Date/Time of Define-XML document generation: 2021-03-04T18:25:39Z
Define-XML version: 2.0.0
Stylesheet version: 2018-11-21
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 | |
| ADFACEVD | Reactogenicity Findings Analysis Dataset | BASIC DATA STRUCTURE | One record per subject per analysis parameter per analysis timepoint | Analysis | STUDYID, USUBJID, ATPTREF, ADT, ADTM, PARCAT1, PARAMN | adfacevd.xpt | |
| ADLB | Laboratory Analysis Dataset | BASIC DATA STRUCTURE | One record per subject per analysis parameter per analysis timepoint | Analysis | STUDYID, USUBJID, PARAMCD, AVISITN, ASEQ | adlb.xpt | |
| ADVA | Immunogenicity Analysis Dataset | BASIC DATA STRUCTURE | One record per subject per analysis parameter per analysis timepoint | Analysis | STUDYID, USUBJID, PARAMCD, AVISITN | adva.xpt | |
| ADVS | Vital Signs Analysis Dataset | BASIC DATA STRUCTURE | One record per subject per analysis parameter per analysis timepoint | Analysis | STUDYID, USUBJID, PARAMCD, AVISITN, ADTM, VSSEQ | advs.xpt | |
| ADAE | Adverse Events Analysis Dataset | OCCURRENCE DATA STRUCTURE | One record per subject per adverse event per event start date | Analysis | STUDYID, USUBJID, AEDECOD, ASTDT, AESEQ | adae.xpt | |
| ADCEVD | Reactogenicity Analysis Dataset | OCCURRENCE DATA STRUCTURE | One record per subject per clinical event per analysis timepoint per vaccination period (identified by traceability variable CESEQ) | Analysis | STUDYID, USUBJID, ACAT1, CETERM, ASTDT, CESEQ | adcevd.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 | 9 | Predecessor: DM.STUDYID | |
| USUBJID | Unique Subject Identifier | text | 21 | Predecessor: DM.USUBJID | |
| SUBJID | Subject Identifier for the Study | text | 5 | Predecessor: DM.SUBJID | |
| SUBJIDN | Subject Identifier for the Study (N) | integer | 8 | Derived DM.SUBJID as numeric value. | |
| SITEID | Study Site Identifier | text | 12 | Study Site Identifier
| Predecessor: DM.SITEID |
| INVID | Investigator Identifier | text | 2 | Investigator Identifier
| Predecessor: DM.INVID |
| INVNAM | Investigator Name | text | 13 | Investigator Name
| Predecessor: DM.INVNAM |
| AGE | Age | integer | 8 | Predecessor: DM.AGE | |
| AGEU | Age Units | text | 5 | Age Unit
| Predecessor: DM.AGEU |
| AGE_M | Add. Months to Age in years (months) | integer | 8 | Predecessor: SUPPDM.QVAL where QNAM='AGE_M' | |
| AAGE | Analysis Age | float | 8 | Derived Set to AGE when AGE_M is missing (i.e. no additional months are specified to be added to age). Otherwise, set to the AGE + AGE_M / 12, rounded to the nearest hundredth. | |
| AGEGR1 | Pooled Age Group 1 | text | 11 | Pooled Age Group 1
| Derived '18 - 55 Yrs' when AGE is between 18 and 55 (inclusive); '> 55 Yrs' when AGE is greater than 55. |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Assigned 1 when AGEGR1 is '18 - 55 Yrs'; 2 when AGEGR1 is '> 55 Yrs'. | |
| SEX | Sex | text | 1 | Sex
| Predecessor: DM.SEX |
| SEXN | Sex (N) | integer | 8 | Assigned 1 when SEX = 'M'; 2 when SEX = 'F'. | |
| RACE | Race | text | 25 | Race [9 Terms] | Predecessor: DM.RACE |
| RACEN | Race (N) | integer | 8 | Assigned 1 when RACE = 'AMERICAN INDIAN OR ALASKA NATIVE'; 2 when RACE = 'ASIAN'; 3 when RACE = 'BLACK OR AFRICAN AMERICAN'; 4 when RACE = 'NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER'; 5 when RACE = 'WHITE'; 6 when RACE = 'NOT REPORTED'; 7 when RACE = 'UNKNOWN'; 8 when RACE = 'OTHER'; 9 when RACE = 'MULTIPLE'. | |
| RACEOTH | Race Other | text | 1 | Predecessor: SUPPDM.QVAL where QNAM='RACEOTH' | |
| RACE1 | Race 1 | text | 1 | Predecessor: SUPPDM.QVAL where QNAM='RACE1' | |
| RACE2 | Race 2 | text | 1 | Predecessor: SUPPDM.QVAL where QNAM='RACE2' | |
| ETHNIC | Ethnicity | text | 22 | Ethnic Group
| Predecessor: DM.ETHNIC |
| ETHNICN | Ethnicity (N) | integer | 8 | Assigned 1 when ETHNIC = 'HISPANIC OR LATINO'; 2 when ETHNIC = 'NOT HISPANIC OR LATINO'; 3 when ETHNIC = 'NOT REPORTED'; 4 when ETHNIC = 'UNKNOWN'. | |
| HEIGHT | Height [cm] | integer | 8 | Derived VS.VSSTRESN where VS.VSTESTCD = 'HEIGHT' and VS.VSBLFL = 'Y'. | |
| WEIGHT | Weight [kg] | float | 8 | Derived VS.VSSTRESN where VS.VSTESTCD = 'WEIGHT' and VS.VSBLFL = 'Y'. | |
| BMI | BMI [kg/m2] | float | 8 | Derived VS.VSSTRESN where VS.VSTESTCD = 'BMI' and VS.VSBLFL = 'Y'. | |
| SCRFL | Screened Population Flag | text | 1 | No Yes Response (Yes Only)
| Derived 'Y' when RFICDTM is not missing; 'N', otherwise. |
| SCRFN | Screened Population Flag (N) | integer | 8 | Assigned 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | |
| EXSCR1 | Reason 1 for Exclusion Screened Set | text | 1 | Derived Always null, since screen failures not included in this data cut. | |
| SAFFL | Safety Population Flag | text | 1 | No Yes Response
| Derived 'Y' when subject has received prime vaccination (when record exists in EC with EC.ECOCCUR = 'Y' and EC.VISITNUM = 2 for given subject). 'N', otherwise. |
| SAFFN | Safety Population Flag (N) | integer | 8 | Assigned 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | |
| EXSAF1 | Reason 1 for Exclusion Safety Set | text | 1 | Derived Always null, since no patients are excluded from the safety population (i.e. all have received the prime vaccination) in this data cut. | |
| SAFBFL | Safety Boost Population Flag | text | 1 | No Yes Response
| Derived 'Y' when subject has received boost vaccination (when record exists in EC with EC.ECOCCUR = 'Y' and EC.VISITNUM = 6 for given subject). 'N', otherwise. |
| SAFBFN | Safety Boost Population Flag (N) | integer | 8 | Assigned 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | |
| EXSAFB1 | Reason 1 for Exclusion Safety Boost Set | text | 40 | Reason 1 for Exclusion Safety Boost Set
| Derived 'Subject did not receive two doses of IMP' when SAFBFL = 'N'. |
| IMMFL | Immunogenicity Population Flag | text | 1 | No Yes Response
| Derived 'Y' when subject is in the Safety Population (SAFFL = 'Y') and has evaluable post-baseline Neutralizing Titer results (when record exists in IS for given subject with IS.VISITNUM > 2 and non-missing IS.ISORRES for IS.ISTESTCD of 'C2NGNT50' or 'C2NGNT90'). 'N', otherwise. |
| IMMFN | Immunogenicity Population Flag (N) | integer | 8 | Assigned 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | |
| EXIMM1 | Reason for Exclusion Immunogenicity Set | text | 99 | Reason for Exclusion Immunogenicity Set
| Derived 'Subject did not receive one dose of IMP or did not have one post-baseline immunogenicity assessment' when IMMFL = 'N'. |
| PPROTFL | Per-Protocol Population Flag | text | 1 | No Yes Response
| Derived 'Y' when subject is in the Immunogenicity Population (IMMFL = 'Y') and has not had a protocol violation (no record exists in DV for given subject). 'N', otherwise. |
| PPROTFN | Per-Protocol Population Flag (N) | integer | 8 | Assigned 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | |
| EXPPROT1 | Reason 1 for Exclusion Per-Protocol Set | text | 81 | Reason 1 for Exclusion Per-Protocol Set
| Derived 'Subject is not included in the immunogenicity set or had major protocol deviation' when PPROTFL = 'N'. |
| CP7FL | Prime + 7 Days Completers Set | text | 1 | No Yes Response
| Derived 'Y' when subject is in the Safety Population (SAFFL = 'Y') and has completed at least 7 days of follow-up after receiving the prime vaccination (either EOSDT is populated and PRIMDT + 7 is less than EOSDT or PRIMDT + 7 is less than or equal to the data cutoff date of 23OCT2020). 'N', otherwise. |
| CP7FN | Prime + 7 Days Completers Set (N) | integer | 8 | Assigned 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | |
| CPBP28FL | Prime to Boost or Prime +28 D. Comp. Set | text | 1 | No Yes Response
| Derived 'Y' when subject is in the Safety Boost Population (SAFBFL = 'Y') or is in the Safety Population (SAFFL = 'Y') and has completed at least 28 days of follow-up after receiving the prime vaccination (either EOSDT is populated and PRIMDT + 28 is less than EOSDT or PRIMDT + 28 is less than or equal to the data cutoff date of 23OCT2020). 'N', otherwise. |
| CPBP28FN | Pri. to Bo. or Pri. +28 D. Comp. Set (N) | integer | 8 | Assigned 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | |
| CB7FL | Boost + 7 Days Completers Set | text | 1 | No Yes Response
| Derived 'Y' when subject is in the Safety Boost Population (SAFBFL = 'Y') and has completed at least 7 days of follow-up after receiving the boost vaccination (either EOSDT is populated and BOIMDT + 7 is less than EOSDT or BOIMDT + 7 is less than or equal to the data cutoff date of 23OCT2020). 'N', otherwise. |
| CB7FN | Boost + 7 Days Completers Set (N) | integer | 8 | Assigned 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | |
| CB28FL | Boost + 28 Days Completers Set | text | 1 | No Yes Response
| Derived 'Y' when subject is in the Safety Boost Population (SAFBFL = 'Y') and has completed at least 28 days of follow-up after receiving the boost vaccination (BOIMDT is not null and either (a) EOSSTT = 'COMPLETED', (b) EOSDT is populated and BOIMDT + 28 is less than EOSDT, or (c) BOIMDT + 28 is less than or equal to the data cutoff date of 23OCT2020). 'N', otherwise. |
| CB28FN | Boost + 28 Days Completers Set (N) | integer | 8 | Assigned 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | |
| CPB28FL | Prime or Boost + 28 Days Completers Set | text | 1 | No Yes Response
| Derived 'Y' when subject is in the Prime to Boost or Prime +28 D. Comp. Population (CPBP28FL = 'Y') and has either (a) not received a boost vaccination (SAFBFL = 'N') or (b) is in the Boost + 28 Days Completers Population (CB28FL = 'Y'). 'N', otherwise. |
| CPB28FN | Prime or Boost + 28 Days Comp. Set (N) | integer | 8 | Assigned 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | |
| COMPLFL | Completers Population Flag | text | 1 | No Yes Response
| Derived 'Y' when EOSSTT = 'COMPLETED'. 'N', otherwise. |
| COMPLFN | Completers Population Flag (N) | integer | 8 | Assigned 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | |
| COHORT | Cohort | text | 9 | Cohort [10 Terms] | Predecessor: SUPPDS.QVAL where QNAM='COHORT' |
| COHORTN | Cohort (N) | integer | 8 | Assigned Numeric value following 'Cohort ' in COHORT variable. | |
| COHCAT1 | Cohort Category 1 | text | 20 | Cohort Category 1
| Derived 'Dose ranging cohorts' when COHORTN <= 10. Null, otherwise. |
| COHCAT1N | Cohort Category 1 (N) | integer | 8 | Assigned 1 when COHCAT1 is 'Dose ranging cohorts'. | |
| COHCAT2 | Cohort Category 2 | text | 28 | Cohort Category 2
| Derived 'Younger dose ranging cohorts' when COHORTN < 8; 'Older dose ranging cohorts' when COHORTN >= 8. |
| COHCAT2N | Cohort Category 2 (N) | integer | 8 | Assigned 1 when COHCAT2 is 'Younger dose ranging cohorts'; 2 when COHCAT2 is 'Elderly dose ranging cohorts'. | |
| GROUP | Group | text | 12 | Group
| Predecessor: SUPPDS.QVAL where QNAM='GROUP' |
| GROUPN | Group (N) | integer | 8 | Assigned 2 when GROUP = 'B (BNT162b1)'; 3 when GROUP = 'C (BNT162b2)'. | |
| ARM | Description of Planned Arm | text | 24 | Description of Planned Arm [18 Terms] | Predecessor: DM.ARM |
| ACTARM | Description of Actual Arm | text | 24 | Description of Actual Arm [18 Terms] | Predecessor: DM.ACTARM |
| TRT01P | Planned Treatment for Period 01 | text | 13 | Planned Treatment for Period 01 [10 Terms] | Derived Set according to the dosing and cohort information provided in DM.ARM, updating the unit value from 'ug' to 'µg', and categorizing cohorts 01-07 as 'Younger' and cohorts 08-10 as 'Older'. [Ex: '10 µg Older' when DM.ARM = 'BNT162b1 Cohort 08 10 ug'] |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | Derived Set to the dose level in TRT01P multiplied by 100, with 100,000 added when subject is in the older cohort (i.e. COHCAT2N = 2). [Ex: 101000 when TRT01P = '10 µg Older'] | |
| TRT01A | Actual Treatment for Period 01 | text | 13 | Actual Treatment for Period 01 [10 Terms] | Derived Set according to the dosing and cohort information provided in DM.ACTARM, updating the unit value from 'ug' to 'µg', and categorizing cohorts 01-07 as 'Younger' and cohorts 08-10 as 'Older'. [Ex: '10 µg Older' when DM.ACTARM = 'BNT162b1 Cohort 08 10 ug'] |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | Derived Set to the dose level in TRT01A multiplied by 100, with 100,000 added when subject is in the older cohort (i.e. COHCAT2N = 2). [Ex: 101000 when TRT01A = '10 µg Older'] | |
| TRTSDT | Date of First Exposure to Treatment | integer | DATE9 | Derived Date part of corresponding -DTM variable. | |
| TRTSTM | Time of First Exposure to Treatment | integer | TIME5 | Derived Time part of corresponding -DTM variable. | |
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME19 | Derived DM.RFXSTDTC as SAS datetime. | |
| TRTEDT | Date of Last Exposure to Treatment | integer | DATE9 | Derived Date part of corresponding -DTM variable. | |
| TRTETM | Time of Last Exposure to Treatment | integer | TIME5 | Derived Time part of corresponding -DTM variable. | |
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME19 | Derived DM.RFXENDTC as SAS datetime. | |
| RFICDT | Date of Informed Consent | integer | DATE9 | Derived Date part of corresponding -DTM variable. | |
| RFICTM | Time of Informed Consent | integer | TIME5 | Derived Time part of corresponding -DTM variable. | |
| RFICDTM | Datetime of Informed Consent | integer | DATETIME19 | Derived DM.RFICDTC as SAS datetime. | |
| SCRDT | Date of Screening | integer | DATE9 | Derived Date part of DM.RFICDTC as SAS date. | |
| ALLOCDT | Date of Allocation | integer | DATE9 | Derived Date part of corresponding -DTM variable. | |
| ALLOCTM | Time of Allocation | integer | TIME5 | Derived Time part of corresponding -DTM variable. | |
| ALLOCDTM | Datetime of Allocation | integer | DATETIME19 | Derived DS.DSSTDTC as SAS datetime, selecting record where DS.DSDECOD = 'ALLOCATED'. | |
| LVDT | Date of Last Visit | integer | DATE9 | Derived When subject has completed the trial (i.e. EOSSTT = ' COMPLETED'), set to date part of DS.DSSTDTC as SAS date, selecting record where DS.DSSCAT = 'END OF TRIAL. When subject discontinued prematurely (i.e. EOSSTT = 'DISCONTINUED'), set to date part of Date of last visit/contact (SUPPDS.QVAL where QNAM = 'LASTCONT') as SAS date. | |
| EOSSTT | End of Study Status | text | 12 | End of Study Status
| Derived 'COMPLETED' when DS.DSDECOD = 'COMPLETED' on record with DS.DSSCAT = 'END OF TRIAL' for given subject. Otherwise, 'DISCONTINUED' when EOSDT is not null. |
| EOSDT | End of Study Date | integer | DATE9 | Derived Date part of DS.DSSTDTC as SAS date, selecting record where DS.DSSCAT = 'END OF TRIAL'. | |
| EOFUDT | End of Follow-up Date | integer | DATE9 | Derived Date part of DS.DSSTDTC as SAS date, selecting record where DS.DSSCAT = 'END OF FOLLOW-UP'. | |
| DCSREAS | Reason for Discontinuation from Study | text | 21 | Reason for Discontinuation from Study [12 Terms] | Derived Populated when EOSSTT = 'DISCONTINUED'. Set to DS.DSDECOD in proper case, selecting record where DS.DSSCAT = 'END OF TRIAL'. |
| DCSREASP | Reason Spec for Discont from Study | text | 22 | Reason Spec for Discont from Study [13 Terms] | Derived Populated when EOSSTT = 'DISCONTINUED'. Set to DS.DSTERM in proper case, selecting record where DS.DSSCAT = 'END OF TRIAL'. |
| DTHFL | Subject Death Flag | text | 1 | No Yes Response (Yes Only)
| Predecessor: DM.DTHFL |
| DTHDT | Date of Death | float | DATE9 | Derived Date part of DM.DTHDTC as SAS date. | |
| PRIMDT | Date of Prime Immunization | integer | DATE9 | Derived Date part of corresponding -DTM variable. | |
| PRIMTM | Time of Prime Immunization | integer | TIME5 | Derived Time part of corresponding -DTM variable. | |
| PRIMDTM | Datetime of Prime Immunization | integer | DATETIME19 | Derived EC.ECSTDTC as SAS datetime, selecting record where EC.ECOCCUR = 'Y' and VISITNUM = 2. | |
| BOIMDT | Date of Boost Immunization | integer | DATE9 | Derived Date part of corresponding -DTM variable. | |
| BOIMTM | Time of Boost Immunization | integer | TIME5 | Derived Time part of corresponding -DTM variable. | |
| BOIMDTM | Datetime of Boost Immunization | integer | DATETIME19 | Derived EC.ECSTDTC as SAS datetime, selecting record where EC.ECOCCUR = 'Y' and EC.VISITNUM = 6. | |
| DSEPRELI | Epi/Pandemic Related Indicator | text | 1 | No Yes Response (No Only)
| Predecessor: SUPPDS.QVAL where QNAM='DSEPRELI' |
| PREV_TSN | Previous TSNs | text | 11 | Predecessor: SUPPDS.QVAL where QNAM='PREV_TSN' | |
| FIRICDT | Date of first Informed Consent | integer | DATE9 | Derived Date part of DS.DSSTDTC as SAS date, selecting record where DS.DSDECOD = 'FIRST INFORMED CONSENT OBTAINED'. | |
| ICR1DT | Date of Informed Consent Reconsented 1 | integer | DATE9 | Derived Date part of corresponding -DTM variable. | |
| ICR1TM | Time of Informed Consent Reconsented 1 | integer | TIME5 | Derived Time part of corresponding -DTM variable. | |
| ICR1DTM | Datetime of Informed Consent Recons. 1 | integer | DATETIME19 | Derived DS.DSSTDTC as SAS datetime, selecting record(s) where DS.DSDECOD = 'INFORMED CONSENT RECONSENTED'. If multiple records exist for a given subject, the 1st record when sorted by DS.DSSTDTC is selected for populating ICR1DTM. | |
| ICR2DT | Date of Informed Consent Reconsented 2 | integer | DATE9 | Derived Date part of corresponding -DTM variable. | |
| ICR2TM | Time of Informed Consent Reconsented 2 | integer | TIME5 | Derived Time part of corresponding -DTM variable. | |
| ICR2DTM | Datetime of Informed Consent Recons. 2 | integer | DATETIME19 | Derived DS.DSSTDTC as SAS datetime, selecting records where DS.DSDECOD = 'INFORMED CONSENT RECONSENTED'. The 2nd record when sorted by DS.DSSTDTC is selected for populating ICR2DTM. | |
| ICR3DT | Date of Informed Consent Reconsented 3 | integer | DATE9 | Derived Date part of corresponding -DTM variable. | |
| ICR3TM | Time of Informed Consent Reconsented 3 | integer | TIME5 | Derived Time part of corresponding -DTM variable. | |
| ICR3DTM | Datetime of Informed Consent Recons. 3 | integer | DATETIME19 | Derived DS.DSSTDTC as SAS datetime, selecting records where DS.DSDECOD = 'INFORMED CONSENT RECONSENTED'. The 3rd record when sorted by DS.DSSTDTC is selected for populating ICR3DTM. | |
| ICR4DT | Date of Informed Consent Reconsented 4 | integer | DATE9 | Derived Date part of corresponding -DTM variable. | |
| ICR4TM | Time of Informed Consent Reconsented 4 | integer | TIME5 | Derived Time part of corresponding -DTM variable. | |
| ICR4DTM | Datetime of Informed Consent Recons. 4 | integer | DATETIME19 | Derived DS.DSSTDTC as SAS datetime, selecting records where DS.DSDECOD = 'INFORMED CONSENT RECONSENTED'. The 4th record when sorted by DS.DSSTDTC is selected for populating ICR4DTM. | |
| PROTVER1 | First Protocol Version signed | text | 16 | First Protocol Version signed
| Derived SUPPDS.QNAM where QVAL = 'PROTVERS'. If multiple records exist for a given subject, the 1st record when sorted by DS.DSSTDTC on the associated parent record is selected for populating PROTVER1. |
| PROTVER2 | Second Protocol Version signed | text | 16 | Second Protocol Version signed
| Derived SUPPDS.QNAM where QVAL = 'PROTVERS'. The 2nd record when sorted by DS.DSSTDTC on the associated parent record is selected for populating PROTVER2. |
| PROTVER3 | Third Protocol Version signed | text | 16 | Third Protocol Version signed
| Derived SUPPDS.QNAM where QVAL = 'PROTVERS'. The 3rd record when sorted by DS.DSSTDTC on the associated parent record is selected for populating PROTVER3. |
| PROTVER4 | Fourth Protocol Version signed | text | 16 | Fourth Protocol Version signed
| Derived SUPPDS.QNAM where QVAL = 'PROTVERS'. The 4th record when sorted by DS.DSSTDTC on the associated parent record is selected for populating PROTVER4. |
| PROTVER5 | Fifth Protocol Version signed | text | 16 | Fifth Protocol Version signed
| Derived SUPPDS.QNAM where QVAL = 'PROTVERS'. The 5th record when sorted by DS.DSSTDTC on the associated parent record is selected for populating PROTVER5. |
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Reactogenicity Findings Analysis Dataset (ADFACEVD)
| Variable | Where Condition | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 9 | Predecessor: ADSL.STUDYID | ||
| USUBJID | Unique Subject Identifier | text | 21 | Predecessor: ADSL.USUBJID | ||
| SUBJID | Subject Identifier for the Study | text | 5 | Predecessor: ADSL.SUBJID | ||
| SUBJIDN | Subject Identifier for the Study (N) | integer | 8 | Predecessor: ADSL.SUBJIDN | ||
| COHORT | Cohort | text | 9 | Cohort [10 Terms] | Predecessor: ADSL.COHORT | |
| COHORTN | Cohort (N) | integer | 8 | Predecessor: ADSL.COHORTN Numeric value following 'Cohort ' in COHORT variable. | ||
| COHCAT1 | Cohort Category 1 | text | 20 | Cohort Category 1
| Predecessor: ADSL.COHCAT1 | |
| COHCAT1N | Cohort Category 1 (N) | integer | 8 | Predecessor: ADSL.COHCAT1N 1 when COHCAT1 is 'Dose ranging cohorts'. | ||
| COHCAT2 | Cohort Category 2 | text | 28 | Cohort Category 2
| Predecessor: ADSL.COHCAT2 | |
| COHCAT2N | Cohort Category 2 (N) | integer | 8 | Predecessor: ADSL.COHCAT2N 1 when COHCAT2 is 'Younger dose ranging cohorts'; 2 when COHCAT2 is 'Elderly dose ranging cohorts'. | ||
| GROUP | Group | text | 12 | Group
| Predecessor: ADSL.GROUP | |
| GROUPN | Group (N) | integer | 8 | Predecessor: ADSL.GROUPN 2 when GROUP = 'B (BNT162b1)'; 3 when GROUP = 'C (BNT162b2)'. | ||
| TRTP | Planned Treatment | text | 13 | Planned Treatment [10 Terms] | Predecessor: ADSL.TRT01P | |
| TRTPN | Planned Treatment (N) | integer | 8 | Predecessor: ADSL.TRT01PN Dose level in TRT01P multiplied by 100, with 100,000 added when subject is in elderly cohort (i.e. COHCAT2N = 2). [Ex: 101000 when TRT01P = '10 µg Elderly'] | ||
| TRTA | Actual Treatment | text | 13 | Actual Treatment [10 Terms] | Predecessor: ADSL.TRT01A | |
| TRTAN | Actual Treatment (N) | integer | 8 | Predecessor: ADSL.TRT01AN Dose level in TRT01A multiplied by 100, with 100,000 added when subject is in elderly cohort (i.e. COHCAT2N = 2). [Ex: 101000 when TRT01A = '10 µg Elderly'] | ||
| ADT | Analysis Date | integer | DATE9 | Derived Null for "duration" records (when PARCAT2 = 'duration' or 'duration grade >= 3'). Otherwise, date part of FADTC as SAS date when SRCDOM = 'FA' and date part of VSDTC as SAS date when SRCDOM = 'VS'. | ||
| ADTM | Analysis Datetime | integer | DATETIME19 | Derived Null for "duration" records (when PARCAT2 = 'duration' or 'duration grade >= 3'). Otherwise, FADTC as SAS datetime when SRCDOM = 'FA' and VSDTC as SAS datetime when SRCDOM = 'VS'. | ||
| ADY | Analysis Relative Day | integer | 8 | Derived Analysis date relative to treatment start: ADT - TRTSDT + 1, when ADT is on or after TRTSDT; ADT - TRTSDT, when ADT is before TRTSDT. | ||
| ASTDT | Analysis Start Date | integer | DATE9 | Derived Populated only for "duration" records (when PARCAT2 = 'duration' or 'duration grade >= 3'). Set to earliest date/time at which a given type of reactogenicity event occurred (i.e. the value of ADT on the first record meeting criteria for the given PARAM value, when sorted by USUBJID, ADY, and PARAMN). | ||
| ASTDY | Analysis Start Relative Day | integer | 8 | Derived Analysis start date relative to treatment start: ASTDT - TRTSDT + 1, when ASTDT is on or after TRTSDT; ASTDT - TRTSDT, when ASTDT is before TRTSDT. | ||
| AENDT | Analysis End Date | integer | DATE9 | Derived Populated only for 'duration" records (when PARCAT2 = 'duration' or 'duration grade >= 3'). Set to latest date/time at which a given type of reactogenicity event occurred (i.e. the value of ADT on the last record meeting criteria for the given PARAM value, when sorted by USUBJID, ADY, and PARAMN). | ||
| AENDY | Analysis End Relative Day | integer | 8 | Derived Analysis end date relative to treatment start: AENDT - TRTSDT + 1, when AENDT is on or after TRTSDT; AENDT - TRTSDT, when AENDT is before TRTSDT. | ||
| FADTC | Date/Time of Collection | datetime | ISO 8601 | Predecessor: FA.FADTC | ||
| VSDTC | Date/Time of Measurements | datetime | ISO 8601 | Predecessor: VS.VSDTC | ||
| ATPT | Analysis Timepoint | text | 6 | Derived Concatenation of 'Day ' and ATPTN. | ||
| ATPTN | Analysis Timepoint (N) | integer | 8 | Derived Numeric part (number following 'DAY') of source variable minus 1. Source variable is FATPT when SRCDOM = 'FA' and VSTPT when SRCDOM = 'VS'. (Ex. 3 when FATPT = 'DAY 4'). | ||
| FATPT | Planned Time Point Name | text | 6 | Predecessor: FA.FATPT | ||
| VSTPT | Planned Time Point Name | text | 6 | Predecessor: VS.VSTPT | ||
| ATPTREF | Analysis Timepoint Reference | text | 5 | Analysis Timepoint Reference in ADCEVD
| Derived 'Prime' when FATPTREF or VSTPTREF = 'PRIME VACCINATION'; 'Boost' when FATPTREF or VSTPTREF = 'BOOST VACCINATION'. | |
| FATPTREF | Time Point Reference | text | 17 | Time Point Reference
| Predecessor: FA.FATPTREF | |
| VSTPTREF | Time Point Reference | text | 17 | Time Point Reference
| Predecessor: VS.VSTPTREF | |
| PARAMVLM | Parameter | text | 68 | |||
| SRCVAR = "FASTRESC" and FATESTCD = "OCCUR" | Parameter for FACE occurrence records | text | 49 | Parameter for FACE occurrence record in ADFACEVD [14 Terms] | Derived Concatenation of FACE.FAOBJ (selecting just the text following a slash '/' or dash '-', when applicable, and adding ' at injection site' for Pain and Tenderness records) and FATEST in proper case. (Ex: FAOBJ = 'Injection site reaction - Pain' --> PARAM = 'Pain at injection site occurrence indicator').
[Note that occurrence records from FACE (where FATESTCD = 'OCCUR') are included in ADFACEVD only if FAEVAL = 'STUDY SUBJECT' and FASTAT is null ('NOT DONE' records are excluded).] | |
| SRCVAR = "FASTRESC" and FATESTCD = "SEV" | Parameter for FACE severity/intensity records | text | 47 | Parameter for FACE severity record in ADFACEVD [14 Terms] | Derived Concatenation of FACE.FAOBJ (selecting just the text following a slash '/' or dash '-', when applicable, and adding ' at injection site' for Pain and Tenderness records) and FATEST in proper case. (Ex: FAOBJ = 'Injection site reaction - Pain' --> PARAM = 'Pain at injection site severity/intensity').
[Note that severity records from FACE (where FATESTCD = 'SEV') are included in ADFACEVD only if FAEVAL = 'STUDY SUBJECT' and FASTRESC is not 'NONE'.] | |
| SRCVAR = "VSSTRESN" | Parameter for VS occurrence and severity/intensity records | text | 26 | Parameter for VS record in ADFACEVD
| Assigned Set to 'Fever occurrence indicator'. When the VSSTRESN value indicates a fever occurred (i.e. VSSTRESN is 38.0 or higher) an additional record exists with PARAM set to 'Fever severity/intensity'. [Note that records from VS are included in ADFACEVD only if VSCAT = 'REACTOGENICITY' and VSSTAT is null ('NOT DONE' records are excluded).] | |
| SRCVAR = "" and AVALCAT1 = "" | Parameter for time to first and time from first to last occurrence records | text | 52 | Parameter for Time to 1st or Time from 1st to last occurrence record in ADFACEVD [36 Terms] | Assigned For each subject having any reactogenicity occurrence records (with PARAM value ending with 'occurrence indicator' and AVALC = 'Y'), the following additional derived records are populated: (1) Records with PARAM = 'Time to first local or systemic reaction' and with PARAM = 'Time from first to last local or systemic reaction'. (2) Records with PARAM = 'Time to first <type> reaction' and with PARAM = 'Time from first to last <type> reaction', for each type of reaction (local or systemic, identified by PARCAT1) when such records exist in those meeting above criteria. (3) Records with PARAM = Time to first <specific reaction>' and with PARAM = 'Time from first to last <specific reaction>' for each specific reaction (obtained from words preceding 'occurrence indicator' from the PARAM value on the records meeting above criteria. Note that traceability variables for these additional records are obtained from the first record meeting the criteria for the given PARAM value, when sorted by USUBJID, ADY, and PARAMN (i.e. the earliest event). | |
| SRCVAR = "" and AVALCAT1 = "grade >= 3" | Parameter for time to first and time from first to last grade>=3 occurrence records | text | 68 | Parameter for Time to 1st or Time from 1st to last grade>=3 occurrence record in ADFACEVD [36 Terms] | Assigned For each subject having any reactogenicity severity records with grade >= 3 (with PARAM value ending with 'severity/intensity' and AVALCAT1 = 'grade >= 3'), the following additional derived records are populated: (1) Records with PARAM = 'Time to first local or systemic reaction with grade >= 3' and with PARAM = 'Time from first to last local or systemic reaction with grade >= 3'. (2) Records with PARAM = 'Time to first <type> reaction with grade >= 3' and with PARAM = 'Time from first to last <type> reaction with grade >= 3', for each type of reaction (local or systemic, identified by PARCAT1) when such records exist in those meeting above criteria. (3) Records with PARAM = Time to first <specific reaction> with grade >= 3' and with PARAM = 'Time from first to last <specific reaction> with grade >= 3' for each specific reaction (obtained from words preceding 'severity/intensity' from the PARAM value on the records meeting above criteria. Note that traceability variables for these additional records are obtained from the first record meeting the criteria for the given PARAM value, when sorted by USUBJID, ADY, and PARAMN (i.e. the earliest event). | |
| PARAMCD | Parameter Code | text | 8 | Parameter Code in ADFACEVD [102 Terms] | Assigned See Controlled Terminology for mapping from PARAM (Decode) to PARAMCD (Code). | |
| PARAMN | Parameter (N) | integer | 8 | Parameter (N) in ADFACEVD [102 Terms] | Assigned See Controlled Terminology for mapping from PARAM (Decode) to PARAMN (Code). | |
| FAOBJ | Object of the Observation | text | 45 | Object of the Observation in ADFACEVD [14 Terms] | Predecessor: FA.FAOBJ | |
| FATEST | Findings About Test Name | text | 20 | Findings About Test Name in ADFACEVD
| Predecessor: FA.FATEST | |
| FATESTCD | Findings About Test Short Name | text | 5 | Findings About Test Short Name in ADFACEVD
| Predecessor: FA.FATESTCD | |
| VSTEST | Vital Signs Test Name | text | 11 | Vital Signs Test Name in ADFACEVD
| Predecessor: VS.VSTEST | |
| VSTESTCD | Vital Signs Test Short Name | text | 4 | Vital Signs Test Short Name in ADFACEVD
| Predecessor: VS.VSTESTCD | |
| PARCAT1 | Parameter Category 1 | text | 8 | Parameter Category 1 in ADFACEVD
| Derived Null for records containing information about both local and systemic reactions (when PARAMCD is 'TTEFAR', 'TTEFAR3', 'DURAR', or 'DURAR3'). Otherwise, 'local' when FASCAT = 'ADMINISTRATION SITE', and 'systemic' when FASCAT = 'SYSTEMIC', SRCDOM = 'VS', or PARAMCD is 'DURFEVE', 'DURFEVE3', 'DURSR' or 'DURSR3'. | |
| PARCAT2 | Parameter Category 2 | text | 24 | Parameter Category 2 in ADFACEVD [6 Terms] | Derived 'occurrence' when PARAMCD begins with 'OC', 'severity/intensity' when PARAMCD begins with 'SEV', 'time to first' when PARAMCD begins with 'TTE' and does not end with '3', 'time to first grade >= 3' when PARAMCD begins with 'TTE' and ends with '3', 'duration' when PARAMCD begins with 'DUR' and does not end with '3', 'duration grade >= 3' when PARAMCD begins with 'DUR' and ends with '3'. | |
| FASCAT | Subcategory for Findings About | text | 19 | Subcategory for Findings About in ADFACEVD
| Predecessor: FA.FASCAT | |
| AVALVLM | Analysis Value | integer | 8 | Null for occurrence indicator records (when PARCAT2 is 'occurrence'). | ||
| PARCAT2 = "severity/intensity" | Analysis Value for severity/intensity records | integer | 1 | Derived 1 when AVALC = 'Mild'; 2 when AVALC = 'Moderate'; 3 when AVALC = 'Severe'; 4 when AVALC = 'Potentially life threatening'. | ||
| PARCAT2 IN ( "time to first", "time to first grade >= 3" ) | Analysis Value for time to first reaction records | integer | 1 | Derived ADFACEVD.ATPTN + 1. | ||
| PARCAT2 IN ( "duration", "duration grade >= 3" ) | Analysis Value for time from first to last reaction records | integer | 2 | Derived Number of days between first and last report of reaction for given subject and reaction category: ADFACEVD.AENDY - ADFACEVD.AESTDY + 1. | ||
| AVALCVLM | Analysis Value (C) | text | 8 | Null for time to first reaction and time from first to last reaction records (when PARCAT2 is 'time to first', 'time to first grade >= 3', 'duration', or 'duration grade >= 3'). | ||
| SRCVAR = "FASTRESC" and FATESTCD = "OCCUR" | Analysis Value (C) for FACE occurrence records | text | 1 | No Yes Response
| Predecessor: FA.FASTRESC | |
| SRCVAR = "FASTRESC" and FATESTCD = "SEV" | Analysis Value (C) for FACE severity/intensity records | text | 8 | Analysis Value (C) for severity/intensity records in ADFACEVD
| Derived FASTRESC in proper case. | |
| PARAMCD = "OCFEVER" (Fever occurrence indicator) | Analysis Value (C) for Fever occurrence records | text | 1 | No Yes Response
| Derived 'Y' when VSSTRESN >= 38.0; 'N', otherwise. | |
| PARAMCD = "SEVFEVER" (Fever severity/intensity) | Analysis Value (C) for Fever severity/intensity records | text | 8 | Analysis Value (C) for severity/intensity records in ADFACEVD
| Derived 'Mild' when 38.0 <= VSSTRESN <= 38.4; 'Moderate' when 38.4 < VSSTRESN <= 38.9; 'Severe' when 38.9 < VSSTRESN <= 40.0; 'Potentially life threatening' when 40.0 < VSSTRESN. | |
| FASTRESC | Character Result/Finding in Std Format | text | 8 | Character Result/Finding in Std Format in ADFACEVD [6 Terms] | Predecessor: FA.FASTRESC | |
| VSSTRESN | Numeric Result/Finding in Standard Units | float | 8 | Predecessor: VS.VSSTRESN | ||
| AVALCAT1VLM | Analysis Value Category 1 | text | 10 | |||
| PARCAT2 = "severity/intensity" | Analysis Value Category 1 for severity/intensity records | text | 10 | Analysis Value Category 1 for severity/intensity records in ADFACEVD
| Derived 'grade < 3' when AVAL < 3; 'grade >= 3' when AVAL >= 3. | |
| PARCAT2 IN ( "time to first grade >= 3", "duration grade >= 3" ) | Analysis Value Category 1 for time to first or time from first to last grade >= 3 occurrence records | text | 10 | Analysis Value Category 1 for time to first or time from first to last grade >= 3 occurrence records in ADFACEVD
| Derived 'grade >= 3' for these records derived from records having this value of AVALCAT1. | |
| ANL01FL | Analysis Flag 01 | text | 1 | No Yes Response (Yes Only)
| Derived Populated only for occurrence and severity/intensity parameters: 'Y' when analysis date/time (ADTM) is on or after the associated reference date/time (PRIMDTM when ATPTREF = 'Prime' and BOIMDTM when ATPTREF = 'Boost'). Null, otherwise. [Event is not included in frequency analyses if not reported to have occurred after the associated vaccination date/time.] | |
| SRCDOM | Source Data | text | 2 | Source Data in ADFACEVD
| Assigned 'FA' for original records or derived "TTE" records from SDTM FACE domain; 'VS' for original records or derived "TTE" records from SDTM VS domain. Null for derived "DUR" records. | |
| SRCVAR | Source Variable | text | 8 | Source Variable in ADFACEVD
| Assigned 'FASTRESC' for original records from SDTM FACE domain. 'VSSTRESN' for original records from SDTM VS domain. Null for derived records. | |
| SRCSEQVLM | Source Sequence Number | integer | 8 | |||
| SRCDOM = "FA" | Source Sequence Number | integer | 3 | Predecessor: FA.FASEQ | ||
| SRCDOM = "VS" | Source Sequence Number | integer | 3 | Predecessor: VS.VSSEQ | ||
| FALNKID | Link ID | text | 83 | Predecessor: FA.FALNKID | ||
| FALNKGRP | Link Group ID | text | 77 | Predecessor: FA.FALNKGRP | ||
| VSLNKID | Link ID | text | 43 | Predecessor: VS.VSLNKID | ||
| VSLNKGRP | Link Group ID | text | 37 | Predecessor: VS.VSLNKGRP | ||
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | ||
| AGEU | Age Units | text | 5 | Age Unit
| Predecessor: ADSL.AGEU | |
| AGEGR1 | Pooled Age Group 1 | text | 11 | Pooled Age Group 1
| Predecessor: ADSL.AGEGR1 | |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Predecessor: ADSL.AGEGR1N 1 when AGEGR1 is '18 - 55 Yrs'; 2 when AGEGR1 is '> 55 Yrs'. | ||
| SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX | |
| SEXN | Sex (N) | integer | 8 | Predecessor: ADSL.SEXN 1 when SEX = 'M'; 2 when SEX = 'F'. | ||
| RACE | Race | text | 25 | Race [9 Terms] | Predecessor: ADSL.RACE | |
| RACEN | Race (N) | integer | 8 | Predecessor: ADSL.RACEN 1 when RACE = 'AMERICAN INDIAN OR ALASKA NATIVE'; 2 when RACE = 'ASIAN'; 3 when RACE = 'BLACK OR AFRICAN AMERICAN'; 4 when RACE = 'NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER'; 5 when RACE = 'WHITE'; 6 when RACE = 'NOT REPORTED'; 7 when RACE = 'UNKNOWN'; 8 when RACE = 'OTHER'; 9 when RACE = 'MULTIPLE'. | ||
| SCRFL | Screened Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SCRFL | |
| SCRFN | Screened Population Flag (N) | integer | 8 | Predecessor: ADSL.SCRFN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| SAFFL | Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAFFL | |
| SAFFN | Safety Population Flag (N) | integer | 8 | Predecessor: ADSL.SAFFN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| SAFBFL | Safety Boost Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAFBFL | |
| SAFBFN | Safety Boost Population Flag (N) | integer | 8 | Predecessor: ADSL.SAFBFN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| IMMFL | Immunogenicity Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.IMMFL | |
| IMMFN | Immunogenicity Population Flag (N) | integer | 8 | Predecessor: ADSL.IMMFN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| PPROTFL | Per-Protocol Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPROTFL | |
| PPROTFN | Per-Protocol Population Flag (N) | integer | 8 | Predecessor: ADSL.PPROTFN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| CP7FL | Prime + 7 Days Completers Set | text | 1 | No Yes Response
| Predecessor: ADSL.CP7FL | |
| CP7FN | Prime + 7 Days Completers Set (N) | integer | 8 | Predecessor: ADSL.CP7FN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| CPBP28FL | Prime to Boost or Prime +28 D. Comp. Set | text | 1 | No Yes Response
| Predecessor: ADSL.CPBP28FL | |
| CPBP28FN | Pri. to Bo. or Pri. +28 D. Comp. Set (N) | integer | 8 | Predecessor: ADSL.CPBP28FN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| CB7FL | Boost + 7 Days Completers Set | text | 1 | No Yes Response
| Predecessor: ADSL.CB7FL | |
| CB7FN | Boost + 7 Days Completers Set (N) | integer | 8 | Predecessor: ADSL.CB7FN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| CB28FL | Boost + 28 Days Completers Set | text | 1 | No Yes Response
| Predecessor: ADSL.CB28FL | |
| CB28FN | Boost + 28 Days Completers Set (N) | integer | 8 | Predecessor: ADSL.CB28FN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| CPB28FL | Prime or Boost + 28 Days Completers Set | text | 1 | No Yes Response
| Predecessor: ADSL.CPB28FL | |
| CPB28FN | Prime or Boost + 28 Days Comp. Set (N) | integer | 8 | Predecessor: ADSL.CPB28FN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| COMPLFL | Completers Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.COMPLFL | |
| COMPLFN | Completers Population Flag (N) | integer | 8 | Predecessor: ADSL.COMPLFN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| TRTSDT | Date of First Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTSDT | ||
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME19 | Predecessor: ADSL.TRTSDTM | ||
| TRTSTM | Time of First Exposure to Treatment | integer | TIME5 | Predecessor: ADSL.TRTSTM | ||
| TRTEDT | Date of Last Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTEDT | ||
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME19 | Predecessor: ADSL.TRTEDTM | ||
| TRTETM | Time of Last Exposure to Treatment | integer | TIME5 | Predecessor: ADSL.TRTETM | ||
| ALLOCDT | Date of Allocation | integer | DATE9 | Predecessor: ADSL.ALLOCDT | ||
| ALLOCTM | Time of Allocation | integer | TIME5 | Predecessor: ADSL.ALLOCTM | ||
| ALLOCDTM | Datetime of Allocation | integer | DATETIME19 | Predecessor: ADSL.ALLOCDTM | ||
| PRIMDT | Date of Prime Immunization | integer | DATE9 | Predecessor: ADSL.PRIMDT | ||
| PRIMTM | Time of Prime Immunization | integer | TIME5 | Predecessor: ADSL.PRIMTM | ||
| PRIMDTM | Datetime of Prime Immunization | integer | DATETIME19 | Predecessor: ADSL.PRIMDTM | ||
| BOIMDT | Date of Boost Immunization | integer | DATE9 | Predecessor: ADSL.BOIMDT | ||
| BOIMTM | Time of Boost Immunization | integer | TIME5 | Predecessor: ADSL.BOIMTM | ||
| BOIMDTM | Datetime of Boost Immunization | integer | DATETIME19 | Predecessor: ADSL.BOIMDTM |
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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 | 9 | Predecessor: ADSL.STUDYID | ||
| USUBJID | Unique Subject Identifier | text | 21 | Predecessor: ADSL.USUBJID | ||
| SUBJID | Subject Identifier for the Study | text | 5 | Predecessor: ADSL.SUBJID | ||
| SUBJIDN | Subject Identifier for the Study (N) | integer | 8 | Predecessor: ADSL.SUBJIDN | ||
| COHORT | Cohort | text | 9 | Cohort [10 Terms] | Predecessor: ADSL.COHORT | |
| COHORTN | Cohort (N) | integer | 8 | Predecessor: ADSL.COHORTN Numeric value following 'Cohort ' in COHORT variable. | ||
| GROUP | Group | text | 12 | Group
| Predecessor: ADSL.GROUP | |
| GROUPN | Group (N) | integer | 8 | Predecessor: ADSL.GROUPN 2 when GROUP = 'B (BNT162b1)'; 3 when GROUP = 'C (BNT162b2)'. | ||
| TRTP | Planned Treatment | text | 13 | Planned Treatment [10 Terms] | Predecessor: ADSL.TRT01P | |
| TRTPN | Planned Treatment (N) | integer | 8 | Predecessor: ADSL.TRT01PN Dose level in TRT01P multiplied by 100, with 100,000 added when subject is in elderly cohort (i.e. COHCAT2N = 2). [Ex: 101000 when TRT01P = '10 µg Elderly'] | ||
| TRTA | Actual Treatment | text | 13 | Actual Treatment [10 Terms] | Predecessor: ADSL.TRT01A | |
| TRTAN | Actual Treatment (N) | integer | 8 | Predecessor: ADSL.TRT01AN Dose level in TRT01A multiplied by 100, with 100,000 added when subject is in elderly cohort (i.e. COHCAT2N = 2). [Ex: 101000 when TRT01A = '10 µg Elderly'] | ||
| LBSEQ | Sequence Number | integer | 8 | Predecessor: LB.LBSEQ | ||
| ASEQ | Analysis Sequence Number | integer | 8 | Derived Sort by USUBJID,PARAMCD, AVISITN. Assign sequential numbers starting with 1 for each subject. | ||
| PARAM | Parameter | text | 48 | Derived PARAM=strip(LB.LBTEST)<||"("||strip(LB.LBSPEC)||")"||>"["||strip(LB.LBSTRESU)||"]" if same lab test is done in 2 or more categories then LB.LBSPEC is included. If not, just the LB.LBTEST and LB.LBSTRESU are used to assign PARAM. If LB.LBSTRESU is missing for a given test, LB.LBORRESU has been used. | ||
| PARAMCD | Parameter Code | text | 8 | Derived LB.LBTESTCD||<suffix as needed>, if same lab test is done in 2 or more categories or has different specimen type then suffix is updated with "B" "BS" "U" "UD" "UM". B for Blood, BS for Blood Serum, U for Urine, UD for Urine and Dipstick method, UM for Urine and Microscopy method. Adjust PARAMCD accordingly. | ||
| PARAMN | Parameter (N) | integer | 8 | Derived =1 for PARAMCD='ALT' ; =2 for PARAMCD='ALB';=3 for PARAMCD='ALP'; =4 for PARAMCD='AMPHET';
=5 for PARAMCD='AMYLASE'; =6 for PARAMCD='ANISO'; =7 for PARAMCD='AST'; =8 for PARAMCD='BACT';
=9 for PARAMCD='BARB'; =11 for PARAMCD='BASOB'; =14 for PARAMCD='BASOBS'; =16 for PARAMCD='BASOLEB';
=17 for PARAMCD='BASOLEBS'; =18 for PARAMCD='BNZDZPN'; =19 for PARAMCD='BILIS'; =20 for PARAMCD='BILIU';
=21 for PARAMCD='CRP'; =22 for PARAMCD='CA';=23 for PARAMCD='CANNAB'; =24 for PARAMCD='CASTS';
=25 for PARAMCD='HCG'; =26 for PARAMCD='COCAINE'; =27 for PARAMCD='CK'; =28 for PARAMCD='CREAT';
=29 for PARAMCD='CRYSTALS'; =31 for PARAMCD='EOSB'; =34 for PARAMCD='EOSBS'; =36 for PARAMCD='EOSLEB';
=37 for PARAMCD='EOSLEBS'; =38 for PARAMCD='EPIC'; =39 for PARAMCD='MCHC'; =40 for PARAMCD='MCH';
=41 for PARAMCD='MCV'; =42 for PARAMCD='RBCB'; =43 for PARAMCD='RBCU'; =44 for PARAMCD='ETHANOL';
=47 for PARAMCD='FERRITIN'; =48 for PARAMCD='FSH'; =49 for PARAMCD='GGT'; =50 for PARAMCD='GLUCB';
=51 for PARAMCD='GLUCU'; =52 for PRAMCD=’GRANBCE’; =53 for PARAMCD='HCT'; =54 for PARAMCD='HGBB';
=55 for PARAMCD='HGBU'; =56 for PARAMCD='KETONES'; =57 for PARAMCD='WBCB'; =58 for PARAMCD='WBCUD';
=59 for PARAMCD='WBCUM'; =60 for PARAMCD='LIPASET'; =62 for PARAMCD='LYMB'; =65 for PARAMCD='LYMBS';
=66 for PARAMCD='LYMATLE'; =68 for PARAMCD='LYMLEB'; =69 for PARAMCD='LYMLEBS'; =70 for PARAMCD=’MACROCY’;
=71 for PARAMCD='METHDN'; =72 for PARAMCD='METHAMPH'; =73 for PARAMCD='MICROCY'; =75 for PARAMCD='MONOB';
=78 for PARAMCD='MONOBS'; =80 for PARAMCD='MONOLEB'; =81 for PARAMCD='MONOLEBS'; =82 for PARAMCD='MYCY';
=84 for PARAMCD='NEUTB'; =87 for PARAMCD='NEUTBS'; =89 for PARAMCD='NEUTLEB'; =90 for PARAMCD='NEUTLEBS';
=91 for PARAMCD='NITRITE'; =92 for PARAMCD='OPIATE'; =93 for PARAMCD='PH'; =94 for PARAMCD='PCP';
=95 for PARAMCD='PLAT'; =96 for PARAMCD='POIKILO'; =97 for PARAMCD='K'; =98 for PARAMCD='PROT';
=99 for PARAMCD='EPIROCE'; =100 for PARAMCD='SMDGCELE'; =101 for PARAMCD='SODIUM'; =102 for PARAMCD='SPGRAV';
=103 for PARAMCD='TRCYANDP'; =104 for PARAMCD='UREAN' ; =105 for PARAMCD='UROBIL'; =106 for PARAMCD='YEAST'; | ||
| PARCAT1 | Parameter Category 1 | text | 10 | Parameter Category 1
| Derived LB.LBCAT | |
| PARCAT1N | Parameter Category 1 (N) | integer | 8 | Derived Numeric Code of PARCAT1, CHEMISTRY=1; HEMATOLOGY=2 ; URINALYSIS=3; | ||
| PARCAT2 | Parameter Category 2 | text | 13 | Parameter Category 2
| Derived LB.LBSCAT | |
| PARCAT2N | Parameter Category 2 (N) | integer | 8 | Derived Numeric Code of PARCAT2, DRUG OF ABUSE=1; PREGNANCY=2 | ||
| LBSPEC | Specimen Type | text | 11 | Specimen Type
| Predecessor: LB.LBSPEC | |
| AVALVLM | Analysis Value | float | 8 | |||
| PARAMCD = "ALB" | Albumin [g/L] | integer | 2 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "ALP" | Alkaline Phosphatase [U/L] | float | 3 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "ALT" | Alanine Aminotransferase [U/L] | float | 3 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "AMYLASE" | Amylase [U/L] | integer | 3 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "AST" | Aspartate Aminotransferase [U/L] | float | 3 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "BASOB" | Basophils (Blood) [10^9/L] | float | 4 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "BASOLEB" | Basophils/Leukocytes (Blood) [%] | float | 3 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "BILIS" | Bilirubin (Serum) [umol/L] | float | 4 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "CA" | Calcium [mmol/L] | float | 4 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "CREAT" | Creatinine [umol/L] | float | 5 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "CRP" | C Reactive Protein [mg/L] | float | 4 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "EOSB" | Eosinophils (Blood) [10^9/L] | float | 4 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "EOSLEB" | Eosinophils/Leukocytes (Blood) [%] | float | 4 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "FERRITIN" | Ferritin [ug/L] | float | 5 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "GGT" | Gamma Glutamyl Transferase [U/L] | integer | 3 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "GLUCB" | Glucose (Blood) [mmol/L] | float | 4 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "HCT" | Hematocrit [L/L] | float | 4 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "HGBB" | Hemoglobin (Blood) [mmol/L] | float | 4 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "HGBU" | Hemoglobin (Urine) [10^6/L] | integer | 3 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "K" | Potassium [mmol/L] | float | 3 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "LIPASET" | Lipase [U/L] | integer | 3 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "LYMB" | Lymphocytes (Blood) [10^9/L] | float | 4 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "LYMLEB" | Lymphocytes/Leukocytes (Blood) [%] | float | 4 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "MONOB" | Monocytes (Blood) [10^9/L] | float | 4 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "MONOLEB" | Monocytes/Leukocytes (Blood) [%] | float | 4 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "NEUTB" | Neutrophils (Blood) [10^9/L] | float | 4 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "NEUTLEB" | Neutrophils/Leukocytes (Blood) [%] | float | 4 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "PH" | pH | float | 3 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "PLAT" | Platelets [10^9/L] | integer | 3 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "PROT" | Protein [mg/L] | integer | 4 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "RBCB" | Erythrocytes (Blood) [10^12/L] | float | 3 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "SODIUM" | Sodium [mmol/L] | integer | 3 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "SPGRAV" | Specific Gravity | float | 5 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "UREAN" | Urea Nitrogen [mmol/L] | float | 6 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "WBCB" | Leukocytes (Blood) [10^9/L] | float | 4 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "WBCUD" | Leukocytes (Urine - Dipstick) [10^6/L] | float | 6 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "BILIU" | Bilirubin (Urine) [umol/L] | integer | 2 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "KETONES" | Ketones [mmol/L] | float | 4 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "UROBIL" | Urobilinogen [umol/L] | integer | 2 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "FSH" | Follicle Stimulating Hormone [IU/L] | float | 5 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "MCH" | Ery. Mean Corpuscular Hemoglobin [fmol] | float | 4 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "MCHC" | Ery. Mean Corpuscular HGB Concentration [mmol/L] | float | 4 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "MCV" | Ery. Mean Corpuscular Volume [fL] | float | 5 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "CK" | Creatine Kinase [U/L] | integer | 3 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "BASOBS" | Basophils (Blood Smear) [10^9/L] | float | 6 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "BASOLEBS" | Basophils/Leukocytes (Blood Smear) [%] | integer | 2 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "EOSBS" | Eosinophils (Blood Smear) [10^9/L] | float | 6 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "EOSLEBS" | Eosinophils/Leukocytes (Blood Smear) [%] | integer | 2 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "LYMATLE" | Lymphocytes Atypical/Leukocytes [%] | integer | 2 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "LYMBS" | Lymphocytes (Blood Smear) [10^9/L] | float | 5 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "LYMLEBS" | Lymphocytes/Leukocytes (Blood Smear) [%] | integer | 4 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "MONOBS" | Monocytes (Blood Smear) [10^9/L] | float | 6 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "MONOLEBS" | Monocytes/Leukocytes (Blood Smear) [%] | integer | 4 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "NEUTBS" | Neutrophils (Blood Smear) [10^9/L] | float | 5 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "NEUTLEBS" | Neutrophils/Leukocytes (Blood Smear) [%] | integer | 4 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "SMDGCELE" | Smudge Cells/Leukocytes [%] | integer | 2 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| PARAMCD = "MYCY" | Myelocytes [%] | integer | 1 | Derived LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. | ||
| AVALCVLM | Analysis Value (C) | text | 50 | |||
| PARCAT2 = "Drug of Abuse" | Drug of Abuse Category | text | 8 | Negative/Positive Result
| Predecessor: LB.LBSTRESC | |
| PARAMCD = "ALB" | Albumin [g/L] | text | 2 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "ALP" | Alkaline Phosphatase [U/L] | text | 3 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "ALT" | Alanine Aminotransferase [U/L] | text | 3 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "AMYLASE" | Amylase [U/L] | text | 3 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "AST" | Aspartate Aminotransferase [U/L] | text | 3 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "BACT" | Bacteria [/HPF] | text | 14 | Analysis Value (C) [7 Terms] | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | |
| PARAMCD = "BASOB" | Basophils (Blood) [10^9/L] | text | 10 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "BASOLEB" | Basophils/Leukocytes (Blood) [%] | text | 10 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "BILIS" | Bilirubin (Serum) [umol/L] | text | 4 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "BILIU" | Bilirubin (Urine) [umol/L] | text | 8 | Analysis Value (C)
| Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | |
| PARAMCD = "CA" | Calcium [mmol/L] | text | 5 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "CASTS" | Casts [/HPF] | text | 14 | Analysis Value (C)
| Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | |
| PARAMCD = "CREAT" | Creatinine [umol/L] | text | 5 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "CRP" | C Reactive Protein [mg/L] | text | 4 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "CRYSTALS" | Crystals [/HPF] | text | 14 | Analysis Value (C)
| Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | |
| PARAMCD = "EOSB" | Eosinophils (Blood) [10^9/L] | text | 10 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "EOSLEB" | Eosinophils/Leukocytes (Blood) [%] | text | 10 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "EPIC" | Epithelial Cells [/HPF] | text | 14 | Analysis Value (C) [9 Terms] | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | |
| PARAMCD = "EPIROCE" | Round Epithelial Cells [/HPF] | text | 14 | Analysis Value (C)
| Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | |
| PARAMCD = "FERRITIN" | Ferritin [ug/L] | text | 5 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "GGT" | Gamma Glutamyl Transferase [U/L] | text | 3 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "GLUCB" | Glucose (Blood) [mmol/L] | text | 4 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "GLUCU" | Glucose (Urine) | text | 8 | Negative/Positive Result
| Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | |
| PARAMCD = "HCG" | Choriogonadotropin Beta | text | 8 | Negative/Positive Result
| Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | |
| PARAMCD = "HCT" | Hematocrit [L/L] | text | 10 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "HGBB" | Hemoglobin (Blood) [mmol/L] | text | 10 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "HGBU" | Hemoglobin (Urine) [10^6/L] | text | 8 | Analysis Value (C) [6 Terms] | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | |
| PARAMCD = "K" | Potassium [mmol/L] | text | 50 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "KETONES" | Ketones [mmol/L] | text | 8 | Analysis Value (C)
| Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | |
| PARAMCD = "LIPASET" | Lipase [U/L] | text | 3 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "LYMB" | Lymphocytes (Blood) [10^9/L] | text | 10 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "LYMLEB" | Lymphocytes/Leukocytes (Blood) [%] | text | 10 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "MONOB" | Monocytes (Blood) [10^9/L] | text | 10 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "MONOLEB" | Monocytes/Leukocytes (Blood) [%] | text | 10 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "NEUTB" | Neutrophils (Blood) [10^9/L] | text | 10 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "NEUTLEB" | Neutrophils/Leukocytes (Blood) [%] | text | 10 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "NITRITE" | Nitrite | text | 8 | Negative/Positive Result
| Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | |
| PARAMCD = "PH" | pH | text | 3 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "PLAT" | Platelets [10^9/L] | text | 10 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "PROT" | Protein [mg/L] | text | 8 | Analysis Value (C)
| Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | |
| PARAMCD = "RBCB" | Erythrocytes (Blood) [10^12/L] | text | 10 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "RBCU" | Erythrocytes (Urine) [/HPF] | text | 14 | Analysis Value (C) [8 Terms] | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | |
| PARAMCD = "SODIUM" | Sodium [mmol/L] | text | 3 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "SPGRAV" | Specific Gravity | text | 5 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "UREAN" | Urea Nitrogen [mmol/L] | text | 6 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "UROBIL" | Urobilinogen [umol/L] | text | 6 | Analysis Value (C)
| Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | |
| PARAMCD = "WBCB" | Leukocytes (Blood) [10^9/L] | text | 10 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "WBCUD" | Leukocytes (Urine - Dipstick) [10^6/L] | text | 8 | Analysis Value (C)
| Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | |
| PARAMCD = "WBCUM" | Leukocytes (Urine - Microscopy) [/HPF] | text | 14 | Analysis Value (C) [8 Terms] | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | |
| PARAMCD = "FSH" | Follicle Stimulating Hormone [IU/L] | text | 5 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "MCH" | Ery. Mean Corpuscular Hemoglobin [fmol] | text | 4 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "MCHC" | Ery. Mean Corpuscular HGB Concentration [mmol/L] | text | 4 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "MCV" | Ery. Mean Corpuscular Volume [fL] | text | 5 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "CK" | Creatine Kinase [U/L] | text | 3 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "BASOBS" | Basophils (Blood Smear) [10^9/L] | text | 14 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "BASOLEBS" | Basophils/Leukocytes (Blood Smear) [%] | text | 22 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "EOSBS" | Eosinophils (Blood Smear) [10^9/L] | text | 14 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "EOSLEBS" | Eosinophils/Leukocytes (Blood Smear) [%] | text | 22 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "LYMATLE" | Lymphocytes Atypical/Leukocytes [%] | text | 2 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "LYMBS" | Lymphocytes (Blood Smear) [10^9/L] | text | 14 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "LYMLEBS" | Lymphocytes/Leukocytes (Blood Smear) [%] | text | 22 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "MONOBS" | Monocytes (Blood Smear) [10^9/L] | text | 14 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "MONOLEBS" | Monocytes/Leukocytes (Blood Smear) [%] | text | 22 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "NEUTBS" | Neutrophils (Blood Smear) [10^9/L] | text | 14 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "NEUTLEBS" | Neutrophils/Leukocytes (Blood Smear) [%] | text | 22 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "POIKILO" | Poikilocytes | text | 3 | Analysis Value (C)
| Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | |
| PARAMCD = "SMDGCELE" | Smudge Cells/Leukocytes [%] | text | 2 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| PARAMCD = "ANISO" | Anisocytes | text | 2 | Analysis Value (C)
| Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | |
| PARAMCD = "YEAST" | Yeast Cells [/HPF] | text | 7 | Analysis Value (C)
| Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | |
| PARAMCD = "MICROCY" | Microcytes | text | 2 | Analysis Value (C)
| Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | |
| PARAMCD = "MYCY" | Myelocytes [%] | text | 1 | Derived Character of AVAL. if AVAL=. then LB.LBSTRESC. | ||
| LBCLSIG | Clinically Significant | text | 1 | No Yes Response
| Predecessor: SUPPLB.QVAL where QNAM='LBCLSIG' | |
| LBCLSIGN | Clinically Significant (N) | integer | 8 | Derived numeric of LB.LBCLSIG, Y=1, N=0 | ||
| ABLFL | Baseline Record Flag | text | 1 | No Yes Response (Yes Only)
| Derived ABLFL='Y' for last non-missing AVAL/AVALC when Analysis date (ADLB.ADT) is on/before treatment start (ADLB.TRTSDT). | |
| BASE | Baseline Value | float | 8 | Derived BASE=AVAL, when ABLFL="Y" | ||
| BASEC | Baseline Value (C) | text | 50 | Baseline Value (C) [16 Terms] | Derived Character of BASE | |
| CHG | Change from Baseline | float | 8 | Derived When AVAL and BASE are non-missing CHG = AVAL - BASE. if AVAL=0 & BASE=0 then CHG=. | ||
| PCHG | Percent Change from Baseline | float | 8 | Derived PCHG = ((AVAL - BASE)/BASE)*100 when AVAL and BASE are not missing. | ||
| ANRIND | Analysis Reference Range Indicator | text | 8 | Analysis Reference Range Indicator
| Derived Derived based on AVAL, ANRHI, ANRLO. For Urinalysis NEGATIVE, NORMAL are considered Normal, anything other than above are ABNORMAL. NOT DETECTABLE, INVALID VALUE are considered as MISSING. If AVAL/AVALC is missing or AVALC=+, for categories other than URINALYSIS, or (ANRHI and ANRLO) are missing but LBCLSIG is non-missing then for URINALYSIS ANRIND="Abnormal", For other categories, ANRIND="HIGH". | |
| ANRINDN | Analysis Reference Range Indicator (N) | integer | 8 | Derived Numeric Code of ANRIND, LOW=1, NORMAL=2, HIGH=3, ABNORMAL=4, MISSING=5 | ||
| BNRIND | Baseline Reference Range Indicator | text | 8 | Baseline Reference Range Indicator
| Derived BNRIND=ANRIND, when ABLFL='Y' | |
| BNRINDN | Baseline Reference Range Indicator (N) | integer | 8 | Derived Numeric Code of BNRIND, LOW=1, NORMAL=2, HIGH=3, ABNORMAL=4, MISSING=5 | ||
| ANRLO | Analysis Normal Range Lower Limit | float | 8 | Derived ADLB.ANRLO=LB.LBSTNRLO. if LB.LBSTNRLO=. and LB.LBSTNRC has values as "X-Y", where X,Y are numeric variables, then X is ADLB.ANRLO. | ||
| ANRLOC | Analysis Normal Range Lower Limit (C) | text | 5 | Derived Character of ANRLO | ||
| ANRHI | Analysis Normal Range Upper Limit | float | 8 | Derived ANRHI=LB.LBSTNRHI. if LB.LBSTNRHI=. and LB.LBSTNRC has values as "X-Y", where X,Y are numeric variables, then Y is ANRHI. | ||
| ANRHIC | Analysis Normal Range Upper Limit (C) | text | 5 | Derived Character of ANRHI. If LB.LBSTNRLO is missing and LB.LBSTNRHI is non-missing then ANRHIC is shown as "<LB.LBSTNRHI+1" | ||
| NABCS | Normal/Abnormal/CS | text | 17 | Normal/Abnormal/CS
| Derived if ANRIND=abnormal and LB.LBCLSIG="Y" then NABCS= "CS Abnormal"; if ANRIND is abnormal and LB.LBCLSIG="N" then NABCS="Abnormal (not CS)"; if ANRIND is normal then NABCS="Normal"; if ANRIND=. Then NABCS="Missing" ; | |
| NABCSN | Normal/Abnormal/CS (N) | integer | 8 | Derived Numeric Code of NABCS, Missing=1, CS abnormal=2, abnormal (not CS)=3, Normal=4 | ||
| DTYPE | Derivation Type | text | 8 | Derivation Type
| Derived Is populated for additional imputed records where LBSTRESN=. And LBSTRESC is like "<x". AVAL for these records will be 0.5*X and DTYPE="HALFLLOQ" . X is a numeric variable. | |
| WPBFL | Worst Post-Baseline Flag | text | 1 | No Yes Response (Yes Only)
| Derived WPBFL=Y for the first occurance of each abnormality for a given PARAM and USUBJID. if there is no abnormality for a given parameter and subject then first post-baseline visit is flagged as 'Y' | |
| ANL01FL | Analysis Flag 01 | text | 1 | No Yes Response (Yes Only)
| Derived ANL01FL='Y' for all scheduled visits and for records with DTYPE="HALFLLOQ". For records where LB.LBSTRESN=. And LB.LBSTRESC is like "<x", where x is numeric variable, ANL01FL=NULL. if ANRIND is derived based on LB.LBCLSIG then those records must be excluded from the analysis. i.e., ANLxxFL flags will be NULL.
If the lab test has been performed on less than 3 subjects then those tests(PARAMs) must be excluded from the analysis. i.e., ANLxxFL flags will be NULL.
ANLxxFL will be set to NULL when PARAMCD in 'yeast', 'lymatle', ‘smdgcele’. | |
| ANL02FL | Analysis Flag 02 | text | 1 | No Yes Response (Yes Only)
| Derived ANL02FL='Y' when DTYPE=NULL.
if ANL01FL=NULL then ANL02FL=NULL | |
| UNSVFL | Unscheduled Visit Flag | text | 1 | No Yes Response (Yes Only)
| Derived if LB.VISIT contains "Unscheduled" then UNSVFL="Y"; else UNSVFL=' '; | |
| POBLFL | Post-Baseline Flag | text | 1 | No Yes Response (Yes Only)
| Derived POBLFL='Y' when ADTM>TRTSDTM, if ADTM=. Then use ADT/TRTSDT. | |
| LBNAM | Vendor Name | text | 44 | Vendor Name
| Predecessor: LB.LBNAM | |
| LBMETHOD | Method of Test or Examination | text | 36 | Method of Test or Examination [10 Terms] | Predecessor: LB.LBMETHOD | |
| LBFAST | Fasting Status | text | 1 | No Yes Response
| Predecessor: LB.LBFAST | |
| LBORRES1 | Identification for Result | text | 24 | Predecessor: SUPPLB.QVAL where QNAM='LBORRES1' | ||
| LBORRES2 | Second Identification for Result | text | 21 | Predecessor: SUPPLB.QVAL where QNAM='LBORRES2' | ||
| LBLOINC1 | LOINC Code for Identification | text | 7 | LOINC Code for Identification
| Predecessor: SUPPLB.QVAL where QNAM='LBLOINC1' | |
| LBLOINC2 | LOINC Code for second Identification | text | 6 | LOINC Code for second Identification
| Predecessor: SUPPLB.QVAL where QNAM='LBLOINC2' | |
| RBB | Report Blood Count | text | 21 | Report Blood Count
| Predecessor: SUPPLB.QVAL where QNAM='RBB' | |
| RBB2 | Report Blood Count 2 | text | 21 | Report Blood Count 2
| Predecessor: SUPPLB.QVAL where QNAM='RBB2' | |
| LBDTC | Date/Time of Specimen Collection | datetime | ISO 8601 | Predecessor: LB.LBDTC | ||
| ADT | Analysis Date | integer | DATE9 | Derived Date part of ADTM. | ||
| ATM | Analysis Time | integer | TIME5 | Derived Time part of ADTM. | ||
| ADTM | Analysis Datetime | integer | DATETIME19 | Derived LB.LBDTC as SAS datetime. | ||
| LBDY | Study Day of Specimen Collection | integer | 8 | Predecessor: LB.LBDY | ||
| ADY | Analysis Relative Day | integer | 8 | Derived Set to LB.LBDY. | ||
| AVISIT | Analysis Visit | text | 26 | ADLB Analysis Visit [14 Terms] | Derived "If LB.VISIT=Visit 0 (Day -30 to 0) then AVISIT= Day -30 to 0
If LB.VISIT=Visit 1 (Day 1) then AVISIT= Day 1
If LB.VISIT=Visit 2 (Day 2) then AVISIT= Day 2
If LB.VISIT=Visit 3 (Day 8) then AVISIT= Day 8
If LB.VISIT=Visit 4 / Dosing (Day 22) then AVISIT= Day 22
If LB.VISIT=Visit 5 (Day 29) then AVISIT= Day 29
If LB.VISIT=Visit 7 / EoT Visit (Day 50) then AVISIT= Day 50
If LB.VISIT=Unscheduled 1.01 then AVISIT=Unscheduled Day -30 to 0
If LB.VISIT=Unscheduled 5.01 then AVISIT=Unscheduled Day 8
If LB.VISIT=Unscheduled 6.01 then AVISIT=Unscheduled Day 22
If LB.VISIT=Unscheduled 7.01 then AVISIT=Unscheduled Day 29
If LB.VISIT=Unscheduled 8.01 then AVISIT=Unscheduled Day 43
If LB.VISIT=Unscheduled 9.01 then AVISIT=Unscheduled Day 50 | |
| AVISITN | Analysis Visit (N) | float | 8 | Derived "If LB.VISIT=Visit 0 (Day -30 to 0) then AVISITN= 1
If LB.VISIT=Visit 1 (Day 1) then AVISITN= 2
If LB.VISIT=Visit 2 (Day 2) then AVISITN= 3
If LB.VISIT=Visit 3 (Day 8) then AVISITN= 5
If LB.VISIT=Visit 4 / Dosing (Day 22) then AVISITN= 6
If LB.VISIT=Visit 5 (Day 29) then AVISITN= 7
If LB.VISIT=Visit 7 / EoT Visit (Day 50) then AVISITN= 9
If LB.VISIT=Unscheduled 1.01 then AVISITN= 1.01
If LB.VISIT=Unscheduled 5.01 then AVISITN= 5.01
If LB.VISIT=Unscheduled 6.01 then AVISITN= 6.01
If LB.VISIT=Unscheduled 7.01 then AVISITN= 7.01
If LB.VISIT=Unscheduled 8.01 then AVISITN= 8.01
If LB.VISIT=Unscheduled 9.01 then AVISITN= 9.01 | ||
| VISIT | Visit Name | text | 28 | Visit Name [14 Terms] | Predecessor: LB.VISIT | |
| VISITNUM | Visit Number | float | 8 | Predecessor: LB.VISITNUM | ||
| EPOCH | Epoch | text | 9 | Epoch
| Predecessor: LB.EPOCH | |
| COMMENT1 | Comments 1 | text | 97 | Derived Comments are captured from CO domain. There will be each COMMENT<x> variable for each records in CO for a given subject. CO.COVAL is ADLB.COMMENT<x>, and corresponding CO.COEVAL is ADLB.COMEVAL<x> | ||
| COMEVAL1 | Comments 1 Evaluator | text | 12 | Comments 1 Evaluator
| Derived Evaluator for COMMENT1 is COMEVAL1. | |
| COMMENT2 | Comments 2 | text | 97 | Derived Comments are captured from CO domain. There will be each COMMENT<x> variable for each records in CO for a given subject. CO.COVAL is ADLB.COMMENT<x>, and corresponding CO.COEVAL is ADLB.COMEVAL<x> | ||
| COMEVAL2 | Comments 2 Evaluator | text | 10 | Comments 2 Evaluator
| Derived Evaluator for COMMENT2 is COMEVAL2. | |
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | ||
| AGEU | Age Units | text | 5 | Age Unit
| Predecessor: ADSL.AGEU | |
| SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX | |
| SEXN | Sex (N) | integer | 8 | Predecessor: ADSL.SEXN 1 when SEX = 'M'; 2 when SEX = 'F'. | ||
| RACE | Race | text | 25 | Race [9 Terms] | Predecessor: ADSL.RACE | |
| RACEN | Race (N) | integer | 8 | Predecessor: ADSL.RACEN 1 when RACE = 'AMERICAN INDIAN OR ALASKA NATIVE'; 2 when RACE = 'ASIAN'; 3 when RACE = 'BLACK OR AFRICAN AMERICAN'; 4 when RACE = 'NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER'; 5 when RACE = 'WHITE'; 6 when RACE = 'NOT REPORTED'; 7 when RACE = 'UNKNOWN'; 8 when RACE = 'OTHER'; 9 when RACE = 'MULTIPLE'. | ||
| SCRFL | Screened Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SCRFL | |
| SCRFN | Screened Population Flag (N) | integer | 8 | Predecessor: ADSL.SCRFN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| SAFFL | Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAFFL | |
| SAFFN | Safety Population Flag (N) | integer | 8 | Predecessor: ADSL.SAFFN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| SAFBFL | Safety Boost Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAFBFL | |
| SAFBFN | Safety Boost Population Flag (N) | integer | 8 | Predecessor: ADSL.SAFBFN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| IMMFL | Immunogenicity Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.IMMFL | |
| IMMFN | Immunogenicity Population Flag (N) | integer | 8 | Predecessor: ADSL.IMMFN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| CP7FL | Prime + 7 Days Completers Set | text | 1 | No Yes Response
| Predecessor: ADSL.CP7FL | |
| CP7FN | Prime + 7 Days Completers Set (N) | integer | 8 | Predecessor: ADSL.CP7FN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| CPBP28FL | Prime to Boost or Prime +28 D. Comp. Set | text | 1 | No Yes Response
| Predecessor: ADSL.CPBP28FL | |
| CPBP28FN | Pri. to Bo. or Pri. +28 D. Comp. Set (N) | integer | 8 | Predecessor: ADSL.CPBP28FN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| CB7FL | Boost + 7 Days Completers Set | text | 1 | No Yes Response
| Predecessor: ADSL.CB7FL | |
| CB7FN | Boost + 7 Days Completers Set (N) | integer | 8 | Predecessor: ADSL.CB7FN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| CB28FL | Boost + 28 Days Completers Set | text | 1 | No Yes Response
| Predecessor: ADSL.CB28FL | |
| CB28FN | Boost + 28 Days Completers Set (N) | integer | 8 | Predecessor: ADSL.CB28FN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| CPB28FL | Prime or Boost + 28 Days Completers Set | text | 1 | No Yes Response
| Predecessor: ADSL.CPB28FL | |
| CPB28FN | Prime or Boost + 28 Days Comp. Set (N) | integer | 8 | Predecessor: ADSL.CPB28FN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| COMPLFL | Completers Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.COMPLFL | |
| COMPLFN | Completers Population Flag (N) | integer | 8 | Predecessor: ADSL.COMPLFN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| TRTSDT | Date of First Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTSDT | ||
| TRTSTM | Time of First Exposure to Treatment | integer | TIME5 | Predecessor: ADSL.TRTSTM | ||
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME19 | Predecessor: ADSL.TRTSDTM | ||
| TRTEDT | Date of Last Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTEDT | ||
| TRTETM | Time of Last Exposure to Treatment | integer | TIME5 | Predecessor: ADSL.TRTETM | ||
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME19 | Predecessor: ADSL.TRTEDTM | ||
| ALLOCDT | Date of Allocation | integer | DATE9 | Predecessor: ADSL.ALLOCDT | ||
| ALLOCTM | Time of Allocation | integer | TIME5 | Predecessor: ADSL.ALLOCTM | ||
| ALLOCDTM | Datetime of Allocation | integer | DATETIME19 | Predecessor: ADSL.ALLOCDTM | ||
| SRCDOM | Source Data | text | 2 | ADLBSource Data
| Derived LB.DOMAIN | |
| SRCVAR | Source Variable | text | 7 | ADLBSource Variable
| Assigned Set to 'LBORRES'. | |
| SRCSEQ | Source Sequence Number | integer | 8 | Derived LB.LBSEQ | ||
| COHCAT1 | Cohort Category 1 | text | 20 | Predecessor: ADSL.COHCAT1 | ||
| COHCAT1N | Cohort Category 1 (N) | integer | 8 | Predecessor: ADSL.COHCAT1N | ||
| COHCAT2 | Cohort Category 2 | text | 28 | Predecessor: ADSL.COHCAT2 | ||
| COHCAT2N | Cohort Category 2 (N) | integer | 8 | Predecessor: ADSL.COHCAT2N |
Go to the top of the Define-XML document
Immunogenicity Analysis Dataset (ADVA)
| Variable | Where Condition | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 9 | Predecessor: ADSL.STUDYID | ||
| USUBJID | Unique Subject Identifier | text | 21 | Predecessor: ADSL.USUBJID | ||
| SUBJID | Subject Identifier for the Study | text | 5 | Predecessor: ADSL.SUBJID | ||
| SITEID | Study Site Identifier | text | 12 | Study Site Identifier
| Predecessor: ADSL.SITEID | |
| TRTP | Planned Treatment | text | 13 | Planned Treatment [10 Terms] | Predecessor: ADSL.TRT01P | |
| TRTPN | Planned Treatment (N) | integer | 8 | Predecessor: ADSL.TRT01PN Dose level in TRT01P multiplied by 100, with 100,000 added when subject is in elderly cohort (i.e. COHCAT2N = 2). [Ex: 101000 when TRT01P = '10 µg Elderly'] | ||
| TRTA | Actual Treatment | text | 13 | Actual Treatment [10 Terms] | Predecessor: ADSL.TRT01A | |
| TRTAN | Actual Treatment (N) | integer | 8 | Predecessor: ADSL.TRT01AN Dose level in TRT01A multiplied by 100, with 100,000 added when subject is in elderly cohort (i.e. COHCAT2N = 2). [Ex: 101000 when TRT01A = '10 µg Elderly'] | ||
| ADT | Analysis Date | integer | DATE9 | Derived ADT = date part of IS.ISDTC | ||
| ADTM | Analysis Datetime | float | DATETIME19 | Derived numeric value of IS.ISDTC | ||
| ATM | Analysis Time | float | TIME5 | Derived ATM = time part of IS.ISDTC | ||
| ADY | Analysis Relative Day | integer | 8 | Derived Analysis date relative to treatment start: ADT - TRTSDT + 1, when ADT is on or after TRTSDT; ADT - TRTSDT, when ADT is before TRTSDT. | ||
| AVISIT | Analysis Visit | text | 28 | ADVA Analysis Visit [9 Terms] | Derived AVISIT=IS.VISIT | |
| AVISITN | Analysis Visit (N) | float | 8 | Assigned Numeric analysis visit per windowing meta file or numeric cycle number based on g_ADVA_visit_cycles parameter. | ||
| PARAMVLM | Parameter | text | 48 | |||
| PARAMCD IN ( "C19S1IGG" (COVID-19 S1 IgG (U/mL)), "C19RBDIG" (COVID-19 RBD IgG (U/mL)) ) | COVID-19 Parameters | text | 23 | ADVA Parameter (COVID-19)
| Derived Concatenation of IS.ISTEST and IS.ISSTRESU in parentheses. | |
| PARAMCD IN ( "C2NGNT50" (SARS-CoV-2 Serum Neutralizing Titer 50), "C2NGNT90" (SARS-CoV-2 Serum Neutralizing Titer 90) ) | Neutralizing Titer Parameters | text | 38 | ADVA Parameter (Neutralizing Titer)
| Predecessor: IS.ISTEST | |
| PARAMCD IN ( "FRC19RBD" (COVID-19 RBD IgG Fold Rise), "FRC19S1I" (COVID-19 S1 IgG Fold Rise), "FRC2NT50" (SARS-CoV-2 Serum Neutralizing Titer 50 Fold Rise), "FRC2NT90" (SARS-CoV-2 Serum Neutralizing Titer 90 Fold Rise) ) | Fold Rise Parameters | text | 48 | ADVA Parameter (Fold Rise)
| Assigned 'COVID-19 RBD IgG Fold Rise' when record created from original record having PARAMCD='C19RBDIG'; 'COVID-19 S1 IgG Fold Rise' when record created from original record having PARAMCD='C19S1GG'; 'SARS-CoV-2 Serum Neutralizing Titer 50 Fold Rise' when record created from original record having PARAMCD='C2NGNT50'; 'SARS-CoV-2 Serum Neutralizing Titer 90 Fold Rise' when record created from original record having PARAMCD='C2NGNT90'. | |
| PARAMCD | Parameter Code | text | 8 | ADVA Parameter Code [8 Terms] | Assigned Assigned values as IS.ISTESTCD for PARAMN=1,2,3,4 and assigned 'FRC19RBD' for 'COVID-19 RBD IgG Fold Rise' , 'FRC19S1I' for 'COVID-19 S1 IgG Fold Rise' , 'FRC2NT50' for 'SARS-CoV-2 Serum Neutralizing Titer 50 Fold Rise', 'FRC2NT90' for 'SARS-CoV-2 Serum Neutralizing Titer 90 Fold Rise' | |
| PARAMN | Parameter (N) | integer | 8 | Assigned Assign: 1 when paramcd="C19RBDIG" 2 when paramcd="C19S1IGG" 3 when paramcd="C2NGNT50" 4 when paramcd="C2NGNT90" 5 when paramcd="FRC19RBD" 6 when paramcd="'FRC19S1I" 7 when paramcd="FRC2NT50" 8 when paramcd="FRC2NT90" | ||
| PARCAT1 | Parameter Category 1 | text | 14 | Parameter Category 1
| Derived Set to IS.ISCAT. | |
| AVALVLM | Analysis Value | float | 8 | |||
| PARAMCD = "C19RBDIG" (COVID-19 RBD IgG (U/mL)) | COVID-19 RBD IgG (U/mL) | float | 10 | Derived if ISSTRESC equal to "BLQ" then set AVAL to 0.5*ISLLOQ; else set to IS.ISSTRESN. For paramn 5,6,7,8;
Create new row for post baseline records of paramn 1,2,3,4 with their non-missing aval and base.
for paramcd="FRC19RBD" subset if paramn=1 then aval eq aval/base.
for paramcd="'FRC19S1I" subset if paramn=2 then aval eq aval/base.
for paramcd="FRC2NT50" subset if paramn=3 then aval eq aval/base.
for paramcd="FRC2NT90" subset if paramn=4 then aval eq aval/base. | ||
| PARAMCD = "C19S1IGG" (COVID-19 S1 IgG (U/mL)) | COVID-19 S1 IgG (U/mL) | float | 11 | Derived if ISSTRESC equal to "BLQ" then set AVAL to 0.5*ISLLOQ; else set to IS.ISSTRESN. For paramn 5,6,7,8;
Create new row for post baseline records of paramn 1,2,3,4 with their non-missing aval and base.
for paramcd="FRC19RBD" subset if paramn=1 then aval eq aval/base.
for paramcd="'FRC19S1I" subset if paramn=2 then aval eq aval/base.
for paramcd="FRC2NT50" subset if paramn=3 then aval eq aval/base.
for paramcd="FRC2NT90" subset if paramn=4 then aval eq aval/base. | ||
| PARAMCD = "C2NGNT50" (SARS-CoV-2 Serum Neutralizing Titer 50) | SARS-CoV-2 Serum Neutralizing Titer 50 | float | 12 | Derived if ISSTRESC equal to "BLQ" then set AVAL to 0.5*ISLLOQ; else set to IS.ISSTRESN. For paramn 5,6,7,8;
Create new row for post baseline records of paramn 1,2,3,4 with their non-missing aval and base.
for paramcd="FRC19RBD" subset if paramn=1 then aval eq aval/base.
for paramcd="'FRC19S1I" subset if paramn=2 then aval eq aval/base.
for paramcd="FRC2NT50" subset if paramn=3 then aval eq aval/base.
for paramcd="FRC2NT90" subset if paramn=4 then aval eq aval/base. | ||
| PARAMCD = "C2NGNT90" (SARS-CoV-2 Serum Neutralizing Titer 90) | SARS-CoV-2 Serum Neutralizing Titer 90 | float | 12 | Derived if ISSTRESC equal to "BLQ" then set AVAL to 0.5*ISLLOQ; else set to IS.ISSTRESN. For paramn 5,6,7,8;
Create new row for post baseline records of paramn 1,2,3,4 with their non-missing aval and base.
for paramcd="FRC19RBD" subset if paramn=1 then aval eq aval/base.
for paramcd="'FRC19S1I" subset if paramn=2 then aval eq aval/base.
for paramcd="FRC2NT50" subset if paramn=3 then aval eq aval/base.
for paramcd="FRC2NT90" subset if paramn=4 then aval eq aval/base. | ||
| PARAMCD = "FRC19RBD" (COVID-19 RBD IgG Fold Rise) | COVID-19 RBD IgG Fold Rise | float | 14 | Derived if ISSTRESC equal to "BLQ" then set AVAL to 0.5*ISLLOQ; else set to IS.ISSTRESN. For paramn 5,6,7,8;
Create new row for post baseline records of paramn 1,2,3,4 with their non-missing aval and base.
for paramcd="FRC19RBD" subset if paramn=1 then aval eq aval/base.
for paramcd="'FRC19S1I" subset if paramn=2 then aval eq aval/base.
for paramcd="FRC2NT50" subset if paramn=3 then aval eq aval/base.
for paramcd="FRC2NT90" subset if paramn=4 then aval eq aval/base. | ||
| PARAMCD = "FRC19S1I" (COVID-19 S1 IgG Fold Rise) | COVID-19 S1 IgG Fold Rise | float | 15 | Derived if ISSTRESC equal to "BLQ" then set AVAL to 0.5*ISLLOQ; else set to IS.ISSTRESN. For paramn 5,6,7,8;
Create new row for post baseline records of paramn 1,2,3,4 with their non-missing aval and base.
for paramcd="FRC19RBD" subset if paramn=1 then aval eq aval/base.
for paramcd="'FRC19S1I" subset if paramn=2 then aval eq aval/base.
for paramcd="FRC2NT50" subset if paramn=3 then aval eq aval/base.
for paramcd="FRC2NT90" subset if paramn=4 then aval eq aval/base. | ||
| PARAMCD = "FRC2NT50" (SARS-CoV-2 Serum Neutralizing Titer 50 Fold Rise) | SARS-CoV-2 Serum Neutralizing Titer 50 Fold Rise | float | 11 | Derived if ISSTRESC equal to "BLQ" then set AVAL to 0.5*ISLLOQ; else set to IS.ISSTRESN. For paramn 5,6,7,8;
Create new row for post baseline records of paramn 1,2,3,4 with their non-missing aval and base.
for paramcd="FRC19RBD" subset if paramn=1 then aval eq aval/base.
for paramcd="'FRC19S1I" subset if paramn=2 then aval eq aval/base.
for paramcd="FRC2NT50" subset if paramn=3 then aval eq aval/base.
for paramcd="FRC2NT90" subset if paramn=4 then aval eq aval/base. | ||
| PARAMCD = "FRC2NT90" (SARS-CoV-2 Serum Neutralizing Titer 90 Fold Rise) | SARS-CoV-2 Serum Neutralizing Titer 90 Fold Rise | float | 11 | Derived if ISSTRESC equal to "BLQ" then set AVAL to 0.5*ISLLOQ; else set to IS.ISSTRESN. For paramn 5,6,7,8;
Create new row for post baseline records of paramn 1,2,3,4 with their non-missing aval and base.
for paramcd="FRC19RBD" subset if paramn=1 then aval eq aval/base.
for paramcd="'FRC19S1I" subset if paramn=2 then aval eq aval/base.
for paramcd="FRC2NT50" subset if paramn=3 then aval eq aval/base.
for paramcd="FRC2NT90" subset if paramn=4 then aval eq aval/base. | ||
| AVALC | Analysis Value (C) | text | 12 | Derived Derived as character value of AVAL. | ||
| BASE | Baseline Value | float | 8 | Derived ADVA.AVAL from the record with ABLFL="Y" for this USUBJID/PARAM | ||
| CHG | Change from Baseline | float | 8 | Derived If AVAL not missing and BASE not missing then CHG=AVAL-BASE. This is calculated only for post-baseline records. | ||
| PCHG | Percent Change from Baseline | float | 8 | Derived For Post baseline records, if AVAL NOT missing and BASE not missing then set it to ((AVAL-BASE)/BASE)*100 | ||
| CRIT1 | Analysis Criterion 1 | text | 14 | Analysis Criterion 1
| Derived Derived as 'Seroconversion' for the post baseline records of ADVA.paramn 1, 2, 3, 4 | |
| CRIT1FL | Criterion 1 Evaluation Result Flag | text | 1 | No Yes Response
| Derived Derived for post baseline records of ADVA.paramn (1, 2, 3, 4); CRIT1FL='Y' when aval/base>=4; else CRIT1FL='N' | |
| CRIT1FN | Criterion 1 Evaluation Result Flag (N) | integer | 8 | Assigned 0 when CRIT1FL = 'N'; 1 when CRIT1FL = 'Y'. | ||
| DTYPE | Derivation Type | text | 8 | Derivation Type
| Derived Derived as 'HALFLLOQ' for records IS.ISSTRESC='BLQ' | |
| ABLFL | Baseline Record Flag | text | 1 | No Yes Response (Yes Only)
| Derived 'Y' for a valid result (AVAL ne .) and last non missing records value before or on the first day of treatment | |
| ISLLOQ | Lower Limit of Quantitation | float | 8 | Predecessor: IS.ISLLOQ | ||
| SAFFL | Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAFFL | |
| SAFFN | Safety Population Flag (N) | integer | 8 | Predecessor: ADSL.SAFFN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| IMMFL | Immunogenicity Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.IMMFL | |
| IMMFN | Immunogenicity Population Flag (N) | integer | 8 | Predecessor: ADSL.IMMFN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| EXIMM1 | Reason for Exclusion Immunogenicity Set | text | 1 | Predecessor: ADSL.EXIMM1 | ||
| PPROTFL | Per-Protocol Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPROTFL | |
| PPROTFN | Per-Protocol Population Flag (N) | integer | 8 | Predecessor: ADSL.PPROTFN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| EXPPROT1 | Reason 1 for Exclusion Per-Protocol Set | text | 81 | Reason 1 for Exclusion Per-Protocol Set
| Predecessor: ADSL.EXPPROT1 | |
| COHORT | Cohort | text | 8 | Cohort [10 Terms] | Predecessor: ADSL.COHORT | |
| COHORTN | Cohort (N) | integer | 8 | Predecessor: ADSL.COHORTN Numeric value following 'Cohort ' in COHORT variable. | ||
| COHCAT1 | Cohort Category 1 | text | 20 | Cohort Category 1
| Predecessor: ADSL.COHCAT1 | |
| COHCAT1N | Cohort Category 1 (N) | integer | 8 | Predecessor: ADSL.COHCAT1N 1 when COHCAT1 is 'Dose ranging cohorts'. | ||
| COHCAT2 | Cohort Category 2 | text | 28 | Cohort Category 2
| Predecessor: ADSL.COHCAT2 | |
| COHCAT2N | Cohort Category 2 (N) | integer | 8 | Predecessor: ADSL.COHCAT2N 1 when COHCAT2 is 'Younger dose ranging cohorts'; 2 when COHCAT2 is 'Elderly dose ranging cohorts'. | ||
| GROUP | Group | text | 12 | Group
| Predecessor: ADSL.GROUP | |
| GROUPN | Group (N) | integer | 8 | Predecessor: ADSL.GROUPN 2 when GROUP = 'B (BNT162b1)'; 3 when GROUP = 'C (BNT162b2)'. | ||
| SRCDOM | Source Data | text | 2 | ADVASource Data
| Assigned Set to "IS" if DTYPE not eq "HALF LLOQ" and paramn not eq 5,6,7,8 | |
| SRCVAR | Source Variable | text | 8 | ADVASource Variable
| Assigned Set to "ISSTRESC" if DTYPE not eq "HALF LLOQ" and paramn not eq 5,6,7,8 | |
| SRCSEQ | Source Sequence Number | integer | 8 | Assigned Assigned as IS.ISSEQ if DTYPE not eq "HALF LLOQ" and paramn not eq 5,6,7,8 | ||
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | ||
| AGEU | Age Units | text | 5 | Age Unit
| Predecessor: ADSL.AGEU | |
| AGEGR1 | Pooled Age Group 1 | text | 11 | Pooled Age Group 1
| Predecessor: ADSL.AGEGR1 | |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Predecessor: ADSL.AGEGR1N 1 when AGEGR1 is '18 - 55 Yrs'; 2 when AGEGR1 is '> 55 Yrs'. | ||
| SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX | |
| SEXN | Sex (N) | integer | 8 | Predecessor: ADSL.SEXN 1 when SEX = 'M'; 2 when SEX = 'F'. | ||
| TRTEDT | Date of Last Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTEDT | ||
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME19 | Predecessor: ADSL.TRTEDTM | ||
| TRTSDT | Date of First Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTSDT | ||
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME19 | Predecessor: ADSL.TRTSDTM | ||
| ARM | Description of Planned Arm | text | 24 | Description of Planned Arm [18 Terms] | Predecessor: ADSL.ARM | |
| ACTARM | Description of Actual Arm | text | 24 | Description of Planned Arm [18 Terms] | Predecessor: ADSL.ACTARM | |
| BOIMDT | Date of Boost Immunization | integer | DATE9 | Predecessor: ADSL.BOIMDT | ||
| BOIMDTM | Datetime of Boost Immunization | integer | DATETIME19 | Predecessor: ADSL.BOIMDTM | ||
| BOIMTM | Time of Boost Immunization | integer | TIME5 | Predecessor: ADSL.BOIMTM | ||
| PRIMDT | Date of Prime Immunization | integer | DATE9 | Predecessor: ADSL.PRIMDT | ||
| PRIMDTM | Datetime of Prime Immunization | integer | DATETIME19 | Predecessor: ADSL.PRIMDTM | ||
| PRIMTM | Time of Prime Immunization | integer | TIME5 | Predecessor: ADSL.PRIMTM |
Go to the top of the Define-XML document
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 | 9 | Predecessor: ADSL.STUDYID | ||
| USUBJID | Unique Subject Identifier | text | 21 | Predecessor: ADSL.USUBJID | ||
| SUBJID | Subject Identifier for the Study | text | 5 | Predecessor: ADSL.SUBJID | ||
| SUBJIDN | Subject Identifier for the Study (N) | integer | 8 | Predecessor: ADSL.SUBJIDN | ||
| COHORT | Cohort | text | 9 | Cohort [10 Terms] | Predecessor: ADSL.COHORT | |
| COHORTN | Cohort (N) | integer | 8 | Predecessor: ADSL.COHORTN Numeric value following 'Cohort ' in COHORT variable. | ||
| GROUP | Group | text | 12 | Group
| Predecessor: ADSL.GROUP | |
| GROUPN | Group (N) | integer | 8 | Predecessor: ADSL.GROUPN 2 when GROUP = 'B (BNT162b1)'; 3 when GROUP = 'C (BNT162b2)'. | ||
| TRTP | Planned Treatment | text | 13 | Planned Treatment [10 Terms] | Predecessor: ADSL.TRT01P | |
| TRTPN | Planned Treatment (N) | integer | 8 | Predecessor: ADSL.TRT01PN Dose level in TRT01P multiplied by 100, with 100,000 added when subject is in elderly cohort (i.e. COHCAT2N = 2). [Ex: 101000 when TRT01P = '10 µg Elderly'] | ||
| TRTA | Actual Treatment | text | 13 | Actual Treatment [10 Terms] | Predecessor: ADSL.TRT01A | |
| TRTAN | Actual Treatment (N) | integer | 8 | Predecessor: ADSL.TRT01AN Dose level in TRT01A multiplied by 100, with 100,000 added when subject is in elderly cohort (i.e. COHCAT2N = 2). [Ex: 101000 when TRT01A = '10 µg Elderly'] | ||
| VSSEQ | Sequence Number | integer | 8 | Predecessor: VS.VSSEQ | ||
| ASEQ | Analysis Sequence Number | integer | 8 | Derived sort the data by USUBJID,PARAMN,AVISITN,ADTM. Assign the sequential numbers starting with 1 for each subject. | ||
| PARAM | Parameter | text | 33 | ADVS Parameter [9 Terms] | Derived VS.VSTEST || VS.VSORRESU | |
| PARAMCD | Parameter Code | text | 6 | ADVS Parameter Code [9 Terms] | Derived VS.VSTESTCD | |
| PARAMN | Parameter (N) | integer | 8 | Derived 1 if paramcd='BMI'; 2 if paramcd = 'DIABP'; 3 if paramcd='HEIGHT' ;4 if paramcd='PULSE'; 5 if paramcd='RESP'; 6 if paramcd='SYSBP'; 7 if paramcd='TEMP'; 8 if paramcd='TEMPR'; 9 if paramcd='WEIGHT' | ||
| PARCAT1 | Parameter Category 1 | text | 14 | Parameter Category 1
| Derived VS.VSCAT | |
| PARCAT1N | Parameter Category 1 (N) | integer | 8 | Derived 1 if parcat1='Reactogenicity' | ||
| PARCAT2 | Parameter Category 2 | text | 8 | Parameter Category 2
| Derived VS.VSSCAT | |
| PARCAT2N | Parameter Category 2 (N) | integer | 8 | Derived 1 if parcat2='Systemic' | ||
| VSPOS | Vital Signs Position of Subject | text | 6 | Vital Signs Position of Subject
| Predecessor: VS.VSPOS | |
| AVALVLM | Analysis Value | float | 8 | Derived VS.VSSTRESN | ||
| PARAMCD = "BMI" (Body Mass Index [kg/m2]) | Body Mass Index [kg/m2] | float | 4 | Derived VS.VSSTRESN | ||
| PARAMCD = "DIABP" (Diastolic Blood Pressure [mmHg]) | Diastolic Blood Pressure [mmHg] | integer | 3 | Derived VS.VSSTRESN | ||
| PARAMCD = "HEIGHT" (Height [cm]) | Height [cm] | integer | 3 | Derived VS.VSSTRESN | ||
| PARAMCD = "PULSE" (Pulse Rate [beats/min]) | Pulse Rate [beats/min] | integer | 3 | Derived VS.VSSTRESN | ||
| PARAMCD = "RESP" (Respiratory Rate [breaths/min]) | Respiratory Rate [breaths/min] | integer | 2 | Derived VS.VSSTRESN | ||
| PARAMCD = "SYSBP" (Systolic Blood Pressure [mmHg]) | Systolic Blood Pressure [mmHg] | integer | 3 | Derived VS.VSSTRESN | ||
| PARAMCD = "TEMP" (Temperature [C]) | Temperature [C] | float | 4 | Derived VS.VSSTRESN | ||
| PARAMCD = "TEMPR" (Temperature (Reactogenicity) [C]) | Temperature (Reactogenicity) [C] | float | 4 | Derived VS.VSSTRESN | ||
| PARAMCD = "WEIGHT" (Weight [kg]) | Weight [kg] | float | 5 | Derived VS.VSSTRESN | ||
| AVALCVLM | Analysis Value (C) | text | 5 | Derived VS.VSSTRESC | ||
| PARAMCD = "BMI" (Body Mass Index [kg/m2]) | Body Mass Index [kg/m2] | text | 4 | Derived VS.VSSTRESC | ||
| PARAMCD = "DIABP" (Diastolic Blood Pressure [mmHg]) | Diastolic Blood Pressure [mmHg] | text | 3 | Derived VS.VSSTRESC | ||
| PARAMCD = "HEIGHT" (Height [cm]) | Height [cm] | text | 3 | Derived VS.VSSTRESC | ||
| PARAMCD = "PULSE" (Pulse Rate [beats/min]) | Pulse Rate [beats/min] | text | 3 | Derived VS.VSSTRESC | ||
| PARAMCD = "RESP" (Respiratory Rate [breaths/min]) | Respiratory Rate [breaths/min] | text | 2 | Derived VS.VSSTRESC | ||
| PARAMCD = "SYSBP" (Systolic Blood Pressure [mmHg]) | Systolic Blood Pressure [mmHg] | text | 3 | Derived VS.VSSTRESC | ||
| PARAMCD = "TEMP" (Temperature [C]) | Temperature [C] | text | 4 | Derived VS.VSSTRESC | ||
| PARAMCD = "TEMPR" (Temperature (Reactogenicity) [C]) | Temperature (Reactogenicity) [C] | text | 4 | Derived VS.VSSTRESC | ||
| PARAMCD = "WEIGHT" (Weight [kg]) | Weight [kg] | text | 5 | Derived VS.VSSTRESC | ||
| VSCLSIG | Clinically Significant | text | 1 | No Yes Response
| Predecessor: SUPPVS.QVAL where QNAM='VSCLSIG' | |
| VSCLSIGN | Clinically Significant (N) | integer | 8 | Derived 1 if VSCLSIG='Y'; 0 if VSCLSIG='N', missing otherwise | ||
| ABLFL | Baseline Record Flag | text | 1 | No Yes Response (Yes Only)
| Derived [Protocol/SAP] Baseline record for each SUBJID/PERIOD/PARAM as defined in the protocol | |
| BASE | Baseline Value | float | 8 | Derived ADVS.AVAL, where ADVS.USUBJID=USUBJID and ADVS.APERIOD=APERIOD and ADVS.PARAM=PARAM and ADVS.ABLFL="Y" | ||
| BASEC | Baseline Value (C) | text | 1 | Derived ADVS.AVALC, where ADVS.USUBJID=USUBJID and ADVS.APERIOD=APERIOD and ADVS.PARAM=PARAM and ADVS.ABLFL="Y" | ||
| CHG | Change from Baseline | float | 8 | Derived CHG = AVAL - BASE | ||
| PCHG | Percent Change from Baseline | float | 8 | Derived PCHG = ((AVAL - BASE)/BASE)*100 | ||
| ANRIND | Analysis Reference Range Indicator | text | 8 | Analysis Reference Range Indicator
| Derived If non-missing AVAL is greater than ANRHI or less than ANRLO then ANRIND=Abnormal. If ANRLO is missing then only ANRHI is used to determine abnormality.
If non-missing AVAL is within ANRLO and ANRHI then ANRIND=Normal. | |
| BNRIND | Baseline Reference Range Indicator | text | 8 | Baseline Reference Range Indicator
| Derived If non-missing BASE is greater than ANRHI or less than ANRLO then ANRIND=Abnormal. If ANRLO is missing then only ANRHI is used to determine abnormality.
If non-missing BASE is within ANRLO and ANRHI then ANRIND=Normal. | |
| ANRLO | Analysis Normal Range Lower Limit | float | 8 | Derived 50 if paramn=4 ; 8 if paramn=5 ; 90 if paramn=6 ; 35.5 if paramn=7 | ||
| ANRHI | Analysis Normal Range Upper Limit | float | 8 | Derived 90 if paramn=2; 100 if paramn=4; 20 if paramn=5 ; 140 if paramn=6 ; 37.5 if paramn=7 | ||
| NABCS | Normal/Abnormal/CS | text | 17 | Normal/Abnormal/CS
| Derived If abnormality is clinically significant then NABCS='CS Abnormal' ; If abnormality is not clinically significant then NABCS='Abnormal (not CS)' ; if no abnormality then NABCS=Normal ; if there is abnormality and clinically significance information is not present then NABCS=Missing. | |
| NABCSN | Normal/Abnormal/CS (N) | integer | 8 | Derived 1 if NABCS = 'Missing'; 2 if NABCS = 'CS Abnormal'; 3 if NABCS = 'Abnormal (not CS); 4 if NABCS = 'Normal’ | ||
| ANL01FL | Analysis Flag 01 | text | 1 | No Yes Response (Yes Only)
| Derived [Protocol/SAP] "Y" for the selected record within each SUBJID/PERIOD/PARAM/AVISIT as determined by the protocol | |
| ANL02FL | Analysis Flag 02 | text | 1 | No Yes Response (Yes Only)
| Derived "Y" when TRTSDT/TRTSTM < ADTM < TRTEDT/TRTETM | |
| UNSVFL | Unscheduled Visit Flag | text | 1 | No Yes Response (Yes Only)
| Derived Y' if index(AVISIT,'Unscheduled') > 0 | |
| POBLFL | Post-Baseline Flag | text | 1 | No Yes Response (Yes Only)
| Derived Populated only on records with null value for PARCAT1. 'Y' if ADTM ne . and ADTM>TRTSDTM. if ADTM=. and ADT>TRTSDT then POBLFL="Y"; | |
| VSLOC | Location of Vital Signs Measurement | text | 11 | Location of Vital Signs Measurement
| Predecessor: VS.VSLOC | |
| VSLAT | Laterality | text | 5 | Laterality
| Predecessor: VS.VSLAT | |
| VSDTC | Date/Time of Measurements | datetime | ISO 8601 | Predecessor: VS.VSDTC | ||
| ADT | Analysis Date | integer | DATE9 | Derived ADT = date part of VS.VSDTC | ||
| ATM | Analysis Time | integer | TIME5 | Derived ATM = time part of VS.VSDTC | ||
| ADTM | Analysis Datetime | integer | DATETIME19 | Derived numeric value of VS.VSDTC | ||
| VSDY | Study Day of Vital Signs | integer | 8 | Predecessor: VS.VSDY | ||
| ADY | Analysis Relative Day | integer | 8 | Derived Analysis date relative to treatment start: ADT - TRTSDT + 1, when ADT is on or after TRTSDT; ADT - TRTSDT, when ADT is before TRTSDT. | ||
| VSTPT | Planned Time Point Name | text | 7 | Planned Time Point Name [29 Terms] | Predecessor: VS.VSTPT | |
| VSTPTNUM | Planned Time Point Name (N) | float | 8 | Predecessor: VS.VSTPTNUM | ||
| ATPT | Analysis Timepoint | text | 7 | ADVS Analysis Timepoint [29 Terms] | Derived VS.VSTPT | |
| ATPTN | Analysis Timepoint (N) | float | 8 | Derived 0 if VS.VSTPT= "predose" ; 1 if VS.VSTPT= "1 hour" ; 3 if VS.VSTPT= "3 hours" ; 6 if VS.VSTPT= "6 hours". | ||
| VSTPTREF | Time Point Reference | text | 17 | Time Point Reference
| Predecessor: VS.VSTPTREF | |
| ATPTREF | Analysis Timepoint Reference | text | 12 | Analysis Timepoint Reference in ADVS
| Derived VS.VSTPTREF | |
| VSRFTDTC | Date/Time of Reference Time Point | datetime | ISO 8601 | Predecessor: VS.VSRFTDTC | ||
| AVISIT | Analysis Visit | text | 26 | ADVS Analysis Visit [15 Terms] | Derived If VS.VISIT=Visit 0 (Day -30 to 0) then AVISIT= Day -30 to 0 ;
If VS.VISIT=Visit 1 (Day 1) then AVISIT= Day 1 ;
If VS.VISIT=Visit 2 (Day 2) then AVISIT= Day 2 ;
If VS.VISIT=Visit 3 (Day 8) then AVISIT= Day 8 ;
If VS.VISIT=Visit 4 / Dosing (Day 22) then AVISIT= Day 22 ;
If VS.VISIT=Visit 5 (Day 29) then AVISIT= Day 29 ;
If VS.VISIT=Visit 6 (Day 43) then AVISIT= Day 43 ;
If VS.VISIT=Visit 7 / EoT Visit (Day 50) then AVISIT= Day 50 ;
If VS.VISIT=Visit 8 / FU Visit (Day 85) then AVISIT= Day 85 ;
If VS.VISIT=Visit 9 / FU Visit (Day 184) then AVISIT= Day 184 ;
If VS.VISIT=Unscheduled 1.01 then AVISIT=Unscheduled 1 Day -30 to 0 ;
If VS.VISIT=Unscheduled 2.01 then AVISIT=Unscheduled 1 Day 1 ;
If VS.VISIT=Unscheduled 3.01 then AVISIT=Unscheduled 1 Day 2 ;
If VS.VISIT=Unscheduled 5.01 then AVISIT=Unscheduled 1 Day 8 ;
If VS.VISIT=Unscheduled 6.01 then AVISIT=Unscheduled 1 Day 22 ;
If VS.VISIT=Unscheduled 7.01 then AVISIT=Unscheduled 1 Day 29 ;
If VS.VISIT=Unscheduled 8.01 then AVISIT=Unscheduled 1 Day 43 ;
If VS.VISIT=Unscheduled 9.01 then AVISIT=Unscheduled 1 Day 50 ; | |
| AVISITN | Analysis Visit (N) | float | 8 | Derived If VS.VISIT=Visit 0 (Day -30 to 0) then AVISITN= 1;
If VS.VISIT=Visit 1 (Day 1) then AVISITN= 2;
If VS.VISIT=Visit 2 (Day 2) then AVISITN= 3;
If VS.VISIT=Visit 3 (Day 8) then AVISITN= 5;
If VS.VISIT=Visit 4 / Dosing (Day 22) then AVISITN= 6;
If VS.VISIT=Visit 5 (Day 29) then AVISITN= 7;
If VS.VISIT=Visit 6 (Day 43) then AVISITN= 8;
If VS.VISIT=Visit 7 / EoT Visit (Day 50) then AVISITN= 9;
If VS.VISIT=Visit 8 / FU Visit (Day 85) then AVISITN=10;
If VS.VISIT=Visit 9 / FU Visit (Day 184) then AVISITN=11;
If VS.VISIT=Unscheduled 1.01 then AVISITN= 1.01 ;
If VS.VISIT=Unscheduled 2.01 then AVISITN=2.01;
If VS.VISIT=Unscheduled 3.01 then AVISITN=3.01;
If VS.VISIT=Unscheduled 5.01 then AVISITN= 5.01 ;
If VS.VISIT=Unscheduled 6.01 then AVISITN= 6.01 ;
If VS.VISIT=Unscheduled 7.01 then AVISITN= 7.01 ;
If VS.VISIT=Unscheduled 8.01 then AVISITN= 8.01 ;
If VS.VISIT=Unscheduled 9.01 then AVISITN= 9.01 ; | ||
| VISIT | Visit Name | text | 28 | Visit Name [15 Terms] | Predecessor: VS.VISIT | |
| VISITNUM | Visit Number | float | 8 | Predecessor: VS.VISITNUM | ||
| EPOCH | Epoch | text | 9 | Epoch
| Predecessor: VS.EPOCH | |
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | ||
| AGEU | Age Units | text | 5 | Age Unit
| Predecessor: ADSL.AGEU | |
| SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX | |
| SEXN | Sex (N) | integer | 8 | Predecessor: ADSL.SEXN 1 when SEX = 'M'; 2 when SEX = 'F'. | ||
| RACE | Race | text | 25 | Race [9 Terms] | Predecessor: ADSL.RACE | |
| RACEN | Race (N) | integer | 8 | Predecessor: ADSL.RACEN 1 when RACE = 'AMERICAN INDIAN OR ALASKA NATIVE'; 2 when RACE = 'ASIAN'; 3 when RACE = 'BLACK OR AFRICAN AMERICAN'; 4 when RACE = 'NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER'; 5 when RACE = 'WHITE'; 6 when RACE = 'NOT REPORTED'; 7 when RACE = 'UNKNOWN'; 8 when RACE = 'OTHER'; 9 when RACE = 'MULTIPLE'. | ||
| SCRFL | Screened Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SCRFL | |
| SCRFN | Screened Population Flag (N) | integer | 8 | Predecessor: ADSL.SCRFN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| SAFFL | Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAFFL | |
| SAFFN | Safety Population Flag (N) | integer | 8 | Predecessor: ADSL.SAFFN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| SAFBFL | Safety Boost Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAFBFL | |
| SAFBFN | Safety Boost Population Flag (N) | integer | 8 | Predecessor: ADSL.SAFBFN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| IMMFL | Immunogenicity Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.IMMFL | |
| IMMFN | Immunogenicity Population Flag (N) | integer | 8 | Predecessor: ADSL.IMMFN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| COHCAT1 | Cohort Category 1 | text | 20 | Cohort Category 1
| Predecessor: ADSL.COHCAT1 | |
| COHCAT1N | Cohort Category 1 (N) | integer | 8 | Predecessor: ADSL.COHCAT1N 1 when COHCAT1 is 'Dose ranging cohorts'. | ||
| COHCAT2 | Cohort Category 2 | text | 28 | Cohort Category 2
| Predecessor: ADSL.COHCAT2 | |
| COHCAT2N | Cohort Category 2 (N) | integer | 8 | Predecessor: ADSL.COHCAT2N 1 when COHCAT2 is 'Younger dose ranging cohorts'; 2 when COHCAT2 is 'Elderly dose ranging cohorts'. | ||
| CP7FL | Prime + 7 Days Completers Set | text | 1 | No Yes Response
| Predecessor: ADSL.CP7FL | |
| CP7FN | Prime + 7 Days Completers Set (N) | integer | 8 | Predecessor: ADSL.CP7FN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| CPBP28FL | Prime to Boost or Prime +28 D. Comp. Set | text | 1 | No Yes Response
| Predecessor: ADSL.CPBP28FL | |
| CPBP28FN | Pri. to Bo. or Pri. +28 D. Comp. Set (N) | integer | 8 | Predecessor: ADSL.CPBP28FN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| CB7FL | Boost + 7 Days Completers Set | text | 1 | No Yes Response
| Predecessor: ADSL.CB7FL | |
| CB7FN | Boost + 7 Days Completers Set (N) | integer | 8 | Predecessor: ADSL.CB7FN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| CB28FL | Boost + 28 Days Completers Set | text | 1 | No Yes Response
| Predecessor: ADSL.CB28FL | |
| CB28FN | Boost + 28 Days Completers Set (N) | integer | 8 | Predecessor: ADSL.CB28FN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| CPB28FL | Prime or Boost + 28 Days Completers Set | text | 1 | No Yes Response
| Predecessor: ADSL.CPB28FL | |
| CPB28FN | Prime or Boost + 28 Days Comp. Set (N) | integer | 8 | Predecessor: ADSL.CPB28FN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| COMPLFL | Completers Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.COMPLFL | |
| COMPLFN | Completers Population Flag (N) | integer | 8 | Predecessor: ADSL.COMPLFN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | ||
| TRTSDT | Date of First Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTSDT | ||
| TRTSTM | Time of First Exposure to Treatment | integer | TIME5 | Predecessor: ADSL.TRTSTM | ||
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME19 | Predecessor: ADSL.TRTSDTM | ||
| TRTEDT | Date of Last Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTEDT | ||
| TRTETM | Time of Last Exposure to Treatment | integer | TIME5 | Predecessor: ADSL.TRTETM | ||
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME19 | Predecessor: ADSL.TRTEDTM | ||
| ALLOCDT | Date of Allocation | integer | DATE9 | Predecessor: ADSL.ALLOCDT | ||
| ALLOCTM | Time of Allocation | integer | TIME5 | Predecessor: ADSL.ALLOCTM | ||
| ALLOCDTM | Datetime of Allocation | integer | DATETIME19 | Predecessor: ADSL.ALLOCDTM | ||
| SRCDOM | Source Data | text | 2 | ADVSSource Data
| Derived VS.DOMAIN | |
| SRCVAR | Source Variable | text | 7 | ADVSSource Variable
| Assigned "VSORRES" | |
| SRCSEQ | Source Sequence Number | integer | 8 | Derived VS.VSSEQ |
Go to the top of the Define-XML document
Adverse Events Analysis Dataset (ADAE)
| Variable | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 9 | Predecessor: ADSL.STUDYID | |
| USUBJID | Unique Subject Identifier | text | 21 | Predecessor: ADSL.USUBJID | |
| SUBJID | Subject Identifier for the Study | text | 5 | Predecessor: ADSL.SUBJID | |
| SUBJIDN | Subject Identifier for the Study (N) | integer | 8 | Predecessor: ADSL.SUBJIDN | |
| COHORT | Cohort | text | 9 | Cohort [10 Terms] | Predecessor: ADSL.COHORT |
| COHORTN | Cohort (N) | integer | 8 | Predecessor: ADSL.COHORTN Numeric value following 'Cohort ' in COHORT variable. | |
| AGEGR1 | Pooled Age Group 1 | text | 11 | Pooled Age Group 1
| Predecessor: ADSL.AGEGR1 |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Predecessor: ADSL.AGEGR1N 1 when AGEGR1 is '18 - 55 Yrs'; 2 when AGEGR1 is '> 55 Yrs'. | |
| COHCAT1 | Cohort Category 1 | text | 20 | Cohort Category 1
| Predecessor: ADSL.COHCAT1 |
| COHCAT1N | Cohort Category 1 (N) | integer | 8 | Predecessor: ADSL.COHCAT1N 1 when COHCAT1 is 'Dose ranging cohorts'. | |
| COHCAT2 | Cohort Category 2 | text | 28 | Cohort Category 2
| Predecessor: ADSL.COHCAT2 |
| COHCAT2N | Cohort Category 2 (N) | integer | 8 | Predecessor: ADSL.COHCAT2N 1 when COHCAT2 is 'Younger dose ranging cohorts'; 2 when COHCAT2 is 'Elderly dose ranging cohorts'. | |
| GROUP | Group | text | 12 | Group
| Predecessor: ADSL.GROUP |
| GROUPN | Group (N) | integer | 8 | Predecessor: ADSL.GROUPN 2 when GROUP = 'B (BNT162b1)'; 3 when GROUP = 'C (BNT162b2)'. | |
| TRTP | Planned Treatment | text | 13 | Planned Treatment [10 Terms] | Predecessor: ADSL.TRT01P |
| TRTPN | Planned Treatment (N) | integer | 8 | Predecessor: ADSL.TRT01PN Dose level in TRT01P multiplied by 100, with 100,000 added when subject is in elderly cohort (i.e. COHCAT2N = 2). [Ex: 101000 when TRT01P = '10 µg Elderly'] | |
| TRTA | Actual Treatment | text | 13 | Actual Treatment [10 Terms] | Predecessor: ADSL.TRT01A |
| TRTAN | Actual Treatment (N) | integer | 8 | Predecessor: ADSL.TRT01AN Dose level in TRT01A multiplied by 100, with 100,000 added when subject is in elderly cohort (i.e. COHCAT2N = 2). [Ex: 101000 when TRT01A = '10 µg Elderly'] | |
| AESEQ | Sequence Number | integer | 8 | Predecessor: AE.AESEQ | |
| AEGRPID | Group ID | text | 1 | Predecessor: AE.AEGRPID | |
| AESPID | Sponsor-Defined Identifier | text | 2 | Predecessor: AE.AESPID | |
| AETERM | Reported Term for the Adverse Event | text | 145 | Predecessor: AE.AETERM | |
| AEMODIFY | Modified Reported Term | text | 37 | Predecessor: AE.AEMODIFY | |
| AELLT | Lowest Level Term | text | 37 | 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 |
| AEDECOD | Dictionary-Derived Term | text | 35 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Predecessor: AE.AEDECOD |
| AEPTCD | Preferred Term Code | integer | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Predecessor: AE.AEPTCD |
| AEHLT | High Level Term | text | 64 | 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 | 58 | 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 |
| AECAT | Category for Adverse Event | text | 7 | Category for Adverse Event
| Predecessor: AE.AECAT |
| AEBODSYS | Body System or Organ Class | text | 52 | 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 |
| AESOC | Primary System Organ Class | text | 52 | 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 |
| AESEV | Severity/Intensity | text | 8 | Severity/Intensity Scale for AE
| Predecessor: AE.AESEV |
| AETOXGR | Standard Toxicity Grade | text | 8 | Standard Toxicity Grade in Adverse Events
| Predecessor: AE.AETOXGR |
| ASEV | Analysis Severity/Intensity | text | 8 | Analysis Severity/Intensity of Adverse Events
| Derived Propcase(AE.AESEV) when AE.AESEV not missing ; else Propcase(AE.AETOXGR) when AE.AETOXGR is not missing. ASEV= ' ' when both AE.AESEV and AE.AETOXGR missing. |
| ASEVN | Analysis Severity/Intensity (N) | integer | 8 | Assigned 1 when ASEV = 'Mild', 2 when ASEV = 'Moderate', 3 when ASEV = 'Severe', 4 when ASEV = 'Potentially life threatening'. | |
| AESER | Serious Event | text | 1 | No Yes Response
| Predecessor: AE.AESER |
| AESERN | Serious Event (N) | integer | 8 | Assigned 0 when AESER = 'N'; 1 when AESER = 'Y'. | |
| AEACN | Action Taken with Study Treatment | text | 16 | Action Taken with Study Treatment [6 Terms] | Predecessor: AE.AEACN |
| AACN | Analysis Action Taken with Study Trtmnt | text | 16 | Analysis Action Taken with Study Trtmnt [6 Terms] | Derived Propcase(AE.AEACN) when AE.AEACN not missing. |
| AACNN | Analysis Action Taken with Trtmnt (N) | integer | 8 | Assigned 1 when AEACN = 'DOSE NOT CHANGED'; 2 when AEACN = 'DOSE REDUCED'; 3 when AEACN = 'DRUG INTERRUPTED'; 4 when AEACN = 'DRUG WITHDRAWN'; 5 when AEACN = 'NOT APPLICABLE'; 6 when AEACN = 'UNKNOWN'. | |
| AEREL | Causality | text | 11 | Causality
| Predecessor: AE.AEREL |
| AREL | Analysis Causality | text | 11 | Analysis Causality
| Derived Propcase (AE.AEREL) when AE.AEREL not missing. |
| ARELN | Analysis Causality (N) | integer | 8 | Assigned 1 when AREL = 'Not Related'; 4 when AREL = 'Related'. | |
| AEOUT | Outcome of Adverse Event | text | 20 | Outcome of Event in AE [6 Terms] | Predecessor: AE.AEOUT |
| AOUT | Analysis Outcome of Adverse Event | text | 20 | Analysis Outcome of Adverse Event [6 Terms] | Derived Propcase(AE.AEOUT) when AE.AEOUT not missing. |
| AOUTN | Analysis Outcome of Adverse Event (N) | integer | 8 | Assigned 1 when AEOUT = 'NOT RECOVERED/NOT RESOLVED'; 2 when AEOUT = 'RECOVERED/RESOLVED'; 3 when AEOUT = 'RECOVERED/RESOLVED WITH SEQUELAE'; 4 when AEOUT = 'RECOVERING/RESOLVING'; 5 when AEOUT = 'FATAL'; 6 when AEOUT = 'UNKNOWN'. | |
| AESCONG | Congenital Anomaly or Birth Defect | text | 1 | No Yes Response (Yes Only)
| Predecessor: AE.AESCONG |
| AESDISAB | Persist or Signif Disability/Incapacity | text | 1 | No Yes Response (Yes Only)
| Predecessor: AE.AESDISAB |
| AESDTH | Results in Death | text | 1 | No Yes Response (Yes Only)
| Predecessor: AE.AESDTH |
| AESHOSP | Requires or Prolongs Hospitalization | text | 1 | No Yes Response (Yes Only)
| Predecessor: AE.AESHOSP |
| AESLIFE | Is Life Threatening | text | 1 | No Yes Response (Yes Only)
| Predecessor: AE.AESLIFE |
| AESMIE | Other Medically Important Serious Event | text | 1 | No Yes Response (Yes Only)
| Predecessor: AE.AESMIE |
| AECONTRT | Concomitant or Additional Trtmnt Given | text | 1 | No Yes Response
| Predecessor: AE.AECONTRT |
| AETRTEM | Treatment Emergent Flag | text | 1 | No Yes Response
| Predecessor: SUPPAE.QVAL where QNAM='AETRTEM' |
| AEDLT | Dose limiting Toxicity | text | 1 | No Yes Response
| Predecessor: SUPPAE.QVAL where QNAM='AEDLT' |
| AEEPRELI | Epi/Pandemic Related Indicator | text | 1 | No Yes Response
| Predecessor: SUPPAE.QVAL where QNAM='AEEPRELI' |
| AEEMREL | Treatment emergent related AE | text | 1 | No Yes Response
| Derived If TRTEMFL='Y' and upcase(arel)='RELATED' then AEEMREL='Y'; else AEEMREL='N'. |
| AEEMS | Treatment emergent severe AE | text | 1 | No Yes Response
| Derived If TRTEMFL='Y' and asevn in (3,4) then AEEMS='Y'; else AEEMS='N'. |
| AEEMSREL | Treatment emergent severe related AE | text | 1 | No Yes Response
| Derived If TRTEMFL='Y' and asevn in (3,4) and upcase(arel)='RELATED' then AEEMSREL='Y'; else AEEMSREL='N'. |
| AEEMSER | Serious treatment emergent AE | text | 1 | No Yes Response
| Derived If TRTEMFL='Y' and aeser='Y' then AEEMSER='Y'; else AEEMSER='N'. |
| AEEMSERR | Serious treatment emergent related AE | text | 1 | No Yes Response
| Derived If TRTEMFL='Y' and aeser='Y' and upcase(arel)='RELATED' then AEEMSERR='Y'; else AEEMSERR='N'. |
| PTDIAFL | Preferred Term based on diary entry | text | 1 | No Yes Response (Yes Only)
| Derived if (AE.AEDECOD in ('Abdominal pain', ' Abdominal pain lower', ' Arthralgia', 'Chills', 'Decreased appetite', 'Diarrhoea', 'Discomfort', 'Fatigue', ' Feeling hot', 'Gastrointestinal disorder', 'Headache', 'Hot flush', 'Influenza like illness', 'Injection site discomfort', 'Injection site erythema', 'Injection site hypersensitivity', 'Injection site pain', 'Injection site paraesthesia', 'Injection site reaction', 'Injection site swelling', 'Malaise', 'Muscle tightness', 'Myalgia', 'Nausea', ' Pyrexia' , 'Vomiting', 'Axillary pain', 'Body temperature increased', 'C-reactive protein increased', 'Dizziness', 'Head discomfort', 'Injection site discolouration', 'Injection site hypoaesthesia', 'Neck pain' ) and ((AENDT - ASTDT)+ 1)<=7) then PTDIAFL='Y'. |
| AESTDTC | Start Date/Time of Adverse Event | datetime | ISO 8601 | Predecessor: AE.AESTDTC | |
| ASTDT | Analysis Start Date | integer | DATE9 | Derived Date part of ASTDTM. | |
| ASTTM | Analysis Start Time | integer | TIME5 | Derived Time part of ASTDTM. | |
| ASTDTM | Analysis Start Date/Time | integer | DATETIME19 | Derived AE.AESTDTC as SAS datetime. | |
| AEENDTC | End Date/Time of Adverse Event | datetime | ISO 8601 | Predecessor: AE.AEENDTC | |
| AENDT | Analysis End Date | integer | DATE9 | Derived Date part of AENDTM. | |
| AENTM | Analysis End Time | integer | TIME5 | Derived Time part of AENDTM. | |
| AENDTM | Analysis End Date/Time | integer | DATETIME19 | Derived AE.AEENDTC as SAS datetime. | |
| AESTDY | Study Day of Start of Adverse Event | integer | 8 | Predecessor: AE.AESTDY | |
| ASTDY | Analysis Start Relative Day | integer | 8 | Derived Analysis start date relative to treatment start: ASTDT - TRTSDT + 1, when ASTDT is on or after TRTSDT; ASTDT - TRTSDT, when ASTDT is before TRTSDT. | |
| AEENDY | Study Day of End of Adverse Event | integer | 8 | Predecessor: AE.AEENDY | |
| AENDY | Analysis End Relative Day | integer | 8 | Derived if AENDT >=PRIMDT then AENDY=(AENDT - PRIMDT)+1; else if AENDT <PRIMDT then AENDY=AENDT - PRIMDT. | |
| ADURN | Analysis Duration (N) | float | 8 | Derived When AENDTM and ASTDTM not missing then ADURN=(AENDTM-ASTDTM)/(60*60). | |
| ADURU | Analysis Duration Units | text | 5 | Analysis Duration Units
| Derived When ADURN not missing ADURU='hours'. |
| LSTDD | Days since last dose | integer | 8 | Derived When BOIMDT not missing: if ASTDT < BOIMDT then LSTDD=ASTDT-PRIMDT +1; else if ASTDT >= BOIMDT then LSTDD=ASTDT-BOIMDT+1; When BOIMDT missing: if ASTDT >= PRIMDT then LSTDD=ASTDT-PRIMDT +1. | |
| AEENRTPT | End Relative to Reference Time Point | text | 7 | Relation to Reference Period (End)
| Predecessor: AE.AEENRTPT |
| AEENTPT | End Reference Time Point | text | 12 | End Reference Time Point
| Predecessor: AE.AEENTPT |
| TRTEMFL | Treatment Emergent Analysis Flag | text | 1 | No Yes Response (Yes Only)
| Derived *if not missing Adverse start date/time and AE start date/time >= first immunization date/time and AE start date/time <= (last immunization date/time + 28 days), then TRTEMFL='Y';
*if missing Adverse start time and AE start date >= first immunization date and AE start date <= (last immunization date + 28 days), then TRTEMFL='Y';
*if not missing Adverse start date/time and AE start date/time > (last immunization date/time + 28 days) but assessed as related to IMP by investigator then TRTEMFL='Y';
*if missing Adverse start time and AE start date > (last immunization date + 28 days) but assessed as related to IMP by investigator then TRTEMFL='Y';
*if AE present before immunization and worsened after first immunization, then TRTEMFL='Y';
*if missing AE date or time and AE cannot be determined TEAE from the above set rules, then TRTEMFL='Y'; |
| TMINT1FL | Time Interval 1 Flag | text | 1 | No Yes Response (Yes Only)
| Derived AE is Treatment-Emergent:
if ASTDTM >= PRIMDTM and (PRIMDTM <= ASTDTM <= (PRIMDTM + 7 days)) then TMINT1FL='Y';
if ASTDTM < PRIMDTM and Adverse Event worsened after Prime immunization then TMINT1FL='Y';
if AE time missing and Date not missing and
(PRIMDT <= ASTDT <= (PRIMDT + 7)) then TMINT1FL='Y';
if missing AE Date/or time and AE cannot be determined with above set rules, then TMINT1FL='Y'; |
| TMINT2FL | Time Interval 2 Flag | text | 1 | No Yes Response (Yes Only)
| Derived AE is Treatment-Emergent:
Identify the minimum of duration - ((Prime to Boost) or (28 days from Prime) - whatever comes first.
When Boost is missing, duration is 28 days from Prime.
if duration < 28 then: (Prime to Boost contribution)
if not missing AE start date/time and PRIMDTM <= ASTDTM <= BOIMDTM then TMINT2FL='Y';
if not missing AE start date/time and ASTDTM < PRIMDTM and Adverse Event worsened after Prime immunization then TMINT2FL='Y';
if missing AE start time and PRIMDT <= ASTDT <= BOIMDT then TMINT2FL='Y';
if missing AE start time and ASTDT < PRIMDT and Adverse Event worsened after Prime immunization then TMINT2FL='Y';
if duration = 28 then: (28 days from prime contribution)
if not missing AE start date/time and PRIMDTM <= ASTDTM <= (PRIMDTM + 28 days) then TMINT2FL='Y';
if not missing AE start date/time and ASTDTM < PRIMDTM and Adverse Event worsened after Prime immunization then TMINT2FL='Y';
if missing AE start time and PRIMDT <= ASTDT <= (PRIMDT + 28) then TMINT2FL='Y';
if missing AE start time and ASTDT < PRIMDT and Adverse Event worsened after Prime immunization then TMINT2FL='Y';
if missing AE Date/or time and AE cannot be determined with above set rules, then TMINT2FL='Y'; |
| TMINT3FL | Time Interval 3 Flag | text | 1 | No Yes Response (Yes Only)
| Derived AE is Treatment-Emergent:
if ASTDTM >= BOIMDTM and (BOIMDTM <= ASTDTM <= (BOIMDTM + 7 days)) then TMINT3FL='Y';
if ASTDTM < BOIMDTM and Adverse Event worsened after boost immunization then TMINT3FL='Y';
if AE time missing and Date not missing and Boost immunization date not missing and (BOIMDT <= ASTDT <= (BOIMDT + 7)) then TMINT3FL='Y';
if missing AE Date/or time and AE cannot be determined with above set rules, then TMINT3FL='Y'; |
| TMINT4FL | Time Interval 4 Flag | text | 1 | No Yes Response (Yes Only)
| Derived AE is Treatment-Emergent:
if ASTDTM >= BOIMDTM and (BOIMDTM <= ASTDTM <= (BOIMDTM + 28 days)) then TMINT4FL='Y';
if ASTDTM < BOIMDTM and Adverse Event worsened after boost immunization then TMINT4FL='Y';
if AE time missing and Date not missing and Boost immunization date not missing and (BOIMDT <= ASTDT <= (BOIMDT + 28)) then TMINT4FL='Y';
if missing AE Date/or time and AE cannot be determined with above set rules, then TMINT4FL='Y'; |
| TMINT5FL | Time Interval 5 Flag | text | 1 | No Yes Response (Yes Only)
| Derived AE is Treatment-Emergent:
if not missing AE Date/time, Prime/Boost immunization date/time and
ASTDTM >= PRIMDTM and (PRIMDTM <= ASTDTM <= (BOIMDTM + 28 days)) then TMINT5FL='Y';
if not missing AE Date/time, Prime/Boost immunization date/time and
ASTDTM < PRIMDTM and Adverse Event worsened on/after prime immunization and before/on (boost immunizaqtion + 28 days) then TMINT5FL='Y';
if not missing AE and Prime immunization date/time and boost date/time missing and
ASTDTM >= PRIMDTM and (PRIMDTM <= ASTDTM <= (PRIMDTM + 28 days)) then TMINT5FL='Y';
if missing AE time and AE date available and
ASTDT >= PRIMDT and (PRIMDT <= ASTDT <= (BOIMDT + 28)) then TMINT5FL='Y';
if missing AE time and AE date available and boost immunization missing and
ASTDT >= PRIMDT and (PRIMDT <= ASTDT <= (PRIMDT + 28)) then TMINT5FL='Y';
if missing AE Date/or time and AE cannot be determined with above set rules, then TMINT5FL='Y'; |
| EPOCH | Epoch | text | 9 | Epoch
| Predecessor: AE.EPOCH |
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | |
| AGEU | Age Units | text | 5 | Age Unit
| Predecessor: ADSL.AGEU |
| SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX |
| SEXN | Sex (N) | integer | 8 | Predecessor: ADSL.SEXN 1 when SEX = 'M'; 2 when SEX = 'F'. | |
| RACE | Race | text | 25 | Race [9 Terms] | Predecessor: ADSL.RACE |
| RACEN | Race (N) | integer | 8 | Predecessor: ADSL.RACEN 1 when RACE = 'AMERICAN INDIAN OR ALASKA NATIVE'; 2 when RACE = 'ASIAN'; 3 when RACE = 'BLACK OR AFRICAN AMERICAN'; 4 when RACE = 'NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER'; 5 when RACE = 'WHITE'; 6 when RACE = 'NOT REPORTED'; 7 when RACE = 'UNKNOWN'; 8 when RACE = 'OTHER'; 9 when RACE = 'MULTIPLE'. | |
| SCRFL | Screened Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SCRFL |
| SCRFN | Screened Population Flag (N) | integer | 8 | Predecessor: ADSL.SCRFN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | |
| SAFFL | Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAFFL |
| SAFFN | Safety Population Flag (N) | integer | 8 | Predecessor: ADSL.SAFFN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | |
| SAFBFL | Safety Boost Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAFBFL |
| SAFBFN | Safety Boost Population Flag (N) | integer | 8 | Predecessor: ADSL.SAFBFN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | |
| IMMFL | Immunogenicity Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.IMMFL |
| IMMFN | Immunogenicity Population Flag (N) | integer | 8 | Predecessor: ADSL.IMMFN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | |
| PPROTFL | Per-Protocol Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPROTFL |
| PPROTFN | Per-Protocol Population Flag (N) | integer | 8 | Predecessor: ADSL.PPROTFN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | |
| CP7FL | Prime + 7 Days Completers Set | text | 1 | No Yes Response
| Predecessor: ADSL.CP7FL |
| CP7FN | Prime + 7 Days Completers Set (N) | integer | 8 | Predecessor: ADSL.CP7FN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | |
| CPBP28FL | Prime to Boost or Prime +28 D. Comp. Set | text | 1 | No Yes Response
| Predecessor: ADSL.CPBP28FL |
| CPBP28FN | Pri. to Bo. or Pri. +28 D. Comp. Set (N) | integer | 8 | Predecessor: ADSL.CPBP28FN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | |
| CB7FL | Boost + 7 Days Completers Set | text | 1 | No Yes Response
| Predecessor: ADSL.CB7FL |
| CB7FN | Boost + 7 Days Completers Set (N) | integer | 8 | Predecessor: ADSL.CB7FN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | |
| CB28FL | Boost + 28 Days Completers Set | text | 1 | No Yes Response
| Predecessor: ADSL.CB28FL |
| CB28FN | Boost + 28 Days Completers Set (N) | integer | 8 | Predecessor: ADSL.CB28FN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | |
| CPB28FL | Prime or Boost + 28 Days Completers Set | text | 1 | No Yes Response
| Predecessor: ADSL.CPB28FL |
| CPB28FN | Prime or Boost + 28 Days Comp. Set (N) | integer | 8 | Predecessor: ADSL.CPB28FN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | |
| COMPLFL | Completers Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.COMPLFL |
| COMPLFN | Completers Population Flag (N) | integer | 8 | Predecessor: ADSL.COMPLFN 0 when corresponding -FL variable is 'N'; 1 when corresponding -FL variable is 'Y'. | |
| TRTSDT | Date of First Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTSDT | |
| TRTSTM | Time of First Exposure to Treatment | integer | TIME5 | Predecessor: ADSL.TRTSTM | |
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME19 | Predecessor: ADSL.TRTSDTM | |
| TRTEDT | Date of Last Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTEDT | |
| TRTETM | Time of Last Exposure to Treatment | integer | TIME5 | Predecessor: ADSL.TRTETM | |
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME19 | Predecessor: ADSL.TRTEDTM | |
| PRIMDT | Date of Prime Immunization | integer | DATE9 | Predecessor: ADSL.PRIMDT | |
| PRIMTM | Time of Prime Immunization | integer | TIME5 | Predecessor: ADSL.PRIMTM | |
| PRIMDTM | Datetime of Prime Immunization | integer | DATETIME19 | Predecessor: ADSL.PRIMDTM | |
| BOIMDT | Date of Boost Immunization | integer | DATE9 | Predecessor: ADSL.BOIMDT | |
| BOIMTM | Time of Boost Immunization | integer | TIME5 | Predecessor: ADSL.BOIMTM | |
| BOIMDTM | Datetime of Boost Immunization | integer | DATETIME19 | Predecessor: ADSL.BOIMDTM | |
| ALLOCDT | Date of Allocation | integer | DATE9 | Predecessor: ADSL.ALLOCDT | |
| ALLOCTM | Time of Allocation | integer | TIME5 | Predecessor: ADSL.ALLOCTM | |
| ALLOCDTM | Datetime of Allocation | integer | DATETIME19 | Predecessor: ADSL.ALLOCDTM |
Go to the top of the Define-XML document
Reactogenicity Analysis Dataset (ADCEVD)
| Variable | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 9 | Predecessor: ADSL.STUDYID | |
| USUBJID | Unique Subject Identifier | text | 21 | Predecessor: ADSL.USUBJID | |
| SUBJID | Subject Identifier for the Study | text | 5 | Predecessor: ADSL.SUBJID | |
| SUBJIDN | Subject Identifier for the Study (N) | integer | 8 | Predecessor: ADSL.SUBJIDN | |
| COHORT | Cohort | text | 9 | Cohort [10 Terms] | Predecessor: ADSL.COHORT |
| COHORTN | Cohort (N) | integer | 8 | Predecessor: ADSL.COHORTN Numeric value following 'Cohort ' in COHORT variable. | |
| COHCAT1 | Cohort Category 1 | text | 20 | Cohort Category 1
| Predecessor: ADSL.COHCAT1 |
| COHCAT1N | Cohort Category 1 (N) | integer | 8 | Predecessor: ADSL.COHCAT1N 1 when COHCAT1 is 'Dose ranging cohorts'. | |
| COHCAT2 | Cohort Category 2 | text | 28 | Cohort Category 2
| Predecessor: ADSL.COHCAT2 |
| COHCAT2N | Cohort Category 2 (N) | integer | 8 | Predecessor: ADSL.COHCAT2N 1 when COHCAT2 is 'Younger dose ranging cohorts'; 2 when COHCAT2 is 'Elderly dose ranging cohorts'. | |
| GROUP | Group | text | 12 | Group
| Predecessor: ADSL.GROUP |
| GROUPN | Group (N) | integer | 8 | Predecessor: ADSL.GROUPN 2 when GROUP = 'B (BNT162b1)'; 3 when GROUP = 'C (BNT162b2)'. | |
| TRTP | Planned Treatment | text | 13 | Planned Treatment [10 Terms] | Predecessor: ADSL.TRT01P |
| TRTPN | Planned Treatment (N) | integer | 8 | Predecessor: ADSL.TRT01PN | |
| TRTA | Actual Treatment | text | 13 | Actual Treatment [10 Terms] | Predecessor: ADSL.TRT01A |
| TRTAN | Actual Treatment (N) | integer | 8 | Predecessor: ADSL.TRT01AN | |
| CESEQ | Sequence Number | integer | 8 | Predecessor: CE.CESEQ | |
| CEGRPID | Group ID | text | 37 | Group ID in ADCEVD
| Predecessor: CE.CEGRPID |
| CETERM | Reported Term for the Clinical Event | text | 45 | Reported Term for the Clinical Event in ADCEVD [15 Terms] | Predecessor: CE.CETERM |
| CEDECOD | Dictionary-Derived Term | text | 23 | Predecessor: CE.CEDECOD | |
| CEBODSYS | Body System or Organ Class | text | 52 | Predecessor: CE.CEBODSYS | |
| CEBDSYCD | Body System or Organ Class Code | integer | 8 | Predecessor: CE.CEBDSYCD | |
| CELLT | Lowest Level Term | text | 25 | Predecessor: CE.CELLT | |
| CELLTCD | Lowest Level Term Code | integer | 8 | Predecessor: CE.CELLTCD | |
| CEPTCD | Preferred Term Code | integer | 8 | Predecessor: CE.CEPTCD | |
| CECAT | Category for Clinical Event | text | 14 | Category for Clinical Event in ADCEVD
| Predecessor: CE.CECAT |
| CESCAT | Subcategory for Clinical Event | text | 19 | Subcategory for Clinical Event in ADCEVD
| Predecessor: CE.CESCAT |
| ACAT1 | Analysis Category 1 | text | 8 | Analysis Category 1 in ADCEVD
| Derived 'local' when CESCAT = 'ADMINISTRATION SITE'; 'systemic' when CESCAT = 'SYSTEMIC'. |
| CESTDTC | Start Date/Time of Clinical Event | date | ISO 8601 | Predecessor: CE.CESTDTC | |
| ASTDT | Analysis Start Date | integer | DATE9 | Derived Date part of CESTDTC as SAS date. | |
| CEENDTC | End Date/Time of Clinical Event | date | ISO 8601 | Predecessor: CE.CEENDTC | |
| AENDT | Analysis End Date | integer | DATE9 | Derived Date part of CEENDTC as SAS date. | |
| ASTDY | Analysis Start Relative Day | integer | 8 | Predecessor: CESTDY | |
| CESTDY | Study Day of Start of Observation | integer | 8 | Predecessor: CE.CESTDY | |
| AENDY | Analysis End Relative Day | integer | 8 | Predecessor: CEENDY | |
| CEENDY | Study Day of End of Observation | integer | 8 | Predecessor: CE.CEENDY | |
| ADURN | Analysis Duration (N) | integer | 8 | Derived The numeric portion of CEDUR (following 'P'). | |
| ADURU | Analysis Duration Units | text | 4 | Analysis Duration Units
| Derived 'DAYS' when CEDUR ends with 'D'. Assigned as "DAYS" |
| CEDUR | Duration | text | 3 | Predecessor: CE.CEDUR | |
| CEENRTPT | End Relative to Reference Time Point | text | 7 | End Relative to Reference Time Point in ADCEVD
| Predecessor: CE.CEENRTPT |
| CEENTPT | End Reference Time Point | text | 5 | End Reference Time Point in ADCEVD
| Predecessor: CE.CEENTPT |
| ATPT | Analysis Timepoint | text | 5 | Analysis Timepoint in ADCEVD
| Derived Concatenation of 'Day ' and the value CETPTNUM - 1. |
| ATPTN | Analysis Timepoint (N) | integer | 8 | Assigned 7 when ATPT = 'DAY 7'. | |
| CETPT | Planned Time Point Name | text | 5 | Planned Time Point Name in ADCEVD
| Predecessor: CE.CETPT |
| ATPTREF | Analysis Timepoint Reference | text | 5 | Analysis Timepoint Reference in ADCEVD
| Derived 'Prime' when CETPTREF = 'PRIME VACCINATION'; 'Boost' when CETPTREF = 'BOOST VACCINATION'. |
| CETPTREF | Time Point Reference | text | 17 | Time Point Reference
| Predecessor: CE.CETPTREF |
| CEOCCUR | Clinical Event Occurrence | text | 1 | No Yes Response
| Predecessor: CE.CEOCCUR |
| CEPRESP | Clinical Event Pre-Specified | text | 1 | No Yes Response (Yes Only)
| Predecessor: CE.CEPRESP |
| AOCCLRFL | 1st Occurrence Local Reaction | text | 1 | No Yes Response (Yes Only)
| Derived 'Y' if first record for given USUBJID when sorted by ASTDT and CETERM having CEOCCUR = 'Y' and ACAT1 = 'local'. |
| AOCCL3FL | 1st Occur Gr>=3 Local Reaction | text | 1 | No Yes Response (Yes Only)
| Derived 'Y' if first record when sorted by ASTDT and CETERM for given USUBJID having CEOCCUR = 'Y' and ACAT1 = 'local' and SEVGR1 = 'grade >= 3'. |
| AOCCLPFL | 1st Occurrence Local Reaction-Prime | text | 1 | No Yes Response (Yes Only)
| Derived 'Y' if first record when sorted by ASTDT and CETERM for given USUBJID having CEOCCUR = 'Y' and ACAT1 = 'local' and ATPTREF = 'Prime'. |
| AOCCXPFL | 1st Occur Gr>=3 Local Reaction-Prime | text | 1 | No Yes Response (Yes Only)
| Derived 'Y' if first record when sorted by ASTDT and CETERM for given USUBJID having CEOCCUR = 'Y' and ACAT1 = 'local' and SEVGR1 = 'grade >= 3' and ATPTREF = 'Prime'. |
| AOCCLBFL | 1st Occurrence Local Reaction-Boost | text | 1 | No Yes Response (Yes Only)
| Derived 'Y' if first record when sorted by ASTDT and CETERM for given USUBJID having CEOCCUR = 'Y' and ACAT1 = 'local' and ATPTREF = 'Boost'. |
| AOCCXBFL | 1st Occur Gr>=3 Local Reaction-Boost | text | 1 | No Yes Response (Yes Only)
| Derived 'Y' if first record when sorted by ASTDT and CETERM for given USUBJID having CEOCCUR = 'Y' and ACAT1 = 'local' and SEVGR1 = 'grade >= 3' and ATPTREF = 'Boost'. |
| AOCCSRFL | 1st Occurrence Systemic Reaction | text | 1 | No Yes Response (Yes Only)
| Derived 'Y' if first record when sorted by ASTDT and CETERM for given USUBJID having CEOCCUR = 'Y' and ACAT1 = 'systemic'. |
| AOCCS3FL | 1st Occur Gr>=3 Systemic Reaction | text | 1 | No Yes Response (Yes Only)
| Derived 'Y' if first record when sorted by ASTDT and CETERM for given USUBJID having CEOCCUR = 'Y' and ACAT1 = 'systemic' and SEVGR1 = 'grade >= 3'. |
| AOCCSPFL | 1st Occurrence Systemic Reaction-Prime | text | 1 | No Yes Response (Yes Only)
| Derived 'Y' if first record when sorted by ASTDT and CETERM for given USUBJID having CEOCCUR = 'Y' and ACAT1 = 'systemic' and ATPTREF = 'Prime'. |
| AOCCYPFL | 1st Occur Gr>=3 Systemic Reaction-Prime | text | 1 | No Yes Response (Yes Only)
| Derived 'Y' if first record when sorted by ASTDT and CETERM for given USUBJID having CEOCCUR = 'Y' and ACAT1 = 'systemic' and SEVGR1 = 'grade >= 3' and ATPTREF = 'Prime'. |
| AOCCSBFL | 1st Occurrence Systemic Reaction-Boost | text | 1 | No Yes Response (Yes Only)
| Derived 'Y' if first record when sorted by ASTDT and CETERM for given USUBJID having CEOCCUR = 'Y' and ACAT1 = 'systemic' and ATPTREF = 'Boost'. |
| AOCCYBFL | 1st Occur Gr>=3 Systemic Reaction-Boost | text | 1 | No Yes Response (Yes Only)
| Derived 'Y' if first record when sorted by ASTDT and CETERM for given USUBJID having CEOCCUR = 'Y' and ACAT1 = 'systemic' and SEVGR1 = 'grade >= 3' and ATPTREF = 'Boost'. |
| ASEV | Analysis Severity/Intensity | text | 8 | Analysis Severity/Intensity of Clinical Events in ADCEVD
| Derived CESEV in proper case. |
| ASEVN | Analysis Severity/Intensity (N) | integer | 8 | Assigned 1 when ASEV = 'Mild', 2 when ASEV = 'Moderate', 3 when ASEV = 'Severe', 4 when ASEV = 'Potentially life threatening'. | |
| CESEV | Severity/Intensity | text | 8 | Severity Response in ADCEVD
| Predecessor: CE.CESEV |
| SEVGR1 | Pooled Severity Group 1 | text | 10 | Pooled Severity Group 1 in ADCEVD
| Derived 'grade < 3' when ASEVN is not missing and less than 3 (Mild or Moderate); 'grade >= 3' when ASEVN is greater than or equal to 3 (Severe or Potentially Life Threatening). |
| SEVGR1N | Pooled Severity Group 1 (N) | integer | 8 | Assigned 1 when SEVGR1 = 'grade < 3', 2 when SEVGR1 = 'grade >= 3'. | |
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | |
| AGEU | Age Units | text | 5 | Age Unit
| Predecessor: ADSL.AGEU |
| AGEGR1 | Pooled Age Group 1 | text | 11 | Pooled Age Group 1
| Predecessor: ADSL.AGEGR1 |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Predecessor: ADSL.AGEGR1N 1 when AGEGR1 is '18 - 55 Yrs'; 2 when AGEGR1 is '> 55 Yrs'. | |
| SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX |
| SEXN | Sex (N) | integer | 8 | Predecessor: ADSL.SEXN | |
| RACE | Race | text | 25 | Race [9 Terms] | Predecessor: ADSL.RACE |
| RACEN | Race (N) | integer | 8 | Predecessor: ADSL.RACEN | |
| SCRFL | Screened Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SCRFL |
| SCRFN | Screened Population Flag (N) | integer | 8 | Predecessor: ADSL.SCRFN | |
| SAFFL | Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAFFL |
| SAFFN | Safety Population Flag (N) | integer | 8 | Predecessor: ADSL.SAFFN | |
| SAFBFL | Safety Boost Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAFBFL |
| SAFBFN | Safety Boost Population Flag (N) | integer | 8 | Predecessor: ADSL.SAFBFN | |
| IMMFL | Immunogenicity Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.IMMFL |
| IMMFN | Immunogenicity Population Flag (N) | integer | 8 | Predecessor: ADSL.IMMFN | |
| PPROTFL | Per-Protocol Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.PPROTFL |
| PPROTFN | Per-Protocol Population Flag (N) | integer | 8 | Predecessor: ADSL.PPROTFN | |
| CP7FL | Prime + 7 Days Completers Set | text | 1 | No Yes Response
| Predecessor: ADSL.CP7FL |
| CP7FN | Prime + 7 Days Completers Set (N) | integer | 8 | Predecessor: ADSL.CP7FN | |
| CPBP28FL | Prime to Boost or Prime +28 D. Comp. Set | text | 1 | No Yes Response
| Predecessor: ADSL.CPBP28FL |
| CPBP28FN | Pri. to Bo. or Pri. +28 D. Comp. Set (N) | integer | 8 | Predecessor: ADSL.CPBP28FN | |
| CB7FL | Boost + 7 Days Completers Set | text | 1 | No Yes Response
| Predecessor: ADSL.CB7FL |
| CB7FN | Boost + 7 Days Completers Set (N) | integer | 8 | Predecessor: ADSL.CB7FN | |
| CB28FL | Boost + 28 Days Completers Set | text | 1 | No Yes Response
| Predecessor: ADSL.CB28FL |
| CB28FN | Boost + 28 Days Completers Set (N) | integer | 8 | Predecessor: ADSL.CB28FN | |
| CPB28FL | Prime or Boost + 28 Days Completers Set | text | 1 | No Yes Response
| Predecessor: ADSL.CPB28FL |
| CPB28FN | Prime or Boost + 28 Days Comp. Set (N) | integer | 8 | Predecessor: ADSL.CPB28FN | |
| COMPLFL | Completers Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.COMPLFL |
| COMPLFN | Completers Population Flag (N) | integer | 8 | Predecessor: ADSL.COMPLFN | |
| TRTSDT | Date of First Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTSDT | |
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME19 | Predecessor: ADSL.TRTSDTM | |
| TRTSTM | Time of First Exposure to Treatment | integer | TIME5 | Predecessor: ADSL.TRTSTM | |
| TRTEDT | Date of Last Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTEDT | |
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME19 | Predecessor: ADSL.TRTEDTM | |
| TRTETM | Time of Last Exposure to Treatment | integer | TIME5 | Predecessor: ADSL.TRTETM | |
| ALLOCDT | Date of Allocation | integer | DATE9 | Predecessor: ADSL.ALLOCDT | |
| ALLOCTM | Time of Allocation | integer | TIME5 | Predecessor: ADSL.ALLOCTM | |
| ALLOCDTM | Datetime of Allocation | integer | DATETIME19 | Predecessor: ADSL.ALLOCDTM | |
| PRIMDT | Date of Prime Immunization | integer | DATE9 | Predecessor: ADSL.PRIMDT | |
| PRIMTM | Time of Prime Immunization | integer | TIME5 | Predecessor: ADSL.PRIMTM | |
| PRIMDTM | Datetime of Prime Immunization | integer | DATETIME19 | Predecessor: ADSL.PRIMDTM | |
| BOIMDT | Date of Boost Immunization | integer | DATE9 | Predecessor: ADSL.BOIMDT | |
| BOIMTM | Time of Boost Immunization | integer | TIME5 | Predecessor: ADSL.BOIMTM | |
| BOIMDTM | Datetime of Boost Immunization | integer | DATETIME19 | Predecessor: ADSL.BOIMDTM |
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CodeLists
Description of Actual Arm
| Permitted Value (Code) |
|---|
| BNT162b1 Cohort 01 10 ug |
| BNT162b1 Cohort 02 30 ug |
| BNT162b1 Cohort 03 1 ug |
| BNT162b1 Cohort 04 60 ug |
| BNT162b1 Cohort 05 50 ug |
| BNT162b1 Cohort 06 3 ug |
| BNT162b1 Cohort 07 20 ug |
| BNT162b1 Cohort 08 10 ug |
| BNT162b1 Cohort 09 20 ug |
| BNT162b1 Cohort 10 30 ug |
| BNT162b2 Cohort 01 10 ug |
| BNT162b2 Cohort 02 30 ug |
| BNT162b2 Cohort 03 1 ug |
| BNT162b2 Cohort 05 20 ug |
| BNT162b2 Cohort 06 3 ug |
| BNT162b2 Cohort 08 10 ug |
| BNT162b2 Cohort 09 20 ug |
| BNT162b2 Cohort 10 30 ug |
Analysis Action Taken with Study Trtmnt
| Permitted Value (Code) |
|---|
| Dose Not Changed |
| Dose Reduced |
| Drug Interrupted |
| Drug Withdrawn |
| Not Applicable |
| Unknown |
Action Taken with Study Treatment [C66767]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| DOSE NOT CHANGED [C49504] | Dose Not Changed |
| DOSE REDUCED [C49505] | Dose Reduced |
| DRUG INTERRUPTED [C49501] | Drug Interrupted |
| DRUG WITHDRAWN [C49502] | Drug Withdrawn |
| NOT APPLICABLE [C48660] | Not Applicable |
| UNKNOWN [C17998] | Unknown |
Category for Adverse Event
| Permitted Value (Code) |
|---|
| GENERAL |
| SPECIAL INTEREST |
Outcome of Event in AE [C66768]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| NOT RECOVERED/NOT RESOLVED [C49494] | Not Recovered or Not Resolved |
| RECOVERED/RESOLVED [C49498] | Recovered or Resolved |
| RECOVERED/RESOLVED WITH SEQUELAE [C49495] | Recovered or Resolved with Sequelae |
| RECOVERING/RESOLVING [C49496] | Recovering or Resolving |
| FATAL [C48275] | Death Related to Adverse Event |
| UNKNOWN [C17998] | Unknown |
Causality
| Permitted Value (Code) |
|---|
| NOT RELATED |
| RELATED |
Severity/Intensity Scale for AE [C66769]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| MILD [C41338] | Mild Adverse Event |
| MODERATE [C41339] | Moderate Adverse Event |
| SEVERE [C41340] | Severe Adverse Event |
Standard Toxicity Grade in Adverse Events
| Permitted Value (Code) |
|---|
| MILD |
| MODERATE |
| SEVERE |
| POTENTIALLY LIFE THREATENING |
Analysis Outcome of Adverse Event
| Permitted Value (Code) |
|---|
| Not Recovered/Not Resolved |
| Recovered/Resolved |
| Recovered/Resolved With Sequelae |
| Recovering/Resolving |
| Fatal |
| Unknown |
Analysis Causality
| Permitted Value (Code) |
|---|
| Not Related |
| Related |
Analysis Severity/Intensity of Adverse Events
| Permitted Value (Code) |
|---|
| Mild |
| Moderate |
| Severe |
| Potentially Life Threatening |
Analysis Category 1 in ADCEVD
| Permitted Value (Code) |
|---|
| local |
| systemic |
Analysis Severity/Intensity of Clinical Events in ADCEVD
| Permitted Value (Code) |
|---|
| Mild |
| Moderate |
| Severe |
| Potentially Life Threatening |
Analysis Timepoint in ADCEVD
| Permitted Value (Code) |
|---|
| Day 7 |
Analysis Timepoint Reference in ADCEVD
| Permitted Value (Code) |
|---|
| Boost |
| Prime |
Category for Clinical Event in ADCEVD
| Permitted Value (Code) |
|---|
| REACTOGENICITY |
End Relative to Reference Time Point in ADCEVD
| Permitted Value (Code) |
|---|
| ONGOING |
End Reference Time Point in ADCEVD
| Permitted Value (Code) |
|---|
| DAY 8 |
Group ID in ADCEVD
| Permitted Value (Code) |
|---|
| BOOST VACCINATION-ADMINISTRATION SITE |
| BOOST VACCINATION-SYSTEMIC |
| PRIME VACCINATION-ADMINISTRATION SITE |
| PRIME VACCINATION-SYSTEMIC |
Subcategory for Clinical Event in ADCEVD
| Permitted Value (Code) |
|---|
| ADMINISTRATION SITE |
| SYSTEMIC |
Severity Response in ADCEVD [C165643]
| Permitted Value (Code) |
|---|
| MILD [C70666] |
| MODERATE [C61376] |
| SEVERE [C70667] |
| POTENTIALLY LIFE THREATENING [*] |
* Extended Value
Reported Term for the Clinical Event in ADCEVD
| Permitted Value (Code) |
|---|
| Injection site reaction - Pain |
| Injection site reaction - Tenderness |
| Injection site reaction - Erythema/Redness |
| Injection site reaction - Induration/Swelling |
| Nausea |
| Vomiting |
| Diarrhea |
| Headache |
| Fatigue |
| Myalgia |
| Arthralgia |
| Chills |
| Loss of Appetite |
| Malaise |
| Fever |
Planned Time Point Name in ADCEVD
| Permitted Value (Code) |
|---|
| DAY 8 |
Pooled Severity Group 1 in ADCEVD
| Permitted Value (Code) |
|---|
| grade < 3 |
| grade >= 3 |
Source Data in ADFACEVD
| Permitted Value (Code) |
|---|
| FA |
| VS |
Source Variable in ADFACEVD
| Permitted Value (Code) |
|---|
| FASTRESC |
| VSSTRESN |
Analysis Timepoint Reference in ADCEVD
| Permitted Value (Code) |
|---|
| Boost |
| Prime |
Analysis Value Category 1 for severity/intensity records in ADFACEVD
| Permitted Value (Code) |
|---|
| grade < 3 |
| grade >= 3 |
Analysis Value Category 1 for time to first or time from first to last grade >= 3 occurrence records in ADFACEVD
| Permitted Value (Code) |
|---|
| grade >= 3 |
Analysis Value (C) for severity/intensity records in ADFACEVD
| Permitted Value (Code) |
|---|
| Mild |
| Moderate |
| Severe |
| Potentially Life Threatening |
Object of the Observation in ADFACEVD
| Permitted Value (Code) |
|---|
| Arthralgia |
| Chills |
| Diarrhea |
| Fatigue |
| Headache |
| Injection site reaction - Erythema/Redness |
| Injection site reaction - Induration/Swelling |
| Injection site reaction - Pain |
| Injection site reaction - Tenderness |
| Loss of Appetite |
| Malaise |
| Myalgia |
| Nausea |
| Vomiting |
Subcategory for Findings About in ADFACEVD
| Permitted Value (Code) |
|---|
| ADMINISTRATION SITE |
| SYSTEMIC |
Character Result/Finding in Std Format in ADFACEVD
| Permitted Value (Code) |
|---|
| N |
| Y |
| MILD |
| MODERATE |
| SEVERE |
| POTENTIALLY LIFE THREATENING |
Findings About Test Name in ADFACEVD
| Permitted Value (Code) |
|---|
| Occurrence Indicator |
| Severity/Intensity |
Findings About Test Short Name in ADFACEVD
| Permitted Value (Code) |
|---|
| OCCUR |
| SEV |
Parameter Code in ADFACEVD
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| TTEFAR | Time to first local or systemic reaction |
| TTEFAR3 | Time to first local or systemic reaction with grade >= 3 |
| DURAR | Time from first to last local or systemic reaction |
| DURAR3 | Time from first to last local or systemic reaction with grade >= 3 |
| TTEFLR | Time to first local reaction |
| TTEFLR3 | Time to first local reaction with grade >= 3 |
| DURLR | Time from first to last local reaction |
| DURLR3 | Time from first to last local reaction with grade >= 3 |
| TTEFSR | Time to first systemic reaction |
| TTEFSR3 | Time to first systemic reaction with grade >= 3 |
| DURSR | Time from first to last systemic reaction |
| DURSR3 | Time from first to last systemic reaction with grade >= 3 |
| OCPIS | Pain at injection site occurrence indicator |
| SEVPIS | Pain at injection site severity/intensity |
| OCTIS | Tenderness at injection site occurrence indicator |
| SEVTIS | Tenderness at injection site severity/intensity |
| OCISR | Redness occurrence indicator |
| SEVREDN | Redness severity/intensity |
| OCINS | Swelling occurrence indicator |
| SEVSWEL | Swelling severity/intensity |
| OCNAUS | Nausea occurrence indicator |
| SEVNAUS | Nausea severity/intensity |
| OCVOMI | Vomiting occurrence indicator |
| SEVVOMI | Vomiting severity/intensity |
| OCDIAR | Diarrhea occurrence indicator |
| SEVDIAR | Diarrhea severity/intensity |
| OCHEAD | Headache occurrence indicator |
| SEVHEAD | Headache severity/intensity |
| OCFATIG | Fatigue occurrence indicator |
| SEVFATI | Fatigue severity/intensity |
| OCMYALG | Myalgia occurrence indicator |
| SEVMYALG | Myalgia severity/intensity |
| OCARTHR | Arthralgia occurrence indicator |
| SEVARTHR | Arthralgia severity/intensity |
| OCCHILLS | Chills occurrence indicator |
| SEVCHIL | Chills severity/intensity |
| OCLOA | Loss of Appetite occurrence indicator |
| SEVLOA | Loss of Appetite severity/intensity |
| OCMALAI | Malaise occurrence indicator |
| SEVMALAI | Malaise severity/intensity |
| OCFEVER | Fever occurrence indicator |
| SEVFEVER | Fever severity/intensity |
| TTEPIS | Time to first pain at injection site |
| TTEPIS3 | Time to first pain at injection site with grade >= 3 |
| DURPIS | Time from first to last pain at injection site |
| DURPIS3 | Time from first to last pain at injection site with grade >= 3 |
| TTETIS | Time to first tenderness at injection site |
| TTETIS3 | Time to first tenderness at injection site with grade >= 3 |
| DURTIS | Time from first to last tenderness at injection site |
| DURTIS3 | Time from first to last tenderness at injection site with grade >= 3 |
| TTEISR | Time to first redness |
| TTEISR3 | Time to first redness with grade >= 3 |
| DURISR | Time from first to last redness |
| DURISR3 | Time from first to last redness with grade >= 3 |
| TTEINS | Time to first swelling |
| TTEINS3 | Time to first swelling with grade >= 3 |
| DURINS | Time from first to last swelling |
| DURINS3 | Time from first to last swelling with grade >= 3 |
| TTENAUS | Time to first nausea |
| TTENAUS3 | Time to first nausea with grade >= 3 |
| DURNAUS | Time from first to last nausea |
| DURNAUS3 | Time from first to last nausea with grade >= 3 |
| TTEVOMI | Time to first vomiting |
| TTEVOMI3 | Time to first vomiting with grade >= 3 |
| DURVOMI | Time from first to last vomiting |
| DURVOMI3 | Time from first to last vomiting with grade >= 3 |
| TTEDIAR | Time to first diarrhea |
| TTEDIAR3 | Time to first diarrhea with grade >= 3 |
| DURDIAR | Time from first to last diarrhea |
| DURDIAR3 | Time from first to last diarrhea with grade >= 3 |
| TTEHEAD | Time to first headache |
| TTEHEAD3 | Time to first headache with grade >= 3 |
| DURHEAD | Time from first to last headache |
| DURHEAD3 | Time from first to last headache with grade >= 3 |
| TTEFATI | Time to first fatigue |
| TTEFATI3 | Time to first fatigue with grade >= 3 |
| DURFATI | Time from first to last fatigue |
| DURFATI3 | Time from first to last fatigue with grade >= 3 |
| TTEMYAL | Time to first myalgia |
| TTEMYAL3 | Time to first myalgia with grade >= 3 |
| DURMYAL | Time from first to last myalgia |
| DURMYAL3 | Time from first to last myalgia with grade >= 3 |
| TTEARTH | Time to first arthralgia |
| TTEARTH3 | Time to first arthralgia with grade >= 3 |
| DURARTH | Time from first to last arthralgia |
| DURARTH3 | Time from first to last arthralgia with grade >= 3 |
| TTECHIL | Time to first chills |
| TTECHIL3 | Time to first chills with grade >= 3 |
| DURCHIL | Time from first to last chills |
| DURCHIL3 | Time from first to last chills with grade >= 3 |
| TTELOA | Time to first loss of appetite |
| TTELOA3 | Time to first loss of appetite with grade >= 3 |
| DURLOA | Time from first to last loss of appetite |
| DURLOA3 | Time from first to last loss of appetite with grade >= 3 |
| TTEMALA | Time to first malaise |
| TTEMALA3 | Time to first malaise with grade >= 3 |
| DURMALA | Time from first to last malaise |
| DURMALA3 | Time from first to last malaise with grade >= 3 |
| TTEFEVE | Time to first fever |
| TTEFEVE3 | Time to first fever with grade >= 3 |
| DURFEVE | Time from first to last fever |
| DURFEVE3 | Time from first to last fever with grade >= 3 |
Parameter (N) in ADFACEVD
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | Time to first local or systemic reaction |
| 2 | Time to first local or systemic reaction with grade >= 3 |
| 3 | Time from first to last local or systemic reaction |
| 4 | Time from first to last local or systemic reaction with grade >= 3 |
| 11 | Time to first local reaction |
| 12 | Time to first local reaction with grade >= 3 |
| 13 | Time from first to last local reaction |
| 14 | Time from first to last local reaction with grade >= 3 |
| 21 | Time to first systemic reaction |
| 22 | Time to first systemic reaction with grade >= 3 |
| 23 | Time from first to last systemic reaction |
| 24 | Time from first to last systemic reaction with grade >= 3 |
| 100 | Pain at injection site occurrence indicator |
| 101 | Pain at injection site severity/intensity |
| 105 | Tenderness at injection site occurrence indicator |
| 106 | Tenderness at injection site severity/intensity |
| 110 | Redness occurrence indicator |
| 111 | Redness severity/intensity |
| 115 | Swelling occurrence indicator |
| 116 | Swelling severity/intensity |
| 200 | Nausea occurrence indicator |
| 201 | Nausea severity/intensity |
| 205 | Vomiting occurrence indicator |
| 206 | Vomiting severity/intensity |
| 210 | Diarrhea occurrence indicator |
| 211 | Diarrhea severity/intensity |
| 215 | Headache occurrence indicator |
| 216 | Headache severity/intensity |
| 220 | Fatigue occurrence indicator |
| 221 | Fatigue severity/intensity |
| 225 | Myalgia occurrence indicator |
| 226 | Myalgia severity/intensity |
| 230 | Arthralgia occurrence indicator |
| 231 | Arthralgia severity/intensity |
| 235 | Chills occurrence indicator |
| 236 | Chills severity/intensity |
| 240 | Loss of Appetite occurrence indicator |
| 241 | Loss of Appetite severity/intensity |
| 245 | Malaise occurrence indicator |
| 246 | Malaise severity/intensity |
| 250 | Fever occurrence indicator |
| 251 | Fever severity/intensity |
| 1001 | Time to first pain at injection site |
| 1002 | Time to first pain at injection site with grade >= 3 |
| 1003 | Time from first to last pain at injection site |
| 1004 | Time from first to last pain at injection site with grade >= 3 |
| 1051 | Time to first tenderness at injection site |
| 1052 | Time to first tenderness at injection site with grade >= 3 |
| 1053 | Time from first to last tenderness at injection site |
| 1054 | Time from first to last tenderness at injection site with grade >= 3 |
| 1101 | Time to first redness |
| 1102 | Time to first redness with grade >= 3 |
| 1103 | Time from first to last redness |
| 1104 | Time from first to last redness with grade >= 3 |
| 1151 | Time to first swelling |
| 1152 | Time to first swelling with grade >= 3 |
| 1153 | Time from first to last swelling |
| 1154 | Time from first to last swelling with grade >= 3 |
| 2001 | Time to first nausea |
| 2002 | Time to first nausea with grade >= 3 |
| 2003 | Time from first to last nausea |
| 2004 | Time from first to last nausea with grade >= 3 |
| 2051 | Time to first vomiting |
| 2052 | Time to first vomiting with grade >= 3 |
| 2053 | Time from first to last vomiting |
| 2054 | Time from first to last vomiting with grade >= 3 |
| 2101 | Time to first diarrhea |
| 2102 | Time to first diarrhea with grade >= 3 |
| 2103 | Time from first to last diarrhea |
| 2104 | Time from first to last diarrhea with grade >= 3 |
| 2151 | Time to first headache |
| 2152 | Time to first headache with grade >= 3 |
| 2153 | Time from first to last headache |
| 2154 | Time from first to last headache with grade >= 3 |
| 2201 | Time to first fatigue |
| 2202 | Time to first fatigue with grade >= 3 |
| 2203 | Time from first to last fatigue |
| 2204 | Time from first to last fatigue with grade >= 3 |
| 2251 | Time to first myalgia |
| 2252 | Time to first myalgia with grade >= 3 |
| 2253 | Time from first to last myalgia |
| 2254 | Time from first to last myalgia with grade >= 3 |
| 2301 | Time to first arthralgia |
| 2302 | Time to first arthralgia with grade >= 3 |
| 2303 | Time from first to last arthralgia |
| 2304 | Time from first to last arthralgia with grade >= 3 |
| 2351 | Time to first chills |
| 2352 | Time to first chills with grade >= 3 |
| 2353 | Time from first to last chills |
| 2354 | Time from first to last chills with grade >= 3 |
| 2401 | Time to first loss of appetite |
| 2402 | Time to first loss of appetite with grade >= 3 |
| 2403 | Time from first to last loss of appetite |
| 2404 | Time from first to last loss of appetite with grade >= 3 |
| 2451 | Time to first malaise |
| 2452 | Time to first malaise with grade >= 3 |
| 2453 | Time from first to last malaise |
| 2454 | Time from first to last malaise with grade >= 3 |
| 2501 | Time to first fever |
| 2502 | Time to first fever with grade >= 3 |
| 2503 | Time from first to last fever |
| 2504 | Time from first to last fever with grade >= 3 |
Parameter for FACE occurrence record in ADFACEVD
| Permitted Value (Code) |
|---|
| Pain at injection site occurrence indicator |
| Tenderness at injection site occurrence indicator |
| Redness occurrence indicator |
| Swelling occurrence indicator |
| Nausea occurrence indicator |
| Vomiting occurrence indicator |
| Diarrhea occurrence indicator |
| Headache occurrence indicator |
| Fatigue occurrence indicator |
| Myalgia occurrence indicator |
| Arthralgia occurrence indicator |
| Chills occurrence indicator |
| Loss of Appetite occurrence indicator |
| Malaise occurrence indicator |
Parameter for FACE severity record in ADFACEVD
| Permitted Value (Code) |
|---|
| Pain at injection site severity/intensity |
| Tenderness at injection site severity/intensity |
| Redness severity/intensity |
| Swelling severity/intensity |
| Nausea severity/intensity |
| Vomiting severity/intensity |
| Diarrhea severity/intensity |
| Headache severity/intensity |
| Fatigue severity/intensity |
| Myalgia severity/intensity |
| Arthralgia severity/intensity |
| Chills severity/intensity |
| Loss of Appetite severity/intensity |
| Malaise severity/intensity |
Parameter for Time to 1st or Time from 1st to last occurrence record in ADFACEVD
| Permitted Value (Code) |
|---|
| Time to first local or systemic reaction |
| Time from first to last local or systemic reaction |
| Time to first local reaction |
| Time from first to last local reaction |
| Time to first systemic reaction |
| Time from first to last systemic reaction |
| Time to first pain at injection site |
| Time from first to last pain at injection site |
| Time to first tenderness at injection site |
| Time from first to last tenderness at injection site |
| Time to first redness |
| Time from first to last redness |
| Time to first swelling |
| Time from first to last swelling |
| Time to first nausea |
| Time from first to last nausea |
| Time to first vomiting |
| Time from first to last vomiting |
| Time to first diarrhea |
| Time from first to last diarrhea |
| Time to first headache |
| Time from first to last headache |
| Time to first fatigue |
| Time from first to last fatigue |
| Time to first myalgia |
| Time from first to last myalgia |
| Time to first arthralgia |
| Time from first to last arthralgia |
| Time to first chills |
| Time from first to last chills |
| Time to first loss of appetite |
| Time from first to last loss of appetite |
| Time to first malaise |
| Time from first to last malaise |
| Time to first fever |
| Time from first to last fever |
Parameter for Time to 1st or Time from 1st to last grade>=3 occurrence record in ADFACEVD
| Permitted Value (Code) |
|---|
| Time to first local or systemic reaction with grade >= 3 |
| Time from first to last local or systemic reaction with grade >= 3 |
| Time to first local reaction with grade >= 3 |
| Time from first to last local reaction with grade >= 3 |
| Time to first systemic reaction with grade >= 3 |
| Time from first to last systemic reaction with grade >= 3 |
| Time to first pain at injection site with grade >= 3 |
| Time from first to last pain at injection site with grade >= 3 |
| Time to first tenderness at injection site with grade >= 3 |
| Time from first to last tenderness at injection site with grade >= 3 |
| Time to first redness with grade >= 3 |
| Time from first to last redness with grade >= 3 |
| Time to first swelling with grade >= 3 |
| Time from first to last swelling with grade >= 3 |
| Time to first nausea with grade >= 3 |
| Time from first to last nausea with grade >= 3 |
| Time to first vomiting with grade >= 3 |
| Time from first to last vomiting with grade >= 3 |
| Time to first diarrhea with grade >= 3 |
| Time from first to last diarrhea with grade >= 3 |
| Time to first headache with grade >= 3 |
| Time from first to last headache with grade >= 3 |
| Time to first fatigue with grade >= 3 |
| Time from first to last fatigue with grade >= 3 |
| Time to first myalgia with grade >= 3 |
| Time from first to last myalgia with grade >= 3 |
| Time to first arthralgia with grade >= 3 |
| Time from first to last arthralgia with grade >= 3 |
| Time to first chills with grade >= 3 |
| Time from first to last chills with grade >= 3 |
| Time to first loss of appetite with grade >= 3 |
| Time from first to last loss of appetite with grade >= 3 |
| Time to first malaise with grade >= 3 |
| Time from first to last malaise with grade >= 3 |
| Time to first fever with grade >= 3 |
| Time from first to last fever with grade >= 3 |
Parameter for VS record in ADFACEVD
| Permitted Value (Code) |
|---|
| Fever occurrence indicator |
| Fever severity/intensity |
Parameter Category 1 in ADFACEVD
| Permitted Value (Code) |
|---|
| local |
| systemic |
Parameter Category 2 in ADFACEVD
| Permitted Value (Code) |
|---|
| occurrence |
| severity/intensity |
| time to first |
| time to first grade >= 3 |
| duration |
| duration grade >= 3 |
Vital Signs Test Name in ADFACEVD [C67153]
| Permitted Value (Code) |
|---|
| Temperature [C25206] |
Vital Signs Test Short Name in ADFACEVD
| Permitted Value (Code) |
|---|
| TEMP |
ADLB Analysis Visit
| Permitted Value (Code) |
|---|
| Day -30 to 0 |
| Day 1 |
| Day 2 |
| Day 22 |
| Day 29 |
| Day 50 |
| Day 8 |
| Unscheduled 1 Day -30 to 0 |
| Unscheduled 1 Day 22 |
| Unscheduled 1 Day 29 |
| Unscheduled 1 Day 43 |
| Unscheduled 1 Day 50 |
| Unscheduled 1 Day 8 |
| Unscheduled 1 Day 85 |
ADLBSource Data
| Permitted Value (Code) |
|---|
| LB |
ADLBSource Variable
| Permitted Value (Code) |
|---|
| LBORRES |
Analysis Reference Range Indicator
| Permitted Value (Code) |
|---|
| Low |
| Normal |
| High |
| Abnormal |
| Missing |
Baseline Value (C)
| Permitted Value (Code) |
|---|
| (+) |
| + |
| ++ |
| +++ |
| 0-2 |
| 11-20 |
| 21-50 |
| 3-6 |
| 7-10 |
| coagulated |
| massive |
| negative |
| normal |
| not detectable |
| positive |
| potassium very high. please send a fresh specimen. |
Baseline Reference Range Indicator
| Permitted Value (Code) |
|---|
| Low |
| Normal |
| High |
| Abnormal |
| Missing |
Comments 1 Evaluator
| Permitted Value (Code) |
|---|
| INVESTIGATOR |
| LABORATORY |
Comments 2 Evaluator
| Permitted Value (Code) |
|---|
| LABORATORY |
LOINC Code for Identification
| Permitted Value (Code) |
|---|
| 5782-8 |
| 58436-7 |
LOINC Code for second Identification
| Permitted Value (Code) |
|---|
| 5782-8 |
Method of Test or Examination [C85492]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| CALCULATION [C54125] | Calculation |
| COLORIMETRY [C111096] | Colorimetry |
| DIPSTICK [C106516] | Dipstick |
| ELECTROCHEMILUMINESCENCE IMMUNOASSAY [C111194] | Electrochemiluminescence Immunoassay |
| FLOW CYTOMETRY [C16585] | Flow Cytometry |
| JAFFE REACTION [C120694] | Jaffe Reaction |
| MICROSCOPY [C16853] | Microscopy |
| PHOTOMETRY [C65109] | Photometry |
| POTENTIOMETRY [*] | POTENTIOMETRY |
| TURBIDIMETRY [C111328] | Turbidimetry |
* Extended Value
Vendor Name
| Permitted Value (Code) |
|---|
| CRS CLINICAL RESEARCH SERVICES BERLIN GMBH |
| CRS CLINICAL RESEARCH SERVICES MANNHEIM GMBH |
| MLM |
Specimen Type [C78734]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| BLOOD [C12434] | Blood |
| BLOOD SMEAR [*] | BLOOD SMEAR |
| EXPIRED AIR [C78741] | Expired Air |
| SERUM [C13325] | Serum |
| URINE [C13283] | Urine |
* Extended Value
Normal/Abnormal/CS
| Permitted Value (Code) |
|---|
| Abnormal (not CS) |
| CS abnormal |
| Missing |
| Normal |
Parameter Category 1
| Permitted Value (Code) |
|---|
| Chemistry |
| Hematology |
| Urinalysis |
Parameter Category 2
| Permitted Value (Code) |
|---|
| Drug of Abuse |
| Pregnancy |
Report Blood Count
| Permitted Value (Code) |
|---|
| cells damaged |
| crenated erythrocytes |
Report Blood Count 2
| Permitted Value (Code) |
|---|
| crenated erythrocytes |
| some crenated cells |
Visit Name
| Permitted Value (Code) |
|---|
| Unscheduled 1.01 |
| Unscheduled 10.01 |
| Unscheduled 5.01 |
| Unscheduled 6.01 |
| Unscheduled 7.01 |
| Unscheduled 8.01 |
| Unscheduled 9.01 |
| Visit 0 (Day -30 to 0) |
| Visit 1 (Day 1) |
| Visit 2 (Day 2) |
| Visit 3 (Day 8) |
| Visit 4 / Dosing (Day 22) |
| Visit 5 (Day 29) |
| Visit 7 / EoT Visit (Day 50) |
Pooled Age Group 1
| Permitted Value (Code) |
|---|
| 18 - 55 Yrs |
| > 55 Yrs |
Cohort Category 1
| Permitted Value (Code) |
|---|
| Dose ranging cohorts |
Cohort Category 2
| Permitted Value (Code) |
|---|
| Younger dose ranging cohorts |
| Older dose ranging cohorts |
Cohort
| Permitted Value (Code) |
|---|
| Cohort 1 |
| Cohort 2 |
| Cohort 3 |
| Cohort 4 |
| Cohort 5 |
| Cohort 6 |
| Cohort 7 |
| Cohort 8 |
| Cohort 9 |
| Cohort 10 |
Reason for Discontinuation from Study
| Permitted Value (Code) |
|---|
| Adverse Event |
| Death |
| Lost to Follow-up |
| Physician Decision |
| Pregnancy |
| Protocol Deviation |
| Screen Failure |
| Site Terminated by Sponsor |
| Study Terminated by Sponsor |
| Technical Problems |
| Withdrawal By Subject |
| Other |
Reason Spec for Discont from Study
| Permitted Value (Code) |
|---|
| Adverse Event |
| Death |
| Lost to Follow-up |
| Physician Decision |
| Pregnancy |
| Protocol Deviation |
| Screen Failure |
| Site Terminated by Sponsor |
| Study Terminated by Sponsor |
| Technical Problems |
| Withdrawal By Subject |
| Due To Private Reason. |
| Private Reason |
Reason for Exclusion Immunogenicity Set
| Permitted Value (Code) |
|---|
| Subject did not receive one dose of IMP or did not have one post-baseline immunogenicity assessment |
Reason 1 for Exclusion Per-Protocol Set
| Permitted Value (Code) |
|---|
| Subject is not included in the immunogenicity set or had major protocol deviation |
Reason 1 for Exclusion Safety Boost Set
| Permitted Value (Code) |
|---|
| Subject did not receive two doses of IMP |
Group
| Permitted Value (Code) |
|---|
| B (BNT162b1) |
| C (BNT162b2) |
Investigator Identifier
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 01 | Armin Schultz - CRS Mannheim |
| 02 | Armin Schultz - CRS Berlin |
Investigator Name
| Permitted Value (Code) |
|---|
| Armin Schultz |
First Protocol Version signed
| Permitted Value (Code) |
|---|
| 3.0, 17 Apr 2020 |
| 5.0, 26 MAY 2020 |
| 7.0, 26 JUN 2020 |
| 8.0, 21 JUL 2020 |
Second Protocol Version signed
| Permitted Value (Code) |
|---|
| 5.0, 26 MAY 2020 |
| 7.0, 26 JUN 2020 |
| 8.0, 21 JUL 2020 |
Third Protocol Version signed
| Permitted Value (Code) |
|---|
| 7.0, 26 JUN 2020 |
| 8.0, 21 JUL 2020 |
Fourth Protocol Version signed
| Permitted Value (Code) |
|---|
| 8.0, 21 JUL 2020 |
Fifth Protocol Version signed
| Permitted Value (Code) |
|---|
| 8.0, 21 JUL 2020 |
Study Site Identifier
| Permitted Value (Code) |
|---|
| CRS Berlin |
| CRS Mannheim |
Analysis Duration Units [C71620]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| DAYS [C25301] | Day |
| hours [*] | hours |
* Extended Value
ADVA Analysis Visit
| Permitted Value (Code) |
|---|
| Unscheduled 5.01 |
| Unscheduled 9.01 |
| Visit 1 (Day 1) |
| Visit 3 (Day 8) |
| Visit 4 / Dosing (Day 22) |
| Visit 5 (Day 29) |
| Visit 6 (Day 43) |
| Visit 7 / EoT Visit (Day 50) |
| Visit 8 / FU Visit (Day 85) |
ADVA Parameter Code
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| C19RBDIG | COVID-19 RBD IgG (U/mL) |
| C19S1IGG | COVID-19 S1 IgG (U/mL) |
| C2NGNT50 | SARS-CoV-2 Serum Neutralizing Titer 50 |
| C2NGNT90 | SARS-CoV-2 Serum Neutralizing Titer 90 |
| FRC19RBD | COVID-19 RBD IgG Fold Rise |
| FRC19S1I | COVID-19 S1 IgG Fold Rise |
| FRC2NT50 | SARS-CoV-2 Serum Neutralizing Titer 50 Fold Rise |
| FRC2NT90 | SARS-CoV-2 Serum Neutralizing Titer 90 Fold Rise |
ADVA Parameter (COVID-19)
| Permitted Value (Code) |
|---|
| COVID-19 RBD IgG (U/mL) |
| COVID-19 S1 IgG (U/mL) |
ADVA Parameter (Neutralizing Titer)
| Permitted Value (Code) |
|---|
| SARS-CoV-2 Serum Neutralizing Titer 50 |
| SARS-CoV-2 Serum Neutralizing Titer 90 |
ADVA Parameter (Fold Rise)
| Permitted Value (Code) |
|---|
| COVID-19 RBD IgG Fold Rise |
| COVID-19 S1 IgG Fold Rise |
| SARS-CoV-2 Serum Neutralizing Titer 50 Fold Rise |
| SARS-CoV-2 Serum Neutralizing Titer 90 Fold Rise |
ADVASource Data
| Permitted Value (Code) |
|---|
| IS |
ADVASource Variable
| Permitted Value (Code) |
|---|
| ISSTRESC |
Analysis Criterion 1
| Permitted Value (Code) |
|---|
| Seroconversion |
Parameter Category 1
| Permitted Value (Code) |
|---|
| Immunogenicity |
ADVS Analysis Timepoint
| Permitted Value (Code) |
|---|
| 1 hour |
| 3 hours |
| 6 hours |
| Predose |
| day 1 |
| day 10 |
| day 11 |
| day 12 |
| day 13 |
| day 14 |
| day 15 |
| day 16 |
| day 2 |
| day 21 |
| day 22 |
| day 23 |
| day 24 |
| day 25 |
| day 26 |
| day 27 |
| day 28 |
| day 29 |
| day 3 |
| day 4 |
| day 5 |
| day 6 |
| day 7 |
| day 8 |
| day 9 |
ADVS Analysis Visit
| Permitted Value (Code) |
|---|
| Day -30 to 0 |
| Day 1 |
| Day 184 |
| Day 2 |
| Day 22 |
| Day 29 |
| Day 43 |
| Day 50 |
| Day 8 |
| Day 85 |
| Unscheduled 1 Day -30 to 0 |
| Unscheduled 1 Day 1 |
| Unscheduled 1 Day 2 |
| Unscheduled 1 Day 50 |
| Unscheduled 1 Day 8 |
ADVS Parameter
| Permitted Value (Code) |
|---|
| Body Mass Index [kg/m2] |
| Diastolic Blood Pressure [mmHg] |
| Height [cm] |
| Pulse Rate [beats/min] |
| Respiratory Rate [breaths/min] |
| Systolic Blood Pressure [mmHg] |
| Temperature (Reactogenicity) [°C] |
| Temperature [°C] |
| Weight [kg] |
ADVS 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] |
| TEMPR | Temperature (Reactogenicity) [C] |
| WEIGHT | Weight [kg] |
ADVSSource Data
| Permitted Value (Code) |
|---|
| VS |
ADVSSource Variable
| Permitted Value (Code) |
|---|
| VSORRES |
Analysis Reference Range Indicator
| Permitted Value (Code) |
|---|
| Abnormal |
| Normal |
Analysis Timepoint Reference in ADVS
| Permitted Value (Code) |
|---|
| Boost Dosing |
| Prime Dosing |
Baseline Reference Range Indicator
| Permitted Value (Code) |
|---|
| Abnormal |
| Normal |
Normal/Abnormal/CS
| Permitted Value (Code) |
|---|
| Missing |
| CS abnormal |
| Abnormal (not CS) |
| Normal |
| Normal (not CS) |
Parameter Category 1
| Permitted Value (Code) |
|---|
| Reactogenicity |
Parameter Category 2
| Permitted Value (Code) |
|---|
| Systemic |
Visit Name
| Permitted Value (Code) |
|---|
| Unscheduled 1.01 |
| Unscheduled 2.01 |
| Unscheduled 3.01 |
| Unscheduled 5.01 |
| Unscheduled 9.01 |
| Visit 0 (Day -30 to 0) |
| Visit 1 (Day 1) |
| Visit 2 (Day 2) |
| Visit 3 (Day 8) |
| Visit 4 / Dosing (Day 22) |
| Visit 5 (Day 29) |
| Visit 6 (Day 43) |
| Visit 7 / EoT Visit (Day 50) |
| Visit 8 / FU Visit (Day 85) |
| Visit 9 / FU Visit (Day 184) |
Laterality [C99073]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| LEFT [C25229] | Left |
| RIGHT [C25228] | Right |
Location of Vital Signs Measurement [C74456]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| ARM [C32141] | Arm |
| ORAL CAVITY [C12421] | Oral Cavity |
Vital Signs Position of Subject
| Permitted Value (Code) |
|---|
| SUPINE |
Planned Time Point Name
| Permitted Value (Code) |
|---|
| 1 HOUR |
| 3 HOURS |
| 6 HOURS |
| DAY 1 |
| DAY 10 |
| DAY 11 |
| DAY 12 |
| DAY 13 |
| DAY 14 |
| DAY 15 |
| DAY 16 |
| DAY 2 |
| DAY 21 |
| DAY 22 |
| DAY 23 |
| DAY 24 |
| DAY 25 |
| DAY 26 |
| DAY 27 |
| DAY 28 |
| DAY 29 |
| DAY 3 |
| DAY 4 |
| DAY 5 |
| DAY 6 |
| DAY 7 |
| DAY 8 |
| DAY 9 |
| PREDOSE |
Age Unit [C66781]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| YEARS [C29848] | Year |
Time Point Reference
| Permitted Value (Code) |
|---|
| PRIME VACCINATION |
| BOOST VACCINATION |
Analysis Value (C)
| Permitted Value (Code) |
|---|
| + |
| ++ |
Description of Planned Arm
| Permitted Value (Code) |
|---|
| BNT162b1 Cohort 01 10 ug |
| BNT162b1 Cohort 02 30 ug |
| BNT162b1 Cohort 03 1 ug |
| BNT162b1 Cohort 04 60 ug |
| BNT162b1 Cohort 05 50 ug |
| BNT162b1 Cohort 06 3 ug |
| BNT162b1 Cohort 07 20 ug |
| BNT162b1 Cohort 08 10 ug |
| BNT162b1 Cohort 09 20 ug |
| BNT162b1 Cohort 10 30 ug |
| BNT162b2 Cohort 01 10 ug |
| BNT162b2 Cohort 02 30 ug |
| BNT162b2 Cohort 03 1 ug |
| BNT162b2 Cohort 05 20 ug |
| BNT162b2 Cohort 06 3 ug |
| BNT162b2 Cohort 08 10 ug |
| BNT162b2 Cohort 09 20 ug |
| BNT162b2 Cohort 10 30 ug |
Analysis Value (C)
| Permitted Value (Code) |
|---|
| (+) |
| + |
| ++ |
| +++ |
| massive |
| negative |
| not detectable |
Analysis Value (C)
| Permitted Value (Code) |
|---|
| 17.0 |
| negative |
Analysis Value (C)
| Permitted Value (Code) |
|---|
| negative |
| positive |
| not detectable |
Derivation Type [C81224]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| HALFLLOQ [C170546] | HALFLLOQ |
End Reference Time Point
| Permitted Value (Code) |
|---|
| END OF STUDY |
End of Study Status
| Permitted Value (Code) |
|---|
| COMPLETED |
| DISCONTINUED |
Analysis Value (C)
| Permitted Value (Code) |
|---|
| 0-2 |
| 3-6 |
| negative |
| not detectable |
Analysis Value (C)
| Permitted Value (Code) |
|---|
| 0-2 |
| 3-6 |
| 7-10 |
| 11-20 |
| 21-50 |
| >50 |
| massive |
| negative |
| not detectable |
Epoch [C99079]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| BASELINE [C125938] | Baseline Epoch |
| FOLLOW-UP [C99158] | Clinical Study Follow-up |
| SCREENING [C48262] | Trial Screening |
| TREATMENT [C101526] | Treatment Epoch |
Analysis Value (C)
| Permitted Value (Code) |
|---|
| 0-2 |
| 3-6 |
| 7-10 |
| 11-20 |
| 21-50 |
| massive |
| negative |
| not detectable |
Ethnic Group [C66790]
| Permitted Value (Code) |
|---|
| HISPANIC OR LATINO [C17459] |
| NOT HISPANIC OR LATINO [C41222] |
| NOT REPORTED [C43234] |
| UNKNOWN [C17998] |
Analysis Value (C)
| Permitted Value (Code) |
|---|
| 10 |
| 25 |
| 50 |
| 150 |
| 250 |
| negative |
Analysis Value (C)
| Permitted Value (Code) |
|---|
| 0.5 |
| 1.5 |
| 5.0 |
| 15.0 |
| negative |
Analysis Value (C)
| Permitted Value (Code) |
|---|
| 25 |
| 100 |
| 500 |
| negative |
No Yes Response (No Only) [C66742]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| N [C49487] | No |
Negative/Positive Result
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| negative [C49487] | No |
| positive [C49488] | Yes |
No Yes Response [C66742]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| N [C49487] | No |
| Y [C49488] | Yes |
Analysis Value (C)
| Permitted Value (Code) |
|---|
| + |
| ++ |
| +++ |
Analysis Value (C)
| Permitted Value (Code) |
|---|
| 250 |
| 750 |
| 1500 |
| 5000 |
| negative |
Race [C74457]
| Permitted Value (Code) |
|---|
| AMERICAN INDIAN OR ALASKA NATIVE [C41259] |
| ASIAN [C41260] |
| BLACK OR AFRICAN AMERICAN [C16352] |
| NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER [C41219] |
| WHITE [C41261] |
| NOT REPORTED [C43234] |
| UNKNOWN [C17998] |
| OTHER [*] |
| MULTIPLE [*] |
* Extended Value
Sex [C66731]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| M [C20197] | Male |
| F [C16576] | Female |
Relation to Reference Period (End) [C66728]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| ONGOING [C53279] | Continue |
Actual Treatment for Period 01
| Permitted Value (Code) |
|---|
| 1 µg Younger |
| 10 µg Younger |
| 20 µg Younger |
| 3 µg Younger |
| 30 µg Younger |
| 50 µg Younger |
| 60 µg Younger |
| 10 µg Older |
| 20 µg Older |
| 30 µg Older |
Planned Treatment for Period 01
| Permitted Value (Code) |
|---|
| 1 µg Younger |
| 10 µg Younger |
| 20 µg Younger |
| 3 µg Younger |
| 30 µg Younger |
| 50 µg Younger |
| 60 µg Younger |
| 10 µg Older |
| 20 µg Older |
| 30 µg Older |
Actual Treatment
| Permitted Value (Code) |
|---|
| 1 µg Younger |
| 3 µg Younger |
| 10 µg Younger |
| 20 µg Younger |
| 30 µg Younger |
| 50 µg Younger |
| 60 µg Younger |
| 10 µg Older |
| 20 µg Older |
| 30 µg Older |
Planned Treatment
| Permitted Value (Code) |
|---|
| 1 µg Younger |
| 3 µg Younger |
| 10 µg Younger |
| 20 µg Younger |
| 30 µg Younger |
| 50 µg Younger |
| 60 µg Younger |
| 10 µg Older |
| 20 µg Older |
| 30 µg Older |
Analysis Value (C)
| Permitted Value (Code) |
|---|
| 17 |
| 68 |
| normal |
No Yes Response (Yes Only) [C66742]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| Y [C49488] | Yes |
Analysis Value (C)
| Permitted Value (Code) |
|---|
| (+) |
| + |
| ++ |
| massive |
Go to the top of the Define-XML document
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 |
|---|---|---|
| Algorithm: ADAE.AACN | Computation | Propcase(AE.AEACN) when AE.AEACN not missing. |
| Algorithm: ADAE.ADURN | Computation | When AENDTM and ASTDTM not missing then ADURN=(AENDTM-ASTDTM)/(60*60). |
| Algorithm: ADAE.ADURU | Computation | When ADURN not missing ADURU='hours'. |
| Algorithm: ADAE.AEEMREL | Computation | If TRTEMFL='Y' and upcase(arel)='RELATED' then AEEMREL='Y'; else AEEMREL='N'. |
| Algorithm: ADAE.AEEMS | Computation | If TRTEMFL='Y' and asevn in (3,4) then AEEMS='Y'; else AEEMS='N'. |
| Algorithm: ADAE.AEEMSER | Computation | If TRTEMFL='Y' and aeser='Y' then AEEMSER='Y'; else AEEMSER='N'. |
| Algorithm: ADAE.AEEMSERR | Computation | If TRTEMFL='Y' and aeser='Y' and upcase(arel)='RELATED' then AEEMSERR='Y'; else AEEMSERR='N'. |
| Algorithm: ADAE.AEEMSREL | Computation | If TRTEMFL='Y' and asevn in (3,4) and upcase(arel)='RELATED' then AEEMSREL='Y'; else AEEMSREL='N'. |
| Algorithm: ADAE.AENDT | Computation | Date part of AENDTM. |
| Algorithm: ADAE.AENDTM | Computation | AE.AEENDTC as SAS datetime. |
| Algorithm: ADAE.AENDY | Computation | if AENDT >=PRIMDT then AENDY=(AENDT - PRIMDT)+1; else if AENDT <PRIMDT then AENDY=AENDT - PRIMDT. |
| Algorithm: ADAE.AENTM | Computation | Time part of AENDTM. |
| Algorithm: ADAE.AOUT | Computation | Propcase(AE.AEOUT) when AE.AEOUT not missing. |
| Algorithm: ADAE.AREL | Computation | Propcase (AE.AEREL) when AE.AEREL not missing. |
| Algorithm: ADAE.ASEV | Computation | Propcase(AE.AESEV) when AE.AESEV not missing ; else Propcase(AE.AETOXGR) when AE.AETOXGR is not missing. ASEV= ' ' when both AE.AESEV and AE.AETOXGR missing. |
| Algorithm: ADAE.ASTDT | Computation | Date part of ASTDTM. |
| Algorithm: ADAE.ASTDTM | Computation | AE.AESTDTC as SAS datetime. |
| Algorithm: ADAE.ASTTM | Computation | Time part of ASTDTM. |
| Algorithm: ADAE.LSTDD | Computation | When BOIMDT not missing: if ASTDT < BOIMDT then LSTDD=ASTDT-PRIMDT +1; else if ASTDT >= BOIMDT then LSTDD=ASTDT-BOIMDT+1; When BOIMDT missing: if ASTDT >= PRIMDT then LSTDD=ASTDT-PRIMDT +1. |
| Algorithm: ADAE.PTDIAFL | Computation | if (AE.AEDECOD in ('Abdominal pain', ' Abdominal pain lower', ' Arthralgia', 'Chills', 'Decreased appetite', 'Diarrhoea', 'Discomfort', 'Fatigue', ' Feeling hot', 'Gastrointestinal disorder', 'Headache', 'Hot flush', 'Influenza like illness', 'Injection site discomfort', 'Injection site erythema', 'Injection site hypersensitivity', 'Injection site pain', 'Injection site paraesthesia', 'Injection site reaction', 'Injection site swelling', 'Malaise', 'Muscle tightness', 'Myalgia', 'Nausea', ' Pyrexia' , 'Vomiting', 'Axillary pain', 'Body temperature increased', 'C-reactive protein increased', 'Dizziness', 'Head discomfort', 'Injection site discolouration', 'Injection site hypoaesthesia', 'Neck pain' ) and ((AENDT - ASTDT)+ 1)<=7) then PTDIAFL='Y'. |
| Algorithm: ADAE.TMINT1FL | Computation | AE is Treatment-Emergent:
if ASTDTM >= PRIMDTM and (PRIMDTM <= ASTDTM <= (PRIMDTM + 7 days)) then TMINT1FL='Y';
if ASTDTM < PRIMDTM and Adverse Event worsened after Prime immunization then TMINT1FL='Y';
if AE time missing and Date not missing and
(PRIMDT <= ASTDT <= (PRIMDT + 7)) then TMINT1FL='Y';
if missing AE Date/or time and AE cannot be determined with above set rules, then TMINT1FL='Y'; |
| Algorithm: ADAE.TMINT2FL | Computation | AE is Treatment-Emergent:
Identify the minimum of duration - ((Prime to Boost) or (28 days from Prime) - whatever comes first.
When Boost is missing, duration is 28 days from Prime.
if duration < 28 then: (Prime to Boost contribution)
if not missing AE start date/time and PRIMDTM <= ASTDTM <= BOIMDTM then TMINT2FL='Y';
if not missing AE start date/time and ASTDTM < PRIMDTM and Adverse Event worsened after Prime immunization then TMINT2FL='Y';
if missing AE start time and PRIMDT <= ASTDT <= BOIMDT then TMINT2FL='Y';
if missing AE start time and ASTDT < PRIMDT and Adverse Event worsened after Prime immunization then TMINT2FL='Y';
if duration = 28 then: (28 days from prime contribution)
if not missing AE start date/time and PRIMDTM <= ASTDTM <= (PRIMDTM + 28 days) then TMINT2FL='Y';
if not missing AE start date/time and ASTDTM < PRIMDTM and Adverse Event worsened after Prime immunization then TMINT2FL='Y';
if missing AE start time and PRIMDT <= ASTDT <= (PRIMDT + 28) then TMINT2FL='Y';
if missing AE start time and ASTDT < PRIMDT and Adverse Event worsened after Prime immunization then TMINT2FL='Y';
if missing AE Date/or time and AE cannot be determined with above set rules, then TMINT2FL='Y'; |
| Algorithm: ADAE.TMINT3FL | Computation | AE is Treatment-Emergent:
if ASTDTM >= BOIMDTM and (BOIMDTM <= ASTDTM <= (BOIMDTM + 7 days)) then TMINT3FL='Y';
if ASTDTM < BOIMDTM and Adverse Event worsened after boost immunization then TMINT3FL='Y';
if AE time missing and Date not missing and Boost immunization date not missing and (BOIMDT <= ASTDT <= (BOIMDT + 7)) then TMINT3FL='Y';
if missing AE Date/or time and AE cannot be determined with above set rules, then TMINT3FL='Y'; |
| Algorithm: ADAE.TMINT4FL | Computation | AE is Treatment-Emergent:
if ASTDTM >= BOIMDTM and (BOIMDTM <= ASTDTM <= (BOIMDTM + 28 days)) then TMINT4FL='Y';
if ASTDTM < BOIMDTM and Adverse Event worsened after boost immunization then TMINT4FL='Y';
if AE time missing and Date not missing and Boost immunization date not missing and (BOIMDT <= ASTDT <= (BOIMDT + 28)) then TMINT4FL='Y';
if missing AE Date/or time and AE cannot be determined with above set rules, then TMINT4FL='Y'; |
| Algorithm: ADAE.TMINT5FL | Computation | AE is Treatment-Emergent:
if not missing AE Date/time, Prime/Boost immunization date/time and
ASTDTM >= PRIMDTM and (PRIMDTM <= ASTDTM <= (BOIMDTM + 28 days)) then TMINT5FL='Y';
if not missing AE Date/time, Prime/Boost immunization date/time and
ASTDTM < PRIMDTM and Adverse Event worsened on/after prime immunization and before/on (boost immunizaqtion + 28 days) then TMINT5FL='Y';
if not missing AE and Prime immunization date/time and boost date/time missing and
ASTDTM >= PRIMDTM and (PRIMDTM <= ASTDTM <= (PRIMDTM + 28 days)) then TMINT5FL='Y';
if missing AE time and AE date available and
ASTDT >= PRIMDT and (PRIMDT <= ASTDT <= (BOIMDT + 28)) then TMINT5FL='Y';
if missing AE time and AE date available and boost immunization missing and
ASTDT >= PRIMDT and (PRIMDT <= ASTDT <= (PRIMDT + 28)) then TMINT5FL='Y';
if missing AE Date/or time and AE cannot be determined with above set rules, then TMINT5FL='Y'; |
| Algorithm: ADAE.TRTEMFL | Computation | *if not missing Adverse start date/time and AE start date/time >= first immunization date/time and AE start date/time <= (last immunization date/time + 28 days), then TRTEMFL='Y';
*if missing Adverse start time and AE start date >= first immunization date and AE start date <= (last immunization date + 28 days), then TRTEMFL='Y';
*if not missing Adverse start date/time and AE start date/time > (last immunization date/time + 28 days) but assessed as related to IMP by investigator then TRTEMFL='Y';
*if missing Adverse start time and AE start date > (last immunization date + 28 days) but assessed as related to IMP by investigator then TRTEMFL='Y';
*if AE present before immunization and worsened after first immunization, then TRTEMFL='Y';
*if missing AE date or time and AE cannot be determined TEAE from the above set rules, then TRTEMFL='Y'; |
| Algorithm: ADCEVD.ACAT1 | Computation | 'local' when CESCAT = 'ADMINISTRATION SITE'; 'systemic' when CESCAT = 'SYSTEMIC'. |
| Algorithm: ADCEVD.ADURN | Computation | The numeric portion of CEDUR (following 'P'). |
| Algorithm: ADCEVD.ADURU | Computation | 'DAYS' when CEDUR ends with 'D'. |
| Algorithm: ADCEVD.AENDT | Computation | Date part of CEENDTC as SAS date. |
| Algorithm: ADCEVD.AOCCL3FL | Computation | 'Y' if first record when sorted by ASTDT and CETERM for given USUBJID having CEOCCUR = 'Y' and ACAT1 = 'local' and SEVGR1 = 'grade >= 3'. |
| Algorithm: ADCEVD.AOCCLBFL | Computation | 'Y' if first record when sorted by ASTDT and CETERM for given USUBJID having CEOCCUR = 'Y' and ACAT1 = 'local' and ATPTREF = 'Boost'. |
| Algorithm: ADCEVD.AOCCLPFL | Computation | 'Y' if first record when sorted by ASTDT and CETERM for given USUBJID having CEOCCUR = 'Y' and ACAT1 = 'local' and ATPTREF = 'Prime'. |
| Algorithm: ADCEVD.AOCCLRFL | Computation | 'Y' if first record for given USUBJID when sorted by ASTDT and CETERM having CEOCCUR = 'Y' and ACAT1 = 'local'. |
| Algorithm: ADCEVD.AOCCS3FL | Computation | 'Y' if first record when sorted by ASTDT and CETERM for given USUBJID having CEOCCUR = 'Y' and ACAT1 = 'systemic' and SEVGR1 = 'grade >= 3'. |
| Algorithm: ADCEVD.AOCCSBFL | Computation | 'Y' if first record when sorted by ASTDT and CETERM for given USUBJID having CEOCCUR = 'Y' and ACAT1 = 'systemic' and ATPTREF = 'Boost'. |
| Algorithm: ADCEVD.AOCCSPFL | Computation | 'Y' if first record when sorted by ASTDT and CETERM for given USUBJID having CEOCCUR = 'Y' and ACAT1 = 'systemic' and ATPTREF = 'Prime'. |
| Algorithm: ADCEVD.AOCCSRFL | Computation | 'Y' if first record when sorted by ASTDT and CETERM for given USUBJID having CEOCCUR = 'Y' and ACAT1 = 'systemic'. |
| Algorithm: ADCEVD.AOCCXBFL | Computation | 'Y' if first record when sorted by ASTDT and CETERM for given USUBJID having CEOCCUR = 'Y' and ACAT1 = 'local' and SEVGR1 = 'grade >= 3' and ATPTREF = 'Boost'. |
| Algorithm: ADCEVD.AOCCXPFL | Computation | 'Y' if first record when sorted by ASTDT and CETERM for given USUBJID having CEOCCUR = 'Y' and ACAT1 = 'local' and SEVGR1 = 'grade >= 3' and ATPTREF = 'Prime'. |
| Algorithm: ADCEVD.AOCCYBFL | Computation | 'Y' if first record when sorted by ASTDT and CETERM for given USUBJID having CEOCCUR = 'Y' and ACAT1 = 'systemic' and SEVGR1 = 'grade >= 3' and ATPTREF = 'Boost'. |
| Algorithm: ADCEVD.AOCCYPFL | Computation | 'Y' if first record when sorted by ASTDT and CETERM for given USUBJID having CEOCCUR = 'Y' and ACAT1 = 'systemic' and SEVGR1 = 'grade >= 3' and ATPTREF = 'Prime'. |
| Algorithm: ADCEVD.ASEV | Computation | CESEV in proper case. |
| Algorithm: ADCEVD.ASTDT | Computation | Date part of CESTDTC as SAS date. |
| Algorithm: ADCEVD.ATPT | Computation | Concatenation of 'Day ' and the value CETPTNUM - 1. |
| Algorithm: ADCEVD.ATPTREF | Computation | 'Prime' when CETPTREF = 'PRIME VACCINATION'; 'Boost' when CETPTREF = 'BOOST VACCINATION'. |
| Algorithm: ADCEVD.SEVGR1 | Computation | 'grade < 3' when ASEVN is not missing and less than 3 (Mild or Moderate); 'grade >= 3' when ASEVN is greater than or equal to 3 (Severe or Potentially Life Threatening). |
| Algorithm: ADFACEVD.ADT | Computation | Null for "duration" records (when PARCAT2 = 'duration' or 'duration grade >= 3'). Otherwise, date part of FADTC as SAS date when SRCDOM = 'FA' and date part of VSDTC as SAS date when SRCDOM = 'VS'. |
| Algorithm: ADFACEVD.ADTM | Computation | Null for "duration" records (when PARCAT2 = 'duration' or 'duration grade >= 3'). Otherwise, FADTC as SAS datetime when SRCDOM = 'FA' and VSDTC as SAS datetime when SRCDOM = 'VS'. |
| Algorithm: ADFACEVD.AENDT | Computation | Populated only for 'duration" records (when PARCAT2 = 'duration' or 'duration grade >= 3'). Set to latest date/time at which a given type of reactogenicity event occurred (i.e. the value of ADT on the last record meeting criteria for the given PARAM value, when sorted by USUBJID, ADY, and PARAMN). |
| Algorithm: ADFACEVD.ANL01FL | Computation | Populated only for occurrence and severity/intensity parameters: 'Y' when analysis date/time (ADTM) is on or after the associated reference date/time (PRIMDTM when ATPTREF = 'Prime' and BOIMDTM when ATPTREF = 'Boost'). Null, otherwise. [Event is not included in frequency analyses if not reported to have occurred after the associated vaccination date/time.] |
| Algorithm: ADFACEVD.ASTDT | Computation | Populated only for "duration" records (when PARCAT2 = 'duration' or 'duration grade >= 3'). Set to earliest date/time at which a given type of reactogenicity event occurred (i.e. the value of ADT on the first record meeting criteria for the given PARAM value, when sorted by USUBJID, ADY, and PARAMN). |
| Algorithm: ADFACEVD.ATPT | Computation | Concatenation of 'Day ' and ATPTN. |
| Algorithm: ADFACEVD.ATPTN | Computation | Numeric part (number following 'DAY') of source variable minus 1. Source variable is FATPT when SRCDOM = 'FA' and VSTPT when SRCDOM = 'VS'. (Ex. 3 when FATPT = 'DAY 4'). |
| Algorithm: ADFACEVD.ATPTREF | Computation | 'Prime' when FATPTREF or VSTPTREF = 'PRIME VACCINATION'; 'Boost' when FATPTREF or VSTPTREF = 'BOOST VACCINATION'. |
| Algorithm: ADFACEVD.AVALCAT1 when PARCAT2 = 'severity/intensity' | Computation | 'grade < 3' when AVAL < 3; 'grade >= 3' when AVAL >= 3. |
| Algorithm: ADFACEVD.AVALCAT1.GR3 | Computation | 'grade >= 3' for these records derived from records having this value of AVALCAT1. |
| Algorithm: ADFACEVD.AVALC for severity/intensity parameters when SRCDOM = 'FA' | Computation | FASTRESC in proper case. |
| Algorithm: ADFACEVD.AVALC when SRCDOM = 'VS' and PARAMCD = 'OCFEVER' | Computation | 'Y' when VSSTRESN >= 38.0; 'N', otherwise. |
| Algorithm: ADFACEVD.AVALC when SRCDOM = 'VS' and PARAMCD = 'SEVFEVER' | Computation | 'Mild' when 38.0 <= VSSTRESN <= 38.4; 'Moderate' when 38.4 < VSSTRESN <= 38.9; 'Severe' when 38.9 < VSSTRESN <= 40.0; 'Potentially life threatening' when 40.0 < VSSTRESN. |
| Algorithm: ADFACEVD.AVAL for time from first to last reaction records | Computation | Number of days between first and last report of reaction for given subject and reaction category: ADFACEVD.AENDY - ADFACEVD.AESTDY + 1. |
| Algorithm: ADFACEVD.AVAL for severity/intensity records | Computation | 1 when AVALC = 'Mild'; 2 when AVALC = 'Moderate'; 3 when AVALC = 'Severe'; 4 when AVALC = 'Potentially life threatening'. |
| Algorithm: ADFACEVD.AVAL for time to first records | Computation | ADFACEVD.ATPTN + 1. |
| Algorithm: ADFACEVD.PARAM when FATESTCD = 'OCCUR' | Computation | Concatenation of FACE.FAOBJ (selecting just the text following a slash '/' or dash '-', when applicable, and adding ' at injection site' for Pain and Tenderness records) and FATEST in proper case. (Ex: FAOBJ = 'Injection site reaction - Pain' --> PARAM = 'Pain at injection site occurrence indicator').
[Note that occurrence records from FACE (where FATESTCD = 'OCCUR') are included in ADFACEVD only if FAEVAL = 'STUDY SUBJECT' and FASTAT is null ('NOT DONE' records are excluded).] |
| Algorithm: ADFACEVD.PARAM when FATESTCD = 'SEV' | Computation | Concatenation of FACE.FAOBJ (selecting just the text following a slash '/' or dash '-', when applicable, and adding ' at injection site' for Pain and Tenderness records) and FATEST in proper case. (Ex: FAOBJ = 'Injection site reaction - Pain' --> PARAM = 'Pain at injection site severity/intensity').
[Note that severity records from FACE (where FATESTCD = 'SEV') are included in ADFACEVD only if FAEVAL = 'STUDY SUBJECT' and FASTRESC is not 'NONE'.] |
| Algorithm: ADFACEVD.PARCAT1 | Computation | Null for records containing information about both local and systemic reactions (when PARAMCD is 'TTEFAR', 'TTEFAR3', 'DURAR', or 'DURAR3'). Otherwise, 'local' when FASCAT = 'ADMINISTRATION SITE', and 'systemic' when FASCAT = 'SYSTEMIC', SRCDOM = 'VS', or PARAMCD is 'DURFEVE', 'DURFEVE3', 'DURSR' or 'DURSR3'. |
| Algorithm: ADFACEVD.PARCAT2 | Computation | 'occurrence' when PARAMCD begins with 'OC', 'severity/intensity' when PARAMCD begins with 'SEV', 'time to first' when PARAMCD begins with 'TTE' and does not end with '3', 'time to first grade >= 3' when PARAMCD begins with 'TTE' and ends with '3', 'duration' when PARAMCD begins with 'DUR' and does not end with '3', 'duration grade >= 3' when PARAMCD begins with 'DUR' and ends with '3'. |
| Algorithm: ADLB.ABLFL | Computation | ABLFL='Y' for last non-missing AVAL/AVALC when Analysis date (ADLB.ADT) is on/before treatment start (ADLB.TRTSDT). |
| Algorithm: ADLB.ADT | Computation | Date part of ADTM. |
| Algorithm: ADLB.ADTM | Computation | LB.LBDTC as SAS datetime. |
| Algorithm: ADLB.ADY | Computation | Set to LB.LBDY. |
| Algorithm: ADLB.ANL01FL | Computation | ANL01FL='Y' for all scheduled visits and for records with DTYPE="HALFLLOQ". For records where LB.LBSTRESN=. And LB.LBSTRESC is like "<x", where x is numeric variable, ANL01FL=NULL. if ANRIND is derived based on LB.LBCLSIG then those records must be excluded from the analysis. i.e., ANLxxFL flags will be NULL.
If the lab test has been performed on less than 3 subjects then those tests(PARAMs) must be excluded from the analysis. i.e., ANLxxFL flags will be NULL.
ANLxxFL will be set to NULL when PARAMCD in 'yeast', 'lymatle', ‘smdgcele’. |
| Algorithm: ADLB.ANL02FL | Computation | ANL02FL='Y' when DTYPE=NULL.
if ANL01FL=NULL then ANL02FL=NULL |
| Algorithm: ADLB.ANRHI | Computation | ANRHI=LB.LBSTNRHI. if LB.LBSTNRHI=. and LB.LBSTNRC has values as "X-Y", where X,Y are numeric variables, then Y is ANRHI. |
| Algorithm: ADLB.ANRHIC | Computation | Character of ANRHI. If LB.LBSTNRLO is missing and LB.LBSTNRHI is non-missing then ANRHIC is shown as "<LB.LBSTNRHI+1" |
| Algorithm: ADLB.ANRIND | Computation | Derived based on AVAL, ANRHI, ANRLO. For Urinalysis NEGATIVE, NORMAL are considered Normal, anything other than above are ABNORMAL. NOT DETECTABLE, INVALID VALUE are considered as MISSING. If AVAL/AVALC is missing or AVALC=+, for categories other than URINALYSIS, or (ANRHI and ANRLO) are missing but LBCLSIG is non-missing then for URINALYSIS ANRIND="Abnormal", For other categories, ANRIND="HIGH". |
| Algorithm: ADLB.ANRINDN | Computation | Numeric Code of ANRIND, LOW=1, NORMAL=2, HIGH=3, ABNORMAL=4, MISSING=5 |
| Algorithm: ADLB.ANRLO | Computation | ADLB.ANRLO=LB.LBSTNRLO. if LB.LBSTNRLO=. and LB.LBSTNRC has values as "X-Y", where X,Y are numeric variables, then X is ADLB.ANRLO. |
| Algorithm: ADLB.ANRLOC | Computation | Character of ANRLO |
| Algorithm: ADLB.ASEQ | Computation | Sort by USUBJID,PARAMCD, AVISITN. Assign sequential numbers starting with 1 for each subject. |
| Algorithm: ADLB.ATM | Computation | Time part of ADTM. |
| Algorithm: ADLB.AVAL | Computation | LB.LBSTRESN, records needs to be added where LB.LBSTRESN=. And LB.LBSTRESC is like "<x". AVAL for these records will be 0.5*X and dtype="HALFLLOQ", X is a numeric variable. if LB.LBORRES captures continous results and LB.LBSTRESN is missing then AVAL=LB.LBORRES. |
| Algorithm: ADLB.AVALC | Computation | Character of AVAL. if AVAL=. then LB.LBSTRESC. |
| Algorithm: ADLB.AVISIT | Computation | "If LB.VISIT=Visit 0 (Day -30 to 0) then AVISIT= Day -30 to 0
If LB.VISIT=Visit 1 (Day 1) then AVISIT= Day 1
If LB.VISIT=Visit 2 (Day 2) then AVISIT= Day 2
If LB.VISIT=Visit 3 (Day 8) then AVISIT= Day 8
If LB.VISIT=Visit 4 / Dosing (Day 22) then AVISIT= Day 22
If LB.VISIT=Visit 5 (Day 29) then AVISIT= Day 29
If LB.VISIT=Visit 7 / EoT Visit (Day 50) then AVISIT= Day 50
If LB.VISIT=Unscheduled 1.01 then AVISIT=Unscheduled Day -30 to 0
If LB.VISIT=Unscheduled 5.01 then AVISIT=Unscheduled Day 8
If LB.VISIT=Unscheduled 6.01 then AVISIT=Unscheduled Day 22
If LB.VISIT=Unscheduled 7.01 then AVISIT=Unscheduled Day 29
If LB.VISIT=Unscheduled 8.01 then AVISIT=Unscheduled Day 43
If LB.VISIT=Unscheduled 9.01 then AVISIT=Unscheduled Day 50 |
| Algorithm: ADLB.AVISITN | Computation | "If LB.VISIT=Visit 0 (Day -30 to 0) then AVISITN= 1
If LB.VISIT=Visit 1 (Day 1) then AVISITN= 2
If LB.VISIT=Visit 2 (Day 2) then AVISITN= 3
If LB.VISIT=Visit 3 (Day 8) then AVISITN= 5
If LB.VISIT=Visit 4 / Dosing (Day 22) then AVISITN= 6
If LB.VISIT=Visit 5 (Day 29) then AVISITN= 7
If LB.VISIT=Visit 7 / EoT Visit (Day 50) then AVISITN= 9
If LB.VISIT=Unscheduled 1.01 then AVISITN= 1.01
If LB.VISIT=Unscheduled 5.01 then AVISITN= 5.01
If LB.VISIT=Unscheduled 6.01 then AVISITN= 6.01
If LB.VISIT=Unscheduled 7.01 then AVISITN= 7.01
If LB.VISIT=Unscheduled 8.01 then AVISITN= 8.01
If LB.VISIT=Unscheduled 9.01 then AVISITN= 9.01 |
| Algorithm: ADLB.BASE | Computation | BASE=AVAL, when ABLFL="Y" |
| Algorithm: ADLB.BASEC | Computation | Character of BASE |
| Algorithm: ADLB.BNRIND | Computation | BNRIND=ANRIND, when ABLFL='Y' |
| Algorithm: ADLB.BNRINDN | Computation | Numeric Code of BNRIND, LOW=1, NORMAL=2, HIGH=3, ABNORMAL=4, MISSING=5 |
| Algorithm: ADLB.CHG | Computation | When AVAL and BASE are non-missing CHG = AVAL - BASE. if AVAL=0 & BASE=0 then CHG=. |
| Algorithm: ADLB.COMEVAL1 | Computation | Evaluator for COMMENT1 is COMEVAL1. |
| Algorithm: ADLB.COMEVAL2 | Computation | Evaluator for COMMENT2 is COMEVAL2. |
| Algorithm: ADLB.COMMENT1 | Computation | Comments are captured from CO domain. There will be each COMMENT<x> variable for each records in CO for a given subject. CO.COVAL is ADLB.COMMENT<x>, and corresponding CO.COEVAL is ADLB.COMEVAL<x> |
| Algorithm: ADLB.COMMENT2 | Computation | Comments are captured from CO domain. There will be each COMMENT<x> variable for each records in CO for a given subject. CO.COVAL is ADLB.COMMENT<x>, and corresponding CO.COEVAL is ADLB.COMEVAL<x> |
| Algorithm: ADLB.DTYPE | Computation | Is populated for additional imputed records where LBSTRESN=. And LBSTRESC is like "<x". AVAL for these records will be 0.5*X and DTYPE="HALFLLOQ" . X is a numeric variable. |
| Algorithm: ADLB.LBCLSIGN | Computation | numeric of LB.LBCLSIG, Y=1, N=0 |
| Algorithm: ADLB.NABCS | Computation | if ANRIND=abnormal and LB.LBCLSIG="Y" then NABCS= "CS Abnormal"; if ANRIND is abnormal and LB.LBCLSIG="N" then NABCS="Abnormal (not CS)"; if ANRIND is normal then NABCS="Normal"; if ANRIND=. Then NABCS="Missing" ; |
| Algorithm: ADLB.NABCSN | Computation | Numeric Code of NABCS, Missing=1, CS abnormal=2, abnormal (not CS)=3, Normal=4 |
| Algorithm: ADLB.PARAM | Computation | PARAM=strip(LB.LBTEST)<||"("||strip(LB.LBSPEC)||")"||>"["||strip(LB.LBSTRESU)||"]" if same lab test is done in 2 or more categories then LB.LBSPEC is included. If not, just the LB.LBTEST and LB.LBSTRESU are used to assign PARAM. If LB.LBSTRESU is missing for a given test, LB.LBORRESU has been used. |
| Algorithm: ADLB.PARAMCD | Computation | LB.LBTESTCD||<suffix as needed>, if same lab test is done in 2 or more categories or has different specimen type then suffix is updated with "B" "BS" "U" "UD" "UM". B for Blood, BS for Blood Serum, U for Urine, UD for Urine and Dipstick method, UM for Urine and Microscopy method. Adjust PARAMCD accordingly. |
| Algorithm: ADLB.PARAMN | Computation | =1 for PARAMCD='ALT' ; =2 for PARAMCD='ALB';=3 for PARAMCD='ALP'; =4 for PARAMCD='AMPHET';
=5 for PARAMCD='AMYLASE'; =6 for PARAMCD='ANISO'; =7 for PARAMCD='AST'; =8 for PARAMCD='BACT';
=9 for PARAMCD='BARB'; =11 for PARAMCD='BASOB'; =14 for PARAMCD='BASOBS'; =16 for PARAMCD='BASOLEB';
=17 for PARAMCD='BASOLEBS'; =18 for PARAMCD='BNZDZPN'; =19 for PARAMCD='BILIS'; =20 for PARAMCD='BILIU';
=21 for PARAMCD='CRP'; =22 for PARAMCD='CA';=23 for PARAMCD='CANNAB'; =24 for PARAMCD='CASTS';
=25 for PARAMCD='HCG'; =26 for PARAMCD='COCAINE'; =27 for PARAMCD='CK'; =28 for PARAMCD='CREAT';
=29 for PARAMCD='CRYSTALS'; =31 for PARAMCD='EOSB'; =34 for PARAMCD='EOSBS'; =36 for PARAMCD='EOSLEB';
=37 for PARAMCD='EOSLEBS'; =38 for PARAMCD='EPIC'; =39 for PARAMCD='MCHC'; =40 for PARAMCD='MCH';
=41 for PARAMCD='MCV'; =42 for PARAMCD='RBCB'; =43 for PARAMCD='RBCU'; =44 for PARAMCD='ETHANOL';
=47 for PARAMCD='FERRITIN'; =48 for PARAMCD='FSH'; =49 for PARAMCD='GGT'; =50 for PARAMCD='GLUCB';
=51 for PARAMCD='GLUCU'; =52 for PRAMCD=’GRANBCE’; =53 for PARAMCD='HCT'; =54 for PARAMCD='HGBB';
=55 for PARAMCD='HGBU'; =56 for PARAMCD='KETONES'; =57 for PARAMCD='WBCB'; =58 for PARAMCD='WBCUD';
=59 for PARAMCD='WBCUM'; =60 for PARAMCD='LIPASET'; =62 for PARAMCD='LYMB'; =65 for PARAMCD='LYMBS';
=66 for PARAMCD='LYMATLE'; =68 for PARAMCD='LYMLEB'; =69 for PARAMCD='LYMLEBS'; =70 for PARAMCD=’MACROCY’;
=71 for PARAMCD='METHDN'; =72 for PARAMCD='METHAMPH'; =73 for PARAMCD='MICROCY'; =75 for PARAMCD='MONOB';
=78 for PARAMCD='MONOBS'; =80 for PARAMCD='MONOLEB'; =81 for PARAMCD='MONOLEBS'; =82 for PARAMCD='MYCY';
=84 for PARAMCD='NEUTB'; =87 for PARAMCD='NEUTBS'; =89 for PARAMCD='NEUTLEB'; =90 for PARAMCD='NEUTLEBS';
=91 for PARAMCD='NITRITE'; =92 for PARAMCD='OPIATE'; =93 for PARAMCD='PH'; =94 for PARAMCD='PCP';
=95 for PARAMCD='PLAT'; =96 for PARAMCD='POIKILO'; =97 for PARAMCD='K'; =98 for PARAMCD='PROT';
=99 for PARAMCD='EPIROCE'; =100 for PARAMCD='SMDGCELE'; =101 for PARAMCD='SODIUM'; =102 for PARAMCD='SPGRAV';
=103 for PARAMCD='TRCYANDP'; =104 for PARAMCD='UREAN' ; =105 for PARAMCD='UROBIL'; =106 for PARAMCD='YEAST'; |
| Algorithm: ADLB.PARCAT1 | Computation | LB.LBCAT |
| Algorithm: ADLB.PARCAT1N | Computation | Numeric Code of PARCAT1, CHEMISTRY=1; HEMATOLOGY=2 ; URINALYSIS=3; |
| Algorithm: ADLB.PARCAT2 | Computation | LB.LBSCAT |
| Algorithm: ADLB.PARCAT2N | Computation | Numeric Code of PARCAT2, DRUG OF ABUSE=1; PREGNANCY=2 |
| Algorithm: ADLB.PCHG | Computation | PCHG = ((AVAL - BASE)/BASE)*100 when AVAL and BASE are not missing. |
| Algorithm: ADLB.POBLFL | Computation | POBLFL='Y' when ADTM>TRTSDTM, if ADTM=. Then use ADT/TRTSDT. |
| Algorithm: ADLB.SRCDOM | Computation | LB.DOMAIN |
| Algorithm: ADLB.SRCSEQ | Computation | LB.LBSEQ |
| Algorithm: ADLB.UNSVFL | Computation | if LB.VISIT contains "Unscheduled" then UNSVFL="Y"; else UNSVFL=' '; |
| Algorithm: ADLB.WPBFL | Computation | WPBFL=Y for the first occurance of each abnormality for a given PARAM and USUBJID. if there is no abnormality for a given parameter and subject then first post-baseline visit is flagged as 'Y' |
| Algorithm: ADSL.AAGE | Computation | Set to AGE when AGE_M is missing (i.e. no additional months are specified to be added to age). Otherwise, set to the AGE + AGE_M / 12, rounded to the nearest hundredth. |
| Algorithm: ADSL.AGEGR1 | Computation | '18 - 55 Yrs' when AGE is between 18 and 55 (inclusive); '> 55 Yrs' when AGE is greater than 55. |
| Algorithm: ADSL.ALLOCDTM | Computation | DS.DSSTDTC as SAS datetime, selecting record where DS.DSDECOD = 'ALLOCATED'. |
| Algorithm: ADSL.BMI | Computation | VS.VSSTRESN where VS.VSTESTCD = 'BMI' and VS.VSBLFL = 'Y'. |
| Algorithm: ADSL.BOIMDTM | Computation | EC.ECSTDTC as SAS datetime, selecting record where EC.ECOCCUR = 'Y' and EC.VISITNUM = 6. |
| Algorithm: ADSL.CB28FL | Computation | 'Y' when subject is in the Safety Boost Population (SAFBFL = 'Y') and has completed at least 28 days of follow-up after receiving the boost vaccination (BOIMDT is not null and either (a) EOSSTT = 'COMPLETED', (b) EOSDT is populated and BOIMDT + 28 is less than EOSDT, or (c) BOIMDT + 28 is less than or equal to the data cutoff date of 23OCT2020). 'N', otherwise. |
| Algorithm: ADSL.CB7FL | Computation | 'Y' when subject is in the Safety Boost Population (SAFBFL = 'Y') and has completed at least 7 days of follow-up after receiving the boost vaccination (either EOSDT is populated and BOIMDT + 7 is less than EOSDT or BOIMDT + 7 is less than or equal to the data cutoff date of 23OCT2020). 'N', otherwise. |
| Algorithm: ADSL.COHCAT1 | Computation | 'Dose ranging cohorts' when COHORTN <= 10. Null, otherwise. |
| Algorithm: ADSL.COHCAT2 | Computation | 'Younger dose ranging cohorts' when COHORTN < 8; 'Older dose ranging cohorts' when COHORTN >= 8. |
| Algorithm: ADSL.COMPLFL | Computation | 'Y' when EOSSTT = 'COMPLETED'. 'N', otherwise. |
| Algorithm: ADSL.CP7FL | Computation | 'Y' when subject is in the Safety Population (SAFFL = 'Y') and has completed at least 7 days of follow-up after receiving the prime vaccination (either EOSDT is populated and PRIMDT + 7 is less than EOSDT or PRIMDT + 7 is less than or equal to the data cutoff date of 23OCT2020). 'N', otherwise. |
| Algorithm: ADSL.CPB28FL | Computation | 'Y' when subject is in the Prime to Boost or Prime +28 D. Comp. Population (CPBP28FL = 'Y') and has either (a) not received a boost vaccination (SAFBFL = 'N') or (b) is in the Boost + 28 Days Completers Population (CB28FL = 'Y'). 'N', otherwise. |
| Algorithm: ADSL.CPBP28FL | Computation | 'Y' when subject is in the Safety Boost Population (SAFBFL = 'Y') or is in the Safety Population (SAFFL = 'Y') and has completed at least 28 days of follow-up after receiving the prime vaccination (either EOSDT is populated and PRIMDT + 28 is less than EOSDT or PRIMDT + 28 is less than or equal to the data cutoff date of 23OCT2020). 'N', otherwise. |
| Algorithm: ADSL.DCSREAS | Computation | Populated when EOSSTT = 'DISCONTINUED'. Set to DS.DSDECOD in proper case, selecting record where DS.DSSCAT = 'END OF TRIAL'. |
| Algorithm: ADSL.DCSREASP | Computation | Populated when EOSSTT = 'DISCONTINUED'. Set to DS.DSTERM in proper case, selecting record where DS.DSSCAT = 'END OF TRIAL'. |
| Algorithm: ADSL.DTHDT | Computation | Date part of DM.DTHDTC as SAS date. |
| Algorithm: ADSL.EOFUDT | Computation | Date part of DS.DSSTDTC as SAS date, selecting record where DS.DSSCAT = 'END OF FOLLOW-UP'. |
| Algorithm: ADSL.EOSDT | Computation | Date part of DS.DSSTDTC as SAS date, selecting record where DS.DSSCAT = 'END OF TRIAL'. |
| Algorithm: ADSL.EOSSTT | Computation | 'COMPLETED' when DS.DSDECOD = 'COMPLETED' on record with DS.DSSCAT = 'END OF TRIAL' for given subject. Otherwise, 'DISCONTINUED' when EOSDT is not null. |
| Algorithm: ADSL.EXIMM1 | Computation | 'Subject did not receive one dose of IMP or did not have one post-baseline immunogenicity assessment' when IMMFL = 'N'. |
| Algorithm: ADSL.EXPPROT1 | Computation | 'Subject is not included in the immunogenicity set or had major protocol deviation' when PPROTFL = 'N'. |
| Algorithm: ADSL.EXSAF1 | Computation | Always null, since no patients are excluded from the safety population (i.e. all have received the prime vaccination) in this data cut. |
| Algorithm: ADSL.EXSAFB1 | Computation | 'Subject did not receive two doses of IMP' when SAFBFL = 'N'. |
| Algorithm: ADSL.EXSCR1 | Computation | Always null, since screen failures not included in this data cut. |
| Algorithm: ADSL.FIRICDT | Computation | Date part of DS.DSSTDTC as SAS date, selecting record where DS.DSDECOD = 'FIRST INFORMED CONSENT OBTAINED'. |
| Algorithm: ADSL.HEIGHT | Computation | VS.VSSTRESN where VS.VSTESTCD = 'HEIGHT' and VS.VSBLFL = 'Y'. |
| Algorithm: ADSL.ICR1DTM | Computation | DS.DSSTDTC as SAS datetime, selecting record(s) where DS.DSDECOD = 'INFORMED CONSENT RECONSENTED'. If multiple records exist for a given subject, the 1st record when sorted by DS.DSSTDTC is selected for populating ICR1DTM. |
| Algorithm: ADSL.ICR2DTM | Computation | DS.DSSTDTC as SAS datetime, selecting records where DS.DSDECOD = 'INFORMED CONSENT RECONSENTED'. The 2nd record when sorted by DS.DSSTDTC is selected for populating ICR2DTM. |
| Algorithm: ADSL.ICR3DTM | Computation | DS.DSSTDTC as SAS datetime, selecting records where DS.DSDECOD = 'INFORMED CONSENT RECONSENTED'. The 3rd record when sorted by DS.DSSTDTC is selected for populating ICR3DTM. |
| Algorithm: ADSL.ICR4DTM | Computation | DS.DSSTDTC as SAS datetime, selecting records where DS.DSDECOD = 'INFORMED CONSENT RECONSENTED'. The 4th record when sorted by DS.DSSTDTC is selected for populating ICR4DTM. |
| Algorithm: ADSL.IMMFL | Computation | 'Y' when subject is in the Safety Population (SAFFL = 'Y') and has evaluable post-baseline Neutralizing Titer results (when record exists in IS for given subject with IS.VISITNUM > 2 and non-missing IS.ISORRES for IS.ISTESTCD of 'C2NGNT50' or 'C2NGNT90'). 'N', otherwise. |
| Algorithm: ADSL.LVDT | Computation | When subject has completed the trial (i.e. EOSSTT = ' COMPLETED'), set to date part of DS.DSSTDTC as SAS date, selecting record where DS.DSSCAT = 'END OF TRIAL. When subject discontinued prematurely (i.e. EOSSTT = 'DISCONTINUED'), set to date part of Date of last visit/contact (SUPPDS.QVAL where QNAM = 'LASTCONT') as SAS date. |
| Algorithm: ADSL.PPROTFL | Computation | 'Y' when subject is in the Immunogenicity Population (IMMFL = 'Y') and has not had a protocol violation (no record exists in DV for given subject). 'N', otherwise. |
| Algorithm: ADSL.PRIMDTM | Computation | EC.ECSTDTC as SAS datetime, selecting record where EC.ECOCCUR = 'Y' and VISITNUM = 2. |
| Algorithm: ADSL.PROTVER1 | Computation | SUPPDS.QNAM where QVAL = 'PROTVERS'. If multiple records exist for a given subject, the 1st record when sorted by DS.DSSTDTC on the associated parent record is selected for populating PROTVER1. |
| Algorithm: ADSL.PROTVER2 | Computation | SUPPDS.QNAM where QVAL = 'PROTVERS'. The 2nd record when sorted by DS.DSSTDTC on the associated parent record is selected for populating PROTVER2. |
| Algorithm: ADSL.PROTVER3 | Computation | SUPPDS.QNAM where QVAL = 'PROTVERS'. The 3rd record when sorted by DS.DSSTDTC on the associated parent record is selected for populating PROTVER3. |
| Algorithm: ADSL.PROTVER4 | Computation | SUPPDS.QNAM where QVAL = 'PROTVERS'. The 4th record when sorted by DS.DSSTDTC on the associated parent record is selected for populating PROTVER4. |
| Algorithm: ADSL.PROTVER5 | Computation | SUPPDS.QNAM where QVAL = 'PROTVERS'. The 5th record when sorted by DS.DSSTDTC on the associated parent record is selected for populating PROTVER5. |
| Algorithm: ADSL.RFICDTM | Computation | DM.RFICDTC as SAS datetime. |
| Algorithm: ADSL.SAFBFL | Computation | 'Y' when subject has received boost vaccination (when record exists in EC with EC.ECOCCUR = 'Y' and EC.VISITNUM = 6 for given subject). 'N', otherwise. |
| Algorithm: ADSL.SAFFL | Computation | 'Y' when subject has received prime vaccination (when record exists in EC with EC.ECOCCUR = 'Y' and EC.VISITNUM = 2 for given subject). 'N', otherwise. |
| Algorithm: ADSL.SCRDT | Computation | Date part of DM.RFICDTC as SAS date. |
| Algorithm: ADSL.SCRFL | Computation | 'Y' when RFICDTM is not missing; 'N', otherwise. |
| Algorithm: ADSL.SUBJIDN | Computation | DM.SUBJID as numeric value. |
| Algorithm: ADSL.TRT01A | Computation | Set according to the dosing and cohort information provided in DM.ACTARM, updating the unit value from 'ug' to 'µg', and categorizing cohorts 01-07 as 'Younger' and cohorts 08-10 as 'Older'. [Ex: '10 µg Older' when DM.ACTARM = 'BNT162b1 Cohort 08 10 ug'] |
| Algorithm: ADSL.TRT01AN | Computation | Set to the dose level in TRT01A multiplied by 100, with 100,000 added when subject is in the older cohort (i.e. COHCAT2N = 2). [Ex: 101000 when TRT01A = '10 µg Older'] |
| Algorithm: ADSL.TRT01P | Computation | Set according to the dosing and cohort information provided in DM.ARM, updating the unit value from 'ug' to 'µg', and categorizing cohorts 01-07 as 'Younger' and cohorts 08-10 as 'Older'. [Ex: '10 µg Older' when DM.ARM = 'BNT162b1 Cohort 08 10 ug'] |
| Algorithm: ADSL.TRT01PN | Computation | Set to the dose level in TRT01P multiplied by 100, with 100,000 added when subject is in the older cohort (i.e. COHCAT2N = 2). [Ex: 101000 when TRT01P = '10 µg Older'] |
| Algorithm: ADSL.TRTEDTM | Computation | DM.RFXENDTC as SAS datetime. |
| Algorithm: ADSL.TRTSDTM | Computation | DM.RFXSTDTC as SAS datetime. |
| Algorithm: ADSL.WEIGHT | Computation | VS.VSSTRESN where VS.VSTESTCD = 'WEIGHT' and VS.VSBLFL = 'Y'. |
| Algorithm: ADVA.ABLFL | Computation | 'Y' for a valid result (AVAL ne .) and last non missing records value before or on the first day of treatment |
| Algorithm: ADVA.ADT | Computation | ADT = date part of IS.ISDTC |
| Algorithm: ADVA.ADTM | Computation | numeric value of IS.ISDTC |
| Algorithm: ADVA.ATM | Computation | ATM = time part of IS.ISDTC |
| Algorithm: ADVA.AVAL | Computation | if ISSTRESC equal to "BLQ" then set AVAL to 0.5*ISLLOQ; else set to IS.ISSTRESN. For paramn 5,6,7,8;
Create new row for post baseline records of paramn 1,2,3,4 with their non-missing aval and base.
for paramcd="FRC19RBD" subset if paramn=1 then aval eq aval/base.
for paramcd="'FRC19S1I" subset if paramn=2 then aval eq aval/base.
for paramcd="FRC2NT50" subset if paramn=3 then aval eq aval/base.
for paramcd="FRC2NT90" subset if paramn=4 then aval eq aval/base. |
| Algorithm: ADVA.AVALC | Computation | Derived as character value of AVAL. |
| Algorithm: ADVA.AVISIT | Computation | AVISIT=IS.VISIT |
| Algorithm: ADVA.BASE | Computation | ADVA.AVAL from the record with ABLFL="Y" for this USUBJID/PARAM |
| Algorithm: ADVA.CHG | Computation | If AVAL not missing and BASE not missing then CHG=AVAL-BASE. This is calculated only for post-baseline records. |
| Algorithm: ADVA.CRIT1 | Computation | Derived as 'Seroconversion' for the post baseline records of ADVA.paramn 1, 2, 3, 4 |
| Algorithm: ADVA.CRIT1FL | Computation | Derived for post baseline records of ADVA.paramn (1, 2, 3, 4); CRIT1FL='Y' when aval/base>=4; else CRIT1FL='N' |
| Algorithm: ADVA.DTYPE | Computation | Derived as 'HALFLLOQ' for records IS.ISSTRESC='BLQ' |
| Algorithm: ADVA.PARAM for COVID-19 records | Computation | Concatenation of IS.ISTEST and IS.ISSTRESU in parentheses. |
| Algorithm: ADVA.PARCAT1 | Computation | Set to IS.ISCAT. |
| Algorithm: ADVA.PCHG | Computation | For Post baseline records, if AVAL NOT missing and BASE not missing then set it to ((AVAL-BASE)/BASE)*100 |
| Algorithm: ADVS.ABLFL | Computation | [Protocol/SAP] Baseline record for each SUBJID/PERIOD/PARAM as defined in the protocol |
| Algorithm: ADVS.ADT | Computation | ADT = date part of VS.VSDTC |
| Algorithm: ADVS.ADTM | Computation | numeric value of VS.VSDTC |
| Algorithm: ADVS.ANL01FL | Computation | [Protocol/SAP] "Y" for the selected record within each SUBJID/PERIOD/PARAM/AVISIT as determined by the protocol |
| Algorithm: ADVS.ANL02FL | Computation | "Y" when TRTSDT/TRTSTM < ADTM < TRTEDT/TRTETM |
| Algorithm: ADVS.ANRHI | Computation | 90 if paramn=2; 100 if paramn=4; 20 if paramn=5 ; 140 if paramn=6 ; 37.5 if paramn=7 |
| Algorithm: ADVS.ANRIND | Computation | If non-missing AVAL is greater than ANRHI or less than ANRLO then ANRIND=Abnormal. If ANRLO is missing then only ANRHI is used to determine abnormality.
If non-missing AVAL is within ANRLO and ANRHI then ANRIND=Normal. |
| Algorithm: ADVS.ANRLO | Computation | 50 if paramn=4 ; 8 if paramn=5 ; 90 if paramn=6 ; 35.5 if paramn=7 |
| Algorithm: ADVS.ASEQ | Computation | sort the data by USUBJID,PARAMN,AVISITN,ADTM. Assign the sequential numbers starting with 1 for each subject. |
| Algorithm: ADVS.ATM | Computation | ATM = time part of VS.VSDTC |
| Algorithm: ADVS.ATPT | Computation | VS.VSTPT |
| Algorithm: ADVS.ATPTN | Computation | 0 if VS.VSTPT= "predose" ; 1 if VS.VSTPT= "1 hour" ; 3 if VS.VSTPT= "3 hours" ; 6 if VS.VSTPT= "6 hours". |
| Algorithm: ADVS.ATPTREF | Computation | VS.VSTPTREF |
| Algorithm: ADVS.AVAL | Computation | VS.VSSTRESN |
| Algorithm: ADVS.AVALC | Computation | VS.VSSTRESC |
| Algorithm: ADVS.AVISIT | Computation | If VS.VISIT=Visit 0 (Day -30 to 0) then AVISIT= Day -30 to 0 ;
If VS.VISIT=Visit 1 (Day 1) then AVISIT= Day 1 ;
If VS.VISIT=Visit 2 (Day 2) then AVISIT= Day 2 ;
If VS.VISIT=Visit 3 (Day 8) then AVISIT= Day 8 ;
If VS.VISIT=Visit 4 / Dosing (Day 22) then AVISIT= Day 22 ;
If VS.VISIT=Visit 5 (Day 29) then AVISIT= Day 29 ;
If VS.VISIT=Visit 6 (Day 43) then AVISIT= Day 43 ;
If VS.VISIT=Visit 7 / EoT Visit (Day 50) then AVISIT= Day 50 ;
If VS.VISIT=Visit 8 / FU Visit (Day 85) then AVISIT= Day 85 ;
If VS.VISIT=Visit 9 / FU Visit (Day 184) then AVISIT= Day 184 ;
If VS.VISIT=Unscheduled 1.01 then AVISIT=Unscheduled 1 Day -30 to 0 ;
If VS.VISIT=Unscheduled 2.01 then AVISIT=Unscheduled 1 Day 1 ;
If VS.VISIT=Unscheduled 3.01 then AVISIT=Unscheduled 1 Day 2 ;
If VS.VISIT=Unscheduled 5.01 then AVISIT=Unscheduled 1 Day 8 ;
If VS.VISIT=Unscheduled 6.01 then AVISIT=Unscheduled 1 Day 22 ;
If VS.VISIT=Unscheduled 7.01 then AVISIT=Unscheduled 1 Day 29 ;
If VS.VISIT=Unscheduled 8.01 then AVISIT=Unscheduled 1 Day 43 ;
If VS.VISIT=Unscheduled 9.01 then AVISIT=Unscheduled 1 Day 50 ; |
| Algorithm: ADVS.AVISITN | Computation | If VS.VISIT=Visit 0 (Day -30 to 0) then AVISITN= 1;
If VS.VISIT=Visit 1 (Day 1) then AVISITN= 2;
If VS.VISIT=Visit 2 (Day 2) then AVISITN= 3;
If VS.VISIT=Visit 3 (Day 8) then AVISITN= 5;
If VS.VISIT=Visit 4 / Dosing (Day 22) then AVISITN= 6;
If VS.VISIT=Visit 5 (Day 29) then AVISITN= 7;
If VS.VISIT=Visit 6 (Day 43) then AVISITN= 8;
If VS.VISIT=Visit 7 / EoT Visit (Day 50) then AVISITN= 9;
If VS.VISIT=Visit 8 / FU Visit (Day 85) then AVISITN=10;
If VS.VISIT=Visit 9 / FU Visit (Day 184) then AVISITN=11;
If VS.VISIT=Unscheduled 1.01 then AVISITN= 1.01 ;
If VS.VISIT=Unscheduled 2.01 then AVISITN=2.01;
If VS.VISIT=Unscheduled 3.01 then AVISITN=3.01;
If VS.VISIT=Unscheduled 5.01 then AVISITN= 5.01 ;
If VS.VISIT=Unscheduled 6.01 then AVISITN= 6.01 ;
If VS.VISIT=Unscheduled 7.01 then AVISITN= 7.01 ;
If VS.VISIT=Unscheduled 8.01 then AVISITN= 8.01 ;
If VS.VISIT=Unscheduled 9.01 then AVISITN= 9.01 ; |
| Algorithm: ADVS.BASE | Computation | ADVS.AVAL, where ADVS.USUBJID=USUBJID and ADVS.APERIOD=APERIOD and ADVS.PARAM=PARAM and ADVS.ABLFL="Y" |
| Algorithm: ADVS.BASEC | Computation | ADVS.AVALC, where ADVS.USUBJID=USUBJID and ADVS.APERIOD=APERIOD and ADVS.PARAM=PARAM and ADVS.ABLFL="Y" |
| Algorithm: ADVS.BNRIND | Computation | If non-missing BASE is greater than ANRHI or less than ANRLO then ANRIND=Abnormal. If ANRLO is missing then only ANRHI is used to determine abnormality.
If non-missing BASE is within ANRLO and ANRHI then ANRIND=Normal. |
| Algorithm: ADVS.CHG | Computation | CHG = AVAL - BASE |
| Algorithm: ADVS.NABCS | Computation | If abnormality is clinically significant then NABCS='CS Abnormal' ; If abnormality is not clinically significant then NABCS='Abnormal (not CS)' ; if no abnormality then NABCS=Normal ; if there is abnormality and clinically significance information is not present then NABCS=Missing. |
| Algorithm: ADVS.NABCSN | Computation | 1 if NABCS = 'Missing'; 2 if NABCS = 'CS Abnormal'; 3 if NABCS = 'Abnormal (not CS); 4 if NABCS = 'Normal’ |
| Algorithm: ADVS.PARAM | Computation | VS.VSTEST || VS.VSORRESU |
| Algorithm: ADVS.PARAMCD | Computation | VS.VSTESTCD |
| Algorithm: ADVS.PARAMN | Computation | 1 if paramcd='BMI'; 2 if paramcd = 'DIABP'; 3 if paramcd='HEIGHT' ;4 if paramcd='PULSE'; 5 if paramcd='RESP'; 6 if paramcd='SYSBP'; 7 if paramcd='TEMP'; 8 if paramcd='TEMPR'; 9 if paramcd='WEIGHT' |
| Algorithm: ADVS.PARCAT1 | Computation | VS.VSCAT |
| Algorithm: ADVS.PARCAT1N | Computation | 1 if parcat1='Reactogenicity' |
| Algorithm: ADVS.PARCAT2 | Computation | VS.VSSCAT |
| Algorithm: ADVS.PARCAT2N | Computation | 1 if parcat2='Systemic' |
| Algorithm: ADVS.PCHG | Computation | PCHG = ((AVAL - BASE)/BASE)*100 |
| Algorithm: ADVS.POBLFL | Computation | Populated only on records with null value for PARCAT1. 'Y' if ADTM ne . and ADTM>TRTSDTM. if ADTM=. and ADT>TRTSDT then POBLFL="Y"; |
| Algorithm: ADVS.SRCDOM | Computation | VS.DOMAIN |
| Algorithm: ADVS.SRCSEQ | Computation | VS.VSSEQ |
| Algorithm: ADVS.UNSVFL | Computation | Y' if index(AVISIT,'Unscheduled') > 0 |
| Algorithm: ADVS.VSCLSIGN | Computation | 1 if VSCLSIG='Y'; 0 if VSCLSIG='N', missing otherwise |
| Algorithm: ADY | Computation | Analysis date relative to treatment start: ADT - TRTSDT + 1, when ADT is on or after TRTSDT; ADT - TRTSDT, when ADT is before TRTSDT. |
| Algorithm: AENDY | Computation | Analysis end date relative to treatment start: AENDT - TRTSDT + 1, when AENDT is on or after TRTSDT; AENDT - TRTSDT, when AENDT is before TRTSDT. |
| Algorithm: ASTDY | Computation | Analysis start date relative to treatment start: ASTDT - TRTSDT + 1, when ASTDT is on or after TRTSDT; ASTDT - TRTSDT, when ASTDT is before TRTSDT. |
| Algorithm: -DT | Computation | Date part of corresponding -DTM variable. |
| Algorithm: -TM | Computation | Time part of corresponding -DTM variable. |
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