADT | Analysis Date | integer | DATE9 | Derived Set to numeric date part of FACE.FADTC if source data are from FACE,
Set to numeric date part of FAAE.FADTC if source data are from FAAE,
Set to numeric date part of VS.VSDTC if source data are from VS | ||
| ATM | Analysis Time | integer | TIME5 | Derived Set to numeric time part of FACE.FADTC if source data are from FACE,
Set to numeric time part of FAAE.FADTC if source data are from FAAE,
Set to numeric time part of VS.VSDTC if source data are from VS | ||
| ADTM | Analysis Datetime | integer | DATETIME20 | Derived Set to numeric of FACE.FADTC if source data are from FACE,
Set to numeric of FAAE.FADTC if source data are from FAAE,
Set to numeric of VS.VSDTC if source data are from VS | ||
| ADY | Analysis Relative Day | integer | 8 | Derived Set to FACE.FADY if source data are from FACE,
Set to FAAE. FADY If source data are from FAAE,
Set to VS.VSDY if source data are from VS | ||
| ATPTREF | Analysis Timepoint Reference | text | 50 | Analysis Timepoint Reference
| Derived If source data are from FACE or FAAE:
Set to 'Vaccination 1' if FATPTREF contains 'DOSE 1'
Set to 'Vaccination 2' if FATPTREF contains 'DOSE 2'
If source data are from VS:
Set to 'Vaccination 1' if VSTPTREF contains 'DOSE 1'
Set to 'Vaccination 2' if VSTPTREF contains 'DOSE 2' | |
| ATPT | Analysis Timepoint | text | 49 | Derived Set to FACE.FATPT if source data are from FACE,
Set to FAAE.FATPT if source data are from FAAE,
Set to VS.VSTPT if source data are from VS | ||
| ATPTN | Analysis Timepoint (N) | integer | 8 | Assigned | ||
| ATPTGR1 | Poolded Analysis Timepoint | text | 6 | Derived Set to 'Day 1' if ATPT contains 'Day 1'
Set to ATPT, otherwise | ||
| ATPTGR1N | Poolded Analysis Timepoint (N) | integer | 8 | Derived Set to1 if ATPT contains 'Day 1',
Set to x part of 'Day x' of ATPT, otherwise | ||
| PARCAT1 | Parameter Category 1 | text | 50 | Derived If source data are from FACE or FAAE:
Set to 'LOCAL' if FASCAT=ADMINISTRATION SITE
Set to FASCAT if FASCAT<>ADMINISTRATION SITE
Set to VSSCAT if source data are from VS | ||
| PARCAT1N | Parameter Category 1 (N) | integer | 8 | Solicited AR Category Code
| Assigned | |
| PARAMCD | Parameter Code | text | 8 | Solicited AR Analysis Dataset Parameter Code [17 Terms] | Assigned | |
| PARAM | Parameter | text | 200 | Derived Set to 'Rash'||' '||FATEST if source data are from FAAE and FAOBJ='Rash', and FATESTCD ne 'SEV'
Set to 'Underarm Gland Swelling or Tenderness' if source data are from FAAE and FAOBJ='Underarm Gland Swelling or Tenderness' and FATESTCD = 'SEV'
Set to 'Nausea/Vomiting' if source data are from FAAE and FAOBJ='Nausea' and FATESTCD = 'SEV'
Set to FAOBJ||' Longest Diameter (mm)' if source data are from FAAE and FAOBJ in ('Erythema' 'Swelling') and FATEST='OCCURRENCE' and FAORRES='N'
Set to 'FAOBJ'||' '||FATEST||' '||'('||FAORRESU||')' if source data are from FAAE and FAOBJ in ('Erythema' 'Swelling') and FATEST='Longest Diameter'
Set to FAOBJ otherwise.
Set to 'Fever'||'('||VSSTRESU||')' if source data are from VS and VSTESTCD in ('TEMP' 'VSALL')
Note:
1. Please add space between the VSTEST and VS unit. If the VSSTRESU is missing, use non-missing VSSTRESU
2. For each PARAM, keep only one record per subject per vaccination (ATPTREF) | ||
| AVALVLM | Analysis Value | integer | 8 | |||
| PARAMCD = "FAVER" | integer | 4 | Derived Set to corresponding VS.VSSTRESN based on corresponding AVALC where PARAMCD=FEVER if the record is from VS | |||
| PARAMCD IN ( "ERYTHDIA" (Erythema Longest Diameter (mm)), "SWELLDIA" (Swelling Longest Diameter (mm)) ) | integer | 4 | Derived Set to corresponding FASTRESN based on corresponding AVALC where PARAMCD in (ERYTHDIA, SWELLDIA) if the record is from FACE or FAAE | |||
| AVALCVLM | Analysis Value (C) | text | 94 | |||
| PARAMCD NOT IN ( "MEDTAK" (Medication Taken Today for Pain or Fever), "MEDTAKT" (Treat Pain or Fever already Occurred), "MEDTAKP" (Prevent Pain or Fever from Occurring) ) | text | 94 | Derived Set to FACE.FASTRESC if source data are from FACE,
Set to FAAE.FASTRESC if source data are from FAAE,
Set to VS.VSSTRESC if source data are from VS, | |||
| PARAMCD IN ( "MEDTAK" (Medication Taken Today for Pain or Fever), "MEDTAKT" (Treat Pain or Fever already Occurred), "MEDTAKP" (Prevent Pain or Fever from Occurring) ) | text | 1 | Derived Set to 'Y' if data is from SUPPVS and SUPPVS.QNAM in ('MEDTAK', 'MEDTAKY', 'MEDTAKP') and QVAL='Y' | |||
| ATOXGRVLM | Analysis Toxicity Grade | text | 20 | Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007) | ||
| PARAMCD IN ( "ERYTHDIA SWELLDIA" ) | Erythema Longest Diameter (mm) Swelling Longest Diameter (mm) | text | 10 | Derived Set to 'Grade 1' if AVAL = 25 - 50 mm or AVALC contains 'GRADE 1',
Set to 'Grade 2' if AVAL = 51 - 100 mm or AVALC contains 'GRADE 2',
Set to 'Grade 3' if AVAL > 100 mm or AVALC contains 'GRADE 3',
Set to 'Grade 4' if AVALC contains 'GRADE 4' | ||
| PARAMCD = "FEVER" (Fever (C)) | Fever (C) | text | 10 | Derived Set to 'Grade 1' if AVAL = 38.0 – 38.4°C or AVALC contains 'GRADE 1',
Set to 'Grade 2' if AVAL = >38.4 – 38.9°C or AVALC contains 'GRADE 2',
Set to 'Grade 3' if AVAL = 39.0 – 40.0°C or AVALC contains 'GRADE 3',
Set to 'Grade 4' if AVAL > 40.0°C or AVALC contains 'GRADE 4', | ||
| PARAMCD = "PAIN" (Pain) | Pain | text | 10 | Derived Set to 'Grade 1' if AVALC=’DOES NOT INTERFERE WITH ACTIVITY’ or contains 'GRADE 1';
Set to 'Grade 2' if AVALC= ‘REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR INTERFERES WITH ACTIVITY’ or contains 'GRADE 2';
Set to 'Grade 3' if AVALC= ‘ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3';
Set to 'Grade 4' if AVALC contains 'GRADE 4' | ||
| PARAMCD = "LYMPH" (Underarm Gland Swelling or Tenderness) | Lymphadenopathy | text | 10 | Derived Set to 'Grade 1' if AVALC=’DOES NOT INTERFERE WITH ACTIVITY’ or contains 'GRADE 1';
Set to 'Grade 2' if AVALC= ‘REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR INTERFERES WITH ACTIVITY’ or contains 'GRADE 2';
Set to 'Grade 3' if AVALC= ‘ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3';
Set to 'Grade 4' if AVALC contains 'GRADE 4' | ||
| PARAMCD = "HEADACHE" (Headache) | Headache | text | 10 | Derived Set to 'Grade 1' if AVALC=’NO INTERFERENCE WITH ACTIVITY or contains 'GRADE 1',
Set to 'Grade 2' if AVALC= ‘REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR SOME INTERFERERENCE WITH ACTIVITY’ or contains 'GRADE 2',
Set to 'Grade 3' if AVALC= ‘ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3',
Set to 'Grade 4' if AVALC contains 'GRADE 4' | ||
| PARAMCD IN ( "FATIGUE" (Fatigue), "MYALGIA" (Myalgia), "ARTHRALG" (Arthralgia) ) | Fatigue, Myalgia, Arthralgia | text | 10 | Derived Set to 'Grade 1' if AVALC= 'NO INTERFERENCE WITH ACTIVITY' or contains 'GRADE 1',
Set to 'Grade 2' if AVALC= ‘SOME INTERFERENCE WITH ACTIVITY’ or contains 'GRADE 2',
Set to 'Grade 3' if AVALC= ‘SIGNIFICANT; PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3',
Set to 'Grade 4' if AVALC contains 'GRADE 4' | ||
| PARAMCD = "NAUSEA" (Nausea/Vomiting) | Nausea/Vomiting | text | 10 | Derived Set to 'Grade 1' if AVALC= ‘NO INTERFERENCE WITH ACTIVITY OR 1-2 EPISODES/24 HOURS’ or contains 'GRADE 1';
Set to 'Grade 2' if AVALC= ‘SOME INTERFERENCE WITH ACTIVITY OR >2 EPISODES/24 HOURS’ or contains 'GRADE 2';
Set to 'Grade 3' if AVALC= ‘PREVENTS DAILY ACTIVITY, REQUIRES OUTPATIENT IV HYDRATION’ or contains 'GRADE 3';
Set to 'Grade 4' if AVALC contains 'GRADE 4' | ||
| PARAMCD = "CHILLS" (Chills) | Chills | text | 10 | Derived Set to 'Grade 1' if AVALC= 'NO INTERFERENCE WITH ACTIVITY or contains 'GRADE 1',
Set to 'Grade 2' if AVALC= 'SOME INTERFERENCE WITH ACTIVITY NOT REQUIRING MEDICAL ATTENTION’ or contains 'GRADE 2',
Set to 'Grade 3' if AVALC= ‘PREVENTS DAILY ACTIVITY AND REQUIRES MEDICAL ATTENTION’ or contains 'GRADE 3',
Set to' Grade 4' if AVALC contains 'GRADE 4' | ||
| ATOXGRN | Analysis Toxicity Grade (N) | integer | 8 | Analysis Toxicity Grade
| Assigned | |
| ANL01FL | Analysis Flag 01 | text | 1 | Derived Set to 'Y' if PARAMCD in ( 'PAIN' or 'ERYTHDIA' or 'SWELLDIA', 'LYMPH') | ||
| ANL02FL | Analysis Flag 02 | text | 1 | Derived Set to 'Y' if the records satisfied both criteria met:
1. ANL01FL = 'Y'
2. the smallest ATPTGR1N >=8 per subject per symptom (PARAMCD) per vaccination (ATPTREF) | ||
| ANL03FL | Analysis Flag 03 | text | 1 | Derived Set to blank if PARAMCD in (MEDTAK, MEDTAKT And MEDTAKP)
Set to 'Y' by selecting the first record with maximum non-missing AVALC (Y>N) per subject per PARAM per vaccination (ATPTREF) per ATPT if PARAMCD in (RASHOCC, LYMPHOCC)
Set to 'Y' by selecting the first record with maximum non-missing ATOXGRN per subject per PARAM per vaccination (ATPTREF) per ATPT, otherwise
Note: Please select the one where FAEVAL='STUDY SUBJECT' or missing for FEVER if there are two records per day with different FAEVAL | ||
| ANL04FL | Analysis Flag 04 | text | 1 | Derived Set to 'Y' to all records per subject per ATPTREF per PARAM if the smallest ATPTGR1N<8 and the largest ATPTGR1N>=8 | ||
| ANL05FL | Analysis Flag 05 | text | 1 | Derived Set 'Y' to all records with correspondent PARAMCD where PARACT1='LOCAL' and records at ATPTN=7 and ATPTN=8 per subject per ATPTREF per PARAMCD | ||
| ANL06FL | Analysis Flag 06 | text | 1 | Derived Set to 'Y' to all records correspondent PARAMCD where PARACT1= 'LOCAL' and any of below criteria met per subject per ATPTREF per PARAMCD
1. Have no record at ATPTN=7
2. Have record at ATPTN=7 but have no record at ATPTN=8. | ||
| SRCDOM | Source Data | text | 4 | Derived Set to 'FAAE' if source data are from FAAE,
Set to 'FACE' if source data are from FACE,
Set to VS.DOMAIN if source data are from VS | ||
| SRCSEQ | Source Sequence Number | integer | 8 | Derived Set to FAAE.FASEQ if source data are from FAAE,
Set to FACE.FASEQ if source data are from FACE,
Set to VS.VSSEQ if source data are from VS | ||
| SRCVAR | Source Variable | text | 32 | Derived Set to 'FASTRESC' if source data are from FAAE or FACE,
Set to QVAL if PARAMCD in ('MEDTAK', 'MEDTAKT', 'MEDTAKP'),
Set to 'VSSTRESN' if source data are from VS | ||
| FAEVAL | Evaluator | text | 13 | Predecessor: FACE.FAEVAL or FAAE.FAEVAL | ||
| MAAEFL | Medically Attended Flag | text | 1 | Derived For each PARAM, ATPTREF, FAEVAL, set to Y if there is one record in SUPPFAAE.QVAL where SUPPFACE.QNAME='MAAEFL' or SUPPFAAE.QNAME='MAAEFL' |
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Solicited AR Summary Analysis Dataset (ADARSUM)
| Variable | Where Condition | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 14 | Study Identifier
| Predecessor: ADSL.STUDYID | |
| USUBJID | Unique Subject Identifier | text | 25 | Predecessor: ADSL.USUBJID | ||
| SUBJID | Subject Identifier for the Study | text | 9 | Predecessor: ADSL.SUBJID | ||
| SITEID | Study Site Identifier | text | 5 | Predecessor: ADSL.SITEID | ||
| COUNTRY | Country | text | 3 | Country
| Predecessor: ADSL.COUNTRY | |
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | ||
| AGEU | Age Units | text | 5 | Predecessor: ADSL.AGEU | ||
| AGEGR1 | Pooled Age Group 1 | text | 30 | Pooled Age Group 1
| Predecessor: ADSL.AGEGR1 | |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Predecessor: ADSL.AGEGR1N | ||
| AGEGR2 | Pooled Age Group 2 | text | 19 | Pooled Age Group 2
| Predecessor: ADSL.AGEGR2 | |
| AGEGR2N | Pooled Age Group 2 (N) | integer | 8 | Predecessor: ADSL.AGEGR2N | ||
| SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX | |
| RACE | Race | text | 41 | Race [8 Terms] | Predecessor: ADSL.RACE | |
| RACESPY | Race Specify | text | 200 | Predecessor: ADSL.RACESPY | ||
| ETHNIC | Ethnicity | text | 22 | Ethnicity
| Predecessor: ADSL.ETHNIC | |
| RANDFL | Randomized Population Flag | text | 1 | No Yes Response (Yes Only)
| Predecessor: ADSL.RANDFL | |
| SAFFL | Safety Population Flag | text | 1 | No Yes Response (Yes Only)
| Predecessor: ADSL.SAFFL | |
| FASBABFL | Full Analysis Set bAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASBABFL | |
| FASNABFL | Full Analysis Set nAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASNABFL | |
| PPBABFL | Per Protocol bAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBABFL | |
| PPNABFL | Per Protocol nAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPNABFL | |
| PPBD29FL | Per Protocol bAb Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBD29FL | |
| PPBD57FL | Per Protocol bAb Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBD57FL | |
| PBD209FL | Per Protocol bAb Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PBD209FL | |
| PPND29FL | Per Protocol nAb Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPND29FL | |
| PPND57FL | Per Protocol nAb Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPND57FL | |
| PND209FL | Per Protocol nAb Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PND209FL | |
| SAR1FL | First Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAR1FL | |
| SAR2FL | Second Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAR2FL | |
| SARAFL | Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SARAFL | |
| FASNA2FL | FAS nAb 2 Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASNA2FL | |
| PPNAB2FL | PP nAb 2 Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPNAB2FL | |
| PN2D29FL | Per Protocol nAb 2 Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2D29FL | |
| PN2D57FL | Per Protocol nAb 2 Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2D57FL | |
| PN2209FL | Per Protocol nAb 2 Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2209FL | |
| DVBABFL | Deviation Impact bAb Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DVBABFL | |
| DVNABFL | Deviation Impact nAb Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DVNABFL | |
| DOSE1FL | Vaccination 1 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSE1FL | |
| DOSE2FL | Vaccination 2 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSE2FL | |
| DOSEROFL | Dosing Error Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSEROFL | |
| COV19BL | Baseline COVID Infection | text | 20 | Baseline COVID Infection
| Predecessor: ADSL.COV19BL | |
| ELECSBL | Baseline Elecsys SARS CoV-2 Assay | text | 20 | Predecessor: ADSL.ELECSBL | ||
| COV19FL | COVID Infection Flag | text | 1 | No Yes Response
| Predecessor: ADSL.COV19FL | |
| SENTLFL | Sentinel Participant Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SENTLFL | |
| D29W7DFL | Day 29 Out of 7-Day Window Flag | text | 1 | No Yes Response
| Predecessor: ADSL.D29W7DFL | |
| TRT01P | Planned Treatment for Period 01 | text | 25 | Planned Treatment for Period 01
| Predecessor: ADSL.TRT01P | |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01PN | ||
| TRT01A | Actual Treatment for Period 01 | text | 25 | Actual Treatment for Period 01
| Predecessor: ADSL.TRT01A | |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01AN | ||
| TR01SDT | Date of First Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01SDT | ||
| TR01SDTM | Datetime of First Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01SDTM | ||
| TR01EDT | Date of Last Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01EDT | ||
| TR01EDTM | Datetime of Last Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01EDTM | ||
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTSDTM | ||
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTEDTM | ||
| DOSE2DT | Date of Dose 2 | integer | DATE9 | Predecessor: ADSL.DOSE2DT | ||
| DOS2DTM | Datetime of Dose 2 | integer | DATETIME20 | Predecessor: ADSL.DOS2DTM | ||
| TRTA | Actual Treatment | text | 50 | Actual Treatment
| Derived Select the last dose record in SDTM.EX before event or assessment Date Time :
Set to 'Placebo' if EX.EXTRT='PLACEBO'
For EX.EXTRT = 'mRNA-1273' :
Set to 'mRNA-1273 50 ug if 0 < EXDOSE <= 75 or EXDOSTXT contains '>0-25', '>25-<50' or '>50-75' ,
Set to 'mRNA-1273 100 ug' if EXDOSE>75 or EXDOSTXT contains '>75-<100' or '>100-125' or '>125'
Note:
Use date only respectively if time part of event or assessment is missing | |
| TRTAN | Actual Treatment (N) | integer | 8 | Assigned 1 if TRT01A=‘Placebo’, 2 if TRT01A=‘mRNA-1273 50 ug’, 3 if TRT01A=‘mRNA-1273 100 ug’" | ||
| ATPTREF | Analysis Timepoint Reference | text | 50 | Analysis Timepoint Reference
| Derived Set to ADAR.ATPTREF if data from ADAR
If source data are from FAAE
Set to ‘Vaccination 1' if FAAE.FATPTREF contains 'DOSE 1',
Set to ‘Vaccination 2' if FAAE.FATPTREF contains 'DOSE 2'
If source data are from VS
Set to 'Vaccination 1' if VS.VSTPTREF contains 'DOSE 1',
Set to 'Vaccination 2' if VS.VSTPTREF contains 'DOSE 2' | |
| PARCAT1 | Parameter Category 1 | text | 50 | Derived Set to 'LOCAL' if PARAMCD in (LYMPHDUR, PAINDUR, ERYTHDUR, SWELLDUR, WLYMPH, WPAIN, WERYTH, WSWELL, WSLAR)
Set to 'SYSTEMIC' if PARAMCD in (HEADADUR, FATIGDUR, MYALGDUR, ARTHRDUR, NAUSEDUR, CHILLDUR, FEVERDUR, RASHDUR, WHEAD, WFATIGUE, WMYALGIA, WARTHR, WNAUSEA, WCHILLS,WFEVER, WSSAR) | ||
| PARCAT1N | Parameter Category 1 (N) | integer | 8 | Solicited AR Category Code
| Assigned | |
| PARAMCD | Parameter Code | text | 8 | Assigned see following reference link | ||
| PARAM | Parameter | text | 200 | Derived Assign the PARAM to each subject and each ATPTREF (i.e., Vaccination 1, Vaccination 2) | ||
| AVALVLM | Analysis Value | integer | 8 | |||
| PARAMCD = "RASHDUR" | Number of Days for Rash | integer | 1 | Derived 1. Use ADAR data, count total number of records with AVALC='Y' per subject per vaccination (ATPTREF) where ADAR.PARAMCD='RASHOCC'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once,
2. Use FAAE data, count total number of records where FAOBJ='Rash' and FASTRESC is not 'N' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once,
3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) | ||
| PARAMCD = "LYMPHDUR" | Number of Days for Lymphadenopathy | integer | 1 | Derived 1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD=' LYMPH '. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once,
2. Use FAAE data, count total number of records where FAOBJ='Underarm Gland Swelling or Tenderness' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once,
3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) | ||
| PARAMCD = "PAINDUR" | Number of Days for Pain | integer | 2 | Derived 1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD=' PAIN '. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once,
2. Use FAAE data, count total number of records where FAOBJ='Pain' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once,
3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) | ||
| PARAMCD = "ERYTHDUR" | Number of Days for Erythema | integer | 2 | Derived 1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='ERYTHDIA'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once,
2. Use FAAE data, count total number of records where (FAOBJ='Erythema' and FATEST='Longest Diameter' and FASTRESN>=25 mm) or (FAOBJ='Erythema' and FATEST contains 'Intensity' and FASTRESC contains GRADE 1, GRADE 2 or GRADE 3 or GRADE 4) per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once,
3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) | ||
| PARAMCD = "SWELLDUR" | Number of Days for Swelling | integer | 2 | Derived 1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='SWELLDIA'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once,
2. Use FAAE data, count total number of records where (FAOBJ='Swelling' and FATEST='Longest Diameter' and FASTRESN>=25 mm) or (FAOBJ='Swelling' and FATEST contains 'Intensity' and FASTRESC contains GRADE 1, GRADE 2 or GRADE 3 or GRADE 4) per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once,
3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) | ||
| PARAMCD = "HEADADUR" | Number of Days for Headache | integer | 2 | Derived 1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='HEADACHE'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once,
2. Use FAAE data, count total number of records where FAOBJ='Headache' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once,
3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) | ||
| PARAMCD = "FATIGDUR" | Number of Days for Fatigue | integer | 2 | Derived 1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='FATIGUE'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once,
2. Use FAAE data, count total number of records where FAOBJ='Fatigue' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once,
3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) | ||
| PARAMCD = "MYALGDUR" | Number of Days for Myalgia | integer | 2 | Derived 1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='MYALGIA'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once,
2. Use FAAE data, count total number of records where FAOBJ='Myalgia' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once,
3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) | ||
| PARAMCD = "ARTHRDUR" | Number of Days for Arthralgia | integer | 2 | Derived 1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='ARTHRALG'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once.
2. Use FAAE data, count total number of records where FAOBJ='Arthralgia' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once.
3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) . | ||
| PARAMCD = "NAUSEDUR" | Number of Days for Nausea | integer | 1 | Derived 1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='NAUSEA'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once,
2. Use FAAE data, count total number of records where FAOBJ='Nausea/Vomiting' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once,
3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) | ||
| PARAMCD = "CHILLDUR" | Number of Days for Chills | integer | 1 | Derived 1.Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='CHILLS'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once.
2. Use FAAE data, count total number of records where FAOBJ='Chills' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once.
3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) . | ||
| PARAMCD = "FEVERDUR" | Number of Days for Fever | integer | 1 | Derived 1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='FEVER'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once,
2. Use VS/FAAE data, count total number of records where (VSTESTCD='TEMP' and VSSTRESN>=38.0°C) or (FAAE.FAOBJ='Fever' and FASTRESC contains GRADE 1, GRADE 2, GRADE 3 or GRADE 4) per subject per vaccination (VSTPTREF/FATPTREF). If there are more than one record within same day (VSTPT/FATPT), subject and vaccination (VSTPTREF/FATPTREF), only count once,
3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/VSTPTREF/FATPTREF) | ||
| PARAMCD = "HPRASDUR" | Number of Days for Rash by Health Provider | integer | 1 | Derived Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD=' RASH'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once | ||
| PARAMCD = "HPLYMDUR" | Number of Days for Lymphadenopathy by Health Provider | integer | 2 | Derived Use ADAR data, count total number of records with AVALC='Y' per subject per vaccination (ATPTREF) where ADAR.PARAMCD='LYMPHOCC'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once | ||
| PARAMCD = "ANYDUR" | Number of Days for Any Solicited AR | integer | 2 | Derived 1) Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD is not 'RASH', 'LYMPHOCC' ,''RASHOCC' or AVALC is Y where PARAMCD is 'RASHOCC'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once.
2) Use FAAE/VS data, count total number of records where (FAOBJ is ('Erythema', 'Swelling') and FATEST='Longest Diameter' and FASTRESN>=25 mm) or (FAOBJ is ('Erythema', 'Swelling') and FATEST contains 'Intensity' and FASTRESC contains GRADE 1, GRADE 2 or GRADE 3 or GRADE 4) or (FAAE.FAOBJ='Fever' and FASTRESC contains GRADE 1, GRADE 2, GRADE 3 or GRADE 4) or (for other FAOBJ and FASTRESC is not 'NONE', 'N' or missing) or (VSTESTCD='TEMP' and VSSTRESN>=38.0°C) per subject per vaccination (FATPTREF/VSTPTREF). If there are more than one record within same day (FATPT/VSTPT), subject and vaccination (FATPTREF/VSTPTREF), only count once.
3) sum of 1) and 2) by vaccination | ||
| PARAMCD = "LOCDUR" | Number of Days for Local Solicited AR | integer | 2 | Derived 1) Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARCAT1 is 'LOCAL'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once,
2) Use FAAE data, count total number of records where (FAOBJ is ('Erythema', 'Swelling') and FATEST='Longest Diameter' and FASTRESN>=25 mm) or (FAOBJ is ('Erythema', 'Swelling') and FATEST contains 'Intensity' and FASTRESC contains GRADE 1, GRADE 2 or GRADE 3 or GRADE 4) or (FAOBJ is ('Pain', 'Underarm Gland Swelling or Tenderness') and FASTRESC is not 'NONE' or missing) per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once,
3) sum of 1) and 2) by vaccination | ||
| PARAMCD = "SYSDUR" | Number of Days for Systemic Solicited AR | integer | 2 | Derived Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARCAT1 is 'SYSTEMIC' and ADAR.PARAMCD is not 'RASH', 'LYMPHOCC' ,''RASHOCC' or AVALC is Y where PARAMCD is 'RASHOCC'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once,
2) Use FAAE/VS data, count total number of records where (FASCAT='SYSTEMIC' and FASTRESC is not 'NONE', 'N' or missing) or (VSTESTCD='TEMP' and VSSTRESN>=38.0°C) per subject per vaccination (FATPTREF/VSTPTREF). If there are more than one record within same day (FATPT/VSTPT), subject and vaccination (FATPTREF/VSTPTREF), only count once,
3) sum of 1) and 2) by vaccination | ||
| AVALCVLM | Analysis Value (C) | text | 100 | |||
| PARAMCD IN ( "RASHOCYN", "LYMOCCYN" ) | text | 1 | Derived Per subject per vaccination (ATPTREF):
Set to the maximum non-missing AVALC (Y>N) where PARAMCD is 'LYMPHOCC', 'RASHOCC' | |||
| PARAMCD IN ( "WRASH", "WLYMPH", "WPAIN", "WERYTH", "WSWELL", "WHEAD", "WFATIGUE", "WMYALGIA", "WARTHR", "WNAUSEA", "WCHILLS", "WFEVER" ) | text | 94 | Derived Set to AVALC of the record used to derive ATOXGR. Use the highest AVALC if multiple records | |||
| ATOXGRVLM | Analysis Toxicity Grade | text | 20 | Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007) | ||
| PARAMCD = "WRASH" | Worst Analysis Toxicity Grade for Rash between Day 1 and Day 7 | text | 10 | Derived Per subject per vaccination (ATPTREF):
Set to the highest ATOXGR where ADAR.PARAMCD='RASH' | ||
| PARAMCD = "WLYMPH" | Worst Analysis Toxicity Grade for Lymphadenopathy between Day 1 and Day 7 | text | 10 | Derived Per subject per vaccination (ATPTREF):
Set to the highest ATOXGR where ADAR.PARAMCD='LYMPH' | ||
| PARAMCD = "WPAIN" | Worst Analysis Toxicity Grade for Pain between Day 1 and Day 7 | text | 10 | Derived Per subject per vaccination (ATPTREF):
Set to the highest ATOXGR where ADAR.PARAMCD='PAIN' | ||
| PARAMCD = "WERYTH" | Worst Analysis Toxicity Grade for Erythema between Day 1 and Day 7 | text | 10 | Derived Per subject per vaccination (ATPTREF):
Set to the highest ATOXGR where ADAR.PARAMCD='ERYTHDIA' | ||
| PARAMCD = "WSWELL" | Worst Analysis Toxicity Grade for Swelling between Day 1 and Day 7 | text | 10 | Derived Per subject per vaccination (ATPTREF):
Set to the highest ATOXGR where ADAR.PARAMCD='SWELLDIA' | ||
| PARAMCD = "WHEAD" | Worst Analysis Toxicity Grade for Headache between Day 1 and Day 7 | text | 10 | Derived Per subject per vaccination (ATPTREF):
Set to the highest ATOXGR where ADAR.PARAMCD='HEADACHE' | ||
| PARAMCD = "WFATIGUE" | Worst Analysis Toxicity Grade for Fatigue between Day 1 and Day 7 | text | 10 | Derived Per subject per vaccination (ATPTREF):
Set to the highest ATOXGR where ADAR.PARAMCD='FATIGUE' | ||
| PARAMCD = "WMYALGIA" | Worst Analysis Toxicity Grade for Myalgia between Day 1 and Day 7 | text | 10 | Derived Per subject per vaccination (ATPTREF):
Set to the highest ATOXGR where ADAR.PARAMCD='MYALGIA' | ||
| PARAMCD = "WARTHR" | Worst Analysis Toxicity Grade for Arthralgia between Day 1 and Day 7 | text | 10 | Derived Per subject per vaccination (ATPTREF):
Set to the highest ATOXGR where ADAR.PARAMCD='ARTHRALG' | ||
| PARAMCD = "WNAUSEA" | Worst Analysis Toxicity Grade for Nausea between Day 1 and Day 7 | text | 10 | Derived Per subject per vaccination (ATPTREF):
Set to the highest ATOXGR where ADAR.PARAMCD='NAUSEA' | ||
| PARAMCD = "WCHILLS" | Worst Analysis Toxicity Grade for Chills between Day 1 and Day 7 | text | 10 | Derived Per subject per vaccination (ATPTREF):
Set to the highest ATOXGR where ADAR.PARAMCD='CHILLS' | ||
| PARAMCD = "WFEVER" | Worst Analysis Toxicity Grade for Fever between Day 1 and Day 7 | text | 10 | Derived Per subject per vaccination (ATPTREF):
Set to the highest ATOXGR where ADAR.PARAMCD='FEVER' | ||
| PARAMCD = "WSAR" | Worst Analysis Toxicity Grade for Any Solicited AR between Day 1 and Day 7 | text | 10 | Derived Per subject per vaccination (ATPTREF):
Set to the highest ATOXGR where ADAR.PARAMCD is not 'RASH', 'LYMPHOCC', 'RASHOCC' | ||
| PARAMCD = "WSLAR" | Worst Analysis Toxicity Grade for Any Solicited Local AR between Day 1 and Day 7 | text | 10 | Derived Per subject per vaccination (ATPTREF):
Set to the highest ATOXGR where ADAR.PARCAT1 is 'LOCAL' | ||
| PARAMCD = "WSSAR" | Worst Analysis Toxicity Grade for Any Solicited Systemic AR between Day 1 and Day 7 | text | 10 | Derived Per subject per vaccination (ATPTREF):
Set to the highest ATOXGR where ADAR.PARCAT1 is 'SYSTEMIC' and ADAR.PARAMCD is not 'RASH', 'LYMPHOCC' ,''RASHOCC' | ||
| ATOXGRN | Analysis Toxicity Grade (N) | integer | 8 | Analysis Toxicity Grade
| Assigned | |
| SRCDOM | Source Data | text | 4 | Derived Set to 'ADAR' if PARAMCD does not contain 'DUR' | ||
| SRCSEQ | Source Sequence Number | integer | 8 | Derived Set to ADAR.ASEQ based on ATOXGR/AVALC derivation for PARAMCD does not contain 'DUR' and set to the smallest one if multiple records | ||
| SRCVAR | Source Variable | text | 8 | Derived Set to 'ATOXGR' if PARAM contains 'Worst'; Set to 'AVALC' if PARAMCD is 'RASHOCYN', 'LYMOCCYN' |
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COVID-19 Analysis Dataset (ADCOV)
| Variable | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 14 | Study Identifier
| Predecessor: ADSL.STUDYID |
| USUBJID | Unique Subject Identifier | text | 25 | Predecessor: ADSL.USUBJID | |
| SUBJID | Subject Identifier for the Study | text | 9 | Predecessor: ADSL.SUBJID | |
| SITEID | Study Site Identifier | text | 5 | Predecessor: ADSL.SITEID | |
| COUNTRY | Country | text | 3 | Country
| Predecessor: ADSL.COUNTRY |
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | |
| AGEU | Age Units | text | 5 | Predecessor: ADSL.AGEU | |
| AGEGR1 | Pooled Age Group 1 | text | 30 | Pooled Age Group 1
| Predecessor: ADSL.AGEGR1 |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Predecessor: ADSL.AGEGR1N | |
| AGEGR2 | Pooled Age Group 2 | text | 19 | Pooled Age Group 2
| Predecessor: ADSL.AGEGR2 |
| AGEGR2N | Pooled Age Group 2 (N) | integer | 8 | Predecessor: ADSL.AGEGR2N | |
| SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX |
| RACE | Race | text | 41 | Race [8 Terms] | Predecessor: ADSL.RACE |
| RACESPY | Race Specify | text | 200 | Predecessor: ADSL.RACESPY | |
| ETHNIC | Ethnicity | text | 22 | Ethnicity
| Predecessor: ADSL.ETHNIC |
| RANDFL | Randomized Population Flag | text | 1 | No Yes Response (Yes Only)
| Predecessor: ADSL.RANDFL |
| SAFFL | Safety Population Flag | text | 1 | No Yes Response (Yes Only)
| Predecessor: ADSL.SAFFL |
| FASBABFL | Full Analysis Set bAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASBABFL |
| FASNABFL | Full Analysis Set nAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASNABFL |
| PPBABFL | Per Protocol bAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBABFL |
| PPNABFL | Per Protocol nAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPNABFL |
| PPBD29FL | Per Protocol bAb Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBD29FL |
| PPBD57FL | Per Protocol bAb Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBD57FL |
| PBD209FL | Per Protocol bAb Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PBD209FL |
| PPND29FL | Per Protocol nAb Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPND29FL |
| PPND57FL | Per Protocol nAb Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPND57FL |
| PND209FL | Per Protocol nAb Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PND209FL |
| SAR1FL | First Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAR1FL |
| SAR2FL | Second Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAR2FL |
| SARAFL | Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SARAFL |
| FASNA2FL | FAS nAb 2 Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASNA2FL |
| PPNAB2FL | PP nAb 2 Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPNAB2FL |
| PN2D29FL | Per Protocol nAb 2 Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2D29FL |
| PN2D57FL | Per Protocol nAb 2 Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2D57FL |
| PN2209FL | Per Protocol nAb 2 Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2209FL |
| DVBABFL | Deviation Impact bAb Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DVBABFL |
| DVNABFL | Deviation Impact nAb Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DVNABFL |
| DOSE1FL | Vaccination 1 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSE1FL |
| DOSE2FL | Vaccination 2 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSE2FL |
| DOSEROFL | Dosing Error Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSEROFL |
| COV19BL | Baseline COVID Infection | text | 20 | Baseline COVID Infection
| Predecessor: ADSL.COV19BL |
| ELECSBL | Baseline Elecsys SARS CoV-2 Assay | text | 20 | Predecessor: ADSL.ELECSBL | |
| COV19FL | COVID Infection Flag | text | 1 | No Yes Response
| Predecessor: ADSL.COV19FL |
| SENTLFL | Sentinel Participant Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SENTLFL |
| D29W7DFL | Day 29 Out of 7-Day Window Flag | text | 1 | No Yes Response
| Predecessor: ADSL.D29W7DFL |
| TRT01P | Planned Treatment for Period 01 | text | 25 | Planned Treatment for Period 01
| Predecessor: ADSL.TRT01P |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01PN | |
| TRT01A | Actual Treatment for Period 01 | text | 25 | Actual Treatment for Period 01
| Predecessor: ADSL.TRT01A |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01AN | |
| TR01SDT | Date of First Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01SDT | |
| TR01SDTM | Datetime of First Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01SDTM | |
| TR01EDT | Date of Last Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01EDT | |
| TR01EDTM | Datetime of Last Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01EDTM | |
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTSDTM | |
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTEDTM | |
| DOSE2DT | Date of Dose 2 | integer | DATE9 | Predecessor: ADSL.DOSE2DT | |
| DOS2DTM | Datetime of Dose 2 | integer | DATETIME20 | Predecessor: ADSL.DOS2DTM | |
| ADT | Analysis Date | integer | DATE9 | Derived Set to numeric date part of FAOT.FADTC if source data are from FAOT,
Set to number date part of ER.ERDTC if source data are from ER,
Set to number date part of SS.SSDTC if source data are from SS | |
| ADY | Analysis Relative Day | integer | 8 | Derived Set to ADT - ADSL.TR01SDT + 1 if ADT >= ADSL.TR01SDT, or
Set to ADT - ADSL.TR01SDT if ADT < ADSL.TR01SDT | |
| VISIT | Visit Name | text | 28 | Predecessor: FAOT.VISIT, ER.VISIT, SS.VISIT | |
| VISITNUM | Visit Number | float | 8 | Predecessor: FAOT.VISITNUM, ER.VISITNUM, SS.VISITNUM | |
| AVISIT | Analysis Visit | text | 50 | Derived Set to 'Day xx' part of VISIT if VISIT doesn't contain 'Unsched',
Set AVISIT by following visit window below if ADY>1 and VISIT contains 'Unsched':
Set to 'Day 8' if VISIT with 1<ADY<=11,
Set to 'Day 15' if VISIT with 12<=ADY<=22,
Set to 'Day 29' if VISIT with 23<=ADY<=32,
Set to 'Day 36' if VISIT with 33<=ADY<=39,
Set to 'Day 43' if VISIT with 40<=ADY<=50 ,
Set to 'Day 57' if VISIT with 51<=ADY<=133,
Set to 'Day 209' if VISIT with 134=<ADY<=301,
Set to 'Day 394' if VISIT with ADY>=302,
After the steps above, sort data by AVISITN and ADY, set the unscheduled visit (i.e., VISIT contains 'Unsched') records to blank if AVISITN >any previous AVISITN AND ADY<=any previous ADY). For example, Scheduled Day 36 is with AVISITN=6 (Day 36) and ADY=42 and an unscheduled visit is with AVISITN=7 (Day 43) and ADY=40, set AVISIT to blank for this unscheduled visit | |
| AVISITN | Analysis Visit (N) | integer | 8 | Analysis Visit Code [10 Terms] | Assigned |
| PARCAT1 | Parameter Category 1 | text | 50 | COVID-19 Parameter Category
| Derived Set to FAOT.FACAT if source data are from FAOT
Set to ER.ERCAT if source data are from ER
For data from SS, set to 'COVID-19 SYMPTOMS' if SSTESTCD='COVIDSYM' and 'COVID-19 EXPOSURE' if SSTESTCD='COVID' |
| PARAMCD | Parameter Code | text | 8 | COVID-19 Analysis Dataset Parameter Code [24 Terms] | Assigned |
| PARAM | Parameter | text | 200 | Derived Set to FAOT.FAOBJ if PARCAT1 = 'COVID-19 SYMPTOMS'
Note:
If there are multiple records where PARAM='Other Symptoms', only keep one, and set FASEQ to the earliest FAOT.FASEQ.
Set to ER.ERTERM if PARCAT1 = 'COVID-19 EXPOSURE'
Create following PARAM based on different source:
Set to PARAM='Duration' if ERDUR is not missing per subject per ERDTC for data is from SDTM.ER
Set to SSTEST per subject per visit for data is from SS | |
| AVAL | Analysis Value | integer | 8 | Derived Set to numeric part of ER.ERDUR | |
| AVALC | Analysis Value (C) | text | 50 | Derived Set to FAOT.FASTRESC if source data are from FAOT
Set to ER.EROCCUR if source data are from ER
Set to SS.SSSTRESC if source data are from SS
Set to numeric part of ER.ERDUR if PARAMCD=DUR and convert to character | |
| T2FSYMP | Time from Last Exposure to First Symptom | integer | 8 | Derived Set to ADT- (last EXPOSEDT on and prior to SYMPTDTC) + 1 per subject, find the first symptom date (SYMPTDTC where PARAMCD='COVID' and AVALC='Y') and the last EXPOSEDT on and prior to first symptom | |
| AWRANGE | Analysis Window Valid Relative Range | text | 50 | Assigned Set to '<=1' for 'Day 1', Set to 'Day 2 - Day 11' for 'Day 8', Set to 'Day 12 - Day 22' for 'Day 15', Set to 'Day 23 - Day 32' for 'Day 29', Set to 'Day 33 - Day 39' for 'Day 36', Set to 'Day 40 - Day 50' for 'Day 43', Set to 'Day 51 - Day 133' for 'Day 57' Set to 'Day 134 - Day 301' for 'Day 209', Set to '>=Day 301' for Day 394' | |
| AWTARGET | Analysis Window Target | integer | 8 | Assigned Set to 2 for 'Day 1' Set to 8 for ‘Day 8’, Set to 15 for 'Day 15', Set to 29 for 'Day 29', Set to 36 for 'Day 36', Set to 43 for 'Day 43', Set to 57 for 'Day 57', Set to 209 for 'Day 209', Set to 394 for 'Day 394' | |
| AWTDIFF | Analysis Window Diff from Target | integer | 8 | Derived Set to absolute value of (ADY - AWTARGET) | |
| ANL01FL | Analysis Flag 01 | text | 1 | No Yes Response (Yes Only)
| Derived Per subject per parameter and per AVISIT:
Set to 'Y' for the worst assessment (AVALC='Y' > 'N') within the same visit to be considered first,
Set 'Y' to the assessment at scheduled visit (i.e., VISIT doesn't contain 'Unshed') if there are multiple with same AVALC,
Set to the last assessment if there are 2 or more scheduled assessments at same visit |
| SYMPTDT | Estimated date of first symptoms | integer | DATE9 | Derived Set numeric of SUPPFAOT.QVAL for date part where PARAMCD='COVID' and AVALC='Y' and QNAM = 'SYMPTDTC' | |
| EXPOSEDT | Estimated start date of exposure | integer | DATE9 | Derived Set numeric of date part from ER.ERSTDTC for records where PARAMCD='CONTACT' and AVALC='Y' | |
| OTHSPY | Symptoms other | text | 200 | Derived Concatenate all the SUPPFAOT.QVAL where QNAM='SYMPOTH' with ', ' if PARAMCD = 'OTHSYMPT' and AVALC = 'Y' for that subject and visit
Set to SUPPER.QVAL where QNAM = 'EXPOSEOT' if PARAMCD = 'EXPOTH' and AVALC='Y' | |
| SRCDOM | Source Data | text | 20 | Derived Set FAOT.DOMAIN if source data are from FAOT,
Set to ER.DOMAIN if source data are from ER,
Set to SS.DOMAIN if source data are from SS | |
| SRCSEQ | Source Sequence Number | integer | 8 | Derived Set to FAOT.FASEQ if source data are from FAOT,
Set to ER.ERSEQ if source data are from ER,
Set to SS.SSEQ if source data are from SS | |
| SRCVAR | Source Variable | text | 50 | Derived Set to 'FASTRESC' if source data are from FAOT,
Set to 'EROCCUR' if source data are from ER and PARAMCD is not 'DUR',
Set to 'ERDUR' if source data are from ER and PARAMCD is 'DUR',
Set to 'SSSTRESC' if source data are from SS |
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Immunogenicity Analysis Dataset (ADIS)
| Variable | Where Condition | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 14 | Study Identifier
| Predecessor: ADSL.STUDYID | |
| USUBJID | Unique Subject Identifier | text | 25 | Predecessor: ADSL.USUBJID | ||
| SUBJID | Subject Identifier for the Study | text | 9 | Predecessor: ADSL.SUBJID | ||
| SITEID | Study Site Identifier | text | 5 | Predecessor: ADSL.SITEID | ||
| COUNTRY | Country | text | 3 | Country
| Predecessor: ADSL.COUNTRY | |
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | ||
| AGEU | Age Units | text | 5 | Predecessor: ADSL.AGEU | ||
| AGEGR1 | Pooled Age Group 1 | text | 30 | Pooled Age Group 1
| Predecessor: ADSL.AGEGR1 | |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Predecessor: ADSL.AGEGR1N | ||
| AGEGR2 | Pooled Age Group 2 | text | 19 | Pooled Age Group 2
| Predecessor: ADSL.AGEGR2 | |
| AGEGR2N | Pooled Age Group 2 (N) | integer | 8 | Predecessor: ADSL.AGEGR2N | ||
| SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX | |
| RACE | Race | text | 41 | Race [8 Terms] | Predecessor: ADSL.RACE | |
| RACESPY | Race Specify | text | 200 | Predecessor: ADSL.RACESPY | ||
| ETHNIC | Ethnicity | text | 22 | Ethnicity
| Predecessor: ADSL.ETHNIC | |
| RANDFL | Randomized Population Flag | text | 1 | No Yes Response (Yes Only)
| Predecessor: ADSL.RANDFL | |
| SAFFL | Safety Population Flag | text | 1 | No Yes Response (Yes Only)
| Predecessor: ADSL.SAFFL | |
| FASBABFL | Full Analysis Set bAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASBABFL | |
| FASNABFL | Full Analysis Set nAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASNABFL | |
| PPBABFL | Per Protocol bAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBABFL | |
| PPNABFL | Per Protocol nAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPNABFL | |
| PPBD29FL | Per Protocol bAb Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBD29FL | |
| PPBD57FL | Per Protocol bAb Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBD57FL | |
| PBD209FL | Per Protocol bAb Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PBD209FL | |
| PPND29FL | Per Protocol nAb Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPND29FL | |
| PPND57FL | Per Protocol nAb Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPND57FL | |
| PND209FL | Per Protocol nAb Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PND209FL | |
| SAR1FL | First Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAR1FL | |
| SAR2FL | Second Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAR2FL | |
| SARAFL | Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SARAFL | |
| FASNA2FL | FAS nAb 2 Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASNA2FL | |
| PPNAB2FL | PP nAb 2 Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPNAB2FL | |
| PN2D29FL | Per Protocol nAb 2 Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2D29FL | |
| PN2D57FL | Per Protocol nAb 2 Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2D57FL | |
| PN2209FL | Per Protocol nAb 2 Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2209FL | |
| DVBABFL | Deviation Impact bAb Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DVBABFL | |
| DVNABFL | Deviation Impact nAb Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DVNABFL | |
| DOSE1FL | Vaccination 1 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSE1FL | |
| DOSE2FL | Vaccination 2 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSE2FL | |
| DOSEROFL | Dosing Error Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSEROFL | |
| COV19BL | Baseline COVID Infection | text | 20 | Baseline COVID Infection
| Predecessor: ADSL.COV19BL | |
| ELECSBL | Baseline Elecsys SARS CoV-2 Assay | text | 20 | Predecessor: ADSL.ELECSBL | ||
| COV19FL | COVID Infection Flag | text | 1 | No Yes Response
| Predecessor: ADSL.COV19FL | |
| SENTLFL | Sentinel Participant Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SENTLFL | |
| D29W7DFL | Day 29 Out of 7-Day Window Flag | text | 1 | No Yes Response
| Predecessor: ADSL.D29W7DFL | |
| TRT01P | Planned Treatment for Period 01 | text | 25 | Planned Treatment for Period 01
| Predecessor: ADSL.TRT01P | |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01PN | ||
| TRT01A | Actual Treatment for Period 01 | text | 25 | Actual Treatment for Period 01
| Predecessor: ADSL.TRT01A | |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01AN | ||
| TR01SDT | Date of First Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01SDT | ||
| TR01SDTM | Datetime of First Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01SDTM | ||
| TR01EDT | Date of Last Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01EDT | ||
| TR01EDTM | Datetime of Last Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01EDTM | ||
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTSDTM | ||
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTEDTM | ||
| DOSE2DT | Date of Dose 2 | integer | DATE9 | Predecessor: ADSL.DOSE2DT | ||
| DOS2DTM | Datetime of Dose 2 | integer | DATETIME20 | Predecessor: ADSL.DOS2DTM | ||
| TRTA | Actual Treatment | text | 50 | Actual Treatment
| Derived Select the last dose record in SDTM.EX before event or assessment Date Time :
Set to 'Placebo' if EX.EXTRT='PLACEBO'
For EX.EXTRT = 'mRNA-1273' :
Set to 'mRNA-1273 50 ug if 0 < EXDOSE <= 75 or EXDOSTXT contains '>0-25', '>25-<50' or '>50-75' ,
Set to 'mRNA-1273 100 ug' if EXDOSE>75 or EXDOSTXT contains '>75-<100' or '>100-125' or '>125'
Note:
Use date only respectively if time part of event or assessment is missing | |
| TRTAN | Actual Treatment (N) | integer | 8 | Assigned 1 if TRT01A=‘Placebo’, 2 if TRT01A=‘mRNA-1273 50 ug’, 3 if TRT01A=‘mRNA-1273 100 ug’" | ||
| ADT | Analysis Date | integer | DATE9 | Derived Set to numeric date part of IS.ISDTC | ||
| ATM | Analysis Time | integer | TIME5 | Derived Set time part of IS.ISDTC | ||
| ADTM | Analysis Datetime | integer | DATETIME20 | Derived Concatenate of ADT and ATM if both are available | ||
| ADY | Analysis Relative Day | integer | 8 | Derived Set to ADT - ADSL.TR01SDT + 1 if ADT >= ADSL.TR01SDT, or
Set to ADT - ADSL.TR01SDT if ADT < ADSL.TR01SDT | ||
| VISIT | Visit Name | text | 28 | Predecessor: IS.VISIT | ||
| VISITNUM | Visit Number | float | 8 | Predecessor: IS.VISITNUM | ||
| AVISIT | Analysis Visit | text | 50 | Derived Set to 'Baseline' if IABLFL='Y'
Set to 'Day xx' part of VISIT if ADY > 1 and VISIT doesn't contain "UNSCHEDULE",
Set AVISIT as follows: using the visit window below if ADY>1 and VISIT contains "UNSCHED":
Set to 'Day 15' if VISIT with 1<ADY<=22,
Set to 'Day 29' if VISIT with 23<=ADY<=36,
Set to 'Day 43' if VISIT with 37<=ADY<=50,
Set to 'Day 57' if VISIT with 51<=ADY<=133,
Set to 'Day 209' if VISIT with 134=<ADY<=301
Set to 'Day 394' if VISIT with ADY>=302 | ||
| AVISITN | Analysis Visit (N) | integer | 8 | Analysis Visit Code [10 Terms] | Assigned | |
| PARCAT1 | Parameter Category 1 | text | 50 | Immunogenicity Parameter Category
| Derived Set to IS.ISCAT | |
| PARAMTYP | Parameter Type | text | 7 | Derived Set to 'DERIVED' if PARAMCD contains 'L10' or 'LV58' | ||
| PARAMCD | Parameter Code | text | 8 | Immunogenicity Analysis Dataset Parameter Code [13 Terms] | Assigned | |
| PARAM | Parameter | text | 50 | Derived Set to 'Elecsys Anti-SARS-CoV-2' if PARAMCD = 'SARSCOV2'
Set to ISTEST if PARCAT1='Serum SARS-CoV-2 Neutralizing Antibodies' and PARAMTYP is null,
Set to ISTEST ' (' || ISSTRESU || ')' * if PARCAT1='Serum SARS-CoV-2 Binding Antibodies' and PARAMTYP is null,
* Use the same PARAMCD with available unit if ISSTRESU is non-missing or ISSTRESU is not available for the test.
PARAMTYP is "Derived then assign PARAM based on PARAMCD:
Set to 'LOG10(MN Endpoint Titer)' if PARAMCD='L10MNET',
Set to 'LOG10(MN50)' if PARAMCD='L10MN50',
Set to 'LOG10(VAC58 Spike IgG Antibody)' if PARAMCD='LV58IGGS',
Set to 'LOG10(VAC58 Nucleocapsid IgG Antibody)' if PARAMCD='LV58IGGN',
Set to 'LOG10(VAC65 Spike IgG Antibody)' if PARAMCD='LV65IGGS',
Set to 'LOG10(VAC66 Nucleocapsid IgG Antibody)' if PARAMCD='LV66IGGN' | ||
| AVALVLM | Analysis Value | float | 8 | |||
| PARAMCD IN ( "L10MNET" (LOG10(MN Endpoint Titer)), "L10MN50" (LOG10(MN50)), "LV58IGGS" (LOG10(VAC58 Spike IgG Antibody)), "LV58IGGN" (LOG10(VAC58 Nucleocapsid IgG Antibody)) ) | float | 12 | Derived Set to LOG10(0.5* times ISLLOQ) if ISSTRESC contains '<' or ISSTRESN<ISLLOQ
Set AVAL as LOG10(ULOQ) If ISSTRESC contains '>' or ISSTRESN>ULOQ,
Set to LOG10(IS.ISSTRESN), Otherwise | |||
| PARAMCD IN ( "MNET" (MN Endpoint Titer), "MN50" (MN50), "V58IGGES" (VAC58 Spike IgG Antibody (ug/ml)), "V58IGGEN" (VAC58 Nucleocapsid IgG Antibody (AU/mL)) ) | float | 9 | Derived Set AVAL as 0.5 times ISLLOQ if ISSTRESC contains '<' or ISSTRESN<ISLLOQ,
Set AVAL as ULOQ if ISSTRESC contains '>' or ISSTRESN>ULOQ,
Otherwise set to IS.ISSTRESN | |||
| PARAMCD IN ( "LV65IGGS" (LOG10(VAC65 Spike IgG Antibody)), "LV66IGGN" (LOG10(VAC66 Nucleocapsid IgG Antibody)) ) | float | 12 | Derived Set to LOG10(0.5* times ISLLOQ) if ISSTRESC contains "<" or ISSTRESN<ISLLOQ or contains 'BQL',
Set AVAL as LOG10(ULOQ) if ISSTRESC contains ">" or ISSTRESN>ULOQ,
Set to LOG10(IS.ISSTRESN), Otherwise | |||
| PARAMCD IN ( "V65IGGS" (VAC65 Spike IgG Antibody (AU/mL)), "V66IGGN" (VAC66 Nucleocapsid IgG Antibody (AU/mL)) ) | float | 9 | Derived Set to 0.5 times ISLLOQ if ISSTRESC contains '<' or ISSTRESN<ISLLOQ or contains 'BQL',
Set to ULOQ if ISSTRESC contains '>' or ISSTRESN>ULOQ
Set to IS.ISSTRESN, Otherwise | |||
| AVALC | Analysis Value (C) | text | 10 | Derived Set to IS.ISSTRESC for PARAMCD='SARSCOV2' | ||
| BASE | Baseline Value | float | 8 | Derived Set to AVAL where ABLFL = 'Y' | ||
| CHG | Change from Baseline | float | 8 | Derived Set to AVAL-BASE for post-baseline records | ||
| AWRANGE | Analysis Window Valid Relative Range | text | 20 | Assigned Set to '<=1 Pre-dose' for 'Baseline’, Set to 'Day 2 – Day 22' for 'Day 15', Set to 'Day 23 – Day 36' for 'Day 29', Set to 'Day 37 – Day 50' for 'Day 43', Set to 'Day 51 – Day 133' for 'Day 57' Set to 'Day 134 – Day 301' for 'Day 209' Set to '>=Day 302' for 'Day 394' | ||
| AWTARGET | Analysis Window Target | integer | 8 | Assigned Set to 1 for 'Baseline' Set to 15 for 'Day 15', Set to 29 for 'Day 29', Set to 43 for 'Day 43', Set to 57 for 'Day 57', Set to 209 for 'Day 209', Set to 394 for 'Day 394' | ||
| AWTDIFF | Analysis Window Diff from Target | integer | 8 | Derived Set to absolute value of (ADY - AWTARGET) | ||
| R2BASE | Ratio to Baseline | float | 8 | Derived Set to AVAL/BASE if both are available and BASE is not 0 | ||
| CRIT1 | Analysis Criterion 1 | text | 100 | Derived Set to '>=2-fold Increase from Baseline' if CRIT1FL = 'Y' | ||
| CRIT1FLVLM | Criterion 1 Evaluation Result Flag | text | 1 | No Yes Response (Yes Only)
| ||
| PARAMCD NOT IN ( "MNET" (MN Endpoint Titer), "MN50" (MN50), "V65IGGS" (VAC65 Spike IgG Antibody (AU/mL)), "V66IGGN" (VAC66 Nucleocapsid IgG Antibody (AU/mL)) ) | text | 1 | Derived Set to bank if PARAMCD not in (MNET, MN50, V65IGGS, V66IGGN) | |||
| PARAMCD IN ( "MNET" (MN Endpoint Titer), "MN50" (MN50) ) | text | 1 | Derived Set to 'Y' if PARAMCD in (MNET, MN50) and post-baseline increase 2 times from the baseline value (R2BASE>=2) | |||
| PARAMCD IN ( "V65ISSG", "V66IGGN" (VAC66 Nucleocapsid IgG Antibody (AU/mL)) ) | text | 1 | Derived Derive when both baseline result (BASE>.) and post-baseline result (AVAL) are non-missing and PARAMCD in (V65IGGS, V66IGGN):
Set to 'Y' if baseline result (BASE)<ISLLOQ and post-baseline >= 2* LLOQ (AVAL>=2*ISLLOQ) or baseline result (BASE) >= ISLLOQ and post-baseline increase 2 times from the baseline value (R2BASE>=2) | |||
| CRIT2 | Analysis Criterion 2 | text | 100 | Derived Set to '>=3-fold Increase from Baseline' if CRIT2FL = 'Y' | ||
| CRIT2FLVLM | Criterion 2 Evaluation Result Flag | text | 1 | No Yes Response (Yes Only)
| ||
| PARAMCD NOT IN ( "MNET" (MN Endpoint Titer), "MN50" (MN50), "V65IGGS" (VAC65 Spike IgG Antibody (AU/mL)), "V66IGGN" (VAC66 Nucleocapsid IgG Antibody (AU/mL)) ) | text | 1 | Derived Set to bank if PARAMCD not in (MNET, MN50, V65IGGS, V66IGGN) | |||
| PARAMCD IN ( "MNET" (MN Endpoint Titer), "MN50" (MN50) ) | text | 1 | Derived Set to 'Y' if PARAMCD in (MNET, MN50) and post-baseline increase 3 times from the baseline value (R2BASE>=3) | |||
| PARAMCD IN ( "V65ISSG", "V66IGGN" (VAC66 Nucleocapsid IgG Antibody (AU/mL)) ) | text | 1 | Derived Derive when both baseline result (BASE>.) and post-baseline result (AVAL) are non-missing and PARAMCD in (V65IGGS, V66IGGN):
Set to 'Y' if baseline result (BASE)<ISLLOQ and post-baseline >= 3* LLOQ (AVAL>=3*ISLLOQ) or baseline result (BASE) >= ISLLOQ and post-baseline increase 2 times from the baseline value (R2BASE>=3) | |||
| CRIT3 | Analysis Criterion 3 | text | 100 | Derived Set to '>=4-fold Increase from Baseline' if CRIT3FL = 'Y' | ||
| CRIT3FLVLM | Criterion 3 Evaluation Result Flag | text | 1 | No Yes Response (Yes Only)
| ||
| PARAMCD NOT IN ( "MNET" (MN Endpoint Titer), "MN50" (MN50), "V65IGGS" (VAC65 Spike IgG Antibody (AU/mL)), "V66IGGN" (VAC66 Nucleocapsid IgG Antibody (AU/mL)) ) | text | 1 | Derived Set to bank if PARAMCD not in (MNET, MN50, V65IGGS, V66IGGN) | |||
| PARAMCD IN ( "MNET" (MN Endpoint Titer), "MN50" (MN50) ) | text | 1 | Derived Set to 'Y' if PARAMCD in (MNET, MN50) and post-baseline increase 3 times from the baseline value (R2BASE>=4) | |||
| PARAMCD IN ( "V65ISSG", "V66IGGN" (VAC66 Nucleocapsid IgG Antibody (AU/mL)) ) | text | 1 | Derived Derive when both baseline result (BASE>.) and post-baseline result (AVAL) are non-missing and PARAMCD in (V65IGGS, V66IGGN):
Set to 'Y' if baseline result (BASE)<ISLLOQ and post-baseline >= 4* LLOQ (AVAL>=4*ISLLOQ) or baseline result (BASE) >= ISLLOQ and post-baseline increase 4 times from the baseline value (R2BASE>=4) | |||
| CRIT4 | Analysis Criterion 4 | text | 100 | Derived Set to 'Seroconversion' if CRIT4FL = 'Y' | ||
| CRIT4FLVLM | Criterion 4 Evaluation Result Flag | text | 1 | No Yes Response (Yes Only)
| ||
| PARAMCD NOT IN ( "MNET" (MN Endpoint Titer), "MN50" (MN50), "V65IGGS" (VAC65 Spike IgG Antibody (AU/mL)) ) | text | 1 | Derived Set to bank if PARAMCD not in (MNET, MN50, V65IGGS) | |||
| PARAMCD IN ( "MNET" (MN Endpoint Titer), "MN50" (MN50), "V65IGGS" (VAC65 Spike IgG Antibody (AU/mL)) ) | text | 1 | Derived Derive when both baseline result (BASE) and post-baseline result (AVAL) are non-missing and PARAMCD in (MNET, MN50, V65IGGS):
Set to 'Y' if baseline result BASE<ISLLOQ and post-baseline >= LLOQ (AVAL>=ISLLOQ) or baseline result BASE>= ISLLOQ and post-baseline increase 4 times from the baseline value (R2BASE>=4) | |||
| CRIT5 | Analysis Criterion 5 | text | 100 | Derived Set to 'Seroresponse' if CRIT5FL = 'Y' | ||
| CRIT5FLVLM | Criterion 5 Evaluation Result Flag | text | 1 | No Yes Response (Yes Only)
| ||
| PARAMCD NOT IN ( "V65IGGS" (VAC65 Spike IgG Antibody (AU/mL)) ) | text | 1 | Derived Set to blank if PARAMCD <> 'V65IGGS' | |||
| PARAMCD = "(V65IGGS)" | text | 1 | Derived Derive when PARAMCD ='V65IGGS' and both baseline result (BASE>.) and post-baseline result (AVAL) are non-missing:
Set to 'Y' if baseline result BASE<ISLLOQ and post-baseline >= LLOQ (AVAL>=ISLLOQ) or baseline result BASE>=ISLLOQ and post-baseline increase 4.6 times from the baseline value (R2BASE>=4.6) | |||
| CRIT6 | Analysis Criterion 6 | text | 100 | Derived Set to 'Seroconversion due to Infection' if CRIT6FL= 'Y' | ||
| CRIT6FLVLM | Criterion 6 Evaluation Result Flag | text | 1 | No Yes Response (Yes Only)
| ||
| PARAMCD NOT IN ( "V66IGGN" (VAC66 Nucleocapsid IgG Antibody (AU/mL)), "SARSCOV2" (Elecsys Anti-SARS-CoV-2) ) | text | 1 | Derived Set to blank if PARAMCD not in ('SARSCOV2', 'V65IGGS') | |||
| PARAMCD IN ( "V66IGGN" (VAC66 Nucleocapsid IgG Antibody (AU/mL)), "SARSCOV2" (Elecsys Anti-SARS-CoV-2) ) | text | 1 | Derived Derive when both ADSL.ELECSBL and post-baseline result (AVAL where PARAMCD=V66IGGN or AVALC where PARAMCD=SARSCOV2) are non-missing:
Set to 'Y' if PARAMCD='SARSCOV2' and ADSL.ELECSBL= 'Negative' and post-baseline AVALC ='Positive',
Set to 'Y' if PARAMCD='V66IGGN' and ADSL.ELECSBL = 'Positive' and post-baseline result where increase 4 times from the baseline value (R2BASE>=4) | |||
| ABLFL | Baseline Record Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' by selecting the latest ADTM or ADT if time is not available with non-missing AVAL/AVALC on or before ADSL.TR01SDTM (TR01SDT if time part of TR01SDTM is missing) for each SUBJID, PARCAT1 and PARAMCD | |
| ANL01FL | Analysis Flag 01 | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if ABLFL='Y',
For post-baseline assessments where AVISITN is non-missing and result (AVAL) is non-missing, per subject per parameter and per AVISIT,
Within an AVISIT,
Set to ‘Y’ for the assessment at scheduled visit (i.e., VISIT doesn't contain "Unsched") or
Set to ‘Y’ for the latest assessment if there are 2 or more assessments at scheduled visit, or
Set to ‘Y’ for the latest assessment if there is no scheduled visit, or
Set to 'Y' for the assessment closest to the target study day in the visit window or
Set to 'Y' for the latest assessment If there are 2 or more assessments equal distance to the target study day | |
| ANL02FL | Analysis Flag 02 | text | 1 | No Yes Response (Yes Only)
| Derived Same as ANL01FL
For PARCAT1='Serum SARS-CoV-2 Neutralizing Antibodies', only consider results from Set 1 LLOQ/ULOQ (MNET 40 and 1280, MN50 91.1 and 2031.87). | |
| PPBABRFL | Per Protocol bAb Record-Level Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if PP_listing.PVSBABFL='Y' for PARCAT1='Serum SARS-CoV-2 Binding Antibodies' based on subject and visit (ADIS.AVISIT and pp_listing.VISITTPT). | |
| PPNABRFL | Per Protocol nAb Record-Level Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if PP_listing.PVSNABFL='Y' for PARCAT1='Serum SARS-CoV-2 Neutralizing Antibodies' based on subject and visit (ADIS.AVISIT and pp_listing.VISITTPT). | |
| PPBABRER | PP bAb Record-Level Exclusion Reason | text | 200 | Derived Set to PP_list.PBABREAS for PARCAT1='Serum SARS-CoV-2 Binding Antibodies' based on subject and visit (ADIS.AVISIT and pp_list.VISITTPT).
if subject has dosing error (ADSL.PPBABERS contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list if applicable | ||
| PPNABRER | PP nAb Record-Level Exclusion Reason | text | 200 | Derived Set to PP_list.PNABREAS for PARCAT1='Serum SARS-CoV-2 Neutralizing Antibodies' based on subject and visit (ADIS.AVISIT and pp_list.VISITTPT).
if subject has dosing error (ADSL.PPNABERS contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list if applicable | ||
| PPNA2RFL | PP nAb 2 Record-Level Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if ADSL.PPNAB2FL='Y' and PP_list2.PVSNABFL='Y' for PARCAT1='Serum SARS-CoV-2 Neutralizing Antibodies' based on subject and visit (ADIS.AVISIT and pp_list2.VISITTPT). | |
| DTYPE | Derivation Type | text | 20 | Derivation Type
| Derived Set to 'HALFLLOQ' if AVAL is imputed with 0.5 times lSLLOQ,
Set to 'ULOQ' if AVAL is imputed with ULOQ | |
| ISSEQ | Sequence Number | integer | 8 | Predecessor: IS.ISSEQ | ||
| ISDTC | Date/Time of Collection | datetime | ISO 8601 | Predecessor: IS.ISDTC | ||
| ISSTRESC | Result or Finding in Standard Format | text | 7 | Predecessor: IS.ISSTRESC | ||
| LOD | Limit of Detection | float | 8 | Derived SUPPIS.QVAL where QNAM is 'LOD' | ||
| ISLLOQ | Lower Limit of Quantitation | float | 8 | Predecessor: IS.ISLLOQ | ||
| ULOQ | Upper Limit of Quantification | integer | 8 | Derived Set to SUPPIS.QVAL where QNAM is 'ULOQ' | ||
| ISSPEC | Specimen Type | text | 5 | Specimen Type
| Predecessor: IS.ISSPEC | |
| ISNAM | Vendor Name | text | 11 | Predecessor: IS.ISNAM |
Go to the top of the Define-XML document
Laboratory Analysis Dataset (ADLB)
| Variable | Where Condition | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 14 | Study Identifier
| Predecessor: ADSL.STUDYID | |
| USUBJID | Unique Subject Identifier | text | 25 | Predecessor: ADSL.USUBJID | ||
| SUBJID | Subject Identifier for the Study | text | 9 | Predecessor: ADSL.SUBJID | ||
| SITEID | Study Site Identifier | text | 5 | Predecessor: ADSL.SITEID | ||
| COUNTRY | Country | text | 3 | Country
| Predecessor: ADSL.COUNTRY | |
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | ||
| AGEU | Age Units | text | 5 | Predecessor: ADSL.AGEU | ||
| AGEGR1 | Pooled Age Group 1 | text | 30 | Pooled Age Group 1
| Predecessor: ADSL.AGEGR1 | |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Predecessor: ADSL.AGEGR1N | ||
| AGEGR2 | Pooled Age Group 2 | text | 19 | Pooled Age Group 2
| Predecessor: ADSL.AGEGR2 | |
| AGEGR2N | Pooled Age Group 2 (N) | integer | 8 | Predecessor: ADSL.AGEGR2N | ||
| SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX | |
| RACE | Race | text | 41 | Race [8 Terms] | Predecessor: ADSL.RACE | |
| RACESPY | Race Specify | text | 200 | Predecessor: ADSL.RACESPY | ||
| ETHNIC | Ethnicity | text | 22 | Ethnicity
| Predecessor: ADSL.ETHNIC | |
| RANDFL | Randomized Population Flag | text | 1 | No Yes Response (Yes Only)
| Predecessor: ADSL.RANDFL | |
| SAFFL | Safety Population Flag | text | 1 | No Yes Response (Yes Only)
| Predecessor: ADSL.SAFFL | |
| FASBABFL | Full Analysis Set bAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASBABFL | |
| FASNABFL | Full Analysis Set nAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASNABFL | |
| PPBABFL | Per Protocol bAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBABFL | |
| PPNABFL | Per Protocol nAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPNABFL | |
| PPBD29FL | Per Protocol bAb Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBD29FL | |
| PPBD57FL | Per Protocol bAb Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBD57FL | |
| PBD209FL | Per Protocol bAb Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PBD209FL | |
| PPND29FL | Per Protocol nAb Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPND29FL | |
| PPND57FL | Per Protocol nAb Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPND57FL | |
| PND209FL | Per Protocol nAb Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PND209FL | |
| SAR1FL | First Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAR1FL | |
| SAR2FL | Second Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAR2FL | |
| SARAFL | Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SARAFL | |
| FASNA2FL | FAS nAb 2 Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASNA2FL | |
| PPNAB2FL | PP nAb 2 Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPNAB2FL | |
| PN2D29FL | Per Protocol nAb 2 Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2D29FL | |
| PN2D57FL | Per Protocol nAb 2 Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2D57FL | |
| PN2209FL | Per Protocol nAb 2 Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2209FL | |
| DVBABFL | Deviation Impact bAb Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DVBABFL | |
| DVNABFL | Deviation Impact nAb Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DVNABFL | |
| DOSE1FL | Vaccination 1 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSE1FL | |
| DOSE2FL | Vaccination 2 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSE2FL | |
| DOSEROFL | Dosing Error Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSEROFL | |
| COV19BL | Baseline COVID Infection | text | 20 | Baseline COVID Infection
| Predecessor: ADSL.COV19BL | |
| ELECSBL | Baseline Elecsys SARS CoV-2 Assay | text | 20 | Predecessor: ADSL.ELECSBL | ||
| COV19FL | COVID Infection Flag | text | 1 | No Yes Response
| Predecessor: ADSL.COV19FL | |
| SENTLFL | Sentinel Participant Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SENTLFL | |
| D29W7DFL | Day 29 Out of 7-Day Window Flag | text | 1 | No Yes Response
| Predecessor: ADSL.D29W7DFL | |
| TRT01P | Planned Treatment for Period 01 | text | 25 | Planned Treatment for Period 01
| Predecessor: ADSL.TRT01P | |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01PN | ||
| TRT01A | Actual Treatment for Period 01 | text | 25 | Actual Treatment for Period 01
| Predecessor: ADSL.TRT01A | |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01AN | ||
| TR01SDT | Date of First Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01SDT | ||
| TR01SDTM | Datetime of First Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01SDTM | ||
| TR01EDT | Date of Last Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01EDT | ||
| TR01EDTM | Datetime of Last Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01EDTM | ||
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTSDTM | ||
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTEDTM | ||
| DOSE2DT | Date of Dose 2 | integer | DATE9 | Predecessor: ADSL.DOSE2DT | ||
| DOS2DTM | Datetime of Dose 2 | integer | DATETIME20 | Predecessor: ADSL.DOS2DTM | ||
| TRTA | Actual Treatment | text | 50 | Actual Treatment
| Derived Select the last dose record in SDTM.EX before event or assessment Date Time :
Set to 'Placebo' if EX.EXTRT='PLACEBO'
For EX.EXTRT = 'mRNA-1273' :
Set to 'mRNA-1273 50 ug if 0 < EXDOSE <= 75 or EXDOSTXT contains '>0-25', '>25-<50' or '>50-75' ,
Set to 'mRNA-1273 100 ug' if EXDOSE>75 or EXDOSTXT contains '>75-<100' or '>100-125' or '>125'
Note: Use date only respectively if time part of event or assessment is missing | |
| TRTAN | Actual Treatment (N) | integer | 8 | Assigned 1 if TRT01A=‘Placebo’, 2 if TRT01A=‘mRNA-1273 50 ug’, 3 if TRT01A=‘mRNA-1273 100 ug’" | ||
| LBSEQ | Sequence Number | integer | 8 | Predecessor: LB.LBSEQ | ||
| LBDTC | Date/Time of Specimen Collection | datetime | ISO 8601 | Predecessor: LB.LBDTC | ||
| ADT | Analysis Date | integer | DATE9 | Derived Set to numeric date part of LB.LBDTC | ||
| ATM | Analysis Time | integer | TIME5 | Derived Set to time part of LB.LBDTC | ||
| ADTM | Analysis Datetime | integer | DATETIME20 | Derived Set to numeric date time of LBDTC if time part is not missing | ||
| ADY | Analysis Relative Day | integer | 8 | Derived Set to ADT - ADSL.TR01SDT + 1 if ADT >= ADSL.TR01SDT, or
Set to ADT - ADSL.TR01SDT if ADT < ADSL.TR01SDT | ||
| MDOSREF | Most Recent Dose Reference | text | 25 | Analysis Timepoint Reference
| Derived Set to 'Vaccination 1' if (.<ADSL.TR01SDTM<=ADTM <ADSL.DOS2DTM) or (.<ADSL.TR01SDTM<=ADTM and ADSL.DOS2DTM is missing),
Set to 'Vaccination 2' if .<ADSL.DOS2DTM<=ADTM
Note: use date variables for comparison when time part is not available | |
| MRDDY | Relative Day from Most Recent Dose | integer | 8 | Derived Set to ADT – ADSL.TR01SDT+ 1 If MDOSREF='Vaccination 1',
Set to ADT – ADSL.DOSE2DT+ 1 If MDOSREF='Vaccination 2' | ||
| VISIT | Visit Name | text | 28 | Predecessor: LB.VISIT | ||
| VISITNUM | Visit Number | float | 8 | Predecessor: LB.VISITNUM | ||
| AVISIT | Analysis Visit | text | 50 | Derived Set to 'Baseline' if ABLFL='Y',
Set to 'Day xx' part of VISIT if ADY>1 and VISIT doesn't contain 'Unsched',
Set AVISIT by following visit window below if ADY>1 and VISIT contains 'Unsched':
Set to 'Day 29' if VISIT with 1<ADY<=43,
Set to 'Day 57' if VISIT with 44<=ADY | ||
| AVISITN | Analysis Visit (N) | integer | 8 | Analysis Visit Code [10 Terms] | Assigned | |
| ASTAGE | Stage | text | 30 | Analysis Stage
| Derived For subjects who received 2 injections (DOSE1FL=’Y’ and DOSE2FL=’Y’), set to ‘Vaccination stage’ If .< ADSL.TR01SDTM <=ADTM and ADT<=earliest date of (date of Visit 7 (i.e. SV.SVSTDTC where SV.VISIT = 'Visit 7 Day 57'), ADSL.EOSDT, ADSL.DTHDT) ; set to 'Follow up stage' if ADT > non-missing date of Visit 7. If date of Visit 7, ADSL.EOSDT, and ADSL.DTHDT are all unavailable, set to ‘Vaccination stage’ for post baseline records. Else leave missing
For subjects who received only injection (DOSE1FL=’Y’ and DOSE2FL ne ’Y’), set to ‘Vaccination stage’ If .< ADSL.TR01SDTM <=ADTM and ADT<=earliest date of (date of Visit 4 (i.e. SV.SVSTDTC where SV.VISIT = 'Visit 4 Day 29'), ADSL.EOSDT, ADSL.DTHDT) ; set to 'Follow up stage' if ADT > non-missing date of Visit 4. If date of Visit 4, ADSL.EOSDT, and ADSL.DTHDT are all unavailable, set to ‘Vaccination stage’ for post baseline records. Else leave missing | |
| ASTAGEN | Stage (N) | integer | 8 | Assigned 1 if ASTAGE= Vaccination stage, 2 if ASTAGE= Follow up stage | ||
| PARCAT1 | Parameter Category 1 | text | 50 | Laboratory Parameter Category
| Derived Set to LB.LBCAT | |
| PARAMCD | Parameter Code | text | 8 | Assigned Set to ECLIAHCG if LBCAT=CHEMISTRY and LBTESTCD=HCG and LBMETHOD=ELECTROCHEMILUMINESCENCE Set to CHEMIHCG if LBCAT=CHEMISTRY and LBTESTCD=HCG and LBMETHOD=CHEMILUMINESCENCE Set to U || LBTESTCD If LBCAT=URINALYSIS Set to LBTESTCD if LBCAT ne URINALYSIS | ||
| PARAM | Parameter | text | 100 | Derived Set to LBMETHOD||' '||LB.LBTEST|| ' (' || LB.LBSTRESU || ')' if LBCAT=CHEMISTRY and LBTESTCD=HCG and LBMETHOD='ELECTROCHEMILUMINESCENCE' or 'CHEMILUMINESCENCE',
Set to Urinary || LB.LBTEST|| ' (' || LB.LBSTRESU || ')' if LBSTRESU is not blank if LBCAT=URINALYSIS
Set to LB.LBTEST || ' (' || LB.LBSTRESU || ')' if LBSTRESU is not blank if LBCAT ne URINALYSIS
Set to LB.LBTEST appended with LBSTRESU from non-missing records in parenthesis if LBSTRESU is blank
Note: Please add space between parameter and unit | ||
| AVAL | Analysis Value | float | 8 | Derived Set to LB.LBSTRESN
Set to 0.5x number part of LBSTRESC if LBSTRESC contains '<',
Set to number part of LBSTRESC if LBSTRESC contains '>' | ||
| BASE | Baseline Value | float | 8 | Derived Set to AVAL where ABLFL = 'Y' | ||
| CHG | Change from Baseline | float | 8 | Derived Set to AVAL-BASE for post-baseline records
Note: post-baseline records are defined as any result where (ADTM > ADSL.TR01SDTM if time is available or ADY > 1 otherwise. | ||
| PCHG | Percent Change from Baseline | float | 8 | Derived Set to (CHG/BASE)*100 if both are available and BASE is not 0 | ||
| AWRANGE | Analysis Window Valid Relative Range | text | 20 | Assigned Set to '<=1' for 'Day 1', Set to 'Day 2 - Day 11' for 'Day 8', Set to 'Day 12 - Day 22' for 'Day 15', Set to 'Day 23 - Day 32' for 'Day 29', Set to 'Day 33 - Day 39' for 'Day 36', Set to 'Day 40 - Day 50' for 'Day 43', Set to 'Day 51 - Day 133' for 'Day 57' Set to 'Day 134 - Day 301' for 'Day 209', Set to '>=Day 301' for Day 394' | ||
| AWTARGET | Analysis Window Target | integer | 8 | Assigned Set to 2 for 'Day 1' Set to 8 for ‘Day 8’, Set to 15 for 'Day 15', Set to 29 for 'Day 29', Set to 36 for 'Day 36', Set to 43 for 'Day 43', Set to 57 for 'Day 57', Set to 209 for 'Day 209', Set to 394 for 'Day 394' | ||
| AWTDIFF | Analysis Window Diff from Target | integer | 8 | Derived Set to absolute value of (ADY - AWTARGET) | ||
| LBORNRLO | Reference Range Lower Limit in Orig Unit | text | 4 | Predecessor: LB.LBORNRLO | ||
| LBORNRHI | Reference Range Upper Limit in Orig Unit | text | 5 | Predecessor: LB.LBORNRHI | ||
| LBORRES | Result or Finding in Original Units | text | 13 | Predecessor: LB.LBORRES | ||
| LBORRESU | Original Units | text | 9 | Original Units [8 Terms] | Predecessor: LB.LBORRESU | |
| LBTOXGR | Standard Toxicity Grade | text | 1 | Predecessor: LB.LBTOXGR | ||
| LBSTRESC | Character Result/Finding in Std Format | text | 13 | Predecessor: LB.LBSTRESC | ||
| ATOXGRLVLM | Analysis Toxicity Grade Low | text | 20 | Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007) | ||
| PARAMCD = "HGB" | Hemoglobin (g/L) | text | 10 | Derived If AVAL is not missing and SEX=’F’, convert AVAL and CHG to g/dl (AVAL*0.1, CHG*0.1),
then assign AVAL toxicity grading as follows:
Set to 'Grade 1' if 11.0 – 12.0
Set to 'Grade 2' if 9.5 – 10.9
Set to 'Grade 3' if 8.0 – 9.4
Set to 'Grade 4' if < 8.0
Otherwise, set to Grade 0.
assign CHG toxicity grading as follows:
Set to 'Grade 1' if -1.5 to <0
Set to 'Grade 2' if -2 to -1.6
Set to 'Grade 3' if -5 to -2.1
Set to 'Grade 4' if < -5
Otherwise, set to 'Grade 0'
Choose the higher grade between the two.
If AVAL is not missing and SEX=’M’, convert AVAL and CHG to g/dl (AVAL*0.1, CHG*0.1),
then assign AVAL toxicity grading as follows:
Set to 'Grade 1' if 12.5 – 13.5
Set to 'Grade 2' if 10.5 – 12.4
Set to 'Grade 3' if 8.5 – 10.4
Set to 'Grade 4' if < 8.5
Otherwise, set to 'Grade 0'
assign CHG toxicity grading as follows:
Set to 'Grade 1' if -1.5 to <0
Set to 'Grade 2' if -2 to -1.6
Set to 'Grade 3' if -5 to -2.1
Set to 'Grade 4' if < -5
Otherwise, set to 'Grade 0'
Choose the higher grade between the two. | ||
| PARAMCD = "LYM" | Lymphocytes (10^9/L) | text | 10 | Derived If AVAL is not missing, convert AVAL to cell/mm3 (AVAL*1000), then assign AVAL toxicity grading as follows:
Set to 'Grade 1' if 750 – 1,000
Set to 'Grade 2' if 500 – 749
Set to 'Grade 3' if 250 – 499
Set to 'Grade 4' if < 250
Otherwise, set to Grade '0' | ||
| PARAMCD = "NEUT" | Neutrophils (10^9/L) | text | 10 | Derived If AVAL is not missing, convert AVAL to cell/mm3 (AVAL*1000), then assign AVAL toxicity grading as follows:
Set to 'Grade 1' if 1,500 – 2,000
Set to 'Grade 2' if 1,000 – 1,499
Set to 'Grade 3' if 500 – 999
Set to 'Grade 4' if < 500
Otherwise, set to 'Grade 0' | ||
| PARAMCD = "PLAT" | Platelets (10^9/L) | text | 10 | Derived If AVAL is not missing, convert AVAL to cell/mm3 (AVAL*1000), then assign AVAL toxicity grading as follows:
Set to 'Grade 1' if 125,000 – 140,000
Set to 'Grade 2' if 100,000 – 124,000
Set to 'Grade 3' if 25,000 – 99,000
Set to 'Grade 4' if < 25,000
Otherwise, set to 'Grade 0' | ||
| PARAMCD = "WBC" | Leukocytes (10^9/L) | text | 10 | Derived If AVAL is not missing, convert AVAL to cell/mm3 (AVAL*1000), then assign AVAL toxicity grading as follows:
Set to 'Grade 1' if 2,500 – 3,500
Set to 'Grade 2' if 1,500 – 2,499
Set to 'Grade 3' if 1,000 – 1,499
Set to 'Grade 4' if < 1,000
Otherwise, set to 'Grade 0' | ||
| ATOXGRLN | Analysis Toxicity Grade Low (N) | integer | 8 | Analysis Toxicity Grade
| Assigned | |
| ATOXGRHVLM | Analysis Toxicity Grade High | text | 20 | Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007) | ||
| PARAMCD = "UREAN" | Urea Nitrogen (mmol/L) | text | 10 | Derived If AVAL is not missing, then assign toxicity grading based on numeric version of LBORRES (mg/dL) as follows:
Set to 'Grade 1' if 23-26
Set to 'Grade 2' if >26 -31
Set to 'Grade 3' if >31
Set to 'Grade 4' if requires dialysis pending
Otherwise, set to Grade '0' | ||
| PARAMCD = "CREAT" | Creatinine (umol/L) | text | 10 | Derived If AVAL is not missing, then assign toxicity grading based on numeric version of LBORRES (mg/dL) as follows:
Set to 'Grade 1' if 1.5-1.7
Set to 'Grade 2' if >1.7 -2.0
Set to 'Grade 3' if >2.0 -2.5
Set to 'Grade 4' if > 2.5 or requires dialysis
Otherwise, set to Set to 'Grade 0' | ||
| PARAMCD = "ALP" | Alkaline Phosphatase (U/L) | text | 10 | Derived If AVAL is not missing, then assign AVAL toxicity grading as follows:
Set to 'Grade 1' if 1.1 – 2.0 × ULN
Set to 'Grade 2' if >2.0 – 3.0 × ULN
Set to 'Grade 3' if >3.0 – 10 × ULN
Set to 'Grade 4' if > 10 × ULN
Otherwise, set to 'Grade 0'
(ULN = upper limit of normal) | ||
| PARAMCD = "ALT" | Alanine Aminotransferase (U/L) | text | 10 | Derived If AVAL is not missing, then assign AVAL toxicity grading as follows:
Set to 'Grade 1' if 1.1 – 2.5 x ULN
Set to 'Grade 2' if >2.5 – 5.0 × ULN
Set to 'Grade 3' if >5.0 – 10 × ULN
Set to 'Grade 4' if > 10 × ULN
Otherwise, set to 'Grade 0'
(ULN = upper limit of normal) | ||
| PARAMCD = "AST" | Aspartate Aminotransferase (U/L) | text | 10 | Derived If AVAL is not missing, then assign AVAL toxicity grading as follows:
Set to 'Grade 1' if 1.1 – 2.5 x ULN
Set to 'Grade 2' if >2.5 – 5.0 × ULN
Set to 'Grade 3' if >5.0 – 10 × ULN
Set to 'Grade 4' if > 10 × ULN
Otherwise, set to 'Grade 0'
(ULN = upper limit of normal) | ||
| PARAMCD = "BILI" | Bilirubin (umol/L) | text | 10 | Derived If AVAL is not missing and (ATOXGRHN>1 where PARAMCD=ALT or ATOXGRHN>1 where PARAMCD=AST), then assign AVAL toxicity grading as follows:
Set to 'Grade 1' if 1.1 – 1.25 × ULN
Set to 'Grade 2' if >1.25 – 1.5 × ULN
Set to 'Grade 3' if >1.5 – 1.75 × ULN
Set to 'Grade 4' if > 1.75 × ULN
Otherwise, set to Grade '0'
(ULN = upper limit of normal)
If AVAL is not missing and (ATOXGRHN=0 where PARAMCD=ALT and ATOXGRHN=0 where PARAMCD=AST), then assign AVAL toxicity grading as follows:
Set to 'Grade 1' if 1.1 – 1.5 × ULN
Set to 'Grade 2' if >1.5 – 2.0 × ULN
Set to 'Grade 3' if >2.0 – 3.0 × ULN
Set to 'Grade 4' if > 3.0 × ULN
Otherwise, set to Grade '0'
(ULN = upper limit of normal) | ||
| PARAMCD = "WBC" | Leukocytes (10^9/L) | text | 10 | Derived If AVAL is not missing, convert AVAL to cell/mm3 (AVAL*1000),, then assign AVAL toxicity grading as follows:
Set to 'Grade 1' if 10,800 – 15,000
Set to 'Grade 2' if 1,5001 – 20,000
Set to 'Grade 3' if 20,001 – 25,000
Set to 'Grade 4' if > 25,000
Otherwise, set to 'Grade 0' | ||
| PARAMCD = "EOS" | Eosinophils (10^9/L) | text | 10 | Derived If AVAL is not missing, convert AVAL to cell/mm3 (AVAL*1000), then assign AVAL toxicity grading as follows:
Set to 'Grade 1' if 650 – 1,500
Set to 'Grade 2' if 1,501 – 5,000
Set to 'Grade 3' if > 5,000
Set to 'Grade 4' if pending Hypereosinophilic (Per medical review)
Otherwise, set to 'Grade 0' | ||
| PARAMCD = "PT" | Erythrocytes (10^12/L) | text | 10 | Derived If AVAL is not missing, then assign AVAL toxicity grading as follows:
Set to 'Grade 1' if >1.0 – 1.10 × ULN (LB.LBSTNRHI)
Set to 'Grade 2' if >1.10 – 1.20 × ULN
Set to 'Grade 3' if >1.20 – 1.25 × ULN
Set to 'Grade 4' if > 1.25 × ULN
Otherwise, set to 'Grade 0'
(ULN = upper limit of normal) | ||
| PARAMCD = "APTT" | Activated Partial Thromboplastin Time (sec) | text | 10 | Derived If AVAL is not missing, then assign AVAL toxicity grading as follows:
Set to 'Grade 1' if >1.0 – 1.2 × ULN
Set to 'Grade 2' if >1.20 – 1.4 × ULN
Set to 'Grade 3' if >1.40 – 1.5 × ULN
Set to 'Grade 4' if > 1.5 × ULN
Otherwise, set to Set to 'Grade 0'
(ULN = upper limit of normal) | ||
| ATOXGRHN | Analysis Toxicity Grade High (N) | integer | 8 | Analysis Toxicity Grade
| Assigned | |
| BTOXGRL | Baseline Toxicity Grade Low | text | 20 | Derived Set to ATOXGRL where ABLFL = 'Y' | ||
| BTOXGRLN | Baseline Toxicity Grade Low (N) | integer | 8 | Analysis Toxicity Grade
| Assigned | |
| BTOXGRH | Baseline Toxicity Grade High | text | 20 | Derived Set to ATOXGRH where ABLFL = 'Y' | ||
| BTOXGRHN | Baseline Toxicity Grade High (N) | integer | 8 | Analysis Toxicity Grade
| Assigned | |
| ATOXDSCL | Analysis Toxicity Description Low | text | 50 | Derived Set to 'Hemoglobin Decreased' if PARAMCD='HGB'
Set to 'Lymphocytes Decreased' if PARAMCD='LYM'
Set to 'Neutrophils Decreased' if PARAMCD='NEUT'
Set to 'Platelets Decreased' if PARAMCD='PLAT'
Set to 'WBC Decreased' if PARAMCD='WBC' | ||
| ATOXDSCH | Analysis Toxicity Description High | text | 50 | Derived Set to 'Blood Urea Nitrogen Increased' if PARAMCD='UREAN'
Set to 'Creatinine Increased' if PARAMCD='CREAT'
Set to 'Alkaline Phosphatase Increased' if PARAMCD='ALP'
Set to 'Alanine Aminotransferase Increased' if PARAMCD='ALT'
Set to 'Aspartate Aminotransferase Increased' if PARAMCD='AST'
Set to 'Bilirubin Increased' if PARAMCD='BILI'
Set to 'WBC Increased' if PARAMCD='WBC'
Set to 'Eosinophils Increased' if PARAMCD='EOS'
Set to 'Prothrombin Time Increased' if PARAMCD='PT'
Set to 'Activated Partial Thromboplastin Time Increased' if PARAMCD='APTT' | ||
| SHIFT1 | Shift 1 | text | 50 | Derived Only populate for post-baseline records
Set to BTOXGRL|| ' to '||ATOXGRL if both of BTOXGRL and ATOXGRL are not missing, or
Set to 'UNK to ' || ATOXGRL or BTOXGRL || 'to UNK' if either BTOXGRL or ATOXGRL is missing
Note:
Post-baseline records are defined as any result where (ADTM > ADSL.TR01SDTM if time is available or ADY > 1 otherwise | ||
| SHIFT2 | Shift 2 | text | 50 | Derived Only populate for post-baseline records
Set to BTOXGRH|| ' to '||ATOXGRH If both of BTOXGRH and ATOXGRH are not missing,
Set to 'UNK to ' || ATOXGRH or BTOXGRH || 'to UNK' If either BTOXGRH or ATOXGRH is missing
Note:
Post-baseline records are defined as any result where (ADTM > ADSL.TR01SDTM if time is available or ADY > 1 otherwise | ||
| ANRIND | Analysis Reference Range Indicator | text | 20 | Analysis Reference Range Indicator
| Derived Set to LB.LBNRIND | |
| BNRIND | Baseline Reference Range Indicator | text | 20 | Analysis Reference Range Indicator
| Derived Set to ANRIND where ABLFL = 'Y' | |
| ANRLO | Analysis Normal Range Lower Limit | float | 8 | Derived Set to LB.LBSTNRLO | ||
| ANRHI | Analysis Normal Range Upper Limit | float | 8 | Derived Set to LB.LBSTNRHI | ||
| CRIT1 | Analysis Criterion 1 | text | 20 | Derived Set to PARAMCD ||' <2 x ULN' if CRIT1FL='Y' and PARAMCD in (ALP);
Set to PARAMCD ||' >=2 x ULN' if CRIT1FL='Y' and PARAMCD in (BILI);
Set to PARAMCD ||' >3 x ULN' if CRIT1FL='Y' and PARAMCD in (ALT, AST) | ||
| CRIT1FL | Criterion 1 Evaluation Result Flag | text | 1 | Derived Set to 'Y' if AVAL/ANRHI <2 and PARAMCD =ALP;
Set to 'Y' if AVAL/ANRHI >=2 and PARAMCD =BILI;
Set to 'Y' if AVAL/ANRHI >3 and PARAMCD in (ALT, AST); | ||
| ABLFL | Baseline Record Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' by selecting the latest ADTM or ADT if time is not available with non-missing AVAL/ LBSTRESC on or before TR01SDTM (TR01SDT if time part of TR01SDTM is missing) for each SUBJID, PARCAT1 and PARAMCD.
Note: If still multiple, selecting the records with the latest sequence number | |
| ANL01FL | Analysis Flag 01 | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if ABLFL='Y',
For post-baseline assessments where AVISITN is non-missing and result (AVAL) is non-missing, per subject per parameter and per AVISIT,
Within an AVISIT,
Set to ‘Y’ for the assessment at scheduled visit (i.e., VISIT doesn't contain "Unsched") or
Set to ‘Y’ for the latest assessment if there are 2 or more assessments at scheduled visit, or
Set to ‘Y’ for the latest assessment if there is no scheduled visit, or
Set to 'Y' for the assessment closest to the target study day in the visit window or
Set to 'Y' for the latest assessment If there are 2 or more assessments equal distance to the target study day | |
| ANL02FL | Analysis Flag 02 | text | 1 | No Yes Response (Yes Only)
| Derived Per subject per parameter, set to Y for the worst post-baseline toxicity grade (ATOXGRL) during vaccination stage (ASTAGEN=1) where ATOXDSCL is not missing using the following order: Grade 4> Grade 3>Grade 2>Grade 1>Grade 0. If there are more than one worst toxicity grades, then set to the first record. | |
| ANL03FL | Analysis Flag 03 | text | 1 | No Yes Response (Yes Only)
| Derived Per subject per parameter, set to Y for the worst post-baseline toxicity grade (ATOXGRH) during vaccination stage (ASTAGEN=1) where ATOXDSCH is not missing using the following order: Grade 4> Grade 3>Grade 2>Grade 1>Grade 0. If there are more than one worst toxicity grades, then set to the first record | |
| DTYPE | Derivation Type | text | 20 | Derivation Type
| Derived Set to 'HALFLLOQ' if LBSTRESC contains '<',
Set to 'ULOQ' if LBSTRESC contains '>'
Set to missing, otherwise |
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Microbiology Analysis Dataset (ADMB)
| Variable | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 14 | Study Identifier
| Predecessor: ADSL.STUDYID |
| USUBJID | Unique Subject Identifier | text | 25 | Predecessor: ADSL.USUBJID | |
| SUBJID | Subject Identifier for the Study | text | 9 | Predecessor: ADSL.SUBJID | |
| SITEID | Study Site Identifier | text | 5 | Predecessor: ADSL.SITEID | |
| COUNTRY | Country | text | 3 | Country
| Predecessor: ADSL.COUNTRY |
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | |
| AGEU | Age Units | text | 5 | Predecessor: ADSL.AGEU | |
| AGEGR1 | Pooled Age Group 1 | text | 30 | Pooled Age Group 1
| Predecessor: ADSL.AGEGR1 |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Predecessor: ADSL.AGEGR1N | |
| AGEGR2 | Pooled Age Group 2 | text | 19 | Pooled Age Group 2
| Predecessor: ADSL.AGEGR2 |
| AGEGR2N | Pooled Age Group 2 (N) | integer | 8 | Predecessor: ADSL.AGEGR2N | |
| SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX |
| RACE | Race | text | 41 | Race [8 Terms] | Predecessor: ADSL.RACE |
| RACESPY | Race Specify | text | 200 | Predecessor: ADSL.RACESPY | |
| ETHNIC | Ethnicity | text | 22 | Ethnicity
| Predecessor: ADSL.ETHNIC |
| RANDFL | Randomized Population Flag | text | 1 | No Yes Response (Yes Only)
| Predecessor: ADSL.RANDFL |
| SAFFL | Safety Population Flag | text | 1 | No Yes Response (Yes Only)
| Predecessor: ADSL.SAFFL |
| FASBABFL | Full Analysis Set bAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASBABFL |
| FASNABFL | Full Analysis Set nAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASNABFL |
| PPBABFL | Per Protocol bAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBABFL |
| PPNABFL | Per Protocol nAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPNABFL |
| PPBD29FL | Per Protocol bAb Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBD29FL |
| PPBD57FL | Per Protocol bAb Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBD57FL |
| PBD209FL | Per Protocol bAb Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PBD209FL |
| PPND29FL | Per Protocol nAb Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPND29FL |
| PPND57FL | Per Protocol nAb Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPND57FL |
| PND209FL | Per Protocol nAb Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PND209FL |
| SAR1FL | First Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAR1FL |
| SAR2FL | Second Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAR2FL |
| SARAFL | Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SARAFL |
| FASNA2FL | FAS nAb 2 Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASNA2FL |
| PPNAB2FL | PP nAb 2 Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPNAB2FL |
| PN2D29FL | Per Protocol nAb 2 Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2D29FL |
| PN2D57FL | Per Protocol nAb 2 Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2D57FL |
| PN2209FL | Per Protocol nAb 2 Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2209FL |
| DVBABFL | Deviation Impact bAb Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DVBABFL |
| DVNABFL | Deviation Impact nAb Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DVNABFL |
| DOSE1FL | Vaccination 1 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSE1FL |
| DOSE2FL | Vaccination 2 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSE2FL |
| DOSEROFL | Dosing Error Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSEROFL |
| COV19BL | Baseline COVID Infection | text | 20 | Baseline COVID Infection
| Predecessor: ADSL.COV19BL |
| ELECSBL | Baseline Elecsys SARS CoV-2 Assay | text | 20 | Predecessor: ADSL.ELECSBL | |
| COV19FL | COVID Infection Flag | text | 1 | No Yes Response
| Predecessor: ADSL.COV19FL |
| SENTLFL | Sentinel Participant Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SENTLFL |
| D29W7DFL | Day 29 Out of 7-Day Window Flag | text | 1 | No Yes Response
| Predecessor: ADSL.D29W7DFL |
| TRT01P | Planned Treatment for Period 01 | text | 25 | Planned Treatment for Period 01
| Predecessor: ADSL.TRT01P |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01PN | |
| TRT01A | Actual Treatment for Period 01 | text | 25 | Actual Treatment for Period 01
| Predecessor: ADSL.TRT01A |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01AN | |
| TR01SDT | Date of First Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01SDT | |
| TR01SDTM | Datetime of First Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01SDTM | |
| TR01EDT | Date of Last Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01EDT | |
| TR01EDTM | Datetime of Last Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01EDTM | |
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTSDTM | |
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTEDTM | |
| DOSE2DT | Date of Dose 2 | integer | DATE9 | Predecessor: ADSL.DOSE2DT | |
| DOS2DTM | Datetime of Dose 2 | integer | DATETIME20 | Predecessor: ADSL.DOS2DTM | |
| TRTA | Actual Treatment | text | 50 | Actual Treatment
| Derived Select the last dose record in SDTM.EX before event or assessment Date Time :
Set to 'Placebo' if EX.EXTRT='PLACEBO'
For EX.EXTRT = 'mRNA-1273' :
Set to 'mRNA-1273 50 ug if 0 < EXDOSE <= 75 or EXDOSTXT contains '>0-25', '>25-<50' or '>50-75' ,
Set to 'mRNA-1273 100 ug' if EXDOSE>75 or EXDOSTXT contains '>75-<100' or '>100-125' or '>125'
Note:
Use date only respectively if time part of event or assessment is missing |
| TRTAN | Actual Treatment (N) | integer | 8 | Assigned | |
| MBSEQ | Sequence Number | integer | 8 | Predecessor: MB.MBSEQ | |
| MBDTC | Date/Time of Specimen Collection | datetime | ISO 8601 | Predecessor: MB.MBDTC | |
| ADT | Analysis Date | integer | DATE9 | Derived Set to numeric date part of MB.MBDTC | |
| ATM | Analysis Time | integer | TIME5 | Derived Set to time part of MB.MBDTC | |
| ADTM | Analysis Datetime | integer | DATETIME20 | Derived Set to numeric date time of MBDTC if time part is not missing | |
| ADY | Analysis Relative Day | integer | 8 | Derived Set to ADT - ADSL.TR01SDT + 1 if ADT >= ADSL.TR01SDT, or
Set to ADT - ADSL.TR01SDT if ADT < ADSL.TR01SDT | |
| VISIT | Visit Name | text | 28 | Predecessor: MB.VISIT | |
| VISITNUM | Visit Number | float | 8 | Predecessor: MB.VISITNUM | |
| AVISIT | Analysis Visit | text | 50 | Derived Set to 'Baseline' if ABLFL='Y',
Set to 'Day xx' part of VISIT if ADY>1 and VISITNUM is 5 or 8,
Set AVISIT by following visit window below if ADY>1 and VISITNUM is not 5, 8:
Set to 'Day 29' if VISIT with 2<=ADY<=43,
Set to 'Day 57' if VISIT with 44<=ADY<=70,
Set to 'Day 71 or Beyond if VISIT with 71<=ADY | |
| AVISITN | Analysis Visit (N) | integer | 8 | Assigned | |
| PARCAT1 | Parameter Category 1 | text | 50 | Microbiology Parameter Category
| Derived Set to MB.MBCAT |
| PARAMCD | Parameter Code | text | 8 | Microbiology Analysis Dataset Parameter Code [21 Terms] | Assigned MB.MBTESTCD |
| PARAM | Parameter | text | 50 | Derived Set to MB.MBTEST | |
| AVALC | Analysis Value (C) | text | 50 | Derived Set to mixed case of MB.MBSTRESC;
Set to 'Not Detected' if MBSTRESC is 'NOTDETECTED' | |
| BASEC | Baseline Value (C) | text | 50 | Derived Set to AVALC where ABLFL = 'Y' | |
| AWRANGE | Analysis Window Valid Relative Range | text | 20 | Assigned | |
| AWTARGET | Analysis Window Target | integer | 8 | Assigned | |
| AWTDIFF | Analysis Window Diff from Target | integer | 8 | Derived Set to absolute value of (ADY - AWTARGET) | |
| ABLFL | Baseline Record Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' for selecting the latest ADTM or ADT if time is not available with non-missing AVALC on or before ADSL.TR01SDTM (TR01SDT if time part of TR01SDTM is missing) for each SUBJID, PARCAT1 and PARAMCD.
Note: ABLFL apply for non-local (LOCALFL is not 'Y') only |
| ANL01FL | Analysis Flag 01 | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if ABLFL='Y',
For post-baseline assessments where AVISITN is non-missing and result (AVAL) is non-missing, per subject per parameter and per AVISIT,
Within an AVISIT,
Set to ‘Y’ for the assessment at scheduled visit (i.e., VISIT doesn't contain "Unsched") or
Set to ‘Y’ for the latest assessment if there are 2 or more assessments at scheduled visit, or
Set to ‘Y’ for the latest assessment if there is no scheduled visit, or
Set to 'Y' for the assessment closest to the target study day in the visit window or
Set to 'Y' for the latest assessment If there are 2 or more assessments equal distance to the target study day |
| MBSCAT | Subcategory for Microbiology Finding | text | 19 | Subcategory for Microbiology Finding
| Predecessor: MB.MBSCAT |
| MBNAM | Vendor Name | text | 38 | Predecessor: MB.MBNAM | |
| MBSPEC | Specimen Type | text | 16 | Specimen Type
| Predecessor: MB.MBSPEC |
| MBMETHOD | Method of Test or Examination | text | 6 | Method of Test or Examination
| Predecessor: MB.MBMETHOD |
| LOCALFL | Local Labs Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to SUPPMB.QVAL where QNAM is 'LOCALFL' |
| LDTTYPE | Type of Diagnostic Test | text | 200 | Derived Set to SUPPMB.QVAL where QNAM is 'LDTTYPE' | |
| LDTSTOTH | Diagnostic Test Other, Specify | text | 200 | Derived Set to SUPPMB.QVAL where QNAM is 'LDTSTOTH' |
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Vital Signs Analysis Dataset (ADVS)
| Variable | Where Condition | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 14 | Study Identifier
| Predecessor: ADSL.STUDYID | |
| USUBJID | Unique Subject Identifier | text | 25 | Predecessor: ADSL.USUBJID | ||
| SUBJID | Subject Identifier for the Study | text | 9 | Predecessor: ADSL.SUBJID | ||
| SITEID | Study Site Identifier | text | 5 | Predecessor: ADSL.SITEID | ||
| COUNTRY | Country | text | 3 | Country
| Predecessor: ADSL.COUNTRY | |
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | ||
| AGEU | Age Units | text | 5 | Predecessor: ADSL.AGEU | ||
| AGEGR1 | Pooled Age Group 1 | text | 30 | Pooled Age Group 1
| Predecessor: ADSL.AGEGR1 | |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Predecessor: ADSL.AGEGR1N | ||
| AGEGR2 | Pooled Age Group 2 | text | 19 | Pooled Age Group 2
| Predecessor: ADSL.AGEGR2 | |
| AGEGR2N | Pooled Age Group 2 (N) | integer | 8 | Predecessor: ADSL.AGEGR2N | ||
| SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX | |
| RACE | Race | text | 41 | Race [8 Terms] | Predecessor: ADSL.RACE | |
| RACESPY | Race Specify | text | 200 | Predecessor: ADSL.RACESPY | ||
| ETHNIC | Ethnicity | text | 22 | Ethnicity
| Predecessor: ADSL.ETHNIC | |
| RANDFL | Randomized Population Flag | text | 1 | No Yes Response (Yes Only)
| Predecessor: ADSL.RANDFL | |
| SAFFL | Safety Population Flag | text | 1 | No Yes Response (Yes Only)
| Predecessor: ADSL.SAFFL | |
| FASBABFL | Full Analysis Set bAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASBABFL | |
| FASNABFL | Full Analysis Set nAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASNABFL | |
| PPBABFL | Per Protocol bAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBABFL | |
| PPNABFL | Per Protocol nAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPNABFL | |
| PPBD29FL | Per Protocol bAb Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBD29FL | |
| PPBD57FL | Per Protocol bAb Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBD57FL | |
| PBD209FL | Per Protocol bAb Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PBD209FL | |
| PPND29FL | Per Protocol nAb Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPND29FL | |
| PPND57FL | Per Protocol nAb Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPND57FL | |
| PND209FL | Per Protocol nAb Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PND209FL | |
| SAR1FL | First Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAR1FL | |
| SAR2FL | Second Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAR2FL | |
| SARAFL | Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SARAFL | |
| FASNA2FL | FAS nAb 2 Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASNA2FL | |
| PPNAB2FL | PP nAb 2 Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPNAB2FL | |
| PN2D29FL | Per Protocol nAb 2 Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2D29FL | |
| PN2D57FL | Per Protocol nAb 2 Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2D57FL | |
| PN2209FL | Per Protocol nAb 2 Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2209FL | |
| DVBABFL | Deviation Impact bAb Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DVBABFL | |
| DVNABFL | Deviation Impact nAb Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DVNABFL | |
| DOSE1FL | Vaccination 1 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSE1FL | |
| DOSE2FL | Vaccination 2 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSE2FL | |
| DOSEROFL | Dosing Error Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSEROFL | |
| COV19BL | Baseline COVID Infection | text | 20 | Baseline COVID Infection
| Predecessor: ADSL.COV19BL | |
| ELECSBL | Baseline Elecsys SARS CoV-2 Assay | text | 20 | Predecessor: ADSL.ELECSBL | ||
| COV19FL | COVID Infection Flag | text | 1 | No Yes Response
| Predecessor: ADSL.COV19FL | |
| SENTLFL | Sentinel Participant Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SENTLFL | |
| D29W7DFL | Day 29 Out of 7-Day Window Flag | text | 1 | No Yes Response
| Predecessor: ADSL.D29W7DFL | |
| TRT01P | Planned Treatment for Period 01 | text | 25 | Planned Treatment for Period 01
| Predecessor: ADSL.TRT01P | |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01PN | ||
| TRT01A | Actual Treatment for Period 01 | text | 25 | Actual Treatment for Period 01
| Predecessor: ADSL.TRT01A | |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01AN | ||
| TR01SDT | Date of First Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01SDT | ||
| TR01SDTM | Datetime of First Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01SDTM | ||
| TR01EDT | Date of Last Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01EDT | ||
| TR01EDTM | Datetime of Last Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01EDTM | ||
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTSDTM | ||
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTEDTM | ||
| DOSE2DT | Date of Dose 2 | integer | DATE9 | Predecessor: ADSL.DOSE2DT | ||
| DOS2DTM | Datetime of Dose 2 | integer | DATETIME20 | Predecessor: ADSL.DOS2DTM | ||
| TRTA | Actual Treatment | text | 50 | Actual Treatment
| Derived Select the last dose record in SDTM.EX before event or assessment Date Time :
Set to 'Placebo' if EX.EXTRT='PLACEBO'
For EX.EXTRT = 'mRNA-1273' :
Set to 'mRNA-1273 50 ug if 0 < EXDOSE <= 75 or EXDOSTXT contains '>0-25', '>25-<50' or '>50-75' ,
Set to 'mRNA-1273 100 ug' if EXDOSE>75 or EXDOSTXT contains '>75-<100' or '>100-125' or '>125'
Note: Use date only respectively if time part of event or assessment is missing | |
| TRTAN | Actual Treatment (N) | integer | 8 | Assigned | ||
| VSSEQ | Sequence Number | integer | 8 | Predecessor: VS.VSSEQ | ||
| VSDTC | Date/Time of Measurements | datetime | ISO 8601 | Predecessor: VS.VSDTC | ||
| ADT | Analysis Date | integer | DATE9 | Derived Set to numeric date part of VS.VSDTC | ||
| ATM | Analysis Time | integer | TIME5 | Derived Set to numeric time part of VS.VSDTC | ||
| ADTM | Analysis Datetime | integer | DATETIME20 | Derived Set to numeric date time of VSDTC if time part is not missing | ||
| ADY | Analysis Relative Day | integer | 8 | Derived Set to ADT - ADSL.TR01SDT + 1 if ADT >= ADSL.TR01SDT, or
Set to ADT - ADSL.TR01SDT if ADT < ADSL.TR01SDT | ||
| MDOSREF | Most Recent Dose Reference | text | 25 | Analysis Timepoint Reference
| Derived Set to 'Vaccination 1' if (.<ADSL.TR01SDTM<=ADTM <ADSL.DOS2DTM) or (.<ADSL.TR01SDTM<=ADTM and ADSL.DOS2DTM is missing),
Set to 'Vaccination 2' if .<ADSL.DOS2DTM<=ADTM
Note: use date variables for comparison when time part is not available | |
| MRDDY | Relative Day from Most Recent Dose | integer | 8 | Derived Set to ADT – ADSL.TR01SDT+ 1 if MDOSREF='Vaccination 1',
Set to ADT – ADSL.DOSE2DT+ 1 if MDOSREF='Vaccination 2' | ||
| VISIT | Visit Name | text | 28 | Predecessor: VS.VISIT | ||
| VISITNUM | Visit Number | float | 8 | Predecessor: VS.VISITNUM | ||
| AVISIT | Analysis Visit | text | 50 | Derived If ABLFL='Y', then AVISIT = 'Baseline',
if VISIT=Visit 1 Day 1 and VSTPT='POST DOSE' then AVISIT='Day 1',
if ADY>1 and VISIT doesn't contain 'Unsched', set to 'Day xx' part of VISIT,
if ADY>1 and VISIT contains 'Unsched', set AVISIT as follows: using the visit window below:
If VISIT with 1<ADY<=11, then AVISIT = 'Day 8',
else if VISIT with 12<=ADY<=22, then AVISIT = 'Day 15',
else if VISIT with 23<=ADY<=32, then AVISIT = 'Day 29',
else if VISIT with 33<=ADY<=39, then AVISIT = 'Day 36',
else if VISIT with 40<=ADY<=50, then AVISIT = 'Day 43',
else if VISIT with 51<=ADY<=133, then AVISIT = 'Day 57',
else if VISIT with 134=<ADY<=301, then AVISIT = 'Day 209',
else if VISIT with ADY>=302, then AVISIT = 'Day 394',
After the steps above, sort data by AVISITN and ADY, set the unscheduled visit (i.e., VISIT contains 'Unsched') records to blank if AVISITN >any previous AVISITN AND ADY<=any previous ADY). For example, Scheduled Day 36 is with AVISITN=6 (Day 36) and ADY=42 and an unscheduled visit is with AVISITN=7 (Day 43) and ADY=40, set AVISIT to blank for this unscheduled visit | ||
| AVISITN | Analysis Visit (N) | integer | 8 | Assigned | ||
| VSTPT | Planned Time Point Name | text | 49 | Planned Time Point Name
| Predecessor: VS.VSTPT | |
| ASTAGE | Stage | text | 30 | Analysis Stage
| Derived For subjects who received 2 injections (DOSE1FL='Y' and DOSE2FL='Y'),
Set to 'Vaccination stage' If .< ADSL.TR01SDTM <=ADTM and ADT<=earliest date of Visit 7, ADSL.EOSDT, ADSL.DTHDT
Set to 'Follow up stage' if ADT > non-missing date of Visit 7 or dates of Visit 7, ADSL.EOSDT, and ADSL.DTHDT are all unavailable,
Set to ‘Vaccination stage’ for post baseline records
For subjects who received only injection (DOSE1FL='Y' and DOSE2FL ne 'Y'),
Set to 'Vaccination stage' If .< ADSL.TR01SDTM <=ADTM and ADT<=earliest date of Visit 4, ADSL.EOSDT, ADSL.DTHDT,
Set to 'Follow up stage' if ADT > non-missing date of Visit 4 or dates of Visit 4, ADSL.EOSDT, and ADSL.DTHDT are all unavailable,
Set to 'Vaccination stage' for post baseline records | |
| ASTAGEN | Stage (N) | integer | 8 | Assigned | ||
| PARAMCD | Parameter Code | text | 8 | Vital Signs Analysis Dataset Parameter Code [8 Terms] | Assigned VS.VSTESTCD | |
| PARAM | Parameter | text | 50 | Derived Set to VS.VSTEST ' (' ||VSSTRESU|| ')' if VSSTRESU is non-missing, if VSSTRESU is missing, use the non-missing VSSTRESU from the same VSTEST | ||
| AVAL | Analysis Value | float | 8 | Derived Set to VS.VSSTRESN | ||
| VSSTRESC | Character Result/Finding in Std Format | text | 5 | Predecessor: VS.VSSTRESC | ||
| ABLFL | Baseline Record Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' by selecting the latest ADTM or ADT if ATM is missing with non-missing AVAL/AVALC on or before TR01SDTM (TR01SDT if time part of TR01SDTM is missing) for each SUBJID and PARAMCD
Note: exclude records where ADT is the same as TR01SDT and VSTPT^='PRE-DOSE' | |
| BASE | Baseline Value | float | 8 | Derived Merge value of no missing AVAL where ABLFL = 'Y' by USUBJID and PARAMCD,
Set to AVAL where ABLFL = 'Y'. | ||
| CHG | Change from Baseline | float | 8 | Derived For post baseline records only, if AVAL and BASE are both non-missing, set to AVAL - BASE
Note: post-baseline records are defined as any result where (ADTM > ADSL.TR01SDTM if time is available, if time is not available use (ADY=1 and VSTPT^='PRE-DOSE') or ADY > 1). | ||
| PCHG | Percent Change from Baseline | float | 8 | Derived Set to 0 if CHG=0 ,
Set to (CHG/BASE)*100 if BASE ne 0 | ||
| ATOXGRLVLM | Analysis Toxicity Grade Low | text | 10 | Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007) | ||
| PARAMCD = "PULSE" (Pulse Rate (beats/min)) | Pulse Rate (beats/min) | text | 8 | Derived Assign AVAL toxicity grading as follows If AVAL is not missing:
Set to 'Grade 1' if 50 – 54
Set to 'Grade 2' if 45 – 49
Set to 'Grade 3' if <45
Set to 'Grade 4' is based on medical input:
Otherwise, set to 'Grade 0' | ||
| PARAMCD = "SYSBP" (Systolic Blood Pressure (mmHg)) | Systolic Blood Pressure (mmHg) | text | 8 | Derived Assign AVAL toxicity grading as follows If AVAL is not missing:
Set to 'Grade 1' if 85 – 89
Set to 'Grade 2' if 80 – 84
Set to 'Grade 3' if <80
Set to 'Grade 4' is based on medical input:
Otherwise, set to Grade '0' | ||
| ATOXGRLN | Analysis Toxicity Grade Low (N) | integer | 8 | Analysis Toxicity Grade
| Assigned | |
| ATOXGRHVLM | Analysis Toxicity Grade High | text | 10 | Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007) | ||
| PARAMCD = "PULSE" (Pulse Rate (beats/min)) | Pulse Rate (beats/min) | text | 8 | Derived Assign AVAL toxicity grading as follows If AVAL is not missing:
Set to 'Grade 1' if 101 – 115
Set to 'Grade 2' if 116 – 130
Set to 'Grade 3' if >130
Set to 'Grade 4' is based on medical input:
Otherwise, set to 'Grade 0' | ||
| PARAMCD = "TEMP" (Temperature (C)) | Temperature (C) | text | 8 | Derived Assign AVAL toxicity grading as follows If AVAL is not missing:
Set to 'Grade 1' if 38.0 – 38.4
Set to 'Grade 2' if 38.5 – 38.9
Set to 'Grade 3' if 39.0 – 40.0
Set to 'Grade 4' if >40.0
Otherwise, set to 'Grade 0' | ||
| PARAMCD = "DIABP" (Diastolic Blood Pressure (mmHg)) | Diastolic Blood Pressure (mmHg) | text | 8 | Derived Assign AVAL toxicity grading as follows If AVAL is not missing:
Set to 'Grade 1' if 91 – 95
Set to 'Grade 2' if 96 – 100
Set to 'Grade 3' if >100
Set to 'Grade 4' is based on medical input:
Otherwise, set to 'Grade 0' | ||
| PARAMCD = "SYSBP" (Systolic Blood Pressure (mmHg)) | Systolic Blood Pressure (mmHg) | text | 8 | Derived Assign AVAL toxicity grading as follows If AVAL is not missing:
Set to 'Grade 1' if 141 – 150
Set to 'Grade 2' if 151 – 155
Set to 'Grade 3' if >155
Set to 'Grade 4' is based on medical input:
Otherwise, set to 'Grade 0' | ||
| PARAMCD = "RESP" (Respiratory Rate (breaths/min)) | Respiratory Rate (breaths/min) | text | 8 | Derived Assign AVAL toxicity grading as follows If AVAL is not missing:
Set to 'Grade 1' if 17 – 20
Set to 'Grade 2' if 21 – 25
Set to 'Grade 3' if >25
Set to 'Grade 4' is based on medical input:
Otherwise, set to 'Grade 0' | ||
| ATOXGRHN | Analysis Toxicity Grade High (N) | integer | 8 | Analysis Toxicity Grade
| Assigned | |
| BTOXGRL | Baseline Toxicity Grade Low | text | 10 | Derived Set to ATOXGRL where ABLFL = 'Y' | ||
| BTOXGRLN | Baseline Toxicity Grade Low (N) | integer | 8 | Analysis Toxicity Grade
| Assigned | |
| BTOXGRH | Baseline Toxicity Grade High | text | 10 | Derived Set to ATOXGRH where ABLFL = 'Y' | ||
| BTOXGRHN | Baseline Toxicity Grade High (N) | integer | 8 | Analysis Toxicity Grade
| Assigned | |
| ATOXDSCL | Analysis Toxicity Description Low | text | 30 | Derived Set to 'Bradycardia' if PARAMCD = 'PULSE',
Set to Hypotension' if PARAMCD = 'SYSBP' | ||
| ATOXDSCH | Analysis Toxicity Description High | text | 30 | Derived Set to 'Fever' if PARAMCD = 'TEMP',
Set to 'Tachycardia' if PARAMCD = 'PULSE',
Set to 'Systolic Hypertension' if PARAMCD = 'SYSBP',
Set to 'Diastolic Hypertension' if PARAMCD = 'DIABP',
Set to 'Respiratory Rate Increased' if PARAMCD = 'RESP' | ||
| SHIFT1 | Shift 1 | text | 20 | Derived Only populate for post-baseline records
Set to BTOXGRL || ' to '||ATOXGRL if both of BTOXGRL and ATOXGRL are not missing
Set to BTOXGRL || ' to UNK' / ' 'UNK to ' || ATOXGRL if either BTOXGRL or ATOXGRL is missing
Note:
Post-baseline records are defined as any result where (ADTM > ADSL.TR01SDTM if time is available, if time is not available use (ADY=1 and VSTPT^='PRE-DOSE') or ADY > 1) | ||
| SHIFT2 | Shift 2 | text | 20 | Derived Only populate for post-baseline records
Set to BTOXGRH || ' to ' || ATOXGRH if both of BTOXGRH and ATOXGRH are not missing,
Set to BTOXGRH || ' to UNK ' or 'UNK to ' || ATOXGRH if either BTOXGRH or ATOXGRH is missing
Note: Post-baseline records are defined as any result where (ADTM > ADSL.TR01SDTM if time is available, if time is not available use (ADY=1 and VSTPT^='PRE-DOSE') or ADY > 1) | ||
| AWRANGE | Analysis Window Valid Relative Range | text | 50 | Assigned | ||
| AWTARGET | Analysis Window Target | integer | 8 | Assigned | ||
| AWTDIFF | Analysis Window Diff from Target | integer | 8 | Derived Set to absolute value of (ADY - AWTARGET) | ||
| ANL01FL | Analysis Flag 01 | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if ABLFL='Y',
For post-baseline assessments where AVISITN is non-missing and result (AVAL) is non-missing, per subject per parameter and per AVISIT,
Within an AVISIT,
Set to ‘Y’ for the assessment at scheduled visit (i.e., VISIT doesn't contain "Unsched") or
Set to ‘Y’ for the latest assessment if there are 2 or more assessments at scheduled visit, or
Set to ‘Y’ for the latest assessment if there is no scheduled visit, or
Set to 'Y' for the assessment closest to the target study day in the visit window or
Set to 'Y' for the latest assessment If there are 2 or more assessments equal distance to the target study day | |
| ANL02FL | Analysis Flag 02 | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' by selecting the first worst toxicity grade (ATOXGRL Worst Case Order: Grade 4> Grade 3>Grade 2>Grade 1>Grade 0) by Subject, Parameter and Analysis Visit | |
| ANL03FL | Analysis Flag 03 | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' by selecting the first worst toxicity grade (ATOXGRH Worst Case Order: Grade 4> Grade 3>Grade 2>Grade 1>Grade 0) by Subject, Parameter and Analysis Visit | |
| VSLOC | Location of Vital Signs Measurement | text | 11 | Location of Vital Signs Measurement
| Predecessor: VS.VSLOC | |
| VSLOCSP | Other Location, specify | text | 200 | Derived Set to SUPPCM.QVAL where QNAM='VSLOCSP' |
Go to the top of the Define-XML document
Adverse Event Analysis Dataset (ADAE)
| Variable | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 14 | Study Identifier
| Predecessor: ADSL.STUDYID |
| USUBJID | Unique Subject Identifier | text | 25 | Predecessor: ADSL.USUBJID | |
| SUBJID | Subject Identifier for the Study | text | 9 | Predecessor: ADSL.SUBJID | |
| SITEID | Study Site Identifier | text | 5 | Predecessor: ADSL.SITEID | |
| COUNTRY | Country | text | 3 | Country
| Predecessor: ADSL.COUNTRY |
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | |
| AGEU | Age Units | text | 5 | Predecessor: ADSL.AGEU | |
| AGEGR1 | Pooled Age Group 1 | text | 30 | Pooled Age Group 1
| Predecessor: ADSL.AGEGR1 |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Predecessor: ADSL.AGEGR1N | |
| AGEGR2 | Pooled Age Group 2 | text | 19 | Pooled Age Group 2
| Predecessor: ADSL.AGEGR2 |
| AGEGR2N | Pooled Age Group 2 (N) | integer | 8 | Predecessor: ADSL.AGEGR2N | |
| SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX |
| RACE | Race | text | 41 | Race [8 Terms] | Predecessor: ADSL.RACE |
| RACESPY | Race Specify | text | 200 | Predecessor: ADSL.RACESPY | |
| ETHNIC | Ethnicity | text | 22 | Ethnicity
| Predecessor: ADSL.ETHNIC |
| RANDFL | Randomized Population Flag | text | 1 | No Yes Response (Yes Only)
| Predecessor: ADSL.RANDFL |
| SAFFL | Safety Population Flag | text | 1 | No Yes Response (Yes Only)
| Predecessor: ADSL.SAFFL |
| FASBABFL | Full Analysis Set bAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASBABFL |
| FASNABFL | Full Analysis Set nAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASNABFL |
| PPBABFL | Per Protocol bAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBABFL |
| PPNABFL | Per Protocol nAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPNABFL |
| PPBD29FL | Per Protocol bAb Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBD29FL |
| PPBD57FL | Per Protocol bAb Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBD57FL |
| PBD209FL | Per Protocol bAb Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PBD209FL |
| PPND29FL | Per Protocol nAb Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPND29FL |
| PPND57FL | Per Protocol nAb Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPND57FL |
| PND209FL | Per Protocol nAb Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PND209FL |
| SAR1FL | First Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAR1FL |
| SAR2FL | Second Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAR2FL |
| SARAFL | Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SARAFL |
| FASNA2FL | FAS nAb 2 Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASNA2FL |
| PPNAB2FL | PP nAb 2 Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPNAB2FL |
| PN2D29FL | Per Protocol nAb 2 Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2D29FL |
| PN2D57FL | Per Protocol nAb 2 Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2D57FL |
| PN2209FL | Per Protocol nAb 2 Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2209FL |
| DVBABFL | Deviation Impact bAb Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DVBABFL |
| DVNABFL | Deviation Impact nAb Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DVNABFL |
| DOSE1FL | Vaccination 1 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSE1FL |
| DOSE2FL | Vaccination 2 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSE2FL |
| DOSEROFL | Dosing Error Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSEROFL |
| COV19BL | Baseline COVID Infection | text | 20 | Baseline COVID Infection
| Predecessor: ADSL.COV19BL |
| ELECSBL | Baseline Elecsys SARS CoV-2 Assay | text | 20 | Predecessor: ADSL.ELECSBL | |
| COV19FL | COVID Infection Flag | text | 1 | No Yes Response
| Predecessor: ADSL.COV19FL |
| SENTLFL | Sentinel Participant Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SENTLFL |
| D29W7DFL | Day 29 Out of 7-Day Window Flag | text | 1 | No Yes Response
| Predecessor: ADSL.D29W7DFL |
| TRT01P | Planned Treatment for Period 01 | text | 25 | Planned Treatment for Period 01
| Predecessor: ADSL.TRT01P |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01PN | |
| TRT01A | Actual Treatment for Period 01 | text | 25 | Actual Treatment for Period 01
| Predecessor: ADSL.TRT01A |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01AN | |
| TR01SDT | Date of First Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01SDT | |
| TR01SDTM | Datetime of First Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01SDTM | |
| TR01EDT | Date of Last Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01EDT | |
| TR01EDTM | Datetime of Last Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01EDTM | |
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTSDTM | |
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTEDTM | |
| DOSE2DT | Date of Dose 2 | integer | DATE9 | Predecessor: ADSL.DOSE2DT | |
| DOS2DTM | Datetime of Dose 2 | integer | DATETIME20 | Predecessor: ADSL.DOS2DTM | |
| AEREFID | Reference ID | text | 25 | Predecessor: AE.AEREFID | |
| AELNKGRP | Link Group ID | text | 4 | Predecessor: AE.AELNKGRP | |
| TRTAN | Actual Treatment (N) | integer | 8 | Assigned 1 if TRT01A=‘Placebo’, 2 if TRT01A=‘mRNA-1273 50 ug’, 3 if TRT01A=‘mRNA-1273 100 ug’" | |
| TRTA | Actual Treatment | text | 20 | Derived Select the last dose record in SDTM.EX before event or assessment Date Time :
Set to 'Placebo' if EX.EXTRT='PLACEBO'
For EX.EXTRT = 'mRNA-1273' :
Set to 'mRNA-1273 50 ug if 0 < EXDOSE <= 75 or EXDOSTXT contains '>0-25', '>25-<50' or '>50-75' ,
Set to 'mRNA-1273 100 ug' if EXDOSE>75 or EXDOSTXT contains '>75-<100' or '>100-125' or '>125'
Note: Use date only respectively if time part of event or assessment is missing | |
| AESPID | Sponsor-Defined Identifier | text | 3 | Predecessor: AE.AESPID | |
| AESEQ | Sequence Number | integer | 8 | Predecessor: AE.AESEQ | |
| AECAT | Category for Adverse Event | text | 14 | Category for Adverse Event
| Predecessor: AE.AECAT |
| AETERM | Reported Term for the Adverse Event | text | 70 | Predecessor: AE.AETERM | |
| AEDECOD | Dictionary-Derived Term | text | 33 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Predecessor: AE.AEDECOD |
| AEBODSYS | Body System or Organ Class | text | 67 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Predecessor: AE.AEBODSYS |
| AEBDSYCD | Body System or Organ Class Code | integer | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Predecessor: AE.AEBDSYCD |
| AELLT | Lowest Level Term | text | 31 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Predecessor: AE.AELLT |
| AELLTCD | Lowest Level Term Code | integer | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Predecessor: AE.AELLTCD |
| AEPTCD | Preferred Term Code | integer | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Predecessor: AE.AEPTCD |
| AEHLT | High Level Term | text | 57 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Predecessor: AE.AEHLT |
| AEHLTCD | High Level Term Code | integer | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Predecessor: AE.AEHLTCD |
| AEHLGT | High Level Group Term | text | 55 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Predecessor: AE.AEHLGT |
| AEHLGTCD | High Level Group Term Code | integer | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Predecessor: AE.AEHLGTCD |
| AESOC | Primary System Organ Class | text | 67 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Predecessor: AE.AESOC |
| AESOCCD | Primary System Organ Class Code | integer | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Predecessor: AE.AESOCCD |
| AESTDTC | Start Date/Time of Adverse Event | datetime | ISO 8601 | Predecessor: AE.AESTDTC | |
| AEENDTC | End Date/Time of Adverse Event | datetime | ISO 8601 | Predecessor: AE.AEENDTC | |
| AESTDY | Study Day of Start of Adverse Event | integer | 8 | Predecessor: AE.AESTDY | |
| AEENDY | Study Day of End of Adverse Event | integer | 8 | Predecessor: AE.AEENDY | |
| AEENRF | End Relative to Reference Period | text | 7 | Predecessor: AE.AEENRF | |
| ASTDT | Analysis Start Date | integer | DATE9 | Derived Date part of AESTDTC convert to numeric,
If AESTDTC is partial or missing, apply the following imputation rule:
-If only DAY is missing:
If the AE end date (AEENDTC) is after the date of first vaccination (ADSL.TR01SDT) or is missing AND the start month and year of the AE (AESTDTC) coincide with the start month and year of the first vaccination (ADSL.TR01SDT), use the date of first vaccination for ASTDT and time of first vaccination for ASTTM,
Otherwise, use the first day of the month,
-If DAY and Month are both missing:
If the AE end date is after the date of first vaccination or is missing AND the start year of the AE coincides with the start year of the first vaccination, use the date of first vaccination,
Otherwise, use the first day of the year,
-If DAY, Month and Year are all missing, the date will not be imputed | |
| ASTTM | Analysis Start Time | integer | TIME5 | Derived Set to numeric time part of AESTDTC and ASTDT for imputation. If ASTDT is imputed and is set to the first vaccination day while time part of AESTDTC not missing, reset ASTTM to the time of first vaccination | |
| ASTDTM | Analysis Start Date/Time | integer | DATETIME20 | Derived Concatenate ASTDT and ASTTM if both are non-missing | |
| ASTDTF | Analysis Start Date Imputation Flag | text | 1 | Derived Set to 'M' if year is present and month is imputed,
Set to 'D' if only day is imputed | |
| ASTTMF | Analysis Start Time Imputation Flag | text | 1 | Derived Set to 'H' if time is imputed based on ASTTM derivation | |
| ASTDY | Analysis Start Relative Day | integer | 8 | Derived Set to ASTDT – ADSL.TR01SDT + 1 if ASTDT >= TR01SDT,
Set to ASTDT – ADSL.TR01SDT if ASTDT< TR01SDT | |
| AENDT | Analysis End Date | integer | DATE9 | Derived Set to numeric date part of AEENDTC | |
| AENTM | Analysis End Time | integer | TIME5 | Derived Set to numeric time part of AEENDTC | |
| AENDTM | Analysis End Date/Time | integer | DATETIME20 | Derived Concatenate AENDT and AENTM if both are non-missing | |
| ASTAGE | Stage | text | 20 | Analysis Stage
| Derived Set to 'Vaccination stage' If .< ADSL.TR01SDTM <=ASTDTM and ASTDT<= ADSL.TR01EDT+27,
Note: Use TR01SDT and ASTDTi f time part of TR01SDTM or time part of ASTDTM is missing,
Set to Follow up stage' if ASTDT> ADSL.TR01EDT+27 |
| ASTAGEN | Stage (N) | integer | 8 | Assigned 1 if ASTAGE= Vaccination stage, 2 if ASTAGE= Follow up stage | |
| AEDUR | Duration of Adverse Event | durationDatetime | ISO 8601 | Predecessor: AE.AEDUR | |
| MDOSREF | Most Recent Dose Reference | text | 50 | Analysis Timepoint Reference
| Derived Set to 'Vaccination 1' if AE.AEREFID contains 'DOSE 1'；
Set to 'Vaccination 2' if AE.AEREFID contains 'DOSE 2' |
| MRDSTDY | Relative Start Day from Most Recent Dose | integer | 8 | Derived Set to (the largest integer less than or equal to (ASTDTM – ADSL.TR01SDTM)/(24*60*60)) + 1 If MDOSREF='Vaccination 1',
Set to (the largest integer less than or equal to (ASTDTM – ADSL.DOS2DTM)/(24*60*60)) + 1 If MDOSREF='Vaccination 2'
if time part of ASTDTM is missing, use ASTDT to replace ASTDTM and calculate as follows:
Set to ASTDT – ADSL.TR01SDT+ 1 If MDOSREF='Vaccination 1'
Set to ASTDT – ADSL.DOSE2DT+ 1 If MDOSREF='Vaccination 2' | |
| MRDENDY | Relative End Day from Most Recent Dose | integer | 8 | Derived Set to (the largest integer less than or equal to (AENDTM – ADSL.TR01SDTM)/(24*60*60)) + 1 If MDOSREF='Vaccination 1',
Set to (the largest integer less than or equal to (AENDTM – ADSL.DOS2DTM)/(24*60*60)) + 1 If MDOSREF='Vaccination 2'
if time part of AENDTM is missing, use AENDT to replace AEENDTM and calculate as follows:
AENDT – ADSL.TR01SDT+ 1 If MDOSREF='Vaccination 1',
AENDT – ADSL.DOSE2DT+ 1 If MDOSREF='Vaccination 2'
(For example, ADSL.TR01SDTM is on 01Mar2020 at 2 pm, the AENDTM is on 02Mar2020 at 8 am, the MRDENDY will be Day 1 with MDOSREF='Vaccination 1',
ADSL.TR01SDTM is on 01Mar2020 at 2 pm, the AENDTM is on 02Mar2020 at 5 pm, the MRDENDY will be Day 2 with MDOSREF='Vaccination 1'. ) | |
| TRTEMFL | Treatment Emergent Analysis Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if .< ADSL.TR01SDTM <= ASTDTM, or (if ASTDT missing and .< ADSL.TR01SDTM <= AENDTM) or both ASTDT and AENDT missing,
Note: Use TR01SDT, ASTDT and AENDT if time is not available |
| AEMAFL | Medically-Attended Flag | text | 20 | No Yes Response
| Derived Set to SUPPAE.QVAL where SUPPAE.QNAM=AEMAFL |
| D28FL | AE Through 28 Days Analysis Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if non-missing MRDSTDY<=28 |
| AEDISFL | Leading to Study Discontinuation Flag | text | 1 | Derived Set 'Y' if subject with DS.DSDECOD countians 'ADVERSE EVENT' or 'AE' and the specified adverse event number match the AE.AESPID where DSCAT = DISPOSITION EVENT and DS.DSSCAT='END OF STUDY' | |
| AESOFL | Solicited Adverse Reaction? | text | 1 | No Yes Response
| Derived Set to SUPPAE.QVAL where SUPPAE.QNAM='AESOFL' |
| AESER | Serious Event | text | 1 | No Yes Response
| Predecessor: AE.AESER |
| AESCONG | Congenital Anomaly or Birth Defect | text | 1 | No Yes Response (No Only)
| Predecessor: AE.AESCONG |
| AESDISAB | Persist or Signif Disability/Incapacity | text | 1 | No Yes Response (No Only)
| Predecessor: AE.AESDISAB |
| AESDTH | Results in Death | text | 1 | No Yes Response (No Only)
| Predecessor: AE.AESDTH |
| AESHOSP | Requires or Prolongs Hospitalization | text | 1 | No Yes Response
| Predecessor: AE.AESHOSP |
| AESLIFE | Is Life Threatening | text | 1 | No Yes Response
| Predecessor: AE.AESLIFE |
| AESMIE | Other Medically Important Serious Event | text | 1 | No Yes Response
| Predecessor: AE.AESMIE |
| AEREL | Causality | text | 14 | Causality
| Predecessor: AE.AEREL |
| AERELNST | Relationship to Non-Study Treatment | text | 14 | Relationship to Non-Study Treatment
| Predecessor: AE.AERELNST |
| AREL | Analysis Causality | text | 20 | Analysis Causality
| Derived Set to AEREL |
| ARELN | Analysis Causality (N) | integer | 8 | Assigned 1 if AREL= 'NOT RELATED', 2 if AREL= 'RELATED', 3 If AREL= 'NOT APPLICABLE' | |
| AETOXGR | Standard Toxicity Grade | text | 1 | Predecessor: AE.AETOXGR | |
| AESEV | Severity/Intensity | text | 8 | Severity/Intensity Scale for Adverse Events
| Predecessor: AE.AESEV |
| ATOXGR | Analysis Toxicity Grade | text | 20 | Adverse Event Toxicity Grade
| Derived Set to 'Grade 1' if AETOXGR='1'
Set to 'Grade 2’ if AETOXGR='2'
Set to ‘Grade 3’ if AETOXGR='3'
Set to ‘Grade 4’ if AETOXGR='4' |
| ATOXGRN | Analysis Toxicity Grade (N) | integer | 8 | Assigned | |
| ASEV | Analysis Severity/Intensity | text | 20 | Analysis Severity/Intensity
| Derived Concatenate ATOXGR and Mixed case of AESEV with '/'
Set to ATOXGR if ATOXGR is 'Grade 4' |
| ASEVN | Analysis Severity/Intensity (N) | integer | 8 | Assigned 1 if ASEV = 'Grade 1/Mild' 2 if ASEV = 'Grade 2/Moderate' 3 if ASEV = 'Grade 4/Severe' 4 if AESEV='Grade 4' | |
| TOXGGR1 | Pooled Toxicity Grade Group 1 | text | 20 | Derived Pooled grouping of toxicity grade for analysis:
Set to '<3' when .<ATOXGRN <3
Set to '>=3' when ATOXGRN >=3 | |
| TOXGGR1N | Pooled Toxicity Grade 1 (N) | integer | 8 | Assigned 1 if TOXGGR1= '<3', 2 if TOXGGR1= '>=3' | |
| AEACN | Action Taken with Study Treatment | text | 16 | Action Taken with Study Treatment
| Predecessor: AE.AEACN |
| AEACNOTH | Other Action Taken | text | 45 | Predecessor: AE.AEACNOTH | |
| AEOUT | Outcome of Adverse Event | text | 26 | Outcome of Adverse Event
| Predecessor: AE.AEOUT |
| AEOUTSP | Recovered/Resolved with Sequelae,Spec | text | 200 | Derived Set to SUPPAE.QVAL where SUPPAE.QNAM=AEOUTSP | |
| AEHSTDTC | Hospital Admission Date | text | 20 | Derived Set to HO.HOSTDTC where HOTERM='HOSPITAL' based on AESPID and HOSPID | |
| AEHENDTC | Hospital Discharge Date | text | 20 | Derived Set to HO.HOENDTC where HOTERM='HOSPITAL' based on AESPID and HOSPID | |
| ICUAD | Admitted to ICU | text | 20 | Derived Set to HO.HOOCCUR where HOTERM='ADMITTED TO ICU' based on AESPID and HOSPID | |
| ICUDAY | Duration of Healthcare Encounter | text | 200 | Derived Set to HO.HODUR where HOTERM='ADMITTED TO ICU' based on AESPID and HOSPID | |
| CQ01NAM | Customized Query 01 Name | text | 45 | Derived Set to 'Autoimmune' if AEPTCD is in import.CMQ where CMQNAME='AUTOIMMUNE' | |
| CQ01FL | Customized Query 01 Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if CQ01NAM is not missing |
| CQ02NAM | Customized Query 02 Name | text | 45 | Derived Set to 'Dermal Filler Reaction Post Vaccination' if AEPTCD is in import.CMQ where CMQNAME='DERMAL FILLER REACTION POST VACCINATION' | |
| CQ02FL | Customized Query 02 Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if CQ02NAM is not missing |
| CQ03NAM | Customized Query 03 Name | text | 45 | Derived Set to 'Bell's Palsy' if AELLT is in ('Bell's palsy', 'Palsy Bells', 'Facial palsy', and 'Facial paralysis') | |
| CQ03FL | Customized Query 03 Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if CQ03NAM is not missing |
| SMQ01NAM | SMQ 01 Name | text | 45 | Derived Set to 'Anaphylactic Reaction' if AEDECOD is in import.SMQ where SMQNAME='ANAPHYLACTIC REACTION' | |
| SMQ01SC | SMQ 01 Scope | text | 6 | Derived Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='ANAPHYLACTIC REACTION' | |
| SMQ01FL | SMQ 01 Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if SMQ01NAM is not missing |
| SMQ02NAM | SMQ 02 Name | text | 45 | Derived Set to 'Angioedema' if AEDECOD is in import.SMQ where SMQNAME='ANGIOEDEMA' | |
| SMQ02SC | SMQ 02 Scope | text | 6 | Derived Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='ANGIOEDEMA' | |
| SMQ02FL | SMQ 02 Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if SMQ02NAM is not missing and SMQ02SC is 'NARROW' |
| SMQ03NAM | SMQ 03 Name | text | 45 | Derived Set to 'Arthritis' if AEDECOD is in import.SMQ where SMQNAME = 'ARTHRITIS' | |
| SMQ03SC | SMQ 03 Scope | text | 6 | Derived Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME = 'ARTHRITIS' | |
| SMQ03FL | SMQ 03 Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if SMQ03NAM is not missing and SMQ03SC is 'NARROW' |
| SMQ04NAM | SMQ 04 Name | text | 45 | Derived Set to 'Convulsions' if AEDECOD is in import.SMQ where SMQNAME = 'CONVULSIONS' | |
| SMQ04SC | SMQ 04 Scope | text | 6 | Derived Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME = 'CONVULSIONS' | |
| SMQ04FL | SMQ 04 Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if SMQ04NAM is not missing and SMQ04SC is 'NARROW' |
| SMQ05NAM | SMQ 05 Name | text | 45 | Derived Set to 'Demyelinating Disease of Central Nervous System' if AEDECOD is in import.SMQ where SMQNAME = 'DEMYELINATION' | |
| SMQ05SC | SMQ 05 Scope | text | 6 | Derived Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME = 'DEMYELINATION' | |
| SMQ05FL | SMQ 05 Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if SMQ05NAM is not missing and SMQ05SC is 'NARROW' |
| SMQ06NAM | SMQ 06 Name | text | 45 | Derived Set to 'Hypersensitivity' if AEDECOD is in import.SMQ where SMQNAME = 'HYPERSENSITIVITY | |
| SMQ06SC | SMQ 06 Scope | text | 6 | Derived Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME = 'HYPERSENSITIVITY' | |
| SMQ06FL | SMQ 06 Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if SMQ06NAM is not missing and SMQ06SC is 'NARROW' |
| SMQ07NAM | SMQ 07 Name | text | 45 | Derived Set to 'Peripheral Neuropathy' if AEDECOD is in import.SMQ where SMQNAME = 'PERIPHERAL NEUROPATHY' | |
| SMQ07SC | SMQ 07 Scope | text | 6 | Derived Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='PERIPHERAL NEUROPATHY' | |
| SMQ07FL | SMQ 07 Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if SMQ07NAM is not missing and SMQ07SC is 'NARROW' |
| SMQ08NAM | SMQ 08 Name | text | 45 | Derived Set to 'Vasculitis' if AEDECOD is in import.SMQ where SMQNAME = 'VASCULITIS' | |
| SMQ08SC | SMQ 08 Scope | text | 6 | Derived Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME = 'VASCULITIS' | |
| SMQ08FL | SMQ 08 Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if SMQ08NAM is not missing and SMQ08SC is 'NARROW' |
| SMQ09NAM | SMQ 09 Name | text | 45 | Derived Set to 'Central Nervous System Vascular Disorders' if AEDECOD is in import.SMQ where SMQNAME = 'CENTRAL NERVOUS SYSTEM VASCULAR DISORDERS' | |
| SMQ09SC | SMQ 09 Scope | text | 6 | Derived Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME = 'CENTRAL NERVOUS SYSTEM VASCULAR DISORDERS' | |
| SMQ09FL | SMQ 09 Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if SMQ09NAM is not missing and SMQ09SC is 'NARROW |
| SMQ10NAM | SMQ 10 Name | text | 45 | Derived Set to 'Embolic and Thrombotic Events' if AEDECOD is in import.SMQ where SMQNAME = 'EMBOLIC AND THROMBOTIC EVENTS' | |
| SMQ10SC | SMQ 10 Scope | text | 6 | Derived Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='EMBOLIC AND THROMBOTIC EVENTS' | |
| SMQ10FL | SMQ 10 Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if SMQ10NAM is not missing and SMQ10SC is 'NARROW' |
| SMQ11NAM | SMQ 11 Name | text | 45 | Derived Set to 'Hearing and Vestibular Disorders' if AEDECOD is in import.SMQ where SMQNAME = 'HEARING AND VESTIBULAR DISORDERS' | |
| SMQ11SC | SMQ 11 Scope | text | 6 | Derived Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME = 'HEARING AND VESTIBULAR DISORDERS' | |
| SMQ11FL | SMQ 11 Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if SMQ11NAM is not missing and SMQ11SC is 'NARROW', else leave missing |
| SMQ12NAM | SMQ 12 Name | text | 45 | Derived Set to 'Thrombophlebitis' if AEDECOD is in import.SMQ where SMQNAME = 'THROMBOPHLEBITIS' | |
| SMQ12SC | SMQ 12 Scope | text | 6 | Derived Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME = 'THROMBOPHLEBITIS' | |
| SMQ12FL | SMQ 12 Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if SMQ12NAM is not missing and SMQ12SC is 'NARROW' |
| SMQ13NAM | SMQ 13 Name | text | 45 | Derived Set to 'Hematopoietic Cytopenias' if AEDECOD is in import.SMQ where SMQNAME = 'HAEMATOPOIETIC CYTOPENIAS' | |
| SMQ13SC | SMQ 13 Scope | text | 6 | Derived Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME = 'HAEMATOPOIETIC CYTOPENIAS' | |
| SMQ13FL | SMQ 13 Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if SMQ13NAM is not missing and SMQ13SC is 'NARROW' |
| SMQ14NAM | SMQ 14 Name | text | 45 | Derived Set to 'Cardiomyopathy' if AEDECOD is in import.SMQ where SMQNAME = 'CARDIOMYOPATHY' | |
| SMQ14SC | SMQ 14 Scope | text | 6 | Derived Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME = 'CARDIOMYOPATHY' | |
| SMQ14FL | SMQ 14 Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if SMQ14NAM is not missing and SMQ14SC is 'NARROW' |
| ARTERM | Collected Term for Adverse Reaction | text | 37 | Derived Set to import.symp.CETERM where ADAESMQ.AEDECOD = symp.CEDECOD | |
| DARFL | Delayed AR Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if ARTERM is not missing |
| ANL01FL | Analysis Flag 01 | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if all the conditions below are met:
1).ARTERM in ('Pain', 'Erythema‘, 'Swelling', 'Underarm Gland Swelling or Tenderness'),
2). MRDSTDY>=8 |
| ANL02FL | Analysis Flag 02 | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if ANL01FL='Y' and MRDSTDY=8 and it exists in FACE where FATPTNUM=7 by SUBJID, MDOSREF(Vaccination x)/FATPTREF(DOSE x), ARTERM/FAOBJ |
| ANL03FL | Analysis Flag 03 | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y if all the conditions below are met:
1). ANL01FL='Y'
2). It exists in FACE by SUBJID, MDOSREF/FATPTREF, ARTERM/FAOBJ. That is, subject's events happen in the same period in FACE, link ADAE and FACE by SUBJID, match the events and corresponding period by ADAE.MDOSREF = FACE.FATPTREF, and ADAE.ARTERM=FACE.FAOBJ. e.g., if subject has ARTERM = 'Pain' after Vaccination 1 in ADAE, and has FAOBJ = 'Pain' and FATPTREF = 'Vaccination 1' in FACE, condition #2 is considered met,
3). If MRDSTDY = 8, the event identified in FACE in step 2) should have max(FATPTNUM) < 7,
4). It does not exist in FAAE by SUBJID, MDOSREF/FATPTREF, ARTERM/FAOBJ Similar linking rule as in Step 2 |
| ANL04FL | Analysis Flag 04 | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y if all the conditions below are met:
1). ANL01FL='Y',
2). It does not exist in FACE by SUBJID, MDOSREF/FATPTREF, ARTERM/FAOBJ |
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Concomitant Medication Analysis Dataset (ADCM)
| Variable | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 14 | Study Identifier
| Predecessor: ADSL.STUDYID |
| USUBJID | Unique Subject Identifier | text | 25 | Predecessor: ADSL.USUBJID | |
| SUBJID | Subject Identifier for the Study | text | 9 | Predecessor: ADSL.SUBJID | |
| SITEID | Study Site Identifier | text | 5 | Predecessor: ADSL.SITEID | |
| COUNTRY | Country | text | 3 | Country
| Predecessor: ADSL.COUNTRY |
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | |
| AGEU | Age Units | text | 5 | Predecessor: ADSL.AGEU | |
| AGEGR1 | Pooled Age Group 1 | text | 30 | Pooled Age Group 1
| Predecessor: ADSL.AGEGR1 |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Predecessor: ADSL.AGEGR1N | |
| AGEGR2 | Pooled Age Group 2 | text | 19 | Pooled Age Group 2
| Predecessor: ADSL.AGEGR2 |
| AGEGR2N | Pooled Age Group 2 (N) | integer | 8 | Predecessor: ADSL.AGEGR2N | |
| SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX |
| RACE | Race | text | 41 | Race [8 Terms] | Predecessor: ADSL.RACE |
| RACESPY | Race Specify | text | 200 | Predecessor: ADSL.RACESPY | |
| ETHNIC | Ethnicity | text | 22 | Ethnicity
| Predecessor: ADSL.ETHNIC |
| RANDFL | Randomized Population Flag | text | 1 | No Yes Response (Yes Only)
| Predecessor: ADSL.RANDFL |
| SAFFL | Safety Population Flag | text | 1 | No Yes Response (Yes Only)
| Predecessor: ADSL.SAFFL |
| FASBABFL | Full Analysis Set bAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASBABFL |
| FASNABFL | Full Analysis Set nAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASNABFL |
| PPBABFL | Per Protocol bAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBABFL |
| PPNABFL | Per Protocol nAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPNABFL |
| PPBD29FL | Per Protocol bAb Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBD29FL |
| PPBD57FL | Per Protocol bAb Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBD57FL |
| PBD209FL | Per Protocol bAb Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PBD209FL |
| PPND29FL | Per Protocol nAb Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPND29FL |
| PPND57FL | Per Protocol nAb Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPND57FL |
| PND209FL | Per Protocol nAb Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PND209FL |
| SAR1FL | First Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAR1FL |
| SAR2FL | Second Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAR2FL |
| SARAFL | Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SARAFL |
| FASNA2FL | FAS nAb 2 Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASNA2FL |
| PPNAB2FL | PP nAb 2 Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPNAB2FL |
| PN2D29FL | Per Protocol nAb 2 Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2D29FL |
| PN2D57FL | Per Protocol nAb 2 Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2D57FL |
| PN2209FL | Per Protocol nAb 2 Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2209FL |
| DVBABFL | Deviation Impact bAb Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DVBABFL |
| DVNABFL | Deviation Impact nAb Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DVNABFL |
| DOSE1FL | Vaccination 1 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSE1FL |
| DOSE2FL | Vaccination 2 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSE2FL |
| DOSEROFL | Dosing Error Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSEROFL |
| COV19BL | Baseline COVID Infection | text | 20 | Baseline COVID Infection
| Predecessor: ADSL.COV19BL |
| ELECSBL | Baseline Elecsys SARS CoV-2 Assay | text | 20 | Predecessor: ADSL.ELECSBL | |
| COV19FL | COVID Infection Flag | text | 1 | No Yes Response
| Predecessor: ADSL.COV19FL |
| SENTLFL | Sentinel Participant Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SENTLFL |
| D29W7DFL | Day 29 Out of 7-Day Window Flag | text | 1 | No Yes Response
| Predecessor: ADSL.D29W7DFL |
| TRT01P | Planned Treatment for Period 01 | text | 25 | Planned Treatment for Period 01
| Predecessor: ADSL.TRT01P |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01PN | |
| TRT01A | Actual Treatment for Period 01 | text | 25 | Actual Treatment for Period 01
| Predecessor: ADSL.TRT01A |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01AN | |
| TR01SDT | Date of First Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01SDT | |
| TR01SDTM | Datetime of First Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01SDTM | |
| TR01EDT | Date of Last Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01EDT | |
| TR01EDTM | Datetime of Last Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01EDTM | |
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTSDTM | |
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTEDTM | |
| DOSE2DT | Date of Dose 2 | integer | DATE9 | Predecessor: ADSL.DOSE2DT | |
| DOS2DTM | Datetime of Dose 2 | integer | DATETIME20 | Predecessor: ADSL.DOS2DTM | |
| CMSEQ | Sequence Number | integer | 8 | Predecessor: CM.CMSEQ | |
| CMCAT | Category for Medication | text | 44 | Category for Medication
| Predecessor: CM.CMCAT |
| CMTRT | Reported Name of Drug, Med, or Therapy | text | 137 | Predecessor: CM.CMTRT | |
| CMDECOD | Standardized Medication Name | text | 189 | Predecessor: CM.CMDECOD | |
| CMINDC | Indication | text | 83 | Predecessor: CM.CMINDC | |
| CMDOSE | Dose per Administration | float | 8 | Predecessor: CM.CMDOSE | |
| CMDOSU | Dose Units | text | 7 | Dose Units [9 Terms] | Predecessor: CM.CMDOSU |
| CMUOTHSP | Dose Unit Other Specficiation | text | 200 | Derived Set to SUPPCM.QVAL where QNAM='CMUOTHSP' | |
| CMDOSFRQ | Dosing Frequency per Interval | text | 10 | Dosing Frequency per Interval [11 Terms] | Predecessor: CM.CMDOSFRQ |
| CMFOTHSP | Dose Frequency Specification | text | 200 | Derived Set to SUPPCM.QVAL where QNAM='CMFOTHSP' | |
| CMROUTE | Route of Administration | text | 13 | Route of Administration [13 Terms] | Predecessor: CM.CMROUTE |
| CMROTHSP | Dose Route Other Specification | text | 200 | Derived Set to SUPPCM.QVAL where QNAM='CMROTHSP' | |
| CMSTDTC | Start Date/Time of Medication | text | 10 | Predecessor: CM.CMSTDTC | |
| CMENDTC | End Date/Time of Medication | text | 10 | Predecessor: CM.CMENDTC | |
| CMSTDY | Study Day of Start of Medication | integer | 8 | Predecessor: CM.CMSTDY | |
| CMENDY | Study Day of End of Medication | integer | 8 | Predecessor: CM.CMENDY | |
| CMENRTPT | End Relative to Reference Time Point | text | 7 | Predecessor: CM.CMENRTPT | |
| CMSOLFL | Medication Taken for Solicited Event | text | 1 | No Yes Response
| Derived Set to SUPPCM.QVAL when QNAM='CMSOL' |
| ASTDT | Analysis Start Date | integer | DATE9 | Derived Set to numeric date part of CM.CMSTDTC if day, month, and year are all present;
If only DAY is missing:
If the CM end date (CMENDTC) is after the date of first vaccination (ADSL.TR01SDT) or is missing and the start month and year of the CM (CMSTDTC) coincide with the start month and year of the first vaccination (ADSL.TR01SDT), use the date of first vaccination;
Otherwise, use the first day of the month,
If DAY and Month are both missing:
If the CM end date is after the date of first vaccination or is missing AND the start year of the CM coincides with the start year of the first vaccination, use the date of first vaccination
Otherwise, use the first day of the year;
If DAY, Month and Year are all missing, the date will not be imputed. blank otherwise
Note: if CMENDTC is partial:
If only day is missing, month and year coincide with or after the month and year of TR01SDT, treat CMENDTC as after TR01SDT, otherwise treat CMENDTC as before TR01SDT.
If month is missing (regardless of day is missing or not), if year coincides with or after the year of TR01SDT, treat CMENDTC as after TR01SDT, otherwise treat CMENDTC as before TR01SDT.
If year is missing (regardless of day and month), treat CMENDTC as after TR01SDT. | |
| ASTDTF | Analysis Start Date Imputation Flag | text | 1 | Derived Set to 'D' if only the day is imputed,
Set to 'M' if the day and the month are imputed | |
| ASTDY | Analysis Start Relative Day | integer | 8 | Derived Set to ASTDT - TR01SDT + 1 if ASTDT >= TR01SDT, or
Set to ASTDT - TR01SDT if ASTDT < TR01SDT | |
| AENDT | Analysis End Date | integer | DATE9 | Derived Set to numeric date part of CM.CMENDTC if day, month, and year are all present, or
Set to min of 31DECYYYY, EOSDT, or DTHDT if both day and month are missing,
Set to min of EOSDT, DTHDT, or xxMMMYYYY where xx is the last day of the month if only day is missing | |
| AENDTF | Analysis End Date Imputation Flag | text | 1 | Derived Set to 'D' if only the day is imputed
Set to 'M' if the day and the month are imputed | |
| AENDY | Analysis End Relative Day | integer | 8 | Derived Set to AENDT - TR01SDT + 1 if AENDT >= TR01SDT
Set to ASTDT - TR01SDT if AENDT < TR01SDT | |
| MDOSREF | Most Recent Dose Reference | text | 50 | Analysis Timepoint Reference
| Derived Set to 'Vaccination 1' if (.<TR01SDT<=ASTDT <DOSE2DT) or (.<TR01SDT<=ASTDT and DOSE2DT missing),
Set to 'Vaccination 2' if .<DOSE2DT<=ASTDT |
| MRDSTDY | Relative Start Day from Most Recent Dose | integer | 8 | Derived Set to ASTDT – TR01SDT + 1 if MDOSREF='Vaccination 1',
Set to ASTDT – DOS2DT + 1 if MDOSREF='Vaccination 2' | |
| CMMOI1FL | Modified Indication 1 Result Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' If CMINDC contains 'Prophylax' and
CMDECOD contains
'PARACETAMOL', 'DIPHENHYDRAMINE HYDROCHLORIDE;PARACETAMOL', 'IBUPROFEN', 'DIPHENHYDRAMINE CITRATE;IBUPROFEN', 'DIPHENHYDRAMINE HYDROCHLORIDE', IBUPROFEN', 'NAPROXEN SODIUM', 'DEXTROMETHORPHAN HYDROBROMIDE' 'GUAIFENESIN', 'PARACETAMOL' 'PSEUDOEPHEDRINE HYDROCHLORIDE', 'DEXTROMETHORPHAN HYDROBROMIDE;DOXYLAMINE SUCCINATE', 'EPHEDRINE SULFATE', 'ETHANOL', 'PARACETAMOL', 'ACETYLSALICYLIC ACID;CAFFEINE', 'PARACETAMOL' |
| CMMOI2FL | Modified Indication 2 Result Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' If CMDECOD contains
'PARACETAMOL', 'DIPHENHYDRAMINE HYDROCHLORIDE;PARACETAMOL', 'IBUPROFEN', 'DIPHENHYDRAMINE CITRATE;IBUPROFEN', 'DIPHENHYDRAMINE HYDROCHLORIDE', 'IBUPROFEN',
'NAPROXEN SODIUM', 'DEXTROMETHORPHAN HYDROBROMIDE', 'GUAIFENESIN', 'PARACETAMOL;PSEUDOEPHEDRINE HYDROCHLORIDE';
'DEXTROMETHORPHAN HYDROBROMIDE;DOXYLAMINE SUCCINATE;EPHEDRINE SULFATE;ETHANOL;PARACETAMOL';
'ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL' |
| PREFL | Pre-treatment Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if ASTDT < TR01SDT or ASTDT is missing |
| ONTRTFL | On Treatment Record Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if (ASTDT <= TR01EDT + 27 days) and (AENDT >= TR01SDT or AENDT is missing), or
if ASTDT is missing and (AENDT >= TR01SDT or AENDT is missing) |
| FUPFL | Follow-up Flag | text | 1 | No Yes Response (Yes Only)
| Derived Set to 'Y' if AENDT > TR01EDT + 27 days or AENDT is missing |
| ATCLEV1T | ATC Level 1 | text | 200 | Derived Set to SUPPCM.QVAL where QNAM='ATCLEV1T' | |
| ATCLEV2T | ATC Level 2 | text | 200 | Derived Set to SUPPCM.QVAL where QNAM='ATCLEV2T' | |
| ATCLEV3T | ATC Level 3 | text | 200 | Derived Set to SUPPCM.QVAL where QNAM='ATCLEV3T' | |
| ATCLEV4T | ATC Level 4 | text | 200 | Derived Set to SUPPCM.QVAL where QNAM='ATCLEV4T' |
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Deviation Analysis Dataset (ADDV)
| Variable | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 14 | Study Identifier
| Predecessor: ADSL.STUDYID |
| USUBJID | Unique Subject Identifier | text | 25 | Predecessor: ADSL.USUBJID | |
| SUBJID | Subject Identifier for the Study | text | 9 | Predecessor: ADSL.SUBJID | |
| SITEID | Study Site Identifier | text | 5 | Predecessor: ADSL.SITEID | |
| COUNTRY | Country | text | 3 | Country
| Predecessor: ADSL.COUNTRY |
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | |
| AGEU | Age Units | text | 5 | Predecessor: ADSL.AGEU | |
| AGEGR1 | Pooled Age Group 1 | text | 30 | Pooled Age Group 1
| Predecessor: ADSL.AGEGR1 |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Predecessor: ADSL.AGEGR1N | |
| AGEGR2 | Pooled Age Group 2 | text | 19 | Pooled Age Group 2
| Predecessor: ADSL.AGEGR2 |
| AGEGR2N | Pooled Age Group 2 (N) | integer | 8 | Predecessor: ADSL.AGEGR2N | |
| SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX |
| RACE | Race | text | 41 | Race [8 Terms] | Predecessor: ADSL.RACE |
| RACESPY | Race Specify | text | 200 | Predecessor: ADSL.RACESPY | |
| ETHNIC | Ethnicity | text | 22 | Ethnicity
| Predecessor: ADSL.ETHNIC |
| RANDFL | Randomized Population Flag | text | 1 | No Yes Response (Yes Only)
| Predecessor: ADSL.RANDFL |
| SAFFL | Safety Population Flag | text | 1 | No Yes Response (Yes Only)
| Predecessor: ADSL.SAFFL |
| FASBABFL | Full Analysis Set bAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASBABFL |
| FASNABFL | Full Analysis Set nAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASNABFL |
| PPBABFL | Per Protocol bAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBABFL |
| PPNABFL | Per Protocol nAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPNABFL |
| PPBD29FL | Per Protocol bAb Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBD29FL |
| PPBD57FL | Per Protocol bAb Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBD57FL |
| PBD209FL | Per Protocol bAb Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PBD209FL |
| PPND29FL | Per Protocol nAb Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPND29FL |
| PPND57FL | Per Protocol nAb Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPND57FL |
| PND209FL | Per Protocol nAb Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PND209FL |
| SAR1FL | First Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAR1FL |
| SAR2FL | Second Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAR2FL |
| SARAFL | Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SARAFL |
| FASNA2FL | FAS nAb 2 Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASNA2FL |
| PPNAB2FL | PP nAb 2 Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPNAB2FL |
| PN2D29FL | Per Protocol nAb 2 Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2D29FL |
| PN2D57FL | Per Protocol nAb 2 Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2D57FL |
| PN2209FL | Per Protocol nAb 2 Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2209FL |
| DVBABFL | Deviation Impact bAb Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DVBABFL |
| DVNABFL | Deviation Impact nAb Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DVNABFL |
| DOSE1FL | Vaccination 1 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSE1FL |
| DOSE2FL | Vaccination 2 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSE2FL |
| DOSEROFL | Dosing Error Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSEROFL |
| COV19BL | Baseline COVID Infection | text | 20 | Baseline COVID Infection
| Predecessor: ADSL.COV19BL |
| ELECSBL | Baseline Elecsys SARS CoV-2 Assay | text | 20 | Predecessor: ADSL.ELECSBL | |
| COV19FL | COVID Infection Flag | text | 1 | No Yes Response
| Predecessor: ADSL.COV19FL |
| SENTLFL | Sentinel Participant Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SENTLFL |
| D29W7DFL | Day 29 Out of 7-Day Window Flag | text | 1 | No Yes Response
| Predecessor: ADSL.D29W7DFL |
| TRT01P | Planned Treatment for Period 01 | text | 25 | Planned Treatment for Period 01
| Predecessor: ADSL.TRT01P |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01PN | |
| TRT01A | Actual Treatment for Period 01 | text | 25 | Actual Treatment for Period 01
| Predecessor: ADSL.TRT01A |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01AN | |
| TR01SDT | Date of First Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01SDT | |
| TR01SDTM | Datetime of First Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01SDTM | |
| TR01EDT | Date of Last Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01EDT | |
| TR01EDTM | Datetime of Last Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01EDTM | |
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTSDTM | |
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTEDTM | |
| DOSE2DT | Date of Dose 2 | integer | DATE9 | Predecessor: ADSL.DOSE2DT | |
| DOS2DTM | Datetime of Dose 2 | integer | DATETIME20 | Predecessor: ADSL.DOS2DTM | |
| DVSEQ | Sequence Number | integer | 8 | Predecessor: DV.DVSEQ | |
| DVCAT | Category for Protocol Deviation | text | 18 | Predecessor: DV.DVCAT | |
| DVSCAT | Subcategory for Protocol Deviation | text | 28 | Subcategory for Protocol Deviation [12 Terms] | Predecessor: DV.DVSCAT |
| DVSTDTC | Start Date/Time of Deviation | date | ISO 8601 | Predecessor: DV.DVSTDTC | |
| DVSTDY | Study Day of Start of Deviation | integer | 8 | Predecessor: DV.DVSTDY | |
| DVTERM | Protocol Deviation Term | text | 199 | Predecessor: DV.DVTERM | |
| DVTERM1 | Protocol Deviation Term 1 | text | 129 | Derived Set to SUPPDV.QVAL where SUPPDV.QNAM='DVTERM1' | |
| DVSIG | Significant Protocol Deviation | text | 15 | Derived Set to SUPPDV.QVAL where SUPPDV.QNAM='DVSIG' |
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Treatment Exposure Analysis Dataset (ADEX)
| Variable | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 14 | Study Identifier
| Predecessor: ADSL.STUDYID |
| USUBJID | Unique Subject Identifier | text | 25 | Predecessor: ADSL.USUBJID | |
| SUBJID | Subject Identifier for the Study | text | 9 | Predecessor: ADSL.SUBJID | |
| SITEID | Study Site Identifier | text | 5 | Predecessor: ADSL.SITEID | |
| COUNTRY | Country | text | 3 | Country
| Predecessor: ADSL.COUNTRY |
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | |
| AGEU | Age Units | text | 5 | Predecessor: ADSL.AGEU | |
| AGEGR1 | Pooled Age Group 1 | text | 30 | Pooled Age Group 1
| Predecessor: ADSL.AGEGR1 |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Predecessor: ADSL.AGEGR1N | |
| AGEGR2 | Pooled Age Group 2 | text | 19 | Pooled Age Group 2
| Predecessor: ADSL.AGEGR2 |
| AGEGR2N | Pooled Age Group 2 (N) | integer | 8 | Predecessor: ADSL.AGEGR2N | |
| SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX |
| RACE | Race | text | 41 | Race [8 Terms] | Predecessor: ADSL.RACE |
| RACESPY | Race Specify | text | 200 | Predecessor: ADSL.RACESPY | |
| ETHNIC | Ethnicity | text | 22 | Ethnicity
| Predecessor: ADSL.ETHNIC |
| RANDFL | Randomized Population Flag | text | 1 | No Yes Response (Yes Only)
| Predecessor: ADSL.RANDFL |
| SAFFL | Safety Population Flag | text | 1 | No Yes Response (Yes Only)
| Predecessor: ADSL.SAFFL |
| FASBABFL | Full Analysis Set bAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASBABFL |
| FASNABFL | Full Analysis Set nAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASNABFL |
| PPBABFL | Per Protocol bAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBABFL |
| PPNABFL | Per Protocol nAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPNABFL |
| PPBD29FL | Per Protocol bAb Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBD29FL |
| PPBD57FL | Per Protocol bAb Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBD57FL |
| PBD209FL | Per Protocol bAb Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PBD209FL |
| PPND29FL | Per Protocol nAb Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPND29FL |
| PPND57FL | Per Protocol nAb Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPND57FL |
| PND209FL | Per Protocol nAb Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PND209FL |
| SAR1FL | First Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAR1FL |
| SAR2FL | Second Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAR2FL |
| SARAFL | Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SARAFL |
| FASNA2FL | FAS nAb 2 Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASNA2FL |
| PPNAB2FL | PP nAb 2 Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPNAB2FL |
| PN2D29FL | Per Protocol nAb 2 Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2D29FL |
| PN2D57FL | Per Protocol nAb 2 Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2D57FL |
| PN2209FL | Per Protocol nAb 2 Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2209FL |
| DVBABFL | Deviation Impact bAb Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DVBABFL |
| DVNABFL | Deviation Impact nAb Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DVNABFL |
| DOSE1FL | Vaccination 1 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSE1FL |
| DOSE2FL | Vaccination 2 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSE2FL |
| DOSEROFL | Dosing Error Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSEROFL |
| COV19BL | Baseline COVID Infection | text | 20 | Baseline COVID Infection
| Predecessor: ADSL.COV19BL |
| ELECSBL | Baseline Elecsys SARS CoV-2 Assay | text | 20 | Predecessor: ADSL.ELECSBL | |
| COV19FL | COVID Infection Flag | text | 1 | No Yes Response
| Predecessor: ADSL.COV19FL |
| SENTLFL | Sentinel Participant Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SENTLFL |
| D29W7DFL | Day 29 Out of 7-Day Window Flag | text | 1 | No Yes Response
| Predecessor: ADSL.D29W7DFL |
| TRT01P | Planned Treatment for Period 01 | text | 25 | Planned Treatment for Period 01
| Predecessor: ADSL.TRT01P |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01PN | |
| TRT01A | Actual Treatment for Period 01 | text | 25 | Actual Treatment for Period 01
| Predecessor: ADSL.TRT01A |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01AN | |
| TR01SDT | Date of First Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01SDT | |
| TR01SDTM | Datetime of First Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01SDTM | |
| TR01EDT | Date of Last Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01EDT | |
| TR01EDTM | Datetime of Last Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01EDTM | |
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTSDTM | |
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTEDTM | |
| DOSE2DT | Date of Dose 2 | integer | DATE9 | Predecessor: ADSL.DOSE2DT | |
| DOS2DTM | Datetime of Dose 2 | integer | DATETIME20 | Predecessor: ADSL.DOS2DTM | |
| ASEQ | Analysis Sequence Number | integer | 8 | Assigned Sort by USUBJID, VISIT, EX.EXSEQ, EC.ECSEQ and start from 1, increase by 1 for records within each subject | |
| EXTRT | Name of Treatment | text | 9 | Name of Treatment
| Predecessor: EX.EXTRT |
| EXDOSE | Dose | integer | 8 | Predecessor: EX.EXDOSE | |
| EXDOSU | Dose Units | text | 2 | Dose Units
| Predecessor: EX.EXDOSU |
| EXDOSTXT | Dose Description | text | 13 | Predecessor: EX.DOSTXT | |
| EXDOSFRM | Dose Form | text | 9 | Dose Form
| Predecessor: EX.EXDOSFRM |
| EXDOSFRQ | Dosing Frequency per Interval | text | 4 | Dosing Frequency per Interval
| Predecessor: EX.EXDOSFRQ |
| EXROUTE | Route of Administration | text | 13 | Route of Administration
| Predecessor: EX.EXROUTE |
| EXLOC | Location of Dose Administration | text | 3 | Location of Dose Administration
| Predecessor: EX.EXLOC |
| EXLAT | Laterality | text | 5 | Laterality
| Predecessor: EX.EXLAT |
| EXSTDTC | Start Date/Time of Treatment | datetime | ISO 8601 | Predecessor: EX.EXSTDTC | |
| EXENDTC | End Date/Time of Treatment | datetime | ISO 8601 | Predecessor: EX.EXENDTC | |
| EXSTDY | Study Day of Start of Treatment | integer | 8 | Predecessor: EX.EXSTDY | |
| VISIT | Visit Name | text | 25 | Predecessor: EX.VISIT if source data are from EX; EC.VISIT if source data are from EC/SUPPEC | |
| VISITNUM | Visit Number | integer | 8 | Predecessor: EX.VISITNUM if source data are from EX; EC.VISITNUM if source data are from EC/SUPPEC | |
| ASTDT | Analysis Start Date | integer | DATE9 | Derived Set numeric of date part of EX.EXSTDTC | |
| AENDT | Analysis End Date | integer | DATE9 | Derived Set numeric of date part of EX.EXENDTC | |
| DOSEYNFL | Study Treatment Occurrence Flag | text | 1 | No Yes Response
| Derived Set to 'Y' if EXSTDTC is not missing.
Set to 'N' if EXSTDTC is missing and EC.ECOCCUR='N' |
| NDOSERS | Reason Study Treatment not Given | text | 200 | Reason Study Treatment not Given [8 Terms] | Derived Set to EC.ECREASOC |
| SRCDOM | Source Data | text | 20 | Derived Set to EX.DOMAIN if source data are from EX, or
Set to EC.DOMAIN if source data are from EC | |
| SRCSEQ | Source Sequence Number | integer | 8 | Derived Set to EX.EXSEQ if source data are from EX,
Set to EC.ECSEQ if source data are from EC |
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Medical History Analysis Dataset (ADMH)
| Variable | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 14 | Study Identifier
| Predecessor: ADSL.STUDYID |
| USUBJID | Unique Subject Identifier | text | 25 | Predecessor: ADSL.USUBJID | |
| SUBJID | Subject Identifier for the Study | text | 9 | Predecessor: ADSL.SUBJID | |
| SITEID | Study Site Identifier | text | 5 | Predecessor: ADSL.SITEID | |
| COUNTRY | Country | text | 3 | Country
| Predecessor: ADSL.COUNTRY |
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | |
| AGEU | Age Units | text | 5 | Predecessor: ADSL.AGEU | |
| AGEGR1 | Pooled Age Group 1 | text | 30 | Pooled Age Group 1
| Predecessor: ADSL.AGEGR1 |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Predecessor: ADSL.AGEGR1N | |
| AGEGR2 | Pooled Age Group 2 | text | 19 | Pooled Age Group 2
| Predecessor: ADSL.AGEGR2 |
| AGEGR2N | Pooled Age Group 2 (N) | integer | 8 | Predecessor: ADSL.AGEGR2N | |
| SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX |
| RACE | Race | text | 41 | Race [8 Terms] | Predecessor: ADSL.RACE |
| RACESPY | Race Specify | text | 200 | Predecessor: ADSL.RACESPY | |
| ETHNIC | Ethnicity | text | 22 | Ethnicity
| Predecessor: ADSL.ETHNIC |
| RANDFL | Randomized Population Flag | text | 1 | No Yes Response (Yes Only)
| Predecessor: ADSL.RANDFL |
| SAFFL | Safety Population Flag | text | 1 | No Yes Response (Yes Only)
| Predecessor: ADSL.SAFFL |
| FASBABFL | Full Analysis Set bAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASBABFL |
| FASNABFL | Full Analysis Set nAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASNABFL |
| PPBABFL | Per Protocol bAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBABFL |
| PPNABFL | Per Protocol nAb Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPNABFL |
| PPBD29FL | Per Protocol bAb Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBD29FL |
| PPBD57FL | Per Protocol bAb Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPBD57FL |
| PBD209FL | Per Protocol bAb Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PBD209FL |
| PPND29FL | Per Protocol nAb Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPND29FL |
| PPND57FL | Per Protocol nAb Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPND57FL |
| PND209FL | Per Protocol nAb Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PND209FL |
| SAR1FL | First Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAR1FL |
| SAR2FL | Second Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAR2FL |
| SARAFL | Solicited Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SARAFL |
| FASNA2FL | FAS nAb 2 Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.FASNA2FL |
| PPNAB2FL | PP nAb 2 Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPNAB2FL |
| PN2D29FL | Per Protocol nAb 2 Day 29 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2D29FL |
| PN2D57FL | Per Protocol nAb 2 Day 57 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2D57FL |
| PN2209FL | Per Protocol nAb 2 Day 209 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PN2209FL |
| DVBABFL | Deviation Impact bAb Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DVBABFL |
| DVNABFL | Deviation Impact nAb Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DVNABFL |
| DOSE1FL | Vaccination 1 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSE1FL |
| DOSE2FL | Vaccination 2 Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSE2FL |
| DOSEROFL | Dosing Error Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DOSEROFL |
| COV19BL | Baseline COVID Infection | text | 20 | Baseline COVID Infection
| Predecessor: ADSL.COV19BL |
| ELECSBL | Baseline Elecsys SARS CoV-2 Assay | text | 20 | Predecessor: ADSL.ELECSBL | |
| COV19FL | COVID Infection Flag | text | 1 | No Yes Response
| Predecessor: ADSL.COV19FL |
| SENTLFL | Sentinel Participant Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SENTLFL |
| D29W7DFL | Day 29 Out of 7-Day Window Flag | text | 1 | No Yes Response
| Predecessor: ADSL.D29W7DFL |
| TRT01P | Planned Treatment for Period 01 | text | 25 | Planned Treatment for Period 01
| Predecessor: ADSL.TRT01P |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01PN | |
| TRT01A | Actual Treatment for Period 01 | text | 25 | Actual Treatment for Period 01
| Predecessor: ADSL.TRT01A |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01AN | |
| TR01SDT | Date of First Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01SDT | |
| TR01SDTM | Datetime of First Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01SDTM | |
| TR01EDT | Date of Last Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01EDT | |
| TR01EDTM | Datetime of Last Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01EDTM | |
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTSDTM | |
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTEDTM | |
| DOSE2DT | Date of Dose 2 | integer | DATE9 | Predecessor: ADSL.DOSE2DT | |
| DOS2DTM | Datetime of Dose 2 | integer | DATETIME20 | Predecessor: ADSL.DOS2DTM | |
| MHSEQ | Sequence Number | integer | 8 | Predecessor: MH.MHSEQ | |
| MHCAT | Category for Medical History | text | 7 | Predecessor: MH.MHCAT | |
| MHTERM | Reported Term for the Medical History | text | 74 | Predecessor: MH.MHTERM | |
| MHBODSYS | Body System or Organ Class | text | 67 | Predecessor: MH.MHBODSYS | |
| MHDECOD | Dictionary-Derived Term | text | 40 | Predecessor: MH.MHDECOD | |
| MHSTDTC | Start Date/Time of Medical History Event | text | 10 | Predecessor: MH.MHSTDTC | |
| MHENDTC | End Date/Time of Medical History Event | text | 10 | Predecessor: MH.MHENDTC | |
| MHENRTPT | End Relative to Reference Time Point | text | 7 | Predecessor: MH.MHENRTPT | |
| MHSTDY | Study Day of Start of Observation | integer | 8 | Predecessor: MH.MHSTDY | |
| MHENDY | Study Day of End of Observation | integer | 8 | Predecessor: MH.MHENDY | |
| CQ01NAM | Customized Query 01 Name | text | 10 | Derived Set to 'Y' if CQ01NAM is not missing | |
| CQ01FL | Customized Query 01 Flag | text | 1 | Derived Set to 'Autoimmune' if MHPTCD is in import.CMQ.PTCODE where CMQNAME='AUTOIMMUNE' | |
| SMQ01NAM | SMQ 01 Name | text | 21 | Derived Set to 'Anaphylactic Reaction' if MHDECOD is in import.SMQ where SMQNAME='ANAPHYLACTIC REACTION', else leave missing | |
| SMQ01SC | SMQ 01 Scope | text | 6 | Derived Set to SMQ.SCOPE if MHDECOD is in import.SMQ where SMQNAME='ANAPHYLACTIC REACTION' | |
| SMQ01FL | SMQ 01 Flag | text | 1 | Derived Set to 'Y' if SMQ01NAM is not missing | |
| SMQ02NAM | SMQ 02 Name | text | 8 | Derived Set to 'Angioedema' if MHDECOD is in import.SMQ where SMQNAME='ANGIOEDEMA' | |
| SMQ02SC | SMQ 02 Scope | text | 6 | Derived Set to SMQ.SCOPE if MHDECOD is in import.SMQ where SMQNAME='ANGIOEDEMA' | |
| SMQ02FL | SMQ 02 Flag | text | 1 | Derived Set to 'Y' if SMQ02NAM is not missing and SMQ02SC is 'NARROW' | |
| SMQ06NAM | SMQ 06 Name | text | 16 | Derived Set to 'Hypersensitivity' if MHDECOD is in import.SMQ where SMQNAME='HYPERSENSITIVITY | |
| SMQ06SC | SMQ 06 Scope | text | 6 | Derived Set to SMQ.SCOPE if MHDECOD is in import.SMQ where SMQNAME='HYPERSENSITIVITY' | |
| SMQ06FL | SMQ 06 Flag | text | 1 | Derived Set 'Y' if SMQ06NAM is not missing and SMQ06SC is 'NARROW' |
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CodeLists
Action Taken with Study Treatment [C66767]
| Permitted Value (Code) |
|---|
| DOSE DELAYED [*] |
| DOSE NOT CHANGED [C49504] |
| DRUG WITHDRAWN [C49502] |
| NOT APPLICABLE [C48660] |
* Extended Value
Category for Adverse Event
| Permitted Value (Code) |
|---|
| ADVERSE EVENT |
| REACTOGENICITY |
Outcome of Adverse Event
| Permitted Value (Code) |
|---|
| NOT RECOVERED/NOT RESOLVED |
| RECOVERED/RESOLVED |
| RECOVERING/RESOLVING |
| RECOVERED/RESOLVED WITH SEQUELAE |
| UNKNOWN |
Causality
| Permitted Value (Code) |
|---|
| NOT APPLICABLE |
| NOT RELATED |
| RELATED |
Relationship to Non-Study Treatment
| Permitted Value (Code) |
|---|
| NOT APPLICABLE |
| NOT RELATED |
| RELATED |
Severity/Intensity Scale for Adverse Events [C66769]
| Permitted Value (Code) |
|---|
| MILD [C41338] |
| MODERATE [C41339] |
| SEVERE [C41340] |
Analysis Causality
| Permitted Value (Code) |
|---|
| NOT APPLICABLE |
| NOT RELATED |
| RELATED |
Analysis Severity/Intensity
| Permitted Value (Code) |
|---|
| Grade 1/Mild |
| Grade 2/Moderate |
| Grade 3/Severe |
| Grade 4 |
Adverse Event Toxicity Grade
| Permitted Value (Code) |
|---|
| Grade 1 |
| Grade 2 |
| Grade 3 |
| Grade 4 |
Evaluator [C78735]
| Permitted Value (Code) |
|---|
| INVESTIGATOR [C25936] |
| STUDY SUBJECT [C41189] |
Location of the Finding About
| Permitted Value (Code) |
|---|
| CHEST AND ABDOMEN |
| LEFT ARM AT INJECTION SITE |
| LEFT CHEEK |
| LEFT DELTOID (INJECTION SITE) |
| LEFT FOREARM AND RIGHT UPPER THIGH |
| LEFT TORSO REGION |
| NO RASH |
| RASH ON RIGHT KNEE NON-URTICARIAL |
| FOREHEAD AND ACROSS UPPER BACK |
| INJECTION SITE- RIGHT ARM. |
| NO RASH PER PI, RIGHT THIGH |
| NO RASH SUBJECT ENTERED YES IN ERROR |
| REPORTED AS REDNESS AND DISCOLORATION AT INJ SITE |
| RIGHT HIP |
| UNKNOWN |
Solicited AR Category Code
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | LOCAL |
| 2 | SYSTEMIC |
Analysis Toxicity Grade
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 0 | Grade 0 |
| 1 | Grade 1 |
| 2 | Grade 2 |
| 3 | Grade 3 |
| 4 | Grade 4 |
Solicited AR Analysis Dataset Parameter Code
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| ARTHRALG | Arthralgia |
| CHILLS | Chills |
| ERYTHDIA | Erythema Longest Diameter (mm) |
| FATIGUE | Fatigue |
| FEVER | Fever (C) |
| HEADACHE | Headache |
| LYMPH | Underarm Gland Swelling or Tenderness |
| LYMPHOCC | Lymphadenopathy Occurrence |
| MEDTAK | Medication Taken Today for Pain or Fever |
| MEDTAKP | Prevent Pain or Fever from Occurring |
| MEDTAKT | Treat Pain or Fever already Occurred |
| MYALGIA | Myalgia |
| NAUSEA | Nausea/Vomiting |
| PAIN | Pain |
| RASH | Rash |
| RASHOCC | Rash Occurrence |
| SWELLDIA | Swelling Longest Diameter (mm) |
Category for Medication
| Permitted Value (Code) |
|---|
| Prior/Concomitant Medication and Vaccination |
Dosing Frequency per Interval
| Permitted Value (Code) |
|---|
| BID |
| EVERY WEEK |
| ONCE |
| OTHER |
| PRN |
| QD |
| QID |
| QM |
| QOD |
| TID |
| UNKNOWN |
Dose Units
| Permitted Value (Code) |
|---|
| CAPSULE |
| IU |
| OTHER |
| PUFF |
| TABLET |
| g |
| mL |
| mg |
| ug |
Route of Administration
| Permitted Value (Code) |
|---|
| INTRAMUSCULAR |
| INTRAOCULAR |
| INTRAVENOUS |
| INTRAVENOUS BOLUS |
| NASAL |
| ORAL |
| OTHER |
| RECTAL |
| RESPIRATORY (INHALATION) |
| SUBCUTANEOUS |
| TOPICAL |
| TRANSDERMAL |
| VAGINAL |
COVID-19 Parameter Category
| Permitted Value (Code) |
|---|
| COVID-19 EXPOSURE |
| COVID-19 SYMPTOMS |
COVID-19 Analysis Dataset Parameter Code
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| ANOSMIA | Anosmia |
| CHESTTP | Chest Tightness/Pressure |
| CHILLS | Chills |
| CONTACT | The participant had close contact with a person known to have SARS-CoV-2 infection or COVID-19 |
| COUGH | Cough |
| COVID | COVID-19 |
| COVIDSYM | Participant COVID-19 Symptomatic |
| DUR | Duration |
| DYSGEUSI | Dysgeusia |
| EXPCOVID | Exposed to COVID-19 |
| EXPFAM | Family member |
| EXPHCF | Health Care Facility |
| EXPOTH | Other exposure |
| EXPSOC | Social setting |
| EXPTRAV | Travel |
| EXPWORK | Work |
| FEVER | Fever |
| HEADACHE | Headache |
| LETHARGY | Lethargy |
| MYALGIA | Myalgia |
| OTHSYMPT | Other Symptoms |
| REPTSHAK | Repeated Shaking with chills |
| SOB | Shortness of Breath |
| SORETHRT | Sore Throat |
Subcategory for Protocol Deviation
| Permitted Value (Code) |
|---|
| Concomitant Medication |
| Exclusion Criteria |
| ICF Process/Timing |
| Inclusion Criteria |
| Informed Consent |
| Inv Record Keeping Source Docs |
| Inv Safety Reporting (CRF) |
| Missing Endpoint Assessments |
| Study Procedures/Assessments |
| Study Treatment Admin/Dispense |
| Visit Scheduling |
| Other GCP Deviation |
Dose Form
| Permitted Value (Code) |
|---|
| INJECTION |
Dosing Frequency per Interval
| Permitted Value (Code) |
|---|
| ONCE |
Dose Units
| Permitted Value (Code) |
|---|
| ug |
Laterality [C99073]
| Permitted Value (Code) |
|---|
| LEFT [C25229] |
| RIGHT [C25228] |
Location of Dose Administration
| Permitted Value (Code) |
|---|
| ARM |
Route of Administration
| Permitted Value (Code) |
|---|
| INTRAMUSCULAR |
Name of Treatment
| Permitted Value (Code) |
|---|
| PLACEBO |
| mRNA-1273 |
Reason Study Treatment not Given
| Permitted Value (Code) |
|---|
| Lost To Follow-Up |
| Other, PATIENT HAD POSITIVE NASAL SWAB RESULTS |
| Other, SUBJECT TESTED POSITIVE FOR COVID-19 NO VACCINE GIVEN ONLY FOLLOWING FOR SAFETY |
| PHYSICIAN AE |
| Physician Decision, THE VACCINE WAS NOT GIVEN AS THE PATIENT HAD BEEN RECENTLY HOSPITALIZED FOR COMMUNITY ACQUIRED PNEUMONIA AND THE ISSUE HAD NOT RESOLVED. |
| Physician withheld dose due to Adverse Event |
| WITHDRAWAL OF CONSENT |
| Withdrawal of Consent by Participant |
Specimen Type [C78734]
| Permitted Value (Code) |
|---|
| SERUM [C13325] |
Immunogenicity Parameter Category
| Permitted Value (Code) |
|---|
| Serum SARS-CoV-2 Binding Antibodies |
| Serum SARS-CoV-2 Neutralizing Antibodies |
Immunogenicity Analysis Dataset Parameter Code
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| MN50 | MN50 |
| L10MN50 | LOG10(MN50) |
| MNET | MN Endpoint Titer |
| L10MNET | LOG10(MN Endpoint Titer) |
| V58IGGEN | VAC58 Nucleocapsid IgG Antibody (AU/mL) |
| LV58IGGN | LOG10(VAC58 Nucleocapsid IgG Antibody) |
| V58IGGES | VAC58 Spike IgG Antibody (ug/ml) |
| LV58IGGS | LOG10(VAC58 Spike IgG Antibody) |
| V65IGGS | VAC65 Spike IgG Antibody (AU/mL) |
| LV65IGGS | LOG10(VAC65 Spike IgG Antibody) |
| V66IGGN | VAC66 Nucleocapsid IgG Antibody (AU/mL) |
| LV66IGGN | LOG10(VAC66 Nucleocapsid IgG Antibody) |
| SARSCOV2 | Elecsys Anti-SARS-CoV-2 |
Analysis Reference Range Indicator
| Permitted Value (Code) |
|---|
| ABNORMAL |
| HIGH |
| LOW |
| NORMAL |
Original Units
| Permitted Value (Code) |
|---|
| % |
| Seconds |
| U/L |
| g/dL |
| mIU/mL |
| mg/dL |
| x 10^3/uL |
| x 10^6/uL |
Laboratory Parameter Category
| Permitted Value (Code) |
|---|
| CHEMISTRY |
| COAGULATION |
| HEMATOLOGY |
| PREGNANCY TEST |
| SEROLOGY |
Method of Test or Examination
| Permitted Value (Code) |
|---|
| RT-PCR |
Subcategory for Microbiology Finding
| Permitted Value (Code) |
|---|
| NASOPHARYNGEAL SWAB |
| SWAB |
Specimen Type [C78734]
| Permitted Value (Code) |
|---|
| OTHER [*] |
| SWABBED MATERIAL [C150895] |
* Extended Value
Microbiology Parameter Category
| Permitted Value (Code) |
|---|
| BIOFIRE |
| SARS-CoV-2 |
Microbiology Analysis Dataset Parameter Code
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| B30854A | Adenovirus |
| B30854B | Bordetella pertussis |
| B30854D | Chlamydophila pneumoniae |
| B30854E | Coronavirus 229E |
| B30854F | Coronavirus HKU1 |
| B30854G | Coronavirus NL63 |
| B30854H | Coronavirus OC43 |
| B30854I | Human metapneumovirus |
| B30854J | Human Rhinovirus/Enterovirus |
| B30854K | Influenza A |
| B30854L | Influenza A subtype H1 |
| B30854M | Influenza A subtype H1/2009 |
| B30854N | Influenza A subtype H3 |
| B30854O | Influenza B |
| B30854P | Mycoplasma pneumoniae |
| B30854Q | Parainfluenza Virus 1 |
| B30854R | Parainfluenza Virus 2 |
| B30854S | Parainfluenza Virus 3 |
| B30854T | Parainfluenza Virus 4 |
| B30854U | Respiratory Syncytial Virus |
| SARSCOV2 | Severe Acute Resp Syndrome Coronavirus 2 |
Pooled Age Group 1
| Permitted Value (Code) |
|---|
| >=18 and <55 Years |
| >=55 Years |
Pooled Age Group 2
| Permitted Value (Code) |
|---|
| >=18 and <=22 Years |
| >=23 and <=25 Years |
| >25 and <55 Years |
| >=55 Years |
Country
| Permitted Value (Code) |
|---|
| USA |
Baseline COVID Infection
| Permitted Value (Code) |
|---|
| Detected |
| Not Detected |
Reason for Discontinuation of Treatment / Study
| Permitted Value (Code) |
|---|
| Adverse Event (COVID-19 Infection) |
| Adverse Event (Other) |
| Death |
| Lost to Follow-Up |
| Physician Decision |
| Pregnancy |
| Protocol Deviation |
| Study Terminated By Sponsor |
| Withdrawal of Consent (Other) |
| Withdrawal of Consent (COVID-19 Non-Infection Related) |
| Other |
Ethnicity
| Permitted Value (Code) |
|---|
| HISPANIC OR LATINO |
| NOT HISPANIC OR LATINO |
| NOT REPORTED |
| UNKNOWN |
Study Identifier
| Permitted Value (Code) |
|---|
| mRNA-1273-P201 |
Actual Treatment for Period 01
| Permitted Value (Code) |
|---|
| Placebo |
| mRNA-1273 100 ug |
| mRNA-1273 50 ug |
Screen Failure Reason
| Permitted Value (Code) |
|---|
| Cohort Full |
| Inclusion/Exclusion |
| Other |
| Withdrew Consent |
Analysis Stage
| Permitted Value (Code) |
|---|
| Follow up stage |
| Vaccination stage |
Location of Vital Signs Measurement
| Permitted Value (Code) |
|---|
| ORAL CAVITY |
| OTHER |
Planned Time Point Name
| Permitted Value (Code) |
|---|
| POST-DOSE |
| PRE-DOSE |
Vital Signs Analysis Dataset Parameter Code
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| BMI | Body Mass Index (kg/m2) |
| DIABP | Diastolic Blood Pressure (mmHg) |
| HEIGHT | Height (cm) |
| PULSE | Pulse Rate (beats/min) |
| RESP | Respiratory Rate (breaths/min) |
| SYSBP | Systolic Blood Pressure (mmHg) |
| TEMP | Temperature (C) |
| WEIGHT | Weight (kg) |
Analysis Timepoint Reference
| Permitted Value (Code) |
|---|
| Vaccination 1 |
| Vaccination 2 |
Description of Planned Arm
| Permitted Value (Code) |
|---|
| Placebo |
| mRNA-1273 100 ug |
| mRNA-1273 50 ug |
Analysis Visit Code
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | Baseline |
| 2 | Day 1 |
| 3 | Day 8 |
| 4 | Day 15 |
| 5 | Day 29 |
| 6 | Day 36 |
| 7 | Day 43 |
| 8 | Day 57 |
| 9 | Day 209 |
| 10 | Day 394 |
Derivation Type [C81224]
| Permitted Value (Code) |
|---|
| HALFLLOQ [C170546] |
| ULOQ [C170544] |
No Yes Response (No Only) [C66742]
| Permitted Value (Code) |
|---|
| N [C49487] |
No Yes Response [C66742]
| Permitted Value (Code) |
|---|
| N [C49487] |
| Y [C49488] |
Race [C74457]
| Permitted Value (Code) |
|---|
| AMERICAN INDIAN OR ALASKA NATIVE [C41259] |
| ASIAN [C41260] |
| BLACK OR AFRICAN AMERICAN [C16352] |
| MULTIPLE [*] |
| NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER [C41219] |
| NOT REPORTED [C43234] |
| OTHER [*] |
| WHITE [C41261] |
* Extended Value
Sex [C66731]
| Permitted Value (Code) |
|---|
| F [C16576] |
| M [C20197] |
Planned Treatment for Period 01
| Permitted Value (Code) |
|---|
| Placebo |
| mRNA-1273 100 ug |
| mRNA-1273 50 ug |
Actual Treatment
| Permitted Value (Code) |
|---|
| Placebo |
| mRNA-1273 100 ug |
| mRNA-1273 50 ug |
No Yes Response (Yes Only) [C66742]
| Permitted Value (Code) |
|---|
| Y [C49488] |
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External Dictionaries
| Reference Name | External Dictionary | Dictionary Version |
|---|---|---|
| Medical Dictionary for Regulatory Activities | MedDRA | 23.0 |
Go to the top of the Define-XML document
Methods
| Method | Type | Description |
|---|---|---|
| AEDISFL | Computation | Set 'Y' if subject with DS.DSDECOD countians 'ADVERSE EVENT' or 'AE' and the specified adverse event number match the AE.AESPID where DSCAT = DISPOSITION EVENT and DS.DSSCAT='END OF STUDY' |
| AEHENDTC | Computation | Set to HO.HOENDTC where HOTERM='HOSPITAL' based on AESPID and HOSPID |
| AEHSTDTC | Computation | Set to HO.HOSTDTC where HOTERM='HOSPITAL' based on AESPID and HOSPID |
| AEMAFL | Computation | Set to SUPPAE.QVAL where SUPPAE.QNAM=AEMAFL |
| AENDT | Computation | Set to numeric date part of AEENDTC |
| AENDTM | Computation | Concatenate AENDT and AENTM if both are non-missing |
| AENTM | Computation | Set to numeric time part of AEENDTC |
| AEOUTSP | Computation | Set to SUPPAE.QVAL where SUPPAE.QNAM=AEOUTSP |
| AESOFL | Computation | Set to SUPPAE.QVAL where SUPPAE.QNAM='AESOFL' |
| ANL01FL | Computation | Set to 'Y' if all the conditions below are met:
1).ARTERM in ('Pain', 'Erythema‘, 'Swelling', 'Underarm Gland Swelling or Tenderness'),
2). MRDSTDY>=8 |
| ANL02FL | Computation | Set to 'Y' if ANL01FL='Y' and MRDSTDY=8 and it exists in FACE where FATPTNUM=7 by SUBJID, MDOSREF(Vaccination x)/FATPTREF(DOSE x), ARTERM/FAOBJ |
| ANL03FL | Computation | Set to 'Y if all the conditions below are met:
1). ANL01FL='Y'
2). It exists in FACE by SUBJID, MDOSREF/FATPTREF, ARTERM/FAOBJ. That is, subject's events happen in the same period in FACE, link ADAE and FACE by SUBJID, match the events and corresponding period by ADAE.MDOSREF = FACE.FATPTREF, and ADAE.ARTERM=FACE.FAOBJ. e.g., if subject has ARTERM = 'Pain' after Vaccination 1 in ADAE, and has FAOBJ = 'Pain' and FATPTREF = 'Vaccination 1' in FACE, condition #2 is considered met,
3). If MRDSTDY = 8, the event identified in FACE in step 2) should have max(FATPTNUM) < 7,
4). It does not exist in FAAE by SUBJID, MDOSREF/FATPTREF, ARTERM/FAOBJ Similar linking rule as in Step 2 |
| ANL04FL | Computation | Set to 'Y if all the conditions below are met:
1). ANL01FL='Y',
2). It does not exist in FACE by SUBJID, MDOSREF/FATPTREF, ARTERM/FAOBJ |
| AREL | Computation | Set to AEREL |
| ARTERM | Computation | Set to import.symp.CETERM where ADAESMQ.AEDECOD = symp.CEDECOD |
| ASEV | Computation | Concatenate ATOXGR and Mixed case of AESEV with '/'
Set to ATOXGR if ATOXGR is 'Grade 4' |
| ASTAGE | Computation | Set to 'Vaccination stage' If .< ADSL.TR01SDTM <=ASTDTM and ASTDT<= ADSL.TR01EDT+27,
Note: Use TR01SDT and ASTDTi f time part of TR01SDTM or time part of ASTDTM is missing,
Set to Follow up stage' if ASTDT> ADSL.TR01EDT+27 |
| ASTDT | Imputation | Date part of AESTDTC convert to numeric,
If AESTDTC is partial or missing, apply the following imputation rule:
-If only DAY is missing:
If the AE end date (AEENDTC) is after the date of first vaccination (ADSL.TR01SDT) or is missing AND the start month and year of the AE (AESTDTC) coincide with the start month and year of the first vaccination (ADSL.TR01SDT), use the date of first vaccination for ASTDT and time of first vaccination for ASTTM,
Otherwise, use the first day of the month,
-If DAY and Month are both missing:
If the AE end date is after the date of first vaccination or is missing AND the start year of the AE coincides with the start year of the first vaccination, use the date of first vaccination,
Otherwise, use the first day of the year,
-If DAY, Month and Year are all missing, the date will not be imputed |
| ASTDTF | Computation | Set to 'M' if year is present and month is imputed,
Set to 'D' if only day is imputed |
| ASTDTM | Computation | Concatenate ASTDT and ASTTM if both are non-missing |
| ASTDY | Computation | Set to ASTDT – ADSL.TR01SDT + 1 if ASTDT >= TR01SDT,
Set to ASTDT – ADSL.TR01SDT if ASTDT< TR01SDT |
| ASTTM | Imputation | Set to numeric time part of AESTDTC and ASTDT for imputation. If ASTDT is imputed and is set to the first vaccination day while time part of AESTDTC not missing, reset ASTTM to the time of first vaccination |
| ASTTMF | Computation | Set to 'H' if time is imputed based on ASTTM derivation |
| ATOXGR | Computation | Set to 'Grade 1' if AETOXGR='1'
Set to 'Grade 2’ if AETOXGR='2'
Set to ‘Grade 3’ if AETOXGR='3'
Set to ‘Grade 4’ if AETOXGR='4' |
| CQ01FL | Computation | Set to 'Y' if CQ01NAM is not missing |
| CQ01NAM | Computation | Set to 'Autoimmune' if AEPTCD is in import.CMQ where CMQNAME='AUTOIMMUNE' |
| CQ02FL | Computation | Set to 'Y' if CQ02NAM is not missing |
| CQ02NAM | Computation | Set to 'Dermal Filler Reaction Post Vaccination' if AEPTCD is in import.CMQ where CMQNAME='DERMAL FILLER REACTION POST VACCINATION' |
| CQ03FL | Computation | Set to 'Y' if CQ03NAM is not missing |
| CQ03NAM | Computation | Set to 'Bell's Palsy' if AELLT is in ('Bell's palsy', 'Palsy Bells', 'Facial palsy', and 'Facial paralysis') |
| D28FL | Computation | Set to 'Y' if non-missing MRDSTDY<=28 |
| DARFL | Computation | Set to 'Y' if ARTERM is not missing |
| ICUAD | Computation | Set to HO.HOOCCUR where HOTERM='ADMITTED TO ICU' based on AESPID and HOSPID |
| ICUDAY | Computation | Set to HO.HODUR where HOTERM='ADMITTED TO ICU' based on AESPID and HOSPID |
| MDOSREF | Computation | Set to 'Vaccination 1' if AE.AEREFID contains 'DOSE 1'；
Set to 'Vaccination 2' if AE.AEREFID contains 'DOSE 2' |
| MRDENDY | Computation | Set to (the largest integer less than or equal to (AENDTM – ADSL.TR01SDTM)/(24*60*60)) + 1 If MDOSREF='Vaccination 1',
Set to (the largest integer less than or equal to (AENDTM – ADSL.DOS2DTM)/(24*60*60)) + 1 If MDOSREF='Vaccination 2'
if time part of AENDTM is missing, use AENDT to replace AEENDTM and calculate as follows:
AENDT – ADSL.TR01SDT+ 1 If MDOSREF='Vaccination 1',
AENDT – ADSL.DOSE2DT+ 1 If MDOSREF='Vaccination 2'
(For example, ADSL.TR01SDTM is on 01Mar2020 at 2 pm, the AENDTM is on 02Mar2020 at 8 am, the MRDENDY will be Day 1 with MDOSREF='Vaccination 1',
ADSL.TR01SDTM is on 01Mar2020 at 2 pm, the AENDTM is on 02Mar2020 at 5 pm, the MRDENDY will be Day 2 with MDOSREF='Vaccination 1'. ) |
| MRDSTDY | Computation | Set to (the largest integer less than or equal to (ASTDTM – ADSL.TR01SDTM)/(24*60*60)) + 1 If MDOSREF='Vaccination 1',
Set to (the largest integer less than or equal to (ASTDTM – ADSL.DOS2DTM)/(24*60*60)) + 1 If MDOSREF='Vaccination 2'
if time part of ASTDTM is missing, use ASTDT to replace ASTDTM and calculate as follows:
Set to ASTDT – ADSL.TR01SDT+ 1 If MDOSREF='Vaccination 1'
Set to ASTDT – ADSL.DOSE2DT+ 1 If MDOSREF='Vaccination 2' |
| SMQ01FL | Computation | Set to 'Y' if SMQ01NAM is not missing |
| SMQ01NAM | Computation | Set to 'Anaphylactic Reaction' if AEDECOD is in import.SMQ where SMQNAME='ANAPHYLACTIC REACTION' |
| SMQ01SC | Computation | Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='ANAPHYLACTIC REACTION' |
| SMQ02FL | Computation | Set to 'Y' if SMQ02NAM is not missing and SMQ02SC is 'NARROW' |
| SMQ02NAM | Computation | Set to 'Angioedema' if AEDECOD is in import.SMQ where SMQNAME='ANGIOEDEMA' |
| SMQ02SC | Computation | Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='ANGIOEDEMA' |
| SMQ03FL | Computation | Set to 'Y' if SMQ03NAM is not missing and SMQ03SC is 'NARROW' |
| SMQ03NAM | Computation | Set to 'Arthritis' if AEDECOD is in import.SMQ where SMQNAME = 'ARTHRITIS' |
| SMQ03SC | Computation | Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME = 'ARTHRITIS' |
| SMQ04FL | Computation | Set to 'Y' if SMQ04NAM is not missing and SMQ04SC is 'NARROW' |
| SMQ04NAM | Computation | Set to 'Convulsions' if AEDECOD is in import.SMQ where SMQNAME = 'CONVULSIONS' |
| SMQ04SC | Computation | Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME = 'CONVULSIONS' |
| SMQ05FL | Computation | Set to 'Y' if SMQ05NAM is not missing and SMQ05SC is 'NARROW' |
| SMQ05NAM | Computation | Set to 'Demyelinating Disease of Central Nervous System' if AEDECOD is in import.SMQ where SMQNAME = 'DEMYELINATION' |
| SMQ05SC | Computation | Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME = 'DEMYELINATION' |
| SMQ06FL | Computation | Set to 'Y' if SMQ06NAM is not missing and SMQ06SC is 'NARROW' |
| SMQ06NAM | Computation | Set to 'Hypersensitivity' if AEDECOD is in import.SMQ where SMQNAME = 'HYPERSENSITIVITY |
| SMQ06SC | Computation | Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME = 'HYPERSENSITIVITY' |
| SMQ07FL | Computation | Set to 'Y' if SMQ07NAM is not missing and SMQ07SC is 'NARROW' |
| SMQ07NAM | Computation | Set to 'Peripheral Neuropathy' if AEDECOD is in import.SMQ where SMQNAME = 'PERIPHERAL NEUROPATHY' |
| SMQ07SC | Computation | Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='PERIPHERAL NEUROPATHY' |
| SMQ08FL | Computation | Set to 'Y' if SMQ08NAM is not missing and SMQ08SC is 'NARROW' |
| SMQ08NAM | Computation | Set to 'Vasculitis' if AEDECOD is in import.SMQ where SMQNAME = 'VASCULITIS' |
| SMQ08SC | Computation | Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME = 'VASCULITIS' |
| SMQ09FL | Computation | Set to 'Y' if SMQ09NAM is not missing and SMQ09SC is 'NARROW |
| SMQ09NAM | Computation | Set to 'Central Nervous System Vascular Disorders' if AEDECOD is in import.SMQ where SMQNAME = 'CENTRAL NERVOUS SYSTEM VASCULAR DISORDERS' |
| SMQ09SC | Computation | Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME = 'CENTRAL NERVOUS SYSTEM VASCULAR DISORDERS' |
| SMQ10FL | Computation | Set to 'Y' if SMQ10NAM is not missing and SMQ10SC is 'NARROW' |
| SMQ10NAM | Computation | Set to 'Embolic and Thrombotic Events' if AEDECOD is in import.SMQ where SMQNAME = 'EMBOLIC AND THROMBOTIC EVENTS' |
| SMQ10SC | Computation | Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='EMBOLIC AND THROMBOTIC EVENTS' |
| SMQ11FL | Computation | Set to 'Y' if SMQ11NAM is not missing and SMQ11SC is 'NARROW', else leave missing |
| SMQ11NAM | Computation | Set to 'Hearing and Vestibular Disorders' if AEDECOD is in import.SMQ where SMQNAME = 'HEARING AND VESTIBULAR DISORDERS' |
| SMQ11SC | Computation | Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME = 'HEARING AND VESTIBULAR DISORDERS' |
| SMQ12FL | Computation | Set to 'Y' if SMQ12NAM is not missing and SMQ12SC is 'NARROW' |
| SMQ12NAM | Computation | Set to 'Thrombophlebitis' if AEDECOD is in import.SMQ where SMQNAME = 'THROMBOPHLEBITIS' |
| SMQ12SC | Computation | Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME = 'THROMBOPHLEBITIS' |
| SMQ13FL | Computation | Set to 'Y' if SMQ13NAM is not missing and SMQ13SC is 'NARROW' |
| SMQ13NAM | Computation | Set to 'Hematopoietic Cytopenias' if AEDECOD is in import.SMQ where SMQNAME = 'HAEMATOPOIETIC CYTOPENIAS' |
| SMQ13SC | Computation | Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME = 'HAEMATOPOIETIC CYTOPENIAS' |
| SMQ14FL | Computation | Set to 'Y' if SMQ14NAM is not missing and SMQ14SC is 'NARROW' |
| SMQ14NAM | Computation | Set to 'Cardiomyopathy' if AEDECOD is in import.SMQ where SMQNAME = 'CARDIOMYOPATHY' |
| SMQ14SC | Computation | Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME = 'CARDIOMYOPATHY' |
| TOXGGR1 | Computation | Pooled grouping of toxicity grade for analysis:
Set to '<3' when .<ATOXGRN <3
Set to '>=3' when ATOXGRN >=3 |
| TRTA | Computation | Select the last dose record in SDTM.EX before event or assessment Date Time :
Set to 'Placebo' if EX.EXTRT='PLACEBO'
For EX.EXTRT = 'mRNA-1273' :
Set to 'mRNA-1273 50 ug if 0 < EXDOSE <= 75 or EXDOSTXT contains '>0-25', '>25-<50' or '>50-75' ,
Set to 'mRNA-1273 100 ug' if EXDOSE>75 or EXDOSTXT contains '>75-<100' or '>100-125' or '>125'
Note: Use date only respectively if time part of event or assessment is missing |
| TRTEMFL | Computation | Set to 'Y' if .< ADSL.TR01SDTM <= ASTDTM, or (if ASTDT missing and .< ADSL.TR01SDTM <= AENDTM) or both ASTDT and AENDT missing,
Note: Use TR01SDT, ASTDT and AENDT if time is not available |
| PPBD29ER | Computation | Only for subjects with RANDFL='Y' and PPBD29FL='N':
Set to PP_list.PBABREAS where VISITTPT='Day 29'
Set to 'Dosing error' and concatenate with the reason from PP_list if subject has dosing error (ADSL.PPBABERS contains 'Dosing error') |
| ADT | Computation | Set to numeric date part of FACE.FADTC if source data are from FACE
Set to number date part of VS.VSDTC if source data are from VS |
| ADTM | Computation | Set to numeric date time of FACE.FADTC if time part is not missing for data is from FACE
Set to numeric date time of VS.VSDTC if time part is not missing for data is from VS |
| ADY | Computation | Set to FACE.FADY if source data are from FACE
Set to VS.VSDY if source data are from VS |
| ANL01FL | Computation | Set to blank if PARAMCD in (MEDTAK, MEDTAKT And MEDTAKP),
Set to 'Y' by selecting the first record with maximum non-missing AVALC (Y>N) per subject per PARAM per vaccination (ATPTREF) per ATPTGR1 if PARAMCD in (RASHOCC, LYMPHOCC),
Set to 'Y' by selecting the first record with maximum non-missing ATOXGRN per subject per PARAM per vaccination (ATPTREF) per ATPTGR1, otherwise
Note: Please select the one where FAEVAL='STUDY SUBJECT' or missing for FEVER if there are two records per day with different FAEVAL |
| ANL02FL | Computation | Set to blank if PARAMCD in (MEDTAK, MEDTAKT And MEDTAKP)
Set to 'Y' by selecting the first record with maximum non-missing AVALC (Y>N) per subject per PARAM per vaccination (ATPTREF) per ATPT if PARAMCD in (RASHOCC, LYMPHOCC)
Set to 'Y' by selecting the first record with maximum non-missing ATOXGRN per subject per PARAM per vaccination (ATPTREF) per ATPT, otherwise
Note: Please select the one where FAEVAL='STUDY SUBJECT' or missing for FEVER if there are two records per day with different FAEVAL |
| ATM | Computation | Set to numeric time part of FACE.FADTC If source data are from FACE
Set to numeric time part of VS.VSDTC if source data are from VS |
| ATPT | Computation | Set to FACE.FATPT if source data are from FACE
Set to VS.VSTPT if source data are from VS,
Recode 'DAY 1' as 'DAY 1, AFTER VACCINATION (AT HOME)' if FAEVAL='INVESTIGATOR' and PARAMCD is not RASH and LYMPHOCC |
| ATPTGR1 | Computation | Set to 'Day 1' if ATPT contains 'Day 1'
Set to ATPT otherwise |
| ATPTREF | Computation | If source data are from FACE:
Set to 'Vaccination 1' if FACE.FATPTREF contains 'DOSE 1'
Set to 'Vaccination 2' if FACE.FATPTREF contains 'DOSE 2'
If source data are from VS:
Set to 'Vaccination 1' if VS.VSTPTREF contains 'DOSE 1'
Set to 'Vaccination 2' if VS.VSTPTREF contains 'DOSE 2' |
| AVAL | Computation | Set to VS.VSSTRESN if source data are from VS |
| AVAL | Computation | Set to 0 If source data are from FACE and FAOBJ = 'Erythema' or 'Swelling' and FATEST='OCCURRENCE' and FAORRES='N'
Set to FACE.FASTRESN, otherwise |
| AVALC | Computation | Set to FACE.FASTRESC if source data are from FACE
Set to VS.VSSTRESC if source data are from VS |
| AVALC | Computation | Set to 'Y' per subject per vaccination (ATPTREF) per timepoint (ATPT) if there is a record in SUPPVS where SUPPVS.QNAM in ('MEDTAK', 'MEDTAKT', 'MEDTAKP') and QVAL='Y' |
| AVALC | Computation | Set to FACE.FASTRESC if source data are from FACE
Set to VS.VSSTRESC if source data are from VS |
| CHILLS | Computation | Set to 'Grade 0' if FASTRESC='NONE' or FASTRESC contains 'GRADE 0'
Set to 'Grade 1' if FASTRESC= 'NO INTERFERENCE WITH ACTIVITY' or contains 'GRADE 1';
Set to 'Grade 2' if FASTRESC= 'SOME INTERFERENCE WITH ACTIVITY NOT REQUIRING MEDICAL ATTENTION' or contains 'GRADE 2';
Set to 'Grade 3' if FASTRESC= 'PREVENTS DAILY ACTIVITY AND REQUIRES MEDICAL ATTENTION' or contains 'GRADE 3';
Set to 'Grade 4' if FASTRESC contains 'GRADE 4' |
| CRIT1 | Computation | Set to '> 102.6 degrees F' if CRIT1FL='Y' |
| CRIT1FL | Computation | Set to 'Y' if PARAMCD='FEVER' and (9*AVAL/5)+32 > 102.6 |
| CRIT2 | Computation | Set to '> 103.1 degrees F' if CRIT2FL='Y' |
| CRIT2FL | Computation | Set to 'Y' if PARAMCD='FEVER' and (9*AVAL/5)+32 > 103.1 |
| CRIT3 | Computation | Set to '> 103.6 degrees F' if CRIT3FL='Y' |
| CRIT3FL | Computation | Set to 'Y' if PARAMCD='FEVER' and (9*AVAL/5)+32 > 103.6 |
| CRIT4 | Computation | Set to '> 104.1 degrees F' if CRIT4FL='Y' |
| CRIT4FL | Computation | Set to 'Y' if PARAMCD='FEVER' and (9*AVAL/5)+32 > 104.1 |
| ES | Computation | Set to 'Grade 0' if .<AVAL < 25 mm or FASTRESC contains 'GRADE 0'
Set to 'Grade 1' if AVAL = 25 - 50 mm or FASTRESC contains 'GRADE 1',
Set to 'Grade 2' if AVAL = 51 - 100 mm or FASTRESC contains 'GRADE 2',
Set to 'Grade 3' if AVAL > 100 mm or FASTRESC contains 'GRADE 3',
Set to 'Grade 4' if FASTRESC contains 'GRADE 4', |
| FEVER | Computation | Set to 'Grade 0' if .<AVAL < 38.0°C or FASTRESC contains 'GRADE 0'
Set to 'Grade 1' if AVAL = 38.0 – 38.4°C or FASTRESC contains 'GRADE 1'
Set to 'Grade 2' if AVAL = 38.5 – 38.9°C or FASTRESC contains 'GRADE 2'
Set to 'Grade 3' if AVAL = 39.0 – 40.0°C or FASTRESC contains 'GRADE 3'
Set to 'Grade 4' if AVAL > 40.0°C or FASTRESC contains 'GRADE 4' |
| HEADACHE | Computation | Set to 'Grade 0' if FASTRESC='NONE' or FASTRESC contains 'GRADE 0'
Set to 'Grade 1' if FASTRESC='NO INTERFERENCE WITH ACTIVITY' or FASTRESC contains 'GRADE 1'
Set to 'Grade 2' if FASTRESC='REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR SOME INTERFERENCE WITH ACTIVITY' or FASTRESC contains 'GRADE 2'
Set to 'Grade 3' if FASTRESC='ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY' or FASTRESC contains 'GRADE 3'
Set to 'Grade 4' if FASTRESC contains 'GRADE 4' |
| LYMPH | Computation | Set to 'Grade 0' if FASTRESC='NONE' or FASTRESC contains 'GRADE 0'
Set to 'Grade 1' if FASTRESC='DOES NOT INTERFERE WITH ACTIVITY' or FASTRESC contains 'GRADE 1'
Set to 'Grade 2' if FASTRESC='REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR INTERFERES WITH SOME ACTIVITY' or FASTRESC contains 'GRADE 2'
Set to 'Grade 3' if FASTRESC='ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY' or FASTRESC contains 'GRADE 3'
Set to 'Grade 4' if FASTRESC contains 'GRADE 4' |
| LYMPHCOM | Computation | Set to CO.COVAL where COREF=LYMPHCOM |
| LYMPHEVL | Computation | Set to SUPPFACE.QVAL where SUPPFACE.QNAME='LYMPHEVL' |
| MAAEFL | Computation | SUPPFACE.QVAL where SUPPFACE.QNAME='MAAEFL' |
| MUSCLE | Computation | Set to 'Grade 0' if FASTRESC=NONE' or FASTRESC contains 'GRADE 0'
Set to 'Grade 1' if FASTRESC='NO INTERFERENCE WITH ACTIVITY' or FASTRESC contains 'GRADE 1'
Set to 'Grade 2' if FASTRESC='SOME INTERFERENCE WITH ACTIVITY' or FASTRESC contains 'GRADE 2'
Set to 'Grade 3' if FASTRESC='SIGNIFICANT; PREVENTS DAILY ACTIVITY' or FASTRESC contains 'GRADE 3'
Set to 'Grade 4' if FASTRESC contains 'GRADE 4' |
| NAUSEA | Computation | Set to 'Grade 0' if FASTRESC='NONE' or FASTRESC contains 'GRADE 0'
Set to 'Grade 1' if FASTRESC= ‘NO INTERFERENCE WITH ACTIVITY OR 1-2 EPISODES/24 HOURS' or FASTRESC contains 'GRADE 1'
Set to 'Grade 2' if FASTRESC='SOME INTERFERENCE WITH ACTIVITY OR >2 EPISODES/24 HOURS' or FASTRESC contains 'GRADE 2'
Set to 'Grade 3' if FASTRESC='PREVENTS DAILY ACTIVITY, REQUIRES OUTPATIENT IV HYDRATION' or FASTRESC contains 'GRADE 3'
Set to 'Grade 4' if FASTRESC contains 'GRADE 4' |
| ADT | Computation | Set to numeric date part of FACE.FADTC if source data are from FACE,
Set to numeric date part of FAAE.FADTC if source data are from FAAE,
Set to numeric date part of VS.VSDTC if source data are from VS |
| ADTM | Computation | Set to numeric of FACE.FADTC if source data are from FACE,
Set to numeric of FAAE.FADTC if source data are from FAAE,
Set to numeric of VS.VSDTC if source data are from VS |
| ADY | Computation | Set to FACE.FADY if source data are from FACE,
Set to FAAE. FADY If source data are from FAAE,
Set to VS.VSDY if source data are from VS |
| ANL01FL | Computation | Set to 'Y' if PARAMCD in ( 'PAIN' or 'ERYTHDIA' or 'SWELLDIA', 'LYMPH') |
| ANL02FL | Computation | Set to 'Y' if the records satisfied both criteria met:
1. ANL01FL = 'Y'
2. the smallest ATPTGR1N >=8 per subject per symptom (PARAMCD) per vaccination (ATPTREF) |
| ANL04FL | Computation | Set to 'Y' to all records per subject per ATPTREF per PARAM if the smallest ATPTGR1N<8 and the largest ATPTGR1N>=8 |
| ANL05FL | Computation | Set 'Y' to all records with correspondent PARAMCD where PARACT1='LOCAL' and records at ATPTN=7 and ATPTN=8 per subject per ATPTREF per PARAMCD |
| ANL06FL | Computation | Set to 'Y' to all records correspondent PARAMCD where PARACT1= 'LOCAL' and any of below criteria met per subject per ATPTREF per PARAMCD
1. Have no record at ATPTN=7
2. Have record at ATPTN=7 but have no record at ATPTN=8. |
| ATM | Computation | Set to numeric time part of FACE.FADTC if source data are from FACE,
Set to numeric time part of FAAE.FADTC if source data are from FAAE,
Set to numeric time part of VS.VSDTC if source data are from VS |
| ATOXGR | Computation | Set to 'Grade 1' if AVALC= 'NO INTERFERENCE WITH ACTIVITY or contains 'GRADE 1',
Set to 'Grade 2' if AVALC= 'SOME INTERFERENCE WITH ACTIVITY NOT REQUIRING MEDICAL ATTENTION’ or contains 'GRADE 2',
Set to 'Grade 3' if AVALC= ‘PREVENTS DAILY ACTIVITY AND REQUIRES MEDICAL ATTENTION’ or contains 'GRADE 3',
Set to' Grade 4' if AVALC contains 'GRADE 4' |
| ATOXGR | Computation | Set to 'Grade 1' if AVAL = 25 - 50 mm or AVALC contains 'GRADE 1',
Set to 'Grade 2' if AVAL = 51 - 100 mm or AVALC contains 'GRADE 2',
Set to 'Grade 3' if AVAL > 100 mm or AVALC contains 'GRADE 3',
Set to 'Grade 4' if AVALC contains 'GRADE 4' |
| ATOXGR | Computation | Set to 'Grade 1' if AVAL = 38.0 – 38.4°C or AVALC contains 'GRADE 1',
Set to 'Grade 2' if AVAL = >38.4 – 38.9°C or AVALC contains 'GRADE 2',
Set to 'Grade 3' if AVAL = 39.0 – 40.0°C or AVALC contains 'GRADE 3',
Set to 'Grade 4' if AVAL > 40.0°C or AVALC contains 'GRADE 4', |
| ATOXGR | Computation | Set to 'Grade 1' if AVALC= 'NO INTERFERENCE WITH ACTIVITY' or contains 'GRADE 1',
Set to 'Grade 2' if AVALC= ‘SOME INTERFERENCE WITH ACTIVITY’ or contains 'GRADE 2',
Set to 'Grade 3' if AVALC= ‘SIGNIFICANT; PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3',
Set to 'Grade 4' if AVALC contains 'GRADE 4' |
| ATOXGR | Computation | Set to 'Grade 1' if AVALC=’NO INTERFERENCE WITH ACTIVITY or contains 'GRADE 1',
Set to 'Grade 2' if AVALC= ‘REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR SOME INTERFERERENCE WITH ACTIVITY’ or contains 'GRADE 2',
Set to 'Grade 3' if AVALC= ‘ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3',
Set to 'Grade 4' if AVALC contains 'GRADE 4' |
| ATOXGR | Computation | Set to 'Grade 1' if AVALC= ‘NO INTERFERENCE WITH ACTIVITY OR 1-2 EPISODES/24 HOURS’ or contains 'GRADE 1';
Set to 'Grade 2' if AVALC= ‘SOME INTERFERENCE WITH ACTIVITY OR >2 EPISODES/24 HOURS’ or contains 'GRADE 2';
Set to 'Grade 3' if AVALC= ‘PREVENTS DAILY ACTIVITY, REQUIRES OUTPATIENT IV HYDRATION’ or contains 'GRADE 3';
Set to 'Grade 4' if AVALC contains 'GRADE 4' |
| ATOXGR | Computation | Set to 'Grade 1' if AVALC=’DOES NOT INTERFERE WITH ACTIVITY’ or contains 'GRADE 1';
Set to 'Grade 2' if AVALC= ‘REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR INTERFERES WITH ACTIVITY’ or contains 'GRADE 2';
Set to 'Grade 3' if AVALC= ‘ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3';
Set to 'Grade 4' if AVALC contains 'GRADE 4' |
| ATPT | Computation | Set to FACE.FATPT if source data are from FACE,
Set to FAAE.FATPT if source data are from FAAE,
Set to VS.VSTPT if source data are from VS |
| ATPTGR1 | Computation | Set to 'Day 1' if ATPT contains 'Day 1'
Set to ATPT, otherwise |
| ATPTGR1N | Computation | Set to1 if ATPT contains 'Day 1',
Set to x part of 'Day x' of ATPT, otherwise |
| ATPTREF | Computation | If source data are from FACE or FAAE:
Set to 'Vaccination 1' if FATPTREF contains 'DOSE 1'
Set to 'Vaccination 2' if FATPTREF contains 'DOSE 2'
If source data are from VS:
Set to 'Vaccination 1' if VSTPTREF contains 'DOSE 1'
Set to 'Vaccination 2' if VSTPTREF contains 'DOSE 2' |
| AVAL | Computation | Set to corresponding FASTRESN based on corresponding AVALC where PARAMCD in (ERYTHDIA, SWELLDIA) if the record is from FACE or FAAE |
| AVAL | Computation | Set to corresponding VS.VSSTRESN based on corresponding AVALC where PARAMCD=FEVER if the record is from VS |
| AVALC | Computation | Set to FACE.FASTRESC if source data are from FACE,
Set to FAAE.FASTRESC if source data are from FAAE,
Set to VS.VSSTRESC if source data are from VS, |
| AVALCY | Computation | Set to 'Y' if data is from SUPPVS and SUPPVS.QNAM in ('MEDTAK', 'MEDTAKY', 'MEDTAKP') and QVAL='Y' |
| MAAEFL | Computation | For each PARAM, ATPTREF, FAEVAL, set to Y if there is one record in SUPPFAAE.QVAL where SUPPFACE.QNAME='MAAEFL' or SUPPFAAE.QNAME='MAAEFL' |
| PARAM | Computation | Set to 'Rash'||' '||FATEST if source data are from FAAE and FAOBJ='Rash', and FATESTCD ne 'SEV'
Set to 'Underarm Gland Swelling or Tenderness' if source data are from FAAE and FAOBJ='Underarm Gland Swelling or Tenderness' and FATESTCD = 'SEV'
Set to 'Nausea/Vomiting' if source data are from FAAE and FAOBJ='Nausea' and FATESTCD = 'SEV'
Set to FAOBJ||' Longest Diameter (mm)' if source data are from FAAE and FAOBJ in ('Erythema' 'Swelling') and FATEST='OCCURRENCE' and FAORRES='N'
Set to 'FAOBJ'||' '||FATEST||' '||'('||FAORRESU||')' if source data are from FAAE and FAOBJ in ('Erythema' 'Swelling') and FATEST='Longest Diameter'
Set to FAOBJ otherwise.
Set to 'Fever'||'('||VSSTRESU||')' if source data are from VS and VSTESTCD in ('TEMP' 'VSALL')
Note:
1. Please add space between the VSTEST and VS unit. If the VSSTRESU is missing, use non-missing VSSTRESU
2. For each PARAM, keep only one record per subject per vaccination (ATPTREF) |
| PARCAT1 | Computation | If source data are from FACE or FAAE:
Set to 'LOCAL' if FASCAT=ADMINISTRATION SITE
Set to FASCAT if FASCAT<>ADMINISTRATION SITE
Set to VSSCAT if source data are from VS |
| SRCDOM | Computation | Set to 'FAAE' if source data are from FAAE,
Set to 'FACE' if source data are from FACE,
Set to VS.DOMAIN if source data are from VS |
| SRCSEQ | Computation | Set to FAAE.FASEQ if source data are from FAAE,
Set to FACE.FASEQ if source data are from FACE,
Set to VS.VSSEQ if source data are from VS |
| SRCVAR | Computation | Set to 'FASTRESC' if source data are from FAAE or FACE,
Set to QVAL if PARAMCD in ('MEDTAK', 'MEDTAKT', 'MEDTAKP'),
Set to 'VSSTRESN' if source data are from VS |
| PAIN | Computation | Set to 'Grade 0' if FASTRESC=’NONE’ or FASTRESC contains 'GRADE 0'
Set to 'Grade 1' if FASTRESC='DOES NOT INTERFERE WITH ACTIVITY' or contains 'GRADE 1';
Set to 'Grade 2' if FASTRESC='REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR INTERFERES WITH ACTIVITY' or contains 'GRADE 2';
Set to 'Grade 3' if FASTRESC='ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY' or contains 'GRADE 3'
Set to 'Grade 4' if FASTRESC contains 'GRADE 4' |
| PARAM | Computation | Set to 'Rash Occurrence' if source data are from FACE and FAOBJ='Rash', and FATESTCD ne 'SEV'
Set to 'Rash' if source data are from FACE and FAOBJ='Solicited Rash', and FATESTCD = 'SEV'
Set to 'Underarm Gland Swelling or Tenderness' if source data are from FACE and FAOBJ='Underarm Gland Swelling or Tenderness' and FATESTCD = 'SEV'
Set to 'Lymphadenopathy Occurrence' if source data are from FACE and FAOBJ='Lymphadenopathy'
Set to 'Nausea/Vomiting' if source data are from FACE and FAOBJ='Nausea/Vomiting' and FATESTCD = 'SEV'
Set to 'Fever' || '(' ||VSSTRESU ||')' if source data are from VS and VSTESTCD in ('TEMP' 'VSALL')
Set to FAOBJ ||' Longest Diameter (mm)' if source data are from FACE and FAOBJ in ('Erythema' 'Swelling') and FATEST contains 'Occurrence' and FAORRES='NO'
Set to FAOBJ || ' ' || FATEST|| ' ' || '(' ||FAORRESU || ')' if source data are from FACE and FAOBJ in ('Erythema' 'Swelling') and FATEST='Longest Diameter'
Set to FAOBJ otherwise.
Create one record with PARAM='Prevent Pain or Fever from Occurring' if there is one record in VS where SUPPVS.QNAM='MEDTAKP' and QVAL='Y',
Create one record with PARAM='Treat Pain or Fever already Occurred' if there is one record in VS where SUPPVS.QNAM='MEDTAKT' and QVAL='Y'
Create one record with PARAM='Medication Taken Today for Pain or Fever' if there is one record in VS where SUPPVS.QNAM='MEDTAK' and QVAL='Y'
Note:
Please add space between the VSTEST and VS unit. If the VSSTRESU is missing, use non-missing VSSTRESU)
and assign AVAL=0 (see specs for AVAL) |
| PARCAT1 | Computation | If source data are from FACE:
Set to 'LOCAL' if FASCAT=ADMINISTRATION SITE
Set to FASCAT if FASCAT<>ADMINISTRATION SITE
Set to VSSCAT if source data are from VS
Set to 'SYSTEMIC' if PARAMCD='RASH'
Set to 'LOCAL' if PARAMCD='LYMPHOCC' |
| RASH | Computation | Set to 'Grade 0' if FASTRESC='GRADE 0 = NO RASH' or contains 'GRADE 0';
Set to 'Grade 1' if FASTRESC='GRADE 1 = LOCALIZED RASH, WITHOUT ASSOCIATED SYMPTOMS' or contains 'GRADE 1';
Set to 'Grade 2' if FASTRESC='GRADE 2 = MACULOPAPULAR RASH, COVERING 50% BODY SURFACE AREA WITH URTICARIA' or contains 'GRADE 2';
Set to 'Grade 3' if FASTRESC='GRADE 3 = GENERALIZED URTICARIAL, COVERING 50% BODY SURFACE AREA' or contains 'GRADE 3';
Set to 'Grade 4' if FASTRESC='GRADE 4 = GENERALIZED EXFOLIATIVE, ULCERATIVE OR BULLOUS DERMATITIS, E.G. STEVENS-JOHNSON SYNDROME OR ERYTHEMA MULTIFORME' or contains 'GRADE 4'; |
| SRCDOM | Computation | Set to FACE.DOMAIN if source data are from FACE
Set to VS.DOMAIN if source data are from VS |
| SRCOMM | Computation | Set to CO.COVAL where COREF=SRCOMMM |
| SRCSEQ | Computation | Set to FACE.FASEQ if source data are from FACE
Set to VS.VSSEQ if source data are from VS |
| SRCVAR | Computation | Set to 'FASTRESC' if source data are from FACE,
Set to 'VSSTRESN' if source data are from VS and PARAMCD = 'FEVER',
Set to 'SUPPVS.QVAL where QNAM='MEDTAK' for PARAMCD='MEDTAK',
Set to 'SUPPVS.QVAL where QNAM='MEDTAKT' for PARAMCD='MEDTAKT',
Set to 'SUPPVS.QVAL where QNAM='MEDTAKP' for PARAMCD='MEDTAKP' |
| SREVLFL | Computation | Set to SUPPFACE.QVAL where SUPPFACE.QNAME='SREVL' |
| ANYDUR | Computation | 1) Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD is not 'RASH', 'LYMPHOCC' ,''RASHOCC' or AVALC is Y where PARAMCD is 'RASHOCC'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once.
2) Use FAAE/VS data, count total number of records where (FAOBJ is ('Erythema', 'Swelling') and FATEST='Longest Diameter' and FASTRESN>=25 mm) or (FAOBJ is ('Erythema', 'Swelling') and FATEST contains 'Intensity' and FASTRESC contains GRADE 1, GRADE 2 or GRADE 3 or GRADE 4) or (FAAE.FAOBJ='Fever' and FASTRESC contains GRADE 1, GRADE 2, GRADE 3 or GRADE 4) or (for other FAOBJ and FASTRESC is not 'NONE', 'N' or missing) or (VSTESTCD='TEMP' and VSSTRESN>=38.0°C) per subject per vaccination (FATPTREF/VSTPTREF). If there are more than one record within same day (FATPT/VSTPT), subject and vaccination (FATPTREF/VSTPTREF), only count once.
3) sum of 1) and 2) by vaccination |
| ARTHRDUR | Computation | 1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='ARTHRALG'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once.
2. Use FAAE data, count total number of records where FAOBJ='Arthralgia' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once.
3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) . |
| ATPTREF | Computation | Set to ADAR.ATPTREF if data from ADAR
If source data are from FAAE
Set to ‘Vaccination 1' if FAAE.FATPTREF contains 'DOSE 1',
Set to ‘Vaccination 2' if FAAE.FATPTREF contains 'DOSE 2'
If source data are from VS
Set to 'Vaccination 1' if VS.VSTPTREF contains 'DOSE 1',
Set to 'Vaccination 2' if VS.VSTPTREF contains 'DOSE 2' |
| AVALC | Computation | Per subject per vaccination (ATPTREF):
Set to the maximum non-missing AVALC (Y>N) where PARAMCD is 'LYMPHOCC', 'RASHOCC' |
| AVALC | Computation | Set to AVALC of the record used to derive ATOXGR. Use the highest AVALC if multiple records |
| CHILLDUR | Computation | 1.Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='CHILLS'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once.
2. Use FAAE data, count total number of records where FAOBJ='Chills' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once.
3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) . |
| ERYTHDUR | Computation | 1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='ERYTHDIA'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once,
2. Use FAAE data, count total number of records where (FAOBJ='Erythema' and FATEST='Longest Diameter' and FASTRESN>=25 mm) or (FAOBJ='Erythema' and FATEST contains 'Intensity' and FASTRESC contains GRADE 1, GRADE 2 or GRADE 3 or GRADE 4) per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once,
3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) |
| FATIGDUR | Computation | 1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='FATIGUE'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once,
2. Use FAAE data, count total number of records where FAOBJ='Fatigue' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once,
3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) |
| FEVERDUR | Computation | 1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='FEVER'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once,
2. Use VS/FAAE data, count total number of records where (VSTESTCD='TEMP' and VSSTRESN>=38.0°C) or (FAAE.FAOBJ='Fever' and FASTRESC contains GRADE 1, GRADE 2, GRADE 3 or GRADE 4) per subject per vaccination (VSTPTREF/FATPTREF). If there are more than one record within same day (VSTPT/FATPT), subject and vaccination (VSTPTREF/FATPTREF), only count once,
3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/VSTPTREF/FATPTREF) |
| HEADADUR | Computation | 1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='HEADACHE'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once,
2. Use FAAE data, count total number of records where FAOBJ='Headache' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once,
3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) |
| HPLYMDUR | Computation | Use ADAR data, count total number of records with AVALC='Y' per subject per vaccination (ATPTREF) where ADAR.PARAMCD='LYMPHOCC'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once |
| HPRASDUR | Computation | Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD=' RASH'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once |
| LOCDUR | Computation | 1) Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARCAT1 is 'LOCAL'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once,
2) Use FAAE data, count total number of records where (FAOBJ is ('Erythema', 'Swelling') and FATEST='Longest Diameter' and FASTRESN>=25 mm) or (FAOBJ is ('Erythema', 'Swelling') and FATEST contains 'Intensity' and FASTRESC contains GRADE 1, GRADE 2 or GRADE 3 or GRADE 4) or (FAOBJ is ('Pain', 'Underarm Gland Swelling or Tenderness') and FASTRESC is not 'NONE' or missing) per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once,
3) sum of 1) and 2) by vaccination |
| LYMPHDUR | Computation | 1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD=' LYMPH '. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once,
2. Use FAAE data, count total number of records where FAOBJ='Underarm Gland Swelling or Tenderness' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once,
3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) |
| MYALGDUR | Computation | 1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='MYALGIA'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once,
2. Use FAAE data, count total number of records where FAOBJ='Myalgia' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once,
3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) |
| NAUSEDUR | Computation | 1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='NAUSEA'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once,
2. Use FAAE data, count total number of records where FAOBJ='Nausea/Vomiting' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once,
3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) |
| PAINDUR | Computation | 1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD=' PAIN '. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once,
2. Use FAAE data, count total number of records where FAOBJ='Pain' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once,
3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) |
| PARAM | Computation | Assign the PARAM to each subject and each ATPTREF (i.e., Vaccination 1, Vaccination 2) |
| PARCAT1 | Computation | Set to 'LOCAL' if PARAMCD in (LYMPHDUR, PAINDUR, ERYTHDUR, SWELLDUR, WLYMPH, WPAIN, WERYTH, WSWELL, WSLAR)
Set to 'SYSTEMIC' if PARAMCD in (HEADADUR, FATIGDUR, MYALGDUR, ARTHRDUR, NAUSEDUR, CHILLDUR, FEVERDUR, RASHDUR, WHEAD, WFATIGUE, WMYALGIA, WARTHR, WNAUSEA, WCHILLS,WFEVER, WSSAR) |
| RASHDUR | Computation | 1. Use ADAR data, count total number of records with AVALC='Y' per subject per vaccination (ATPTREF) where ADAR.PARAMCD='RASHOCC'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once,
2. Use FAAE data, count total number of records where FAOBJ='Rash' and FASTRESC is not 'N' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once,
3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) |
| SRCDOM | Computation | Set to 'ADAR' if PARAMCD does not contain 'DUR' |
| SRCSEQ | Computation | Set to ADAR.ASEQ based on ATOXGR/AVALC derivation for PARAMCD does not contain 'DUR' and set to the smallest one if multiple records |
| SRCVAR | Computation | Set to 'ATOXGR' if PARAM contains 'Worst'; Set to 'AVALC' if PARAMCD is 'RASHOCYN', 'LYMOCCYN' |
| SWELLDUR | Computation | 1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='SWELLDIA'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once,
2. Use FAAE data, count total number of records where (FAOBJ='Swelling' and FATEST='Longest Diameter' and FASTRESN>=25 mm) or (FAOBJ='Swelling' and FATEST contains 'Intensity' and FASTRESC contains GRADE 1, GRADE 2 or GRADE 3 or GRADE 4) per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once,
3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) |
| SYSDUR | Computation | Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARCAT1 is 'SYSTEMIC' and ADAR.PARAMCD is not 'RASH', 'LYMPHOCC' ,''RASHOCC' or AVALC is Y where PARAMCD is 'RASHOCC'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once,
2) Use FAAE/VS data, count total number of records where (FASCAT='SYSTEMIC' and FASTRESC is not 'NONE', 'N' or missing) or (VSTESTCD='TEMP' and VSSTRESN>=38.0°C) per subject per vaccination (FATPTREF/VSTPTREF). If there are more than one record within same day (FATPT/VSTPT), subject and vaccination (FATPTREF/VSTPTREF), only count once,
3) sum of 1) and 2) by vaccination |
| WARTHR | Computation | Per subject per vaccination (ATPTREF):
Set to the highest ATOXGR where ADAR.PARAMCD='ARTHRALG' |
| WCHILLS | Computation | Per subject per vaccination (ATPTREF):
Set to the highest ATOXGR where ADAR.PARAMCD='CHILLS' |
| WERYTH | Computation | Per subject per vaccination (ATPTREF):
Set to the highest ATOXGR where ADAR.PARAMCD='ERYTHDIA' |
| WFATIGUE | Computation | Per subject per vaccination (ATPTREF):
Set to the highest ATOXGR where ADAR.PARAMCD='FATIGUE' |
| WFEVER | Computation | Per subject per vaccination (ATPTREF):
Set to the highest ATOXGR where ADAR.PARAMCD='FEVER' |
| WHEAD | Computation | Per subject per vaccination (ATPTREF):
Set to the highest ATOXGR where ADAR.PARAMCD='HEADACHE' |
| WLYMPH | Computation | Per subject per vaccination (ATPTREF):
Set to the highest ATOXGR where ADAR.PARAMCD='LYMPH' |
| WMYALGIA | Computation | Per subject per vaccination (ATPTREF):
Set to the highest ATOXGR where ADAR.PARAMCD='MYALGIA' |
| WNAUSEA | Computation | Per subject per vaccination (ATPTREF):
Set to the highest ATOXGR where ADAR.PARAMCD='NAUSEA' |
| WPAIN | Computation | Per subject per vaccination (ATPTREF):
Set to the highest ATOXGR where ADAR.PARAMCD='PAIN' |
| WRASH | Computation | Per subject per vaccination (ATPTREF):
Set to the highest ATOXGR where ADAR.PARAMCD='RASH' |
| WSAR | Computation | Per subject per vaccination (ATPTREF):
Set to the highest ATOXGR where ADAR.PARAMCD is not 'RASH', 'LYMPHOCC', 'RASHOCC' |
| WSLAR | Computation | Per subject per vaccination (ATPTREF):
Set to the highest ATOXGR where ADAR.PARCAT1 is 'LOCAL' |
| WSSAR | Computation | Per subject per vaccination (ATPTREF):
Set to the highest ATOXGR where ADAR.PARCAT1 is 'SYSTEMIC' and ADAR.PARAMCD is not 'RASH', 'LYMPHOCC' ,''RASHOCC' |
| WSWELL | Computation | Per subject per vaccination (ATPTREF):
Set to the highest ATOXGR where ADAR.PARAMCD='SWELLDIA' |
| AENDT | Imputation | Set to numeric date part of CM.CMENDTC if day, month, and year are all present, or
Set to min of 31DECYYYY, EOSDT, or DTHDT if both day and month are missing,
Set to min of EOSDT, DTHDT, or xxMMMYYYY where xx is the last day of the month if only day is missing |
| AENDTF | Computation | Set to 'D' if only the day is imputed
Set to 'M' if the day and the month are imputed |
| AENDY | Computation | Set to AENDT - TR01SDT + 1 if AENDT >= TR01SDT
Set to ASTDT - TR01SDT if AENDT < TR01SDT |
| ASTDT | Imputation | Set to numeric date part of CM.CMSTDTC if day, month, and year are all present;
If only DAY is missing:
If the CM end date (CMENDTC) is after the date of first vaccination (ADSL.TR01SDT) or is missing and the start month and year of the CM (CMSTDTC) coincide with the start month and year of the first vaccination (ADSL.TR01SDT), use the date of first vaccination;
Otherwise, use the first day of the month,
If DAY and Month are both missing:
If the CM end date is after the date of first vaccination or is missing AND the start year of the CM coincides with the start year of the first vaccination, use the date of first vaccination
Otherwise, use the first day of the year;
If DAY, Month and Year are all missing, the date will not be imputed. blank otherwise
Note: if CMENDTC is partial:
If only day is missing, month and year coincide with or after the month and year of TR01SDT, treat CMENDTC as after TR01SDT, otherwise treat CMENDTC as before TR01SDT.
If month is missing (regardless of day is missing or not), if year coincides with or after the year of TR01SDT, treat CMENDTC as after TR01SDT, otherwise treat CMENDTC as before TR01SDT.
If year is missing (regardless of day and month), treat CMENDTC as after TR01SDT. |
| ASTDTF | Computation | Set to 'D' if only the day is imputed,
Set to 'M' if the day and the month are imputed |
| ASTDY | Computation | Set to ASTDT - TR01SDT + 1 if ASTDT >= TR01SDT, or
Set to ASTDT - TR01SDT if ASTDT < TR01SDT |
| ATCLEV1T | Computation | Set to SUPPCM.QVAL where QNAM='ATCLEV1T' |
| ATCLEV2T | Computation | Set to SUPPCM.QVAL where QNAM='ATCLEV2T' |
| ATCLEV3T | Computation | Set to SUPPCM.QVAL where QNAM='ATCLEV3T' |
| ATCLEV4T | Computation | Set to SUPPCM.QVAL where QNAM='ATCLEV4T' |
| CMFOTHSP | Computation | Set to SUPPCM.QVAL where QNAM='CMFOTHSP' |
| CMMOI1FL | Computation | Set to 'Y' If CMINDC contains 'Prophylax' and
CMDECOD contains
'PARACETAMOL', 'DIPHENHYDRAMINE HYDROCHLORIDE;PARACETAMOL', 'IBUPROFEN', 'DIPHENHYDRAMINE CITRATE;IBUPROFEN', 'DIPHENHYDRAMINE HYDROCHLORIDE', IBUPROFEN', 'NAPROXEN SODIUM', 'DEXTROMETHORPHAN HYDROBROMIDE' 'GUAIFENESIN', 'PARACETAMOL' 'PSEUDOEPHEDRINE HYDROCHLORIDE', 'DEXTROMETHORPHAN HYDROBROMIDE;DOXYLAMINE SUCCINATE', 'EPHEDRINE SULFATE', 'ETHANOL', 'PARACETAMOL', 'ACETYLSALICYLIC ACID;CAFFEINE', 'PARACETAMOL' |
| CMMOI2FL | Computation | Set to 'Y' If CMDECOD contains
'PARACETAMOL', 'DIPHENHYDRAMINE HYDROCHLORIDE;PARACETAMOL', 'IBUPROFEN', 'DIPHENHYDRAMINE CITRATE;IBUPROFEN', 'DIPHENHYDRAMINE HYDROCHLORIDE', 'IBUPROFEN',
'NAPROXEN SODIUM', 'DEXTROMETHORPHAN HYDROBROMIDE', 'GUAIFENESIN', 'PARACETAMOL;PSEUDOEPHEDRINE HYDROCHLORIDE';
'DEXTROMETHORPHAN HYDROBROMIDE;DOXYLAMINE SUCCINATE;EPHEDRINE SULFATE;ETHANOL;PARACETAMOL';
'ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL' |
| CMROTHSP | Computation | Set to SUPPCM.QVAL where QNAM='CMROTHSP' |
| CMSOLFL | Computation | Set to SUPPCM.QVAL when QNAM='CMSOL' |
| CMUOTHSP | Computation | Set to SUPPCM.QVAL where QNAM='CMUOTHSP' |
| FUPFL | Computation | Set to 'Y' if AENDT > TR01EDT + 27 days or AENDT is missing |
| MDOSREF | Computation | Set to 'Vaccination 1' if (.<TR01SDT<=ASTDT <DOSE2DT) or (.<TR01SDT<=ASTDT and DOSE2DT missing),
Set to 'Vaccination 2' if .<DOSE2DT<=ASTDT |
| MRDSTDY | Computation | Set to ASTDT – TR01SDT + 1 if MDOSREF='Vaccination 1',
Set to ASTDT – DOS2DT + 1 if MDOSREF='Vaccination 2' |
| ONTRTFL | Computation | Set to 'Y' if (ASTDT <= TR01EDT + 27 days) and (AENDT >= TR01SDT or AENDT is missing), or
if ASTDT is missing and (AENDT >= TR01SDT or AENDT is missing) |
| PREFL | Computation | Set to 'Y' if ASTDT < TR01SDT or ASTDT is missing |
| ADT | Computation | Set to numeric date part of FAOT.FADTC if source data are from FAOT,
Set to number date part of ER.ERDTC if source data are from ER,
Set to number date part of SS.SSDTC if source data are from SS |
| ANL01FL | Computation | Per subject per parameter and per AVISIT:
Set to 'Y' for the worst assessment (AVALC='Y' > 'N') within the same visit to be considered first,
Set 'Y' to the assessment at scheduled visit (i.e., VISIT doesn't contain 'Unshed') if there are multiple with same AVALC,
Set to the last assessment if there are 2 or more scheduled assessments at same visit |
| AVAL | Computation | Set to numeric part of ER.ERDUR |
| AVALC | Computation | Set to FAOT.FASTRESC if source data are from FAOT
Set to ER.EROCCUR if source data are from ER
Set to SS.SSSTRESC if source data are from SS
Set to numeric part of ER.ERDUR if PARAMCD=DUR and convert to character |
| AVISIT | Computation | Set to 'Day xx' part of VISIT if VISIT doesn't contain 'Unsched',
Set AVISIT by following visit window below if ADY>1 and VISIT contains 'Unsched':
Set to 'Day 8' if VISIT with 1<ADY<=11,
Set to 'Day 15' if VISIT with 12<=ADY<=22,
Set to 'Day 29' if VISIT with 23<=ADY<=32,
Set to 'Day 36' if VISIT with 33<=ADY<=39,
Set to 'Day 43' if VISIT with 40<=ADY<=50 ,
Set to 'Day 57' if VISIT with 51<=ADY<=133,
Set to 'Day 209' if VISIT with 134=<ADY<=301,
Set to 'Day 394' if VISIT with ADY>=302,
After the steps above, sort data by AVISITN and ADY, set the unscheduled visit (i.e., VISIT contains 'Unsched') records to blank if AVISITN >any previous AVISITN AND ADY<=any previous ADY). For example, Scheduled Day 36 is with AVISITN=6 (Day 36) and ADY=42 and an unscheduled visit is with AVISITN=7 (Day 43) and ADY=40, set AVISIT to blank for this unscheduled visit |
| EXPOSEDT | Computation | Set numeric of date part from ER.ERSTDTC for records where PARAMCD='CONTACT' and AVALC='Y' |
| OTHSPY | Computation | Concatenate all the SUPPFAOT.QVAL where QNAM='SYMPOTH' with ', ' if PARAMCD = 'OTHSYMPT' and AVALC = 'Y' for that subject and visit
Set to SUPPER.QVAL where QNAM = 'EXPOSEOT' if PARAMCD = 'EXPOTH' and AVALC='Y' |
| PARAM | Computation | Set to FAOT.FAOBJ if PARCAT1 = 'COVID-19 SYMPTOMS'
Note:
If there are multiple records where PARAM='Other Symptoms', only keep one, and set FASEQ to the earliest FAOT.FASEQ.
Set to ER.ERTERM if PARCAT1 = 'COVID-19 EXPOSURE'
Create following PARAM based on different source:
Set to PARAM='Duration' if ERDUR is not missing per subject per ERDTC for data is from SDTM.ER
Set to SSTEST per subject per visit for data is from SS |
| PARCAT1 | Computation | Set to FAOT.FACAT if source data are from FAOT
Set to ER.ERCAT if source data are from ER
For data from SS, set to 'COVID-19 SYMPTOMS' if SSTESTCD='COVIDSYM' and 'COVID-19 EXPOSURE' if SSTESTCD='COVID' |
| SRCDOM | Computation | Set FAOT.DOMAIN if source data are from FAOT,
Set to ER.DOMAIN if source data are from ER,
Set to SS.DOMAIN if source data are from SS |
| SRCSEQ | Computation | Set to FAOT.FASEQ if source data are from FAOT,
Set to ER.ERSEQ if source data are from ER,
Set to SS.SSEQ if source data are from SS |
| SRCVAR | Computation | Set to 'FASTRESC' if source data are from FAOT,
Set to 'EROCCUR' if source data are from ER and PARAMCD is not 'DUR',
Set to 'ERDUR' if source data are from ER and PARAMCD is 'DUR',
Set to 'SSSTRESC' if source data are from SS |
| SYMPTDT | Computation | Set numeric of SUPPFAOT.QVAL for date part where PARAMCD='COVID' and AVALC='Y' and QNAM = 'SYMPTDTC' |
| T2FSYMP | Computation | Set to ADT- (last EXPOSEDT on and prior to SYMPTDTC) + 1 per subject, find the first symptom date (SYMPTDTC where PARAMCD='COVID' and AVALC='Y') and the last EXPOSEDT on and prior to first symptom |
| DVSIG | Computation | Set to SUPPDV.QVAL where SUPPDV.QNAM='DVSIG' |
| DVTERM1 | Computation | Set to SUPPDV.QVAL where SUPPDV.QNAM='DVTERM1' |
| AENDT | Computation | Set numeric of date part of EX.EXENDTC |
| ASTDT | Computation | Set numeric of date part of EX.EXSTDTC |
| DOSEYNFL | Computation | Set to 'Y' if EXSTDTC is not missing.
Set to 'N' if EXSTDTC is missing and EC.ECOCCUR='N' |
| NDOSERS | Computation | Set to EC.ECREASOC |
| SRCDOM | Computation | Set to EX.DOMAIN if source data are from EX, or
Set to EC.DOMAIN if source data are from EC |
| SRCSEQ | Computation | Set to EX.EXSEQ if source data are from EX,
Set to EC.ECSEQ if source data are from EC |
| ABLFL | Computation | Set to 'Y' by selecting the latest ADTM or ADT if time is not available with non-missing AVAL/AVALC on or before ADSL.TR01SDTM (TR01SDT if time part of TR01SDTM is missing) for each SUBJID, PARCAT1 and PARAMCD |
| ADT | Computation | Set to numeric date part of IS.ISDTC |
| ADTM | Computation | Concatenate of ADT and ATM if both are available |
| ANL02FL | Computation | Same as ANL01FL
For PARCAT1='Serum SARS-CoV-2 Neutralizing Antibodies', only consider results from Set 1 LLOQ/ULOQ (MNET 40 and 1280, MN50 91.1 and 2031.87). |
| ATM | Computation | Set time part of IS.ISDTC |
| AVAL | Computation | Set to LOG10(0.5* times ISLLOQ) if ISSTRESC contains '<' or ISSTRESN<ISLLOQ
Set AVAL as LOG10(ULOQ) If ISSTRESC contains '>' or ISSTRESN>ULOQ,
Set to LOG10(IS.ISSTRESN), Otherwise |
| AVAL | Computation | Set AVAL as 0.5 times ISLLOQ if ISSTRESC contains '<' or ISSTRESN<ISLLOQ,
Set AVAL as ULOQ if ISSTRESC contains '>' or ISSTRESN>ULOQ,
Otherwise set to IS.ISSTRESN |
| AVAL | Computation | Set to LOG10(0.5* times ISLLOQ) if ISSTRESC contains "<" or ISSTRESN<ISLLOQ or contains 'BQL',
Set AVAL as LOG10(ULOQ) if ISSTRESC contains ">" or ISSTRESN>ULOQ,
Set to LOG10(IS.ISSTRESN), Otherwise |
| AVAL | Computation | Set to 0.5 times ISLLOQ if ISSTRESC contains '<' or ISSTRESN<ISLLOQ or contains 'BQL',
Set to ULOQ if ISSTRESC contains '>' or ISSTRESN>ULOQ
Set to IS.ISSTRESN, Otherwise |
| AVAL | Computation | Set to IS.ISSTRESC for PARAMCD='SARSCOV2' |
| AVISIT | Computation | Set to 'Baseline' if IABLFL='Y'
Set to 'Day xx' part of VISIT if ADY > 1 and VISIT doesn't contain "UNSCHEDULE",
Set AVISIT as follows: using the visit window below if ADY>1 and VISIT contains "UNSCHED":
Set to 'Day 15' if VISIT with 1<ADY<=22,
Set to 'Day 29' if VISIT with 23<=ADY<=36,
Set to 'Day 43' if VISIT with 37<=ADY<=50,
Set to 'Day 57' if VISIT with 51<=ADY<=133,
Set to 'Day 209' if VISIT with 134=<ADY<=301
Set to 'Day 394' if VISIT with ADY>=302 |
| BASE | Computation | Set to AVAL where ABLFL = 'Y' |
| CHG | Computation | Set to AVAL-BASE for post-baseline records |
| CRIT1 | Computation | Set to '>=2-fold Increase from Baseline' if CRIT1FL = 'Y' |
| CRIT1FL | Computation | Set to bank if PARAMCD not in (MNET, MN50, V65IGGS, V66IGGN) |
| CRIT1FL | Computation | Set to 'Y' if PARAMCD in (MNET, MN50) and post-baseline increase 2 times from the baseline value (R2BASE>=2) |
| CRIT1FL | Computation | Derive when both baseline result (BASE>.) and post-baseline result (AVAL) are non-missing and PARAMCD in (V65IGGS, V66IGGN):
Set to 'Y' if baseline result (BASE)<ISLLOQ and post-baseline >= 2* LLOQ (AVAL>=2*ISLLOQ) or baseline result (BASE) >= ISLLOQ and post-baseline increase 2 times from the baseline value (R2BASE>=2) |
| CRIT2 | Computation | Set to '>=3-fold Increase from Baseline' if CRIT2FL = 'Y' |
| CRIT2FL | Computation | Set to bank if PARAMCD not in (MNET, MN50, V65IGGS, V66IGGN) |
| CRIT2FL | Computation | Set to 'Y' if PARAMCD in (MNET, MN50) and post-baseline increase 3 times from the baseline value (R2BASE>=3) |
| CRIT2FL | Computation | Derive when both baseline result (BASE>.) and post-baseline result (AVAL) are non-missing and PARAMCD in (V65IGGS, V66IGGN):
Set to 'Y' if baseline result (BASE)<ISLLOQ and post-baseline >= 3* LLOQ (AVAL>=3*ISLLOQ) or baseline result (BASE) >= ISLLOQ and post-baseline increase 2 times from the baseline value (R2BASE>=3) |
| CRIT3 | Computation | Set to '>=4-fold Increase from Baseline' if CRIT3FL = 'Y' |
| CRIT3FL | Computation | Set to bank if PARAMCD not in (MNET, MN50, V65IGGS, V66IGGN) |
| CRIT3FL | Computation | Set to 'Y' if PARAMCD in (MNET, MN50) and post-baseline increase 3 times from the baseline value (R2BASE>=4) |
| CRIT3FL | Computation | Derive when both baseline result (BASE>.) and post-baseline result (AVAL) are non-missing and PARAMCD in (V65IGGS, V66IGGN):
Set to 'Y' if baseline result (BASE)<ISLLOQ and post-baseline >= 4* LLOQ (AVAL>=4*ISLLOQ) or baseline result (BASE) >= ISLLOQ and post-baseline increase 4 times from the baseline value (R2BASE>=4) |
| CRIT4 | Computation | Set to 'Seroconversion' if CRIT4FL = 'Y' |
| CRIT4FL | Computation | Set to bank if PARAMCD not in (MNET, MN50, V65IGGS) |
| CRIT4FL | Computation | Derive when both baseline result (BASE) and post-baseline result (AVAL) are non-missing and PARAMCD in (MNET, MN50, V65IGGS):
Set to 'Y' if baseline result BASE<ISLLOQ and post-baseline >= LLOQ (AVAL>=ISLLOQ) or baseline result BASE>= ISLLOQ and post-baseline increase 4 times from the baseline value (R2BASE>=4) |
| CRIT5 | Computation | Set to 'Seroresponse' if CRIT5FL = 'Y' |
| CRIT5FL | Computation | Set to blank if PARAMCD <> 'V65IGGS' |
| CRIT5FL | Computation | Derive when PARAMCD ='V65IGGS' and both baseline result (BASE>.) and post-baseline result (AVAL) are non-missing:
Set to 'Y' if baseline result BASE<ISLLOQ and post-baseline >= LLOQ (AVAL>=ISLLOQ) or baseline result BASE>=ISLLOQ and post-baseline increase 4.6 times from the baseline value (R2BASE>=4.6) |
| CRIT6 | Computation | Set to 'Seroconversion due to Infection' if CRIT6FL= 'Y' |
| CRIT6FL | Computation | Set to blank if PARAMCD not in ('SARSCOV2', 'V65IGGS') |
| CRIT6FL | Computation | Derive when both ADSL.ELECSBL and post-baseline result (AVAL where PARAMCD=V66IGGN or AVALC where PARAMCD=SARSCOV2) are non-missing:
Set to 'Y' if PARAMCD='SARSCOV2' and ADSL.ELECSBL= 'Negative' and post-baseline AVALC ='Positive',
Set to 'Y' if PARAMCD='V66IGGN' and ADSL.ELECSBL = 'Positive' and post-baseline result where increase 4 times from the baseline value (R2BASE>=4) |
| DTYPE | Computation | Set to 'HALFLLOQ' if AVAL is imputed with 0.5 times lSLLOQ,
Set to 'ULOQ' if AVAL is imputed with ULOQ |
| LOD | Computation | SUPPIS.QVAL where QNAM is 'LOD' |
| PARAM | Computation | Set to 'Elecsys Anti-SARS-CoV-2' if PARAMCD = 'SARSCOV2'
Set to ISTEST if PARCAT1='Serum SARS-CoV-2 Neutralizing Antibodies' and PARAMTYP is null,
Set to ISTEST ' (' || ISSTRESU || ')' * if PARCAT1='Serum SARS-CoV-2 Binding Antibodies' and PARAMTYP is null,
* Use the same PARAMCD with available unit if ISSTRESU is non-missing or ISSTRESU is not available for the test.
PARAMTYP is "Derived then assign PARAM based on PARAMCD:
Set to 'LOG10(MN Endpoint Titer)' if PARAMCD='L10MNET',
Set to 'LOG10(MN50)' if PARAMCD='L10MN50',
Set to 'LOG10(VAC58 Spike IgG Antibody)' if PARAMCD='LV58IGGS',
Set to 'LOG10(VAC58 Nucleocapsid IgG Antibody)' if PARAMCD='LV58IGGN',
Set to 'LOG10(VAC65 Spike IgG Antibody)' if PARAMCD='LV65IGGS',
Set to 'LOG10(VAC66 Nucleocapsid IgG Antibody)' if PARAMCD='LV66IGGN' |
| PARAMTYP | Computation | Set to 'DERIVED' if PARAMCD contains 'L10' or 'LV58' |
| PARCAT1 | Computation | Set to IS.ISCAT |
| PPBABRER | Computation | Set to PP_list.PBABREAS for PARCAT1='Serum SARS-CoV-2 Binding Antibodies' based on subject and visit (ADIS.AVISIT and pp_list.VISITTPT).
if subject has dosing error (ADSL.PPBABERS contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list if applicable |
| PPBABRFL | Computation | Set to 'Y' if PP_listing.PVSBABFL='Y' for PARCAT1='Serum SARS-CoV-2 Binding Antibodies' based on subject and visit (ADIS.AVISIT and pp_listing.VISITTPT). |
| PPNA2RFL | Computation | Set to 'Y' if ADSL.PPNAB2FL='Y' and PP_list2.PVSNABFL='Y' for PARCAT1='Serum SARS-CoV-2 Neutralizing Antibodies' based on subject and visit (ADIS.AVISIT and pp_list2.VISITTPT). |
| PPNABRER | Computation | Set to PP_list.PNABREAS for PARCAT1='Serum SARS-CoV-2 Neutralizing Antibodies' based on subject and visit (ADIS.AVISIT and pp_list.VISITTPT).
if subject has dosing error (ADSL.PPNABERS contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list if applicable |
| PPNABRFL | Computation | Set to 'Y' if PP_listing.PVSNABFL='Y' for PARCAT1='Serum SARS-CoV-2 Neutralizing Antibodies' based on subject and visit (ADIS.AVISIT and pp_listing.VISITTPT). |
| R2BASE | Computation | Set to AVAL/BASE if both are available and BASE is not 0 |
| ULOQ | Computation | Set to SUPPIS.QVAL where QNAM is 'ULOQ' |
| ABLFL | Computation | Set to 'Y' by selecting the latest ADTM or ADT if time is not available with non-missing AVAL/ LBSTRESC on or before TR01SDTM (TR01SDT if time part of TR01SDTM is missing) for each SUBJID, PARCAT1 and PARAMCD.
Note: If still multiple, selecting the records with the latest sequence number |
| ADT | Computation | Set to numeric date part of LB.LBDTC |
| ADTM | Computation | Set to numeric date time of LBDTC if time part is not missing |
| ANL02FL | Computation | Per subject per parameter, set to Y for the worst post-baseline toxicity grade (ATOXGRL) during vaccination stage (ASTAGEN=1) where ATOXDSCL is not missing using the following order: Grade 4> Grade 3>Grade 2>Grade 1>Grade 0. If there are more than one worst toxicity grades, then set to the first record. |
| ANL03FL | Computation | Per subject per parameter, set to Y for the worst post-baseline toxicity grade (ATOXGRH) during vaccination stage (ASTAGEN=1) where ATOXDSCH is not missing using the following order: Grade 4> Grade 3>Grade 2>Grade 1>Grade 0. If there are more than one worst toxicity grades, then set to the first record |
| ANRHI | Computation | Set to LB.LBSTNRHI |
| ANRIND | Computation | Set to LB.LBNRIND |
| ANRLO | Computation | Set to LB.LBSTNRLO |
| ASTAGE | Computation | For subjects who received 2 injections (DOSE1FL=’Y’ and DOSE2FL=’Y’), set to ‘Vaccination stage’ If .< ADSL.TR01SDTM <=ADTM and ADT<=earliest date of (date of Visit 7 (i.e. SV.SVSTDTC where SV.VISIT = 'Visit 7 Day 57'), ADSL.EOSDT, ADSL.DTHDT) ; set to 'Follow up stage' if ADT > non-missing date of Visit 7. If date of Visit 7, ADSL.EOSDT, and ADSL.DTHDT are all unavailable, set to ‘Vaccination stage’ for post baseline records. Else leave missing
For subjects who received only injection (DOSE1FL=’Y’ and DOSE2FL ne ’Y’), set to ‘Vaccination stage’ If .< ADSL.TR01SDTM <=ADTM and ADT<=earliest date of (date of Visit 4 (i.e. SV.SVSTDTC where SV.VISIT = 'Visit 4 Day 29'), ADSL.EOSDT, ADSL.DTHDT) ; set to 'Follow up stage' if ADT > non-missing date of Visit 4. If date of Visit 4, ADSL.EOSDT, and ADSL.DTHDT are all unavailable, set to ‘Vaccination stage’ for post baseline records. Else leave missing |
| ATM | Computation | Set to time part of LB.LBDTC |
| ATOXDSCH | Computation | Set to 'Blood Urea Nitrogen Increased' if PARAMCD='UREAN'
Set to 'Creatinine Increased' if PARAMCD='CREAT'
Set to 'Alkaline Phosphatase Increased' if PARAMCD='ALP'
Set to 'Alanine Aminotransferase Increased' if PARAMCD='ALT'
Set to 'Aspartate Aminotransferase Increased' if PARAMCD='AST'
Set to 'Bilirubin Increased' if PARAMCD='BILI'
Set to 'WBC Increased' if PARAMCD='WBC'
Set to 'Eosinophils Increased' if PARAMCD='EOS'
Set to 'Prothrombin Time Increased' if PARAMCD='PT'
Set to 'Activated Partial Thromboplastin Time Increased' if PARAMCD='APTT' |
| ATOXDSCL | Computation | Set to 'Hemoglobin Decreased' if PARAMCD='HGB'
Set to 'Lymphocytes Decreased' if PARAMCD='LYM'
Set to 'Neutrophils Decreased' if PARAMCD='NEUT'
Set to 'Platelets Decreased' if PARAMCD='PLAT'
Set to 'WBC Decreased' if PARAMCD='WBC' |
| ATOXGRH | Computation | If AVAL is not missing, then assign AVAL toxicity grading as follows:
Set to 'Grade 1' if 1.1 – 2.0 × ULN
Set to 'Grade 2' if >2.0 – 3.0 × ULN
Set to 'Grade 3' if >3.0 – 10 × ULN
Set to 'Grade 4' if > 10 × ULN
Otherwise, set to 'Grade 0'
(ULN = upper limit of normal) |
| ATOXGRH | Computation | If AVAL is not missing, then assign AVAL toxicity grading as follows:
Set to 'Grade 1' if 1.1 – 2.5 x ULN
Set to 'Grade 2' if >2.5 – 5.0 × ULN
Set to 'Grade 3' if >5.0 – 10 × ULN
Set to 'Grade 4' if > 10 × ULN
Otherwise, set to 'Grade 0'
(ULN = upper limit of normal) |
| ATOXGRH | Computation | If AVAL is not missing, then assign AVAL toxicity grading as follows:
Set to 'Grade 1' if >1.0 – 1.2 × ULN
Set to 'Grade 2' if >1.20 – 1.4 × ULN
Set to 'Grade 3' if >1.40 – 1.5 × ULN
Set to 'Grade 4' if > 1.5 × ULN
Otherwise, set to Set to 'Grade 0'
(ULN = upper limit of normal) |
| ATOXGRH | Computation | If AVAL is not missing, then assign AVAL toxicity grading as follows:
Set to 'Grade 1' if 1.1 – 2.5 x ULN
Set to 'Grade 2' if >2.5 – 5.0 × ULN
Set to 'Grade 3' if >5.0 – 10 × ULN
Set to 'Grade 4' if > 10 × ULN
Otherwise, set to 'Grade 0'
(ULN = upper limit of normal) |
| ATOXGRH | Computation | If AVAL is not missing and (ATOXGRHN>1 where PARAMCD=ALT or ATOXGRHN>1 where PARAMCD=AST), then assign AVAL toxicity grading as follows:
Set to 'Grade 1' if 1.1 – 1.25 × ULN
Set to 'Grade 2' if >1.25 – 1.5 × ULN
Set to 'Grade 3' if >1.5 – 1.75 × ULN
Set to 'Grade 4' if > 1.75 × ULN
Otherwise, set to Grade '0'
(ULN = upper limit of normal)
If AVAL is not missing and (ATOXGRHN=0 where PARAMCD=ALT and ATOXGRHN=0 where PARAMCD=AST), then assign AVAL toxicity grading as follows:
Set to 'Grade 1' if 1.1 – 1.5 × ULN
Set to 'Grade 2' if >1.5 – 2.0 × ULN
Set to 'Grade 3' if >2.0 – 3.0 × ULN
Set to 'Grade 4' if > 3.0 × ULN
Otherwise, set to Grade '0'
(ULN = upper limit of normal) |
| ATOXGRH | Computation | If AVAL is not missing, then assign toxicity grading based on numeric version of LBORRES (mg/dL) as follows:
Set to 'Grade 1' if 1.5-1.7
Set to 'Grade 2' if >1.7 -2.0
Set to 'Grade 3' if >2.0 -2.5
Set to 'Grade 4' if > 2.5 or requires dialysis
Otherwise, set to Set to 'Grade 0' |
| ATOXGRH | Computation | If AVAL is not missing, convert AVAL to cell/mm3 (AVAL*1000), then assign AVAL toxicity grading as follows:
Set to 'Grade 1' if 650 – 1,500
Set to 'Grade 2' if 1,501 – 5,000
Set to 'Grade 3' if > 5,000
Set to 'Grade 4' if pending Hypereosinophilic (Per medical review)
Otherwise, set to 'Grade 0' |
| ATOXGRH | Computation | If AVAL is not missing, then assign AVAL toxicity grading as follows:
Set to 'Grade 1' if >1.0 – 1.10 × ULN (LB.LBSTNRHI)
Set to 'Grade 2' if >1.10 – 1.20 × ULN
Set to 'Grade 3' if >1.20 – 1.25 × ULN
Set to 'Grade 4' if > 1.25 × ULN
Otherwise, set to 'Grade 0'
(ULN = upper limit of normal) |
| ATOXGRH | Computation | If AVAL is not missing, then assign toxicity grading based on numeric version of LBORRES (mg/dL) as follows:
Set to 'Grade 1' if 23-26
Set to 'Grade 2' if >26 -31
Set to 'Grade 3' if >31
Set to 'Grade 4' if requires dialysis pending
Otherwise, set to Grade '0' |
| ATOXGRH | Computation | If AVAL is not missing, convert AVAL to cell/mm3 (AVAL*1000),, then assign AVAL toxicity grading as follows:
Set to 'Grade 1' if 10,800 – 15,000
Set to 'Grade 2' if 1,5001 – 20,000
Set to 'Grade 3' if 20,001 – 25,000
Set to 'Grade 4' if > 25,000
Otherwise, set to 'Grade 0' |
| ATOXGRL | Computation | If AVAL is not missing and SEX=’F’, convert AVAL and CHG to g/dl (AVAL*0.1, CHG*0.1),
then assign AVAL toxicity grading as follows:
Set to 'Grade 1' if 11.0 – 12.0
Set to 'Grade 2' if 9.5 – 10.9
Set to 'Grade 3' if 8.0 – 9.4
Set to 'Grade 4' if < 8.0
Otherwise, set to Grade 0.
assign CHG toxicity grading as follows:
Set to 'Grade 1' if -1.5 to <0
Set to 'Grade 2' if -2 to -1.6
Set to 'Grade 3' if -5 to -2.1
Set to 'Grade 4' if < -5
Otherwise, set to 'Grade 0'
Choose the higher grade between the two.
If AVAL is not missing and SEX=’M’, convert AVAL and CHG to g/dl (AVAL*0.1, CHG*0.1),
then assign AVAL toxicity grading as follows:
Set to 'Grade 1' if 12.5 – 13.5
Set to 'Grade 2' if 10.5 – 12.4
Set to 'Grade 3' if 8.5 – 10.4
Set to 'Grade 4' if < 8.5
Otherwise, set to 'Grade 0'
assign CHG toxicity grading as follows:
Set to 'Grade 1' if -1.5 to <0
Set to 'Grade 2' if -2 to -1.6
Set to 'Grade 3' if -5 to -2.1
Set to 'Grade 4' if < -5
Otherwise, set to 'Grade 0'
Choose the higher grade between the two. |
| ATOXGRL | Computation | If AVAL is not missing, convert AVAL to cell/mm3 (AVAL*1000), then assign AVAL toxicity grading as follows:
Set to 'Grade 1' if 750 – 1,000
Set to 'Grade 2' if 500 – 749
Set to 'Grade 3' if 250 – 499
Set to 'Grade 4' if < 250
Otherwise, set to Grade '0' |
| ATOXGRL | Computation | If AVAL is not missing, convert AVAL to cell/mm3 (AVAL*1000), then assign AVAL toxicity grading as follows:
Set to 'Grade 1' if 1,500 – 2,000
Set to 'Grade 2' if 1,000 – 1,499
Set to 'Grade 3' if 500 – 999
Set to 'Grade 4' if < 500
Otherwise, set to 'Grade 0' |
| ATOXGRL | Computation | If AVAL is not missing, convert AVAL to cell/mm3 (AVAL*1000), then assign AVAL toxicity grading as follows:
Set to 'Grade 1' if 125,000 – 140,000
Set to 'Grade 2' if 100,000 – 124,000
Set to 'Grade 3' if 25,000 – 99,000
Set to 'Grade 4' if < 25,000
Otherwise, set to 'Grade 0' |
| ATOXGRL | Computation | If AVAL is not missing, convert AVAL to cell/mm3 (AVAL*1000), then assign AVAL toxicity grading as follows:
Set to 'Grade 1' if 2,500 – 3,500
Set to 'Grade 2' if 1,500 – 2,499
Set to 'Grade 3' if 1,000 – 1,499
Set to 'Grade 4' if < 1,000
Otherwise, set to 'Grade 0' |
| AVAL | Computation | Set to LB.LBSTRESN
Set to 0.5x number part of LBSTRESC if LBSTRESC contains '<',
Set to number part of LBSTRESC if LBSTRESC contains '>' |
| AVISIT | Computation | Set to 'Baseline' if ABLFL='Y',
Set to 'Day xx' part of VISIT if ADY>1 and VISIT doesn't contain 'Unsched',
Set AVISIT by following visit window below if ADY>1 and VISIT contains 'Unsched':
Set to 'Day 29' if VISIT with 1<ADY<=43,
Set to 'Day 57' if VISIT with 44<=ADY |
| BASE | Computation | Set to AVAL where ABLFL = 'Y' |
| BNRIND | Computation | Set to ANRIND where ABLFL = 'Y' |
| BTOXGRH | Computation | Set to ATOXGRH where ABLFL = 'Y' |
| BTOXGRL | Computation | Set to ATOXGRL where ABLFL = 'Y' |
| CHG | Computation | Set to AVAL-BASE for post-baseline records
Note: post-baseline records are defined as any result where (ADTM > ADSL.TR01SDTM if time is available or ADY > 1 otherwise. |
| CRIT1 | Computation | Set to PARAMCD ||' <2 x ULN' if CRIT1FL='Y' and PARAMCD in (ALP);
Set to PARAMCD ||' >=2 x ULN' if CRIT1FL='Y' and PARAMCD in (BILI);
Set to PARAMCD ||' >3 x ULN' if CRIT1FL='Y' and PARAMCD in (ALT, AST) |
| CRIT1FL | Computation | Set to 'Y' if AVAL/ANRHI <2 and PARAMCD =ALP;
Set to 'Y' if AVAL/ANRHI >=2 and PARAMCD =BILI;
Set to 'Y' if AVAL/ANRHI >3 and PARAMCD in (ALT, AST); |
| DTYPE | Computation | Set to 'HALFLLOQ' if LBSTRESC contains '<',
Set to 'ULOQ' if LBSTRESC contains '>'
Set to missing, otherwise |
| MDOSREF | Computation | Set to 'Vaccination 1' if (.<ADSL.TR01SDTM<=ADTM <ADSL.DOS2DTM) or (.<ADSL.TR01SDTM<=ADTM and ADSL.DOS2DTM is missing),
Set to 'Vaccination 2' if .<ADSL.DOS2DTM<=ADTM
Note: use date variables for comparison when time part is not available |
| MRDDY | Computation | Set to ADT – ADSL.TR01SDT+ 1 If MDOSREF='Vaccination 1',
Set to ADT – ADSL.DOSE2DT+ 1 If MDOSREF='Vaccination 2' |
| PARAM | Computation | Set to LBMETHOD||' '||LB.LBTEST|| ' (' || LB.LBSTRESU || ')' if LBCAT=CHEMISTRY and LBTESTCD=HCG and LBMETHOD='ELECTROCHEMILUMINESCENCE' or 'CHEMILUMINESCENCE',
Set to Urinary || LB.LBTEST|| ' (' || LB.LBSTRESU || ')' if LBSTRESU is not blank if LBCAT=URINALYSIS
Set to LB.LBTEST || ' (' || LB.LBSTRESU || ')' if LBSTRESU is not blank if LBCAT ne URINALYSIS
Set to LB.LBTEST appended with LBSTRESU from non-missing records in parenthesis if LBSTRESU is blank
Note: Please add space between parameter and unit |
| PARCAT1 | Computation | Set to LB.LBCAT |
| PCHG | Computation | Set to (CHG/BASE)*100 if both are available and BASE is not 0 |
| SHIFT1 | Computation | Only populate for post-baseline records
Set to BTOXGRL|| ' to '||ATOXGRL if both of BTOXGRL and ATOXGRL are not missing, or
Set to 'UNK to ' || ATOXGRL or BTOXGRL || 'to UNK' if either BTOXGRL or ATOXGRL is missing
Note:
Post-baseline records are defined as any result where (ADTM > ADSL.TR01SDTM if time is available or ADY > 1 otherwise |
| SHIFT2 | Computation | Only populate for post-baseline records
Set to BTOXGRH|| ' to '||ATOXGRH If both of BTOXGRH and ATOXGRH are not missing,
Set to 'UNK to ' || ATOXGRH or BTOXGRH || 'to UNK' If either BTOXGRH or ATOXGRH is missing
Note:
Post-baseline records are defined as any result where (ADTM > ADSL.TR01SDTM if time is available or ADY > 1 otherwise |
| ABLFL | Computation | Set to 'Y' for selecting the latest ADTM or ADT if time is not available with non-missing AVALC on or before ADSL.TR01SDTM (TR01SDT if time part of TR01SDTM is missing) for each SUBJID, PARCAT1 and PARAMCD.
Note: ABLFL apply for non-local (LOCALFL is not 'Y') only |
| ADT | Computation | Set to numeric date part of MB.MBDTC |
| ADTM | Computation | Set to numeric date time of MBDTC if time part is not missing |
| ATM | Computation | Set to time part of MB.MBDTC |
| AVALC | Computation | Set to mixed case of MB.MBSTRESC;
Set to 'Not Detected' if MBSTRESC is 'NOTDETECTED' |
| AVISIT | Computation | Set to 'Baseline' if ABLFL='Y',
Set to 'Day xx' part of VISIT if ADY>1 and VISITNUM is 5 or 8,
Set AVISIT by following visit window below if ADY>1 and VISITNUM is not 5, 8:
Set to 'Day 29' if VISIT with 2<=ADY<=43,
Set to 'Day 57' if VISIT with 44<=ADY<=70,
Set to 'Day 71 or Beyond if VISIT with 71<=ADY |
| AWTDIFF | Computation | Set to absolute value of (ADY - AWTARGET) |
| BASEC | Computation | Set to AVALC where ABLFL = 'Y' |
| LDTSTOTH | Computation | Set to SUPPMB.QVAL where QNAM is 'LDTSTOTH' |
| LDTTYPE | Computation | Set to SUPPMB.QVAL where QNAM is 'LDTTYPE' |
| LOCALFL | Computation | Set to SUPPMB.QVAL where QNAM is 'LOCALFL' |
| PARAM | Computation | Set to MB.MBTEST |
| PARCAT1 | Computation | Set to MB.MBCAT |
| CQ01FL | Computation | Set to 'Y' if CQ01NAM is not missing |
| CQ01NAM | Computation | Set to 'Autoimmune' if MHPTCD is in import.CMQ.PTCODE where CMQNAME='AUTOIMMUNE' |
| SMQ01FL | Computation | Set to 'Y' if SMQ01NAM is not missing |
| SMQ01NAM | Computation | Set to 'Anaphylactic Reaction' if MHDECOD is in import.SMQ where SMQNAME='ANAPHYLACTIC REACTION', else leave missing |
| SMQ01SC | Computation | Set to SMQ.SCOPE if MHDECOD is in import.SMQ where SMQNAME='ANAPHYLACTIC REACTION' |
| SMQ02FL | Computation | Set to 'Y' if SMQ02NAM is not missing and SMQ02SC is 'NARROW' |
| SMQ02NAM | Computation | Set to 'Angioedema' if MHDECOD is in import.SMQ where SMQNAME='ANGIOEDEMA' |
| SMQ02SC | Computation | Set to SMQ.SCOPE if MHDECOD is in import.SMQ where SMQNAME='ANGIOEDEMA' |
| SMQ06FL | Computation | Set 'Y' if SMQ06NAM is not missing and SMQ06SC is 'NARROW' |
| SMQ06NAM | Computation | Set to 'Hypersensitivity' if MHDECOD is in import.SMQ where SMQNAME='HYPERSENSITIVITY |
| SMQ06SC | Computation | Set to SMQ.SCOPE if MHDECOD is in import.SMQ where SMQNAME='HYPERSENSITIVITY' |
| AGEGR1 | Computation | Based on SUPPDM.QVALwhere QNAM='COHORT':
Set to '>=18 and <55 Years' if contains 'COHORT 1'
Set to '>=55 Years' if COHORT contains 'COHORT 2' |
| AGEGR2 | Computation | Based on AGE:
Set to '>=18 and <=22 Years' if 18<=AGE<=22';
Set to '>=23 and <=25 Years' if 23<=AGE<=25';
Set to '>25 and <55 Years' if 25<AGE<55';
Set to '>=55 Years' if COHORT contains 'COHORT 2' |
| BMIBL | Computation | Set to WEIGHTBL/(HEIGHTBL in meters)^2 |
| CBNRS | Computation | Set to SUPPRP.QVAL where QNAM='CBRSN' and VISIT=Screening |
| CHILDBP | Computation | Set to RP.RPORRES where RPTESTCD is CHILDPOT and VISIT=Screening |
| COMPFL | Computation | Set to "Y" if USUBJID exists in DS where DSCAT ="DISPOSITION EVENT" and DS.DSSCAT ="END OF STUDY" and DSDECOD = "COMPLETED";
Set to "N" if USUBJID exists in DS where DSCAT = "DISPOSITION EVENT" and DS.DSSCAT = "END OF STUDY" and DSDECOD^= "COMPLETED". |
| COV19BL | Computation | Based on MB.MBSTRESC where MBTESTCD='SARSCOV2' and SUPPMB.QVAL is not 'Y' where QNAM is 'LOCALFL' and (MBDTC is before the first vaccination (DM.RFXSTDTC) or on the first vaccination date if time is not available:
Set to 'Not Detected' if 'NOTDETECTED' and 'Detected' if 'DETECTED' |
| COV19FL | Computation | Set to 'Y' if there is one record in MB where MB.MBSTRESC is 'DETECTED' or 'POSITIVE' and MBTESTCD='SARSCOV2' or there is record in AE where AEDECOD is 'COVID-19', 'Asymptomatic COVID-19' or 'SARS-CoV-2 test positive',
Set to 'N', Otherwise |
| D29W7DFL | Computation | Set to 'Y' if DOSE2DT-TR01SDT+1>36;
Otherwise set to 'N' |
| DCSREAS | Computation | Mixed case of DS.DSTERM where DSCAT='DISPOSITION EVENT' and DSSCAT='END OF STUDY' AND DSDECOD not in ('COMPLETED', 'AE COVID', 'ADVERSE EVENT (OTHER)', 'PHYSICIAN DESICION', 'WITHDRAWAL BY SUBJECT (OTHER)', 'WITHDRAWAL BY SUBJECT (COVID-19 NON-INFECTION RELATED)', 'PROTOCOL DEVIATION', 'OTHER').
Set to 'Adverse Event (COVID-19 Infection)' if DS.DSDECOD is 'AE COVID'
Set to 'Adverse Event (Other)' if DS.DSDECOD is 'ADVERSE EVENT (OTHER)'
Set to 'Physician Decision' if DS.DSDECOD is 'PHYSICIAN DESICION'
Set to 'Withdrawal of Consent (Other)' if DS.DSDECOD is 'WITHDRAWAL BY SUBJECT (OTHER)'
Set to 'Withdrawal of Consent (COVID-19 Non-Infection Related)' if DS.DSDECOD is 'WITHDRAWAL BY SUBJECT (COVID-19 NON-INFECTION RELATED)'
Set to 'Protocol Deviation' if DS.DSDECOD is 'PROTOCOL DEVIATION'
Set to 'Other' if DS.DSDECOD is 'OTHER' |
| DCSREASP | Computation | DS.DSTERM where DSCAT='DISPOSITION EVENT' and DSSCAT='END OF STUDY' AND DSDECOD in ('ADVERSE EVENT (OTHER)', 'PHYSICIAN DESICION', 'WITHDRAWAL BY SUBJECT (OTHER)', 'WITHDRAWAL BY SUBJECT (COVID-19 NON-INFECTION RELATED)', 'PROTOCOL DEVIATION', 'OTHER') |
| DCTREAS | Computation | Mixed case of DS.DSTERM where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' AND DSDECOD not in ('COMPLETED', 'AE COVID', 'ADVERSE EVENT (OTHER)', 'PHYSICIAN DESICION', 'WITHDRAWAL BY SUBJECT (OTHER)', 'WITHDRAWAL BY SUBJECT (COVID-19 NON-INFECTION RELATED)', 'PROTOCOL DEVIATION', 'OTHER'):
Set to 'Adverse Event (COVID-19 Infection)' if DS.DSDECOD is 'AE COVID'
Set to 'Adverse Event (Other)' if DS.DSDECOD is 'ADVERSE EVENT (OTHER)'
Set to 'Physician Decision' if DS.DSDECOD is 'PHYSICIAN DESICION'
Set to 'Withdrawal of Consent (Other)' if DS.DSDECOD is 'WITHDRAWAL BY SUBJECT (OTHER)'
Set to 'Withdrawal of Consent (COVID-19 Non-Infection Related)' if DS.DSDECOD is 'WITHDRAWAL BY SUBJECT (COVID-19 NON-INFECTION RELATED)'
Set to 'Protocol Deviation' if DS.DSDECOD is 'PROTOCOL DEVIATION'
Set to 'Other' if DS.DSDECOD is 'OTHER' |
| DCTREASP | Computation | DS.DSTERM where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' AND DSDECOD in ('ADVERSE EVENT (OTHER)', 'PHYSICIAN DESICION', 'WITHDRAWAL BY SUBJECT (OTHER)', 'WITHDRAWAL BY SUBJECT (COVID-19 NON-INFECTION RELATED)', 'PROTOCOL DEVIATION', 'OTHER') |
| DOSE1FL | Computation | Set to 'Y' if USUBJID exists in EX with non-missing EXSTDTC where EX.VISIT contains 'Day 1'; Set to 'N' otherwise |
| DOSE2FL | Computation | Set to 'Y' if USUBJID exists in EX with non-missing EXSTDTC where EX.VISIT contains 'Day 29'; Set to 'N' otherwise |
| DOSEROFL | Computation | Set to 'Y' if subject received any dose (based on EX.EXTRT, EX.EXDOSE or EX.EXDOSTXT) which is different from the randomized arm (ARM);
'N' otherwise |
| DTHAUTOP | Computation | Set to SUPPDS.QVAL where QNAM='DTHAUTOP' |
| DTHDT | Computation | Set to DM.DTHDTC and convert to numeric |
| DVBABFL | Computation | Based on PP_LISTING, If a subject is excluded from subject-level PP set for bAb and has one record with PBABDVFL='Y', then set to 'Y'.
Set to 'N' otherwise. |
| DVNABFL | Computation | Based on PP_LISTING, If a subject is excluded from subject-level PP set for nAb and has one record with PNABDVFL='Y', then set to 'Y'.
set to 'N' otherwise. |
| ELECSBL | Computation | Based on IS.ISSTRESC where ISTESTCD = 'SARSCOV2' and (date of ISDTC is on or before the date of first vaccination (DM.RFXSTDTC) |
| FASBABFL | Computation | Set to 'Y' if
1. SAFFL='Y; and
2. Have at least one non-missing IS.ISSTRESC with ISCAT contains 'Serum SARS-CoV-2 Binding Antibodies' before the first vaccination (DM.RFSTDTC), and
3. Have at least one non-missing IS.ISSTRESC with ISCAT contains 'Serum SARS-CoV-2 Binding Antibodies' post the first vaccination |
| FASBABRS | Computation | Only for subjects with RANDFL='Y'.
If SAFFL='N', set to 'Did not receive any study vaccination';
If SAFFL='Y' and FASBABFL='N', set to 'There were no immunogenicity results at baseline and at least one post-vaccination.'.
blank otherwise. |
| FASNA2FL | Computation | Set to 'Y' if
1. SAFFL='Y' and
2. Have at least one non-missing IS.ISSTRESC with ISCAT contains 'Serum SARS-CoV-2 Neutralizing Antibodies' on or before the date of the first vaccination (TR01SDT), and
3. Have at least one non-missing IS.ISSTRESC with ISCAT contains 'Serum SARS-CoV-2 Neutralizing Antibodies' post the date of first vaccination,
Set to 'N' otherwise |
| FASNABFL | Computation | Set to 'Y' if
1. SAFFL='Y; and
2. Have at least one non-missing IS.ISSTRESC with ISCAT contains 'Serum SARS-CoV-2 Neutralizing Antibodies' before the first vaccination (DM.RFSTDTC), and
3. Have at least one non-missing IS.ISSTRESC with ISCAT contains 'Serum SARS-CoV-2 Neutralizing Antibodies' post the first vaccination |
| FASNABRS | Computation | Only for subjects with RANDFL='Y'.
If SAFFL='N', set to 'Did not receive any study vaccination';
If SAFFL='Y' and FASNABFL='N', set to 'There were no immunogenicity results at baseline and at least one post-vaccination.'
blank otherwise |
| HEIGHTBL | Computation | The last non-missing VS.VSSTRESN where VSTESTCD = “HEIGHT” and (VSDTC is before the first vaccination (DM.RFXSTDTC) or on the first vaccination date with VSTPT contains 'PRE-DOSE'.) |
| PBD209ER | Computation | Only for subjects with RANDFL='Y' and PBD209FL='N':
Set to PP_list.PBABREAS where VISITTPT = 'Day 209'
If subject has dosing error (ADSL.PPBABERS contains 'Dosing error') then Set to 'Dosing error' and concatenate with the reason from PP_list if applicable |
| PBD209FL | Computation | Set PP_LIST.PVSBABFL where VISITTPT='Day 209'
Set to 'N' if subject's actual doses is outside + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose (refer to PPBABFL) |
| PN2209ER | Computation | Only for subjects with RANDFL='Y' and PN2209FL='N':
Set to PP_list2.PNABREAS where VISITTPT='Day 209'
If subject has dosing error (ADSL.PPNAB2ER contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list2 if applicable |
| PN2209FL | Computation | Set PP_LIST2.PVSNABFL where VISITTPT='Day 209'
Set to 'N' if subject's actual doses is outside + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose (refer to PPBABFL) |
| PN2D29ER | Computation | Only for subjects with RANDFL='Y' and PN2D29FL='N':
Set to PP_list2.PNABREAS where VISITTPT='Day 29'.
if subject has dosing error (ADSL.PPNAB2ER contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list2 if applicable |
| PN2D29FL | Computation | Set PP_LIST2.PVSNABFL where VISITTPT='Day 29',
Set to 'N' if subject's actual doses is outside + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose (refer to PPBABFL) |
| PN2D57ER | Computation | Only for subjects with RANDFL='Y' and PN2D57FL='N':
Set to PP_list2.PNABREAS where VISITTPT='Day 57'.
if subject has dosing error (ADSL.PPNAB2ER contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list2 if applicable |
| PN2D57FL | Computation | Set PP_LIST2.PVSNABFL where VISITTPT='Day 57',
Set to 'N' if subject's actual doses is outside + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose (refer to PPBABFL) |
| PND209ER | Computation | Only for subjects with RANDFL='Y' and PND209FL='N':
Set to PP_list.PNABREAS where VISITTPT='Day 209'
If subject has dosing error (ADSL.PPNABERS contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list if applicable |
| PND209FL | Computation | Set PP_LIST.PVSNABFL where VISITTPT='Day 209'
Set to 'N' if subject's actual doses is outside + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose (refer to PPBABFL) |
| PPBABERS | Computation | Only for subjects with RANDFL='Y' and PPBABFL='N':
if subject is excluded due to dosing error as defined in PPBABFL then set to 'Dosing error' and concatenate the reasons from PP_list if the subject is also excluded due to other reasons,
For exclusion based on PP_list, set to PP_list.PBABREAS and concatenate all unique reasons (Note: merge data by USUBJID) |
| PPBABFL | Computation | Subjects in FAS for bAb and
1. Complied with the injection schedule as defined in the protocol visit window,
2. don’t have COVID-19 infection at baseline,
3. don't have deviation impact bAb responses.
4. both actual doses are within + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose
set to 'Y' if
1) for #1-3, based on PP_LIST, If a subject has one record with PVSBABFL='Y', and
2) for #4,
a) both TRT01P and TRT01A are 'Placebo', or
b) both TRT01P and TRT01A are 'mRNA-1273 50 ug' and there is no record in EX where EXTRT is 'Placebo' or (EXTRT is 'mRNA-1273' and EXDOSTXT contains '>0-25', '>75-<100' or '>100-125', or '>125 or above'), or
c) both TRT01P and TRT01A are 'mRNA-1273 100 ug' and there is no record in EX where EXTRT is 'Placebo' or (EXTRT is 'mRNA-1273' and EXDOSTXT contains '>0-25', '>25-<50' or >50-75', '>125 or above'),
Set to 'N' otherwise |
| PPBD29FL | Computation | Set PP_LIST.PVSBABFL where VISITTPT='Day 29',
Set to 'N' if subject's actual doses is outside + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose (refer to PPBABFL) |
| PPBD57ER | Computation | Only for subjects with RANDFL='Y' and PPBD57FL='N':
Set to PP_list.PBABREAS where VISITTPT='Day 57'.
if subject has dosing error (ADSL.PPBABERS contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list if applicable |
| PPBD57FL | Computation | Set PP_LIST.PVSBABFL where VISITTPT='Day 57'
Set to 'N' if subject's actual doses is outside + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose (refer to PPBABFL) |
| PPNAB2ER | Computation | Only for subjects with RANDFL='Y' and PPNAB2FL='N'.
if subject is excluded due to dosing error as defined in PPNABFL then set to 'Dosing error' and concatenate the reasons from PP_list2 if the subject is also excluded due to other reasons.
For exclusion based on PP_list2, set to PP_list2.PNABREAS and concatenate all unique reasons (Note: merge data by USUBJID) |
| PPNAB2FL | Computation | Subjects with FAS for nAb and
1. Complied with the injection schedule as defined in the protocol visit window,
2. don’t have COVID-19 infection at baseline,
3. don't have deviation impact nAb responses.
4. both actual doses are within + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose.
set to 'Y' if
1) for #1-3, based on PP_LIST2, If a subject has one record with PVSNABFL='Y', and
2) for #4,
a) both TRT01P and TRT01A are 'Placebo'; or
b) both TRT01P and TRT01A are 'mRNA-1273 50 ug' and there is no record in EX where EXTRT is 'Placebo' or (EXTRT is 'mRNA-1273' and EXDOSTXT contains '>0-25', '>75-<100' or '>100-125', or '>125'); or
c) both TRT01P and TRT01A are 'mRNA-1273 100 ug' and there is no record in EX where EXTRT is 'Placebo' or (EXTRT is 'mRNA-1273' and EXDOSTXT contains '>0-25', '>25-<50 ug' or >50-75', '>125');
'N' otherwise. |
| PPNABERS | Computation | Only for subjects with RANDFL='Y' and PPNABFL='N',
if subject is excluded due to dosing error as defined in PPNABFL then set to 'Dosing error' and concatenate the reasons from PP_list if the subject is also excluded due to other reasons,
For exclusion based on PP_list, set to PP_list.PNABREAS and concatenate all unique reasons (Note: merge data by USUBJID) |
| PPNABFL | Computation | Subjects with FAS for nAb and
1. Complied with the injection schedule as defined in the protocol visit window,
2. don’t have COVID-19 infection at baseline,
3. don't have deviation impact nAb responses.
4. both actual doses are within + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose.
set to 'Y' if
1) for #1-3, based on PP_LIST, If a subject has one record with PVSNABFL='Y', and
2) for #4,
a) both TRT01P and TRT01A are 'Placebo', or
b) both TRT01P and TRT01A are 'mRNA-1273 50 ug' and there is no record in EX where EXTRT is 'Placebo' or (EXTRT is 'mRNA-1273' and EXDOSTXT contains '>0-25', '>75-<100' or '>100-125', or '>125'), or
c) both TRT01P and TRT01A are 'mRNA-1273 100 ug' and there is no record in EX where EXTRT is 'Placebo' or (EXTRT is 'mRNA-1273' and EXDOSTXT contains '>0-25', '>25-<50 ug' or >50-75', '>125'),
Set to 'N' otherwise |
| PPND29ER | Computation | Only for subjects with RANDFL='Y' and PPND29FL='N':
Set to PP_list.PNABREAS where VISITTPT='Day 29'.
if subject has dosing error (ADSL.PPNABERS contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list if applicable |
| PPND29FL | Computation | Set PP_LIST.PVSNABFL where VISITTPT='Day 29',
Set to 'N' if subject's actual doses is outside + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose (refer to PPBABFL) |
| PPND57ER | Computation | Only for subjects with RANDFL='Y' and PPND57FL='N':
Set to PP_list.PNABREAS where VISITTPT='Day 57'.
if subject has dosing error (ADSL.PPNABERS contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list if applicable |
| PPND57FL | Computation | Set PP_LIST.PVSNABFL where VISITTPT='Day 57',
Set to 'N' if subject's actual doses is outside + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose (refer to PPBABFL) |
| PREVSCR | Computation | Set to SUPPDM.QVAL where QNAM='PREVSCR' per USUBJID |
| PROTVER | Computation | Set to SUPPDM.QVAL where QNAM is PROTVER |
| RACESPY | Computation | If RACE='OTHER' then set to SUPPDM.QVAL where QNAM is RACEOTH;
If RACE='MULTIPLE' then set to SUPPDM.QVAL where QNAM is MULRACE |
| RANDDT | Computation | DS.DSSTDTC where DSTERM='RANDOMIZED' and DSCAT='PROTOCOL MILESTONE' |
| RANDFL | Computation | Set to 'Y' if USUBJID exists in DS where DSDECOD='RANDOMIZED' and DSSTDTC not missing and DSREFID not missing. Set to 'N' otherwise |
| RANDNUM | Computation | Set to DS.DSREFID |
| RFICDT | Computation | Date part of DM.RFICDTC |
| SAFEREAS | Computation | Only for subjects with RANDFL='Y'.
Set to 'Did not receive any vaccination' if SAFFL='N'.
blank otherwise |
| SAR1ERS | Computation | Only for subjects with RANDFL='Y'.
If SAFFL='N', set to 'Did not receive any study vaccination';
If SAFFL='Y' and SAR1FL='N', set to 'Did not contribute any solicited AR data for Vaccination #1'.
blank otherwise |
| SAR1FL | Computation | Set to 'Y' if both criteria met:
1. SAFFL='Y';
2. Have at least one non-missing FAORRES where FATPTREF = 'DOSE 1' in FACE OR have at least one non-missing VSORRES where VSTPTREF = 'DOSE 1' and VSTEST contains "Temperature" where VSCAT contains "REACTOGENICITY" in VS;
Set to 'N' otherwise. |
| SAR2ERS | Computation | Only for subjects with RANDFL='Y'.
If SAFFL='N', set to 'Did not receive any study vaccination';
If SAFFL='Y' and DOSE2FL='N', set to 'Did not receive Vaccination #2'.
If SAFFL='Y'and DOSE2FL='Y' and SAR2FL='N', set to 'Did not contribute any solicited AR data for Vaccination #2'.
blank otherwise |
| SAR2FL | Computation | Set to 'Y' if all criteria met:
1. SAFFL='Y';
2. Have at least one non-missing FAORRES where FATPTREF = 'DOSE 2' in FACE OR have at least one non-missing VSORRES where VSTPTREF = 'DOSE 2' and VSTEST contains "Temperature" where VSCAT contains "REACTOGENICITY" in VS;
3. DOSE2FL='Y';
Set to 'N' otherwise |
| SARAFL | Computation | Set to 'Y' if SAR1FL='Y' or SAR2FL='Y' |
| SENTLFL | Computation | Set to SUPPDM.QVAL where QNAM='SENTL' |
| CBNRS | Computation | Set to SUPPRP.QVAL where QNAM='CBRSN' |
| CHILDBP | Computation | Set to RP.RPORRES where RPTESTCD is CHILDPOTand VISIT=Screening |
| PREVSCR | Computation | Set to SUPPDM.QVAL where QNAM='PREVSCR' per USUBJID |
| PROTVER | Computation | Set to SUPPDM.QVAL where QNAM is PROTVER and VISIT=Screening |
| RACESPY | Computation | Set to SUPPDM.QVAL where QNAM is RACEOTH if RACE='OTHER',
Set to SUPPDM.QVAL where QNAM is MULRACE if RACE='MULTIPLE' |
| RFICDT | Computation | Set to Date part of DM.RFICDTC |
| SCFREAS | Computation | Set to DS.DSTERM where DSCAT='DISPOSITION EVENT' and DSSCAT='SCREEN FAILURE' and DS.DSDECOD^='OTHER',
Set to 'Other' if DS.DSDECOD='OTHER' where DSCAT = 'DISPOSITION EVENT' and DSSCAT= 'SCREEN FAILURE' |
| SCFREASP | Computation | Set to DS.DSTERM where SCFREAS='OTHER' |
| UICF | Computation | Set to 'Y' if there is a record in DS where DSSCAT = 'OPEN LABEL' and DSDECOD = 'INFORMED CONSENT OBTAINED',
Set to 'N' |
| UNBLND | Computation | Set to SUPPDM.QVAL where QNAM = 'UNBLNDYN' |
| WEIGHTBL | Computation | The last non-missing VS.VSSTRESN where VSTESTCD = 'WEIGHT' and (VSDTC is before the first vaccination (DM.RFXSTDTC) or on the first vaccination date with VSTPT contains 'PRE-DOSE') |
| ABLFL | Computation | Set to 'Y' by selecting the latest ADTM or ADT if ATM is missing with non-missing AVAL/AVALC on or before TR01SDTM (TR01SDT if time part of TR01SDTM is missing) for each SUBJID and PARAMCD
Note: exclude records where ADT is the same as TR01SDT and VSTPT^='PRE-DOSE' |
| ADT | Computation | Set to numeric date part of VS.VSDTC |
| ADTM | Computation | Set to numeric date time of VSDTC if time part is not missing |
| ANL02FL | Computation | Set to 'Y' by selecting the first worst toxicity grade (ATOXGRL Worst Case Order: Grade 4> Grade 3>Grade 2>Grade 1>Grade 0) by Subject, Parameter and Analysis Visit |
| ANL03FL | Computation | Set to 'Y' by selecting the first worst toxicity grade (ATOXGRH Worst Case Order: Grade 4> Grade 3>Grade 2>Grade 1>Grade 0) by Subject, Parameter and Analysis Visit |
| ASTAGE | Computation | For subjects who received 2 injections (DOSE1FL='Y' and DOSE2FL='Y'),
Set to 'Vaccination stage' If .< ADSL.TR01SDTM <=ADTM and ADT<=earliest date of Visit 7, ADSL.EOSDT, ADSL.DTHDT
Set to 'Follow up stage' if ADT > non-missing date of Visit 7 or dates of Visit 7, ADSL.EOSDT, and ADSL.DTHDT are all unavailable,
Set to ‘Vaccination stage’ for post baseline records
For subjects who received only injection (DOSE1FL='Y' and DOSE2FL ne 'Y'),
Set to 'Vaccination stage' If .< ADSL.TR01SDTM <=ADTM and ADT<=earliest date of Visit 4, ADSL.EOSDT, ADSL.DTHDT,
Set to 'Follow up stage' if ADT > non-missing date of Visit 4 or dates of Visit 4, ADSL.EOSDT, and ADSL.DTHDT are all unavailable,
Set to 'Vaccination stage' for post baseline records |
| ATM | Computation | Set to numeric time part of VS.VSDTC |
| ATOXDSCH | Computation | Set to 'Fever' if PARAMCD = 'TEMP',
Set to 'Tachycardia' if PARAMCD = 'PULSE',
Set to 'Systolic Hypertension' if PARAMCD = 'SYSBP',
Set to 'Diastolic Hypertension' if PARAMCD = 'DIABP',
Set to 'Respiratory Rate Increased' if PARAMCD = 'RESP' |
| ATOXDSCL | Computation | Set to 'Bradycardia' if PARAMCD = 'PULSE',
Set to Hypotension' if PARAMCD = 'SYSBP' |
| ATOXGRH | Computation | Assign AVAL toxicity grading as follows If AVAL is not missing:
Set to 'Grade 1' if 91 – 95
Set to 'Grade 2' if 96 – 100
Set to 'Grade 3' if >100
Set to 'Grade 4' is based on medical input:
Otherwise, set to 'Grade 0' |
| ATOXGRH | Computation | Assign AVAL toxicity grading as follows If AVAL is not missing:
Set to 'Grade 1' if 101 – 115
Set to 'Grade 2' if 116 – 130
Set to 'Grade 3' if >130
Set to 'Grade 4' is based on medical input:
Otherwise, set to 'Grade 0' |
| ATOXGRH | Computation | Assign AVAL toxicity grading as follows If AVAL is not missing:
Set to 'Grade 1' if 17 – 20
Set to 'Grade 2' if 21 – 25
Set to 'Grade 3' if >25
Set to 'Grade 4' is based on medical input:
Otherwise, set to 'Grade 0' |
| ATOXGRH | Computation | Assign AVAL toxicity grading as follows If AVAL is not missing:
Set to 'Grade 1' if 141 – 150
Set to 'Grade 2' if 151 – 155
Set to 'Grade 3' if >155
Set to 'Grade 4' is based on medical input:
Otherwise, set to 'Grade 0' |
| ATOXGRH | Computation | Assign AVAL toxicity grading as follows If AVAL is not missing:
Set to 'Grade 1' if 38.0 – 38.4
Set to 'Grade 2' if 38.5 – 38.9
Set to 'Grade 3' if 39.0 – 40.0
Set to 'Grade 4' if >40.0
Otherwise, set to 'Grade 0' |
| ATOXGRL | Computation | Assign AVAL toxicity grading as follows If AVAL is not missing:
Set to 'Grade 1' if 50 – 54
Set to 'Grade 2' if 45 – 49
Set to 'Grade 3' if <45
Set to 'Grade 4' is based on medical input:
Otherwise, set to 'Grade 0' |
| ATOXGRL | Computation | Assign AVAL toxicity grading as follows If AVAL is not missing:
Set to 'Grade 1' if 85 – 89
Set to 'Grade 2' if 80 – 84
Set to 'Grade 3' if <80
Set to 'Grade 4' is based on medical input:
Otherwise, set to Grade '0' |
| AVAL | Computation | Set to VS.VSSTRESN |
| AVISIT | Computation | If ABLFL='Y', then AVISIT = 'Baseline',
if VISIT=Visit 1 Day 1 and VSTPT='POST DOSE' then AVISIT='Day 1',
if ADY>1 and VISIT doesn't contain 'Unsched', set to 'Day xx' part of VISIT,
if ADY>1 and VISIT contains 'Unsched', set AVISIT as follows: using the visit window below:
If VISIT with 1<ADY<=11, then AVISIT = 'Day 8',
else if VISIT with 12<=ADY<=22, then AVISIT = 'Day 15',
else if VISIT with 23<=ADY<=32, then AVISIT = 'Day 29',
else if VISIT with 33<=ADY<=39, then AVISIT = 'Day 36',
else if VISIT with 40<=ADY<=50, then AVISIT = 'Day 43',
else if VISIT with 51<=ADY<=133, then AVISIT = 'Day 57',
else if VISIT with 134=<ADY<=301, then AVISIT = 'Day 209',
else if VISIT with ADY>=302, then AVISIT = 'Day 394',
After the steps above, sort data by AVISITN and ADY, set the unscheduled visit (i.e., VISIT contains 'Unsched') records to blank if AVISITN >any previous AVISITN AND ADY<=any previous ADY). For example, Scheduled Day 36 is with AVISITN=6 (Day 36) and ADY=42 and an unscheduled visit is with AVISITN=7 (Day 43) and ADY=40, set AVISIT to blank for this unscheduled visit |
| BASE | Computation | Merge value of no missing AVAL where ABLFL = 'Y' by USUBJID and PARAMCD,
Set to AVAL where ABLFL = 'Y'. |
| BTOXGRH | Computation | Set to ATOXGRH where ABLFL = 'Y' |
| BTOXGRL | Computation | Set to ATOXGRL where ABLFL = 'Y' |
| CHG | Computation | For post baseline records only, if AVAL and BASE are both non-missing, set to AVAL - BASE
Note: post-baseline records are defined as any result where (ADTM > ADSL.TR01SDTM if time is available, if time is not available use (ADY=1 and VSTPT^='PRE-DOSE') or ADY > 1). |
| MDOSREF | Computation | Set to 'Vaccination 1' if (.<ADSL.TR01SDTM<=ADTM <ADSL.DOS2DTM) or (.<ADSL.TR01SDTM<=ADTM and ADSL.DOS2DTM is missing),
Set to 'Vaccination 2' if .<ADSL.DOS2DTM<=ADTM
Note: use date variables for comparison when time part is not available |
| MRDDY | Computation | Set to ADT – ADSL.TR01SDT+ 1 if MDOSREF='Vaccination 1',
Set to ADT – ADSL.DOSE2DT+ 1 if MDOSREF='Vaccination 2' |
| PARAM | Computation | Set to VS.VSTEST ' (' ||VSSTRESU|| ')' if VSSTRESU is non-missing, if VSSTRESU is missing, use the non-missing VSSTRESU from the same VSTEST |
| PCHG | Computation | Set to 0 if CHG=0 ,
Set to (CHG/BASE)*100 if BASE ne 0 |
| SHIFT | Computation | Only populate for post-baseline records
Set to BTOXGRL || ' to '||ATOXGRL if both of BTOXGRL and ATOXGRL are not missing
Set to BTOXGRL || ' to UNK' / ' 'UNK to ' || ATOXGRL if either BTOXGRL or ATOXGRL is missing
Note:
Post-baseline records are defined as any result where (ADTM > ADSL.TR01SDTM if time is available, if time is not available use (ADY=1 and VSTPT^='PRE-DOSE') or ADY > 1) |
| SHIFT2 | Computation | Only populate for post-baseline records
Set to BTOXGRH || ' to ' || ATOXGRH if both of BTOXGRH and ATOXGRH are not missing,
Set to BTOXGRH || ' to UNK ' or 'UNK to ' || ATOXGRH if either BTOXGRH or ATOXGRH is missing
Note: Post-baseline records are defined as any result where (ADTM > ADSL.TR01SDTM if time is available, if time is not available use (ADY=1 and VSTPT^='PRE-DOSE') or ADY > 1) |
| VSLOCSP | Computation | Set to SUPPCM.QVAL where QNAM='VSLOCSP' |
| ADY | Computation | Set to ADT - ADSL.TR01SDT + 1 if ADT >= ADSL.TR01SDT, or
Set to ADT - ADSL.TR01SDT if ADT < ADSL.TR01SDT |
| ANL01FL | Computation | Set to 'Y' if ABLFL='Y',
For post-baseline assessments where AVISITN is non-missing and result (AVAL) is non-missing, per subject per parameter and per AVISIT,
Within an AVISIT,
Set to ‘Y’ for the assessment at scheduled visit (i.e., VISIT doesn't contain "Unsched") or
Set to ‘Y’ for the latest assessment if there are 2 or more assessments at scheduled visit, or
Set to ‘Y’ for the latest assessment if there is no scheduled visit, or
Set to 'Y' for the assessment closest to the target study day in the visit window or
Set to 'Y' for the latest assessment If there are 2 or more assessments equal distance to the target study day |
| TRTA | Computation | Select the last dose record in SDTM.EX before event or assessment Date Time :
Set to 'Placebo' if EX.EXTRT='PLACEBO'
For EX.EXTRT = 'mRNA-1273' :
Set to 'mRNA-1273 50 ug if 0 < EXDOSE <= 75 or EXDOSTXT contains '>0-25', '>25-<50' or '>50-75' ,
Set to 'mRNA-1273 100 ug' if EXDOSE>75 or EXDOSTXT contains '>75-<100' or '>100-125' or '>125'
Note:
Use date only respectively if time part of event or assessment is missing |
| DOS2DTM | Computation | Set to numeric of non-missing EX.EXSTDTC where EX.VISIT contains 'Day 29' |
| DOSE2DT | Computation | Set to numeric date part of non-missing EX.EXSTDTC where EX.VISIT contains 'Day 29' |
| EOSDT | Computation | Set to numeric of DS.DSSTDTC where DSCAT='DISPOSITION EVENT' and DSSCAT='END OF STUDY' |
| EOSDY | Computation | Set to EOSDT-TR01SDT+1 if EOSDT>=TR01SDT |
| EOSSTT | Computation | Set to 'COMPLETED' if COMPLFL='Y'
Set to 'DISCONTINUED' if COMPLFL='N'
Set to 'ONGOING', otherwise |
| EOTDT | Computation | Set to numeric of DS.DSSTDTC where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' |
| EOTDY | Computation | Set to EOTDT-TR01SDT+1 if EOTDT>=TR01SDT |
| EOTSTT | Computation | Set to 'COMPLETED' if USUBJID exists in DS where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' AND DSDECOD='COMPLETED',
Set to 'DISCONTINUED' if USUBJID exists in DS where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' AND DSDECOD^='COMPLETED',
Set to 'ONGOING', otherwise |
| SAFFL | Computation | Set to "Y" if RANDFL="Y" AND USUBJID exists in EX with non-missing EXSTDTC. Set to "N" otherwise |
| TR01EDT | Computation | Set to numeric date part of DM.RFXENDTC |
| TR01EDTM | Computation | Set to numeric of DM.RFXENDTC |
| TR01SDT | Computation | Set to numeric date part of DM.RFXSTDTC |
| TR01SDTM | Computation | Set to numeric of DM.RFXSTDTC |
| TRT01A | Computation | Set to ACTARM if SAFFL='Y' |
| TRT01P | Computation | Set to ARM |
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