Date/Time of Define-XML document generation: 2021-04-30T19:31:53Z

Define-XML version: 2.0.0

Stylesheet version: 2018-11-21

Standard: ADaM-IG 1.1
Study Name: COVID-19 Phase 2
Study Description: A Phase 2a, Randomized, Observer-Blind, Placebo-Controlled, Dose-Finding Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older
Protocol Name: mRNA-1273-P201
Metadata Name: Study COVID-19 Phase 2 Data Definitions

Analysis Results Metadata - Summary

Table 14.2.1.1.1Summary of Binding Antibody Levels Per-Protocol Set for SARS-CoV-2-specific bAb

Summary of Binding Antibody Levels Per-Protocol Set for SARS-CoV-2-specific bAb

Table 14.3.1.1.1Summary of Solicited Adverse Reactions within 7 Days After First Injection by Grade First Injection Solicited Safety Set

Summary of Solicited Adverse Reactions within 7 Days After First Injection by Grade First Injection Solicited Safety Set

Table 14.3.1.1.2Summary of Solicited Adverse Reactions within 7 Days After Second Injection by Grade Second Injection Solicited Safety Set

Summary of Solicited Adverse Reactions within 7 Days After Second Injection by Grade Second Injection Solicited Safety Set

Analysis Results Metadata - Detail

Table 14.2.1.1.1
Display	Summary of Binding Antibody Levels Per-Protocol Set for SARS-CoV-2-specific bAb Summary of Binding Antibody Levels Per-Protocol Set for SARS-CoV-2-specific bAb
Analysis Result	Summary of Binding Antibody Levels Per-Protocol Set for SARS-CoV-2-specific bAb
Analysis Parameter(s)	PARAMCD IN ( "V58IGGEN" (VAC58 Nucleocapsid IgG Antibody (AU/ml)), "V58IGGES" (VAC58 Spike IgG Antibody (ug/ml)) )
Analysis Variable(s)	ADIS.AVAL (Analysis Value)
Analysis Reason	SPECIFIED IN SAP
Analysis Purpose	PRIMARY OUTCOME MEASURE
Data References (incl. Selection Criteria)	ADIS [AVISIT IN ("BASELINE", "DAY 29", "DAY 43", "DAY 57") and PARCAT1 = "Serum SARS-CoV-2 Binding Antibodies" and PARAMCD IN ("V58IGGEN", "V58IGGES") and ANL01FL = "Y" and PPBABRFL = "Y"]
Documentation	SAP
Programming Statements	[SAS version 9.4] SAS program codes could be found from m5\datasets\mRNA-1273-P201\analysis\adam\programs\t1402010101.txt

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Table 14.3.1.1.1
Display	Summary of Solicited Adverse Reactions within 7 Days After First Injection by Grade First Injection Solicited Safety Set Summary of Solicited Adverse Reactions within 7 Days After First Injection by Grade First Injection Solicited Safety Set
Analysis Result	Summary of Solicited Adverse Reactions within 7 Days After First Injection by Grade First Injection Solicited Safety Set
Analysis Parameter(s)	PARAMCD NOT IN ( "RASH" (Rash), "LYMPHOCC" (Lymphadenopathy Occurrence) )
Analysis Variable(s)	ADAR.ATOXGRN (Analysis Toxicity Grade (N))
Analysis Reason	SPECIFIED IN SAP
Analysis Purpose	PRIMARY OUTCOME MEASURE
Data References (incl. Selection Criteria)	ADAR [SAR1FL = "Y" and ATPTREF = "Vaccination 1" and PARAMCD NOT IN ("RASH", "LYMPHOCC") ]
Documentation	SAP
Programming Statements	[SAS version 9.4] SAS program codes could be found from m5\datasets\mRNA-1273-P201\analysis\adam\programs\t1403010101.txt

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Table 14.3.1.1.2
Display	Summary of Solicited Adverse Reactions within 7 Days After Second Injection by Grade Second Injection Solicited Safety Set Summary of Solicited Adverse Reactions within 7 Days After Second Injection by Grade Second Injection Solicited Safety Set
Analysis Result	Summary of Solicited Adverse Reactions within 7 Days After Second Injection by Grade Second Injection Solicited Safety Set
Analysis Parameter(s)	PARAMCD NOT IN ( "RASH" (Rash), "LYMPHOCC" (Lymphadenopathy Occurrence) )
Analysis Variable(s)	ADAR.ATOXGRN (Analysis Toxicity Grade (N))
Analysis Reason	SPECIFIED IN SAP
Analysis Purpose	PRIMARY OUTCOME MEASURE
Data References (incl. Selection Criteria)	ADAR [SAR2FL = "Y" and ATPTREF = "Vaccination 2" and PARAMCD NOT IN ("RASH", "LYMPHOCC") ]
Documentation	SAP
Programming Statements	[SAS version 9.4] SAS program codes could be found from m5\datasets\mRNA-1273-P201\analysis\adam\programs\t1403010102.txt

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Datasets

Datasets
Dataset	Description	Class	Structure	Purpose	Keys	Location
ADSL	Subject-Level Analysis Dataset	SUBJECT LEVEL ANALYSIS DATASET	One record per subject	Analysis	STUDYID, USUBJID	adsl.xpt
ADSLSF	Screen Fail Subj-Level Analysis Dataset	SUBJECT LEVEL ANALYSIS DATASET	One record per screen failed subject	Analysis	USUBJID, SUBJID	adslsf.xpt
ADAR	Solicited AR Analysis Dataset	BASIC DATA STRUCTURE	One or more records per subject per analysis parameter per analysis timepoint	Analysis	USUBJID, PARCAT1, PARAMCD, ATPTREF, ATPTN, ADT, ATM	adar.xpt
ADARP7D	Solicited AR post D7 Analysis Dataset	BASIC DATA STRUCTURE	One or more records per subject per analysis parameter per analysis timepoint	Analysis	USUBJID, PARCAT1, PARAMCD, ATPTREF	adarp7d.xpt
ADARSUM	Solicited AR Summary Analysis Dataset	BASIC DATA STRUCTURE	One or more records per subject per analysis parameter per analysis timepoint	Analysis	USUBJID, PARCAT1, PARAMCD, ATPTREF	adarsum.xpt
ADCOV	COVID-19 Analysis Dataset	BASIC DATA STRUCTURE	One or more records per subject per analysis parameter per analysis timepoint	Analysis	USUBJID, PARCAT1, PARAMCD, VISITNUM, ADT	adcov.xpt
ADIS	Immunogenicity Analysis Dataset	BASIC DATA STRUCTURE	One or more records per subject per analysis parameter per analysis timepoint	Analysis	USUBJID, PARCAT1, PARAMCD, AVISITN, ISDTC	adis.xpt
ADLB	Laboratory Analysis Dataset	BASIC DATA STRUCTURE	One or more records per subject per analysis parameter per analysis timepoint	Analysis	USUBJID, PARAMCD, AVISITN, LBDTC	adlb.xpt
ADMB	Microbiology Analysis Dataset	BASIC DATA STRUCTURE	One or more records per subject per analysis parameter per analysis timepoint	Analysis	USUBJID, PARCAT1, PARAMCD, AVISITN, MBDTC	admb.xpt
ADVS	Vital Signs Analysis Dataset	BASIC DATA STRUCTURE	One or more records per subject per analysis parameter per analysis timepoint	Analysis	USUBJID, PARAMCD, AVISITN, VSDTC	advs.xpt
ADAE	Adverse Event Analysis Dataset	OCCURRENCE DATA STRUCTURE	One record per subject per adverse event	Analysis	AEBODSYS, AEDECOD, AESTDTC, AEENDTC	adae.xpt
ADCM	Concomitant Medication Analysis Dataset	OCCURRENCE DATA STRUCTURE	One record per subject per medication per medication start date	Analysis	USUBJID, CMTRT, CMSTDTC, CMENDTC	adcm.xpt
ADDV	Deviation Analysis Dataset	OCCURRENCE DATA STRUCTURE	One record per subject per deviation	Analysis	USUBJID, DVCAT, DVSCAT, DVSTDTC, DVTERM	addv.xpt
ADEX	Treatment Exposure Analysis Dataset	OCCURRENCE DATA STRUCTURE	One record per subject per administration	Analysis	USUBJID, EXSTDTC	adex.xpt
ADMH	Medical Hisotry Analysis Dataset	OCCURRENCE DATA STRUCTURE	One record per subject per medical history	Analysis	USUBJID, MHDECOD	admh.xpt

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Subject-Level Analysis Dataset (ADSL)

ADSL (Subject-Level Analysis Dataset) - SUBJECT LEVEL ANALYSIS DATASET Location: adsl.xpt
Variable	Label / Description	Type	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	14	Study Identifier • "mRNA-1273-P201"	Predecessor: DM.STUDYID
USUBJID	Unique Subject Identifier	text	25		Predecessor: DM.USUBJID
SUBJID	Subject Identifier for the Study	text	9		Predecessor: DM.SUBJID
SITEID	Study Site Identifier	text	5		Predecessor: DM.SITEID
COUNTRY	Country	text	3	Country • "USA"	Predecessor: DM.COUNTRY
AGE	Age	integer	8		Predecessor: DM.AGE
AGEU	Age Units	text	5		Predecessor: DM.AGEU
AGEGR1	Pooled Age Group 1	text	30	Pooled Age Group 1 • ">=18 and <55 Years" • ">=55 Years"	Derived Based on SUPPDM.QVALwhere QNAM='COHORT': Set to '>=18 and <55 Years' if contains 'COHORT 1' Set to '>=55 Years' if COHORT contains 'COHORT 2'
AGEGR1N	Pooled Age Group 1 (N)	integer	8		Assigned Based on AGECHRT: Set to 1 if '>=18 and <55 Years' Set to 2 if '>=55 Years'
AGEGR2	Pooled Age Group 2	text	19	Pooled Age Group 2 • ">=18 and <=22 Years" • ">=23 and <=25 Years" • ">25 and <55 Years" • ">=55 Years"	Derived 'Based on AGE: '>=18 and <=22 Years' if 18<=AGE<=22'; '>=23 and <=25 Years' if 23<=AGE<=25'; '>25 and <55 Years' if 25<AGE<55'; '>=55 Years' if COHORT contains 'COHORT 2'
AGEGR2N	Pooled Age Group 2 (N)	integer	8		Assigned
SEX	Sex	text	1	Sex • "F" • "M"	Predecessor: DM.SEX
RACE	Race	text	41	Race [8 Terms]	Predecessor: DM.RACE
RACESPY	Race Specify	text	200		Derived If RACE='OTHER' then set to SUPPDM.QVAL where QNAM is RACEOTH; If RACE='MULTIPLE' then set to SUPPDM.QVAL where QNAM is MULRACE
ETHNIC	Ethnicity	text	22	Ethnicity • "HISPANIC OR LATINO" • "NOT HISPANIC OR LATINO" • "NOT REPORTED" • "UNKNOWN"	Predecessor: DM.ETHNIC
PROTVER	Protocol Version	text	25		Derived Set to SUPPDM.QVAL where QNAM is PROTVER
CHILDBP	Childbearing Potential	text	10	No Yes Response • "N" • "Y"	Derived Set to RP.RPORRES where RPTESTCD is CHILDPOT and VISIT=Screening
CBNRS	Reason for No Childbearing Potential	text	200		Derived Set to SUPPRP.QVAL where QNAM='CBRSN' and VISIT=Screening
RANDFL	Randomized Population Flag	text	1	No Yes Response • "N" • "Y"	Derived Set to 'Y' if USUBJID exists in DS where DSDECOD='RANDOMIZED' and DSSTDTC not missing and DSREFID not missing. Set to 'N' otherwise
RANDNUM	Randomization Number	text	20		Derived Set to DS.DSREFID
SAFFL	Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Derived Set to "Y" if RANDFL="Y" AND USUBJID exists in EX with non-missing EXSTDTC. Set to "N" otherwise
FASBABFL	Full Analysis Set bAb Population Flag	text	1	No Yes Response • "N" • "Y"	Derived Set to 'Y' if 1. SAFFL='Y; and 2. Have at least one non-missing IS.ISSTRESC with ISCAT contains 'Serum SARS-CoV-2 Binding Antibodies' before the first vaccination (DM.RFSTDTC), and 3. Have at least one non-missing IS.ISSTRESC with ISCAT contains 'Serum SARS-CoV-2 Binding Antibodies' post the first vaccination
FASNABFL	Full Analysis Set nAb Population Flag	text	1	No Yes Response • "N" • "Y"	Derived Set to 'Y' if 1. SAFFL='Y; and 2. Have at least one non-missing IS.ISSTRESC with ISCAT contains 'Serum SARS-CoV-2 Neutralizing Antibodies' before the first vaccination (DM.RFSTDTC), and 3. Have at least one non-missing IS.ISSTRESC with ISCAT contains 'Serum SARS-CoV-2 Neutralizing Antibodies' post the first vaccination
PPBABFL	Per Protocol bAb Population Flag	text	1	No Yes Response • "N" • "Y"	Derived "Subjects in FAS for bAb and 1. Complied with the injection schedule as defined in the protocol visit window, 2. don’t have COVID-19 infection at baseline, 3. don't have deviation impact bAb responses. 4. both actual doses are within + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose set to 'Y' if 1) for #1-3, based on PP_LIST, If a subject has one record with PVSBABFL='Y', and 2) for #4, a) both TRT01P and TRT01A are 'Placebo'; or b) both TRT01P and TRT01A are 'mRNA-1273 50 ug' and there is no record in EX where EXTRT is 'Placebo' or (EXTRT is 'mRNA-1273' and EXDOSTXT contains '>0-25', '>75-<100' or '>100-125', or '>125 or above'); or c) both TRT01P and TRT01A are 'mRNA-1273 100 ug' and there is no record in EX where EXTRT is 'Placebo' or (EXTRT is 'mRNA-1273' and EXDOSTXT contains '>0-25', '>25-<50' or >50-75', '>125 or above'); 'N' otherwise."
PPNABFL	Per Protocol nAb Population Flag	text	1	No Yes Response • "N" • "Y"	Derived "Subjects with FAS for nAb and 1. Complied with the injection schedule as defined in the protocol visit window, 2. don’t have COVID-19 infection at baseline, 3. don't have deviation impact nAb responses. 4. both actual doses are within + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose. set to 'Y' if 1) for #1-3, based on PP_LIST, If a subject has one record with PVSNABFL='Y', and 2) for #4, a) both TRT01P and TRT01A are 'Placebo'; or b) both TRT01P and TRT01A are 'mRNA-1273 50 ug' and there is no record in EX where EXTRT is 'Placebo' or (EXTRT is 'mRNA-1273' and EXDOSTXT contains '>0-25', '>75-<100' or '>100-125', or '>125'); or c) both TRT01P and TRT01A are 'mRNA-1273 100 ug' and there is no record in EX where EXTRT is 'Placebo' or (EXTRT is 'mRNA-1273' and EXDOSTXT contains '>0-25', '>25-<50 ug' or >50-75', '>125'); 'N' otherwise."
PPBD29FL	Per Protocol bAb Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Derived set PP_LIST.PVSBABFL where VISITTPT='Day 29'; set to 'N' if subject's actual doses is outside + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose (refer tp PPBABFL).
PPBD57FL	Per Protocol bAb Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Derived set PP_LIST.PVSBABFL where VISITTPT='Day 57'; set to 'N' if subject's actual doses is outside + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose (refer tp PPBABFL)
PPND29FL	Per Protocol nAb Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Derived set PP_LIST.PVSNABFL where VISITTPT='Day 29'; set to 'N' if subject's actual doses is outside + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose (refer to PPBABFL)
PPND57FL	Per Protocol nAb Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Derived set PP_LIST.PVSNABFL where VISITTPT='Day 57'; set to 'N' if subject's actual doses is outside + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose (refer to PPBABFL)
SAR2FL	Second Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Derived Set to 'Y' if all criteria met: 1. SAFFL='Y'; 2. Have at least one non-missing FAORRES where FATPTREF = 'DOSE 2' in FACE OR have at least one non-missing VSORRES where VSTPTREF = 'DOSE 2' and VSTEST contains "Temperature" where VSCAT contains "REACTOGENICITY" in VS; 3. DOSE2FL='Y'; Set to 'N' otherwise
SAR1FL	First Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Derived Set to 'Y' if both criteria met: 1. SAFFL='Y'; 2. Have at least one non-missing FAORRES where FATPTREF = 'DOSE 1' in FACE OR have at least one non-missing VSORRES where VSTPTREF = 'DOSE 1' and VSTEST contains "Temperature" where VSCAT contains "REACTOGENICITY" in VS; Set to 'N' otherwise.
SARAFL	Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Derived Set to 'Y' if SAR1FL='Y' or SAR2FL='Y'
FASNA2FL	FAS nAb 2 Population Flag	text	1	No Yes Response • "N" • "Y"	Derived Y' if 1. SAFFL='Y; and 2. Have at least one non-missing IS.ISSTRESC with ISCAT contains 'Serum SARS-CoV-2 Neutralizing Antibodies' on or before the date of the first vaccination (TR01SDT), and 3. Have at least one non-missing IS.ISSTRESC with ISCAT contains 'Serum SARS-CoV-2 Neutralizing Antibodies' post the date of first vaccination. 'N' otherwise.
PPNAB2FL	PP nAb 2 Population Flag	text	1	No Yes Response • "N" • "Y"	Derived Subjects with FAS for nAb and 1. Complied with the injection schedule as defined in the protocol visit window, 2. don’t have COVID-19 infection at baseline, 3. don't have deviation impact nAb responses. 4. both actual doses are within + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose. set to 'Y' if 1) for #1-3, based on PP_LIST2, If a subject has one record with PVSNABFL='Y', and 2) for #4, a) both TRT01P and TRT01A are 'Placebo'; or b) both TRT01P and TRT01A are 'mRNA-1273 50 ug' and there is no record in EX where EXTRT is 'Placebo' or (EXTRT is 'mRNA-1273' and EXDOSTXT contains '>0-25', '>75-<100' or '>100-125', or '>125'); or c) both TRT01P and TRT01A are 'mRNA-1273 100 ug' and there is no record in EX where EXTRT is 'Placebo' or (EXTRT is 'mRNA-1273' and EXDOSTXT contains '>0-25', '>25-<50 ug' or >50-75', '>125'); 'N' otherwise.
PN2D29FL	Per Protocol nAb 2 Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Derived set PP_LIST2.PVSNABFL where VISITTPT='Day 29'; set to 'N' if subject's actual doses is outside + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose (refer to PPBABFL)
PN2D57FL	Per Protocol nAb 2 Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Derived set PP_LIST2.PVSNABFL where VISITTPT='Day 57'; set to 'N' if subject's actual doses is outside + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose (refer to PPBABFL)
COMPLFL	Completers Population Flag	text	1	No Yes Response • "N" • "Y"	Derived Set to "Y" if USUBJID exists in DS where DSCAT ="DISPOSITION EVENT" and DS.DSSCAT ="END OF STUDY" and DSDECOD = "COMPLETED"; Set to "N" if USUBJID exists in DS where DSCAT = "DISPOSITION EVENT" and DS.DSSCAT = "END OF STUDY" and DSDECOD^= "COMPLETED".
DVBABFL	Deviation Impact bAb Flag	text	1	No Yes Response • "N" • "Y"	Derived Based on PP_LISTING, If a subject is excluded from subject-level PP set for bAb and has one record with PBABDVFL='Y', then set to 'Y'. Set to 'N' otherwise.
DVNABFL	Deviation Impact nAb Flag	text	1	No Yes Response • "N" • "Y"	Derived Based on PP_LISTING, If a subject is excluded from subject-level PP set for nAb and has one record with PNABDVFL='Y', then set to 'Y'. set to 'N' otherwise.
DOSE1FL	Vaccination 1 Flag	text	1	No Yes Response (Yes Only) • "Y"	Derived Set to 'Y' if USUBJID exists in EX with non-missing EXSTDTC where EX.VISIT contains 'Day 1'; Set to 'N' otherwise
DOSE2FL	Vaccination 2 Flag	text	1	No Yes Response • "N" • "Y"	Derived Set to 'Y' if USUBJID exists in EX with non-missing EXSTDTC where EX.VISIT contains 'Day 29'; Set to 'N' otherwise
DOSEROFL	Dosing Error Flag	text	1	No Yes Response • "N" • "Y"	Derived Set to 'Y' if subject received any dose (based on EX.EXTRT, EX.EXDOSE or EX.EXDOSTXT) which is different from the randomized arm (ARM); 'N' otherwise
COV19BL	Baseline COVID Infection	text	20	Baseline COVID Infection • "Detected" • "Not Detected"	Derived Based on MB.MBSTRESC where MBTESTCD='SARSCOV2' and SUPPMB.QVAL is not 'Y' where QNAM is 'LOCALFL' and (MBDTC is before the first vaccination (DM.RFXSTDTC) or on the first vaccination date if time is not available: set to 'Not Detected' if 'NOTDETECTED' and 'Detected' if 'DETECTED'
HEIGHTBL	Baseline Height (cm)	float	8		Derived The last non-missing VS.VSSTRESN where VSTESTCD = “HEIGHT” and (VSDTC is before the first vaccination (DM.RFXSTDTC) or on the first vaccination date with VSTPT contains 'PRE-DOSE'.)
WEIGHTBL	Baseline Weight (kg)	float	8		Derived The last non-missing VS.VSSTRESN where VSTESTCD = 'WEIGHT' and (VSDTC is before the first vaccination (DM.RFXSTDTC) or on the first vaccination date with VSTPT contains 'PRE-DOSE'.)
BMIBL	Baseline BMI (kg/m2)	float	8		Derived Set to WEIGHTBL/(HEIGHTBL in meters)^2
COV19FL	COVID Infection Flag	text	20	No Yes Response • "N" • "Y"	Derived "Set to 'Y' if there is one record in MB where MB.MBSTRESC is 'DETECTED' or 'POSITIVE' and MBTESTCD='SARSCOV2' or there is record in AE where AEDECOD is 'COVID-19', 'Asymptomatic COVID-19' or 'SARS-CoV-2 test positive'; Otherwise set to 'N' "
SENTLFL	Sentinel Participant Flag	text	3	No Yes Response • "N" • "Y"	Derived Set to SUPPDM.QVAL where QNAM='SENTL'
D29W7DFL	Day 29 Out of 7-Day Window Flag	text	1	No Yes Response • "N" • "Y"	Derived Set to 'Y' if DOSE2DT-TR01SDT+1>36; Otherwise set to 'N'
ARM	Description of Planned Arm	text	16	Description of Planned Arm • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Predecessor: DM.ARM
ACTARM	Description of Actual Arm	text	16	Description of Planned Arm • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Predecessor: DM.ACTARM
TRT01P	Planned Treatment for Period 01	text	25	Planned Treatment for Period 01 • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Derived Set to ARM
TRT01PN	Planned Treatment for Period 01 (N)	integer	8		Assigned 1 if TRT01P=‘Placebo’, 2 if TRT01P=‘mRNA-1273 50 ug’, 3 if TRT01P=‘mRNA-1273 100 ug’"
TRT01A	Actual Treatment for Period 01	text	25	Actual Treatment for Period 01 • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Derived Set to ACTARM if SAFFL='Y'
TRT01AN	Actual Treatment for Period 01 (N)	integer	8		Assigned 1 if TRT01A=‘Placebo’, 2 if TRT01A=‘mRNA-1273 50 ug’, 3 if TRT01A=‘mRNA-1273 100 ug’"
RFICDT	Date of Informed Consent	integer	DATE9		Derived Date part of DM.RFICDTC
RANDDT	Date of Randomization	integer	DATE9		Derived DS.DSSTDTC where DSTERM='RANDOMIZED' and DSCAT='PROTOCOL MILESTONE'
RFXSTDTC	Date/Time of First Study Treatment	datetime		ISO 8601	Predecessor: DM.RFXSTDTC
TR01SDT	Date of First Exposure in Period 01	integer	DATE9		Derived Date part of DM.RFXSTDTC and convert to numeric
TR01SDTM	Datetime of First Exposure in Period 01	integer	DATETIME20		Derived DM.RFXSTDTC and convert to numeric
TR01EDT	Date of Last Exposure in Period 01	integer	DATE9		Derived Date part of DM.RFXENDTC and convert to numeric
TR01EDTM	Datetime of Last Exposure in Period 01	integer	DATETIME20		Derived DM.RFXENDTC and convert to numeric
TRTSDTM	Datetime of First Exposure to Treatment	integer	DATETIME20		Derived DM.RFXSTDTC and convert to numeric
TRTEDTM	Datetime of Last Exposure to Treatment	integer	DATETIME20		Derived DM.RFXENDTC and convert to numeric
DOSE2DT	Date of Dose 2	integer	DATE9		Derived Date part of non-missing EX.EXSTDTC where EX.VISIT contains 'Day 29' and convert to numeric
DOS2DTM	Datetime of Dose 2	integer	DATETIME20		Derived Non-missing EX.EXSTDTC where EX.VISIT contains 'Day 29' and convert to numeric
EOSSTT	End of Study Status	text	20		Derived Set to 'COMPLETED' if COMPLFL='Y' Set to 'DISCONTINUED' if COMPLFL='N' Else set to 'ONGOING'.
EOSDT	End of Study Date	integer	DATE9		Derived DS.DSSTDTC where DSCAT='DISPOSITION EVENT' and DSSCAT='END OF STUDY' and convert to numeric
EOSDY	End of Study Relative Day	integer	8		Derived EOSDT-TR01SDT+1 if EOSDT>=TR01SDT
DCSREAS	Reason for Discontinuation from Study	text	100	Reason for Discontinuation from Study • "Withdrawal of Consent (COVID-19 Non-Infection Related)" • "Lost to Follow-Up"	Derived Mixed case of DS.DSTERM where DSCAT='DISPOSITION EVENT' and DSSCAT='END OF STUDY' AND DSDECOD not in ('COMPLETED', 'AE COVID', 'ADVERSE EVENT (OTHER)', 'PHYSICIAN DESICION', 'WITHDRAWAL BY SUBJECT (OTHER)', 'WITHDRAWAL BY SUBJECT (COVID-19 NON-INFECTION RELATED)', 'PROTOCOL DEVIATION', 'OTHER'). Set to 'Adverse Event (COVID-19 Infection)' if DS.DSDECOD is 'AE COVID' Set to 'Adverse Event (Other)' if DS.DSDECOD is 'ADVERSE EVENT (OTHER)' Set to 'Physician Decision' if DS.DSDECOD is 'PHYSICIAN DESICION' Set to 'Withdrawal of Consent (Other)' if DS.DSDECOD is 'WITHDRAWAL BY SUBJECT (OTHER)' Set to 'Withdrawal of Consent (COVID-19 Non-Infection Related)' if DS.DSDECOD is 'WITHDRAWAL BY SUBJECT (COVID-19 NON-INFECTION RELATED)' Set to 'Protocol Deviation' if DS.DSDECOD is 'PROTOCOL DEVIATION' Set to 'Other' if DS.DSDECOD is 'OTHER'
DCSREASP	Reason Spec for Discont from Study	text	200		Derived DS.DSTERM where DSCAT='DISPOSITION EVENT' and DSSCAT='END OF STUDY' AND DSDECOD in ('ADVERSE EVENT (OTHER)', 'PHYSICIAN DESICION', 'WITHDRAWAL BY SUBJECT (OTHER)', 'WITHDRAWAL BY SUBJECT (COVID-19 NON-INFECTION RELATED)', 'PROTOCOL DEVIATION', 'OTHER')
EOTSTT	End of Treatment Status	text	20		Derived Set to 'COMPLETED' if USUBJID exists in DS where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' AND DSDECOD='COMPLETED'. Set to 'DISCONTINUED' if USUBJID exists in DS where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' AND DSDECOD^='COMPLETED'. Else set to 'ONGOING'.
EOTDT	End of Treatment Date	integer	DATE9		Derived DS.DSSTDTC where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' and convert to numeric
EOTDY	End of Treatment Relative Day	integer	8		Derived EOTDT-TR01SDT+1 if EOTDT>=TR01SDT
DCTREAS	Reason for Discontinuation of Treatment	text	100	Reason for Discontinuation of Treatment • "Adverse Event (COVID-19 Infection)" • "Adverse Event (Other)" • "Lost to Follow-Up" • "Other" • "Withdrawal of Consent (COVID-19 Non-Infection Related)"	Derived Mixed case of DS.DSTERM where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' AND DSDECOD not in ('COMPLETED', 'AE COVID', 'ADVERSE EVENT (OTHER)', 'PHYSICIAN DESICION', 'WITHDRAWAL BY SUBJECT (OTHER)', 'WITHDRAWAL BY SUBJECT (COVID-19 NON-INFECTION RELATED)', 'PROTOCOL DEVIATION', 'OTHER'): Set to 'Adverse Event (COVID-19 Infection)' if DS.DSDECOD is 'AE COVID' Set to 'Adverse Event (Other)' if DS.DSDECOD is 'ADVERSE EVENT (OTHER)' Set to 'Physician Decision' if DS.DSDECOD is 'PHYSICIAN DESICION' Set to 'Withdrawal of Consent (Other)' if DS.DSDECOD is 'WITHDRAWAL BY SUBJECT (OTHER)' Set to 'Withdrawal of Consent (COVID-19 Non-Infection Related)' if DS.DSDECOD is 'WITHDRAWAL BY SUBJECT (COVID-19 NON-INFECTION RELATED)' Set to 'Protocol Deviation' if DS.DSDECOD is 'PROTOCOL DEVIATION' Set to 'Other' if DS.DSDECOD is 'OTHER'
DCTREASP	Reason Specify for Discont of Treatment	text	200		Derived DS.DSTERM where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' AND DSDECOD in ('ADVERSE EVENT (OTHER)', 'PHYSICIAN DESICION', 'WITHDRAWAL BY SUBJECT (OTHER)', 'WITHDRAWAL BY SUBJECT (COVID-19 NON-INFECTION RELATED)', 'PROTOCOL DEVIATION', 'OTHER')
DTHDT	Date of Death	integer	DATE9		Derived Set to DM.DTHDTC and convert to numeric
DTHAUTOP	Was autopsy performed?	text	8		Derived Set to SUPPDS.QVAL where QNAM='DTHAUTOP'
CUTOFFDT	Data Cutoff Date	integer	DATE9		Assigned
SAFEREAS	Reason for Safety Set Exclusion	text	200		Derived Only for subjects with RANDFL='Y'. Set to 'Did not receive any vaccination' if SAFFL='N'. blank otherwise
SAR1ERS	Reason for 1st Solicited Safety Set Exc	text	200		Derived Only for subjects with RANDFL='Y'. If SAFFL='N', set to 'Did not receive any study vaccination'; If SAFFL='Y' and SAR1FL='N', set to 'Did not contribute any solicited AR data for Vaccination #1'. blank otherwise
SAR2ERS	Reason for 2nd Solicited Safety Set Exc	text	200		Derived Only for subjects with RANDFL='Y'. If SAFFL='N', set to 'Did not receive any study vaccination'; If SAFFL='Y' and DOSE2FL='N', set to 'Did not receive Vaccination #2'. If SAFFL='Y'and DOSE2FL='Y' and SAR2FL='N', set to 'Did not contribute any solicited AR data for Vaccination #2'. blank otherwise
FASBABRS	Reason for BAB Full Analysis Set Exc	text	200		Derived Only for subjects with RANDFL='Y'. If SAFFL='N', set to 'Did not receive any study vaccination'; If SAFFL='Y' and FASBABFL='N', set to 'There were no immunogenicity results at baseline and at least one post-vaccination.'. blank otherwise.
FASNABRS	Reason for NAB Full Analysis Set Exc	text	200		Derived Only for subjects with RANDFL='Y'. If SAFFL='N', set to 'Did not receive any study vaccination'; If SAFFL='Y' and FASNABFL='N', set to 'There were no immunogenicity results at baseline and at least one post-vaccination.' blank otherwise
PPBABERS	Reason for BAB Per-Protocol Set Exc	text	200		Derived "Only for subjects with RANDFL='Y' and PPBABFL='N': if subject is excluded due to dosing error as defined in PPBABFL then set to 'Dosing error' and concatenate the reasons from PP_list if the subject is also excluded due to other reasons. For exclusion based on PP_list, set to PP_list.PBABREAS and concatenate all unique reasons (Note: merge data by USUBJID)"
PPNABERS	Reason for nAb Per-Protocol Set Exc	text	200		Derived "Only for subjects with RANDFL='Y' and PPNABFL='N'. if subject is excluded due to dosing error as defined in PPNABFL then set to 'Dosing error' and concatenate the reasons from PP_list if the subject is also excluded due to other reasons. For exclusion based on PP_list, set to PP_list.PNABREAS and concatenate all unique reasons (Note: merge data by USUBJID)"
PPBD29ER	Reason for bAb Per-Protocol Day 29 Exc	text	138		Derived Only for subjects with RANDFL='Y' and PPBD29FL='N': Set to PP_list.PBABREAS where VISITTPT='Day 29'. if subejct has dosing error (ADSL.PPBABERS contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list if applicable
PPBD57ER	Reason for bAb Per-Protocol Day 57 Exc	text	138		Derived Only for subjects with RANDFL='Y' and PPBD57FL='N': Set to PP_list.PBABREAS where VISITTPT='Day 57'. if subejct has dosing error (ADSL.PPBABERS contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list if applicable
PPND29ER	Reason for nAb Per-Protocol Day 29 Exc	text	138		Derived Only for subjects with RANDFL='Y' and PPND29FL='N': Set to PP_list.PNABREAS where VISITTPT='Day 29'. if subejct has dosing error (ADSL.PPNABERS contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list if applicable
PPND57ER	Reason for nAb Per-Protocol Day 57 Exc	text	138		Derived Only for subjects with RANDFL='Y' and PPND57FL='N': Set to PP_list.PNABREAS where VISITTPT='Day 57'. if subejct has dosing error (ADSL.PPNABERS contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list if applicable
PPNAB2ER	Reason for nAb 2 Per-Protocol Set Exc	text	174		Derived Only for subjects with RANDFL='Y' and PPNAB2FL='N'. if subject is excluded due to dosing error as defined in PPNABFL then set to 'Dosing error' and concatenate the reasons from PP_list2 if the subject is also excluded due to other reasons. For exclusion based on PP_list2, set to PP_list2.PNABREAS and concatenate all unique reasons (Note: merge data by USUBJID)
PN2D29ER	Reason for nAb 2 PP Day 29 Exc	text	138		Derived Only for subjects with RANDFL='Y' and PN2D29FL='N': Set to PP_list2.PNABREAS where VISITTPT='Day 29'. if subejct has dosing error (ADSL.PPNAB2ER contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list2 if applicable
PN2D57ER	Reason for nAb 2 PP Day 57 Exc	text	138		Derived Only for subjects with RANDFL='Y' and PN2D57FL='N': Set to PP_list2.PNABREAS where VISITTPT='Day 57'. if subejct has dosing error (ADSL.PPNAB2ER contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list2 if applicable
PREVSCR	Was this participant screened previously	text	1	No Yes Response • "N" • "Y"	Derived Set to SUPPDM.QVAL where QNAM='PREVSCR' per USUBJID

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Screen Fail Subj-Level Analysis Dataset (ADSLSF)

ADSLSF (Screen Fail Subj-Level Analysis Dataset) - SUBJECT LEVEL ANALYSIS DATASET Location: adslsf.xpt
Variable	Label / Description	Type	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	14	Study Identifier • "mRNA-1273-P201"	Predecessor: DM.STUDYID
USUBJID	Unique Subject Identifier	text	25		Predecessor: DM.USUBJID
SUBJID	Subject Identifier for the Study	text	9		Predecessor: DM.SUBJID
SITEID	Study Site Identifier	text	5		Predecessor: DM.SITEID
COUNTRY	Country	text	3	Country • "USA"	Predecessor: DM.COUNTRY
AGE	Age	integer	8		Predecessor: DM.AGE
AGEU	Age Units	text	5		Predecessor: DM.AGEU
SEX	Sex	text	1	Sex • "F" • "M"	Predecessor: DM.SEX
RACE	Race	text	41	Race [8 Terms]	Predecessor: DM.RACE
RACESPY	Race Specify	text	200		Derived If RACE='OTHER' then set to SUPPDM.QVAL where QNAM is RACEOTH If RACE='MULTIPLE' then set to SUPPDM.QVAL where QNAM is MULRACE
ETHNIC	Ethnicity	text	22	Ethnicity • "HISPANIC OR LATINO" • "NOT HISPANIC OR LATINO" • "NOT REPORTED" • "UNKNOWN"	Predecessor: DM.ETHNIC
PROTVER	Protocol Version	text	25		Derived Set to SUPPDM.QVAL where QNAM is PROTVER and VISIT=Screening
CHILDBP	Childbearing Potential	text	10	No Yes Response • "N" • "Y"	Derived Set to RP.RPORRES where RPTESTCD is CHILDPOTand VISIT=Screening
CBNRS	Reason for No Childbearing Potential	text	200		Derived Set to SUPPRP.QVAL where QNAM='CBRSN'
RFICDT	Date of Informed Consent	integer	DATE9		Derived Date part of DM.RFICDTC
SCFREAS	Screen Failure Reason	text	200	Screen Failure Reason • "Cohort Full" • "Inclusion/Exclusion" • "Other" • "Withdrew Consent"	Derived Mixed case of DS.DSTERM where DSCAT="DISPOSITION EVENT" and DSSCAT='SCREEN FAILURE' and DS.DSDECOD^='OTHER'. Set to 'Other' if DS.DSDECOD='OTHER' where DSCAT="DISPOSITION EVENT" and DSSCAT='SCREEN FAILURE'.
SCFREASP	Screen Failure Reason Specify	text	200		Derived Set to DS.DSTERM where SCFREAS='OTHER'
PREVSCR	Was this participant screened previously	text	1	No Yes Response • "N" • "Y"	Derived Set to SUPPDM.QVAL where QNAM='PREVSCR' per USUBJID

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Solicited AR Analysis Dataset (ADAR)

ADAR (Solicited AR Analysis Dataset) - BASIC DATA STRUCTURE Location: adar.xpt
Variable	Where Condition	Label / Description	Type	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID		Study Identifier	text	14	Study Identifier • "mRNA-1273-P201"	Predecessor: ADSL.STUDYID
USUBJID		Unique Subject Identifier	text	25		Predecessor: ADSL.USUBJID
SUBJID		Subject Identifier for the Study	text	9		Predecessor: ADSL.SUBJID
SITEID		Study Site Identifier	text	5		Predecessor: ADSL.SITEID
COUNTRY		Country	text	3	Country • "USA"	Predecessor: ADSL.COUNTRY
AGE		Age	integer	8		Predecessor: ADSL.AGE
AGEU		Age Units	text	5		Predecessor: ADSL.AGEU
AGEGR1		Pooled Age Group 1	text	30	Pooled Age Group 1 • ">=18 and <55 Years" • ">=55 Years"	Predecessor: ADSL.AGEGR1
AGEGR1N		Pooled Age Group 1 (N)	integer	8		Predecessor: ADSL.AGEGR1N
AGEGR2		Pooled Age Group 2	text	19	Pooled Age Group 2 • ">=18 and <=22 Years" • ">=23 and <=25 Years" • ">25 and <55 Years" • ">=55 Years"	Predecessor: ADSL.AGEGR2
AGEGR2N		Pooled Age Group 2 (N)	integer	8		Predecessor: ADSL.AGEGR2N
SEX		Sex	text	1	Sex • "F" • "M"	Predecessor: ADSL.SEX
RACE		Race	text	41	Race [8 Terms]	Predecessor: ADSL.RACE
RACESPY		Race Specify	text	200		Predecessor: ADSL.RACESPY
ETHNIC		Ethnicity	text	22	Ethnicity • "HISPANIC OR LATINO" • "NOT HISPANIC OR LATINO" • "NOT REPORTED" • "UNKNOWN"	Predecessor: ADSL.ETHNIC
RANDFL		Randomized Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.RANDFL
SAFFL		Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAFFL
FASBABFL		Full Analysis Set bAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASBABFL
FASNABFL		Full Analysis Set nAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASNABFL
PPBABFL		Per Protocol bAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBABFL
PPNABFL		Per Protocol nAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPNABFL
PPBD29FL		Per Protocol bAb Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBD29FL
PPBD57FL		Per Protocol bAb Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBD57FL
PPND29FL		Per Protocol nAb Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPND29FL
PPND57FL		Per Protocol nAb Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPND57FL
SAR1FL		First Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAR1FL
SAR2FL		Second Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAR2FL
SARAFL		Solicited Safety Population Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.SARAFL
FASNA2FL		FAS nAb 2 Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASNA2FL
PPNAB2FL		PP nAb 2 Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPNAB2FL
PN2D29FL		Per Protocol nAb 2 Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PN2D29FL
PN2D57FL		Per Protocol nAb 2 Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PN2D57FL
COMPLFL		Completers Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.COMPLFL
DVBABFL		Deviation Impact bAb Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DVBABFL
DVNABFL		Deviation Impact nAb Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DVNABFL
DOSE1FL		Vaccination 1 Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.DOSE1FL
DOSE2FL		Vaccination 2 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DOSE2FL
DOSEROFL		Dosing Error Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DOSEROFL
COV19BL		Baseline COVID Infection	text	20	Baseline COVID Infection • "Detected" • "Not Detected"	Predecessor: ADSL.COV19BL
COV19FL		COVID Infection Flag	text	20	No Yes Response • "N" • "Y"	Predecessor: ADSL.COV19FL
SENTLFL		Sentinel Participant Flag	text	3	No Yes Response • "N" • "Y"	Predecessor: ADSL.SENTLFL
D29W7DFL		Day 29 Out of 7-Day Window Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.D29W7DFL
TRT01P		Planned Treatment for Period 01	text	25	Planned Treatment for Period 01 • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Predecessor: ADSL.TRT01P
TRT01PN		Planned Treatment for Period 01 (N)	integer	8		Predecessor: ADSL.TRT01PN
TRT01A		Actual Treatment for Period 01	text	25	Actual Treatment for Period 01 • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Predecessor: ADSL.TRT01A
TRT01AN		Actual Treatment for Period 01 (N)	integer	8		Predecessor: ADSL.TRT01AN
TR01SDT		Date of First Exposure in Period 01	integer	DATE9		Predecessor: ADSL.TR01SDT
TR01SDTM		Datetime of First Exposure in Period 01	integer	DATETIME20		Predecessor: ADSL.TR01SDTM
TR01EDT		Date of Last Exposure in Period 01	integer	DATE9		Predecessor: ADSL.TR01EDT
TR01EDTM		Datetime of Last Exposure in Period 01	integer	DATETIME20		Predecessor: ADSL.TR01EDTM
TRTSDTM		Datetime of First Exposure to Treatment	integer	DATETIME20		Predecessor: ADSL.TRTSDTM
TRTEDTM		Datetime of Last Exposure to Treatment	integer	DATETIME20		Predecessor: ADSL.TRTEDTM
DOSE2DT		Date of Dose 2	integer	DATE9		Predecessor: ADSL.DOSE2DT
DOS2DTM		Datetime of Dose 2	integer	DATETIME20		Predecessor: ADSL.DOS2DTM
TRTA		Actual Treatment	text	50	Actual Treatment • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Derived "If (.<ADSL.TR01SDTM<=ADTM <DOS2DTM) or (.<ADSL.TR01SDTM<=ADTM and ADSL.DOS2DTM is missing): 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'Day 1' ; 'mRNA-1273 50 ug' if EX.EXTRT='mRNA-1273' and 1) 0<EXDOSE<=75 where EX.VISIT contains 'Day 1', or 2) EXDOSTXT contains '>0-25', '>25-<50' or '>50-75' where EX.VISIT contains 'Day 1'; 'mRNA-1273 100 ug' if EX.EXTRT='mRNA-1273' and 1) EXDOSE>75 where EX.VISIT contains 'Day 1', or 2) EXDOSTXT contains '>75-<100' or '>100-125' or '>125' where EX.VISIT contains 'Day 1'; if .<ADSL.DOS2DTM<=ASTDTM: 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'Day 29' ; 'mRNA-1273 50 ug' if 1) EX.EXTRT='mRNA-1273' and 0<EXDOSE<=75 where EX.VISIT contains 'Day 29', or 2) EXDOSTXT contains '>0-25', '>25-<50' or '>50-75' where EX.VISIT contains 'Day 29'; 'mRNA-1273 100 ug' if EX.EXTRT='mRNA-1273' and 1) EXDOSE>75 where EX.VISIT contains 'Day 29', or 2) EXDOSTXT contains '>75-<100' or '>100-125' or '>125' where EX.VISIT contains 'Day 29'; if time part of ADTM, TR01SDTM, or DOS2DTM is missing, use ADT, TR01SDT, and DOSE2DT to replace ADTM, TR01SDTM, and DOS2DTM, respectively."
TRTAN		Actual Treatment (N)	integer	8		Assigned 1 if TRT01A=‘Placebo’, 2 if TRT01A=‘mRNA-1273 50 ug’, 3 if TRT01A=‘mRNA-1273 100 ug’"
ASEQ		Analysis Sequence Number	integer	8		Assigned Sort by USUBJID, PARCAT1, PARAMCD, ATPTREF, ATPTN and start from 1, increase by 1 for records within each subject
ADT		Analysis Date	integer	DATE9		Derived Set to numeric date part of FACE.FADTC if source data are from FACE Set to number date part of VS.VSDTC if source data are from VS
ATM		Analysis Time	integer	TIME5		Derived Set to numeric time part of FACE.FADTC If source data are from FACE Set to numeric time part of VS.VSDTC if source data are from VS
ADTM		Analysis Datetime	integer	DATETIME20		Derived Set to numeric date time of FACE.FADTC if time part is not missing for data is from FACE Set to numeric date time of VS.VSDTC if time part is not missing for data is from VS
ADY		Analysis Relative Day	integer	8		Derived Set to FACE.FADY if source data are from FACE Set to VS.VSDY if source data are from VS
ATPT		Analysis Timepoint	text	50		Derived If source data are from FACE and FAEVAL='STUDY SUBJECT', set to FACE.CRFTMPT, If source data are from FACE and FAEVAL=''INVESTIGATOR', set to FACE.FATPT, If source data are from VS, set to VS.VSTPT; Recode 'DAY 1' as 'DAY 1, AFTER VACCINATION (AT HOME)' if FAEVAL='INVESTIGATOR' and PARAMCD is not RASH and LYMPHOCC
ATPTN		Analysis Timepoint (N)	float	8		Assigned 1 if ATPT='DAY 1', 1.1 If ATPT='DAY 1, 1 HOUR AFTER VACCINATION (AT STUDY CLINIC)' , 1.2 if ATPT='DAY 1, AFTER VACCINATION (AT HOME)', 2 if ATPT='DAY 2', 3 if ATPT='DAY 3', 4 if ATPT='DAY 4', 5 if ATPT='DAY 5', 6 if ATPT='DAY 6', 7 if ATPT='DAY 7'
ATPTREF		Analysis Timepoint Reference	text	50	Analysis Timepoint Reference • "Vaccination 1" • "Vaccination 2"	Derived If source data are from FACE: Set to 'Vaccination 1' if FACE.FATPTREF contains 'DOSE 1' Set to 'Vaccination 2' if FACE.FATPTREF contains 'DOSE 2' If source data are from VS: Set to 'Vaccination 1' if VS.VSTPTREF contains 'DOSE 1' Set to 'Vaccination 2' if VS.VSTPTREF contains 'DOSE 2'
ATPTGR1		Poolded Analysis Timepoint	text	50		Derived Set to 'Day 1' if ATPT contains 'Day 1' Set to ATPT otherwise
ATPTGR1N		Poolded Analysis Timepoint (N)	integer	8		Assigned 1 if ATPT contains 'Day 1', 2 if ATPT=’DAY 2’, 3 if ATPT=’DAY 3’, 4 if ATPT=’DAY 4’, 5 if ATPT=’DAY 5’, 6 if ATPT=’DAY 6’ 7 if ATPT=’DAY 7’
PARCAT1		Parameter Category 1	text	50	Solicited AR Category • "LOCAL" • "SYSTEMIC"	Derived If source data are from FACE: Set to 'LOCAL' if FASCAT=ADMINISTRATION SITE Set to FASCAT if FASCAT<>ADMINISTRATION SITE Set to VSSCAT if source data are from VS Set to 'SYSTEMIC' if PARAMCD='RASH' Set to 'LOCAL' if PARAMCD='LYMPHOCC'
PARCAT1N		Parameter Category 1 (N)	integer	8		Assigned 1 if PACAT1='LOCAL' 2 if PACAT1='SYSTEMIC'
PARAMCD		Parameter Code	text	8	Solicited AR Analysis Dataset Parameter Code [15 Terms]	Assigned RASH if PARAM=’Rash’, RASHOCC if PARAM=’Rash Occurrence’, LYMPHOCC if PARAM=’Lymphadenopathy Occurrence’, LYMPH if PARAM='Lymphadenopathy', PAIN if PARAM='Pain', ERYTHDIA if PARAM='Erythema Longest Diameter (mm)' SWELLDIA if PARAM='Swelling Longest Diameter (mm)', HEADACHE if PARAM='Headache', FATIGUE if PARAM='Fatigue', MYALGIA if PARAM='Myalgia', ARTHRALG if PARAM='Arthralgia' NAUSEA if PARAM='Nausea/Vomiting', CHILLS if PARAM='Chills', MEDATTEN if PARAM='Receive Medical Attention?' FEVER if PARAM='Fever (C)'
PARAM		Parameter	text	200		Derived Set to 'Rash Occurrence' if source data are from FACE and FAOBJ='Rash', and FATESTCD ne 'SEV' Set to 'Rash' if source data are from FACE and FAOBJ='Solicited Rash', and FATESTCD = 'SEV' Set to 'Lymphadenopathy' if source data are from FACE and FAOBJ='Underarm Gland Swelling or Tenderness' and FATESTCD = 'SEV' Set to 'Lymphadenopathy Occurrence' if source data are from FACE and FAOBJ='Lymphadenopathy' Set to 'Nausea/Vomiting' if source data are from FACE and FAOBJ='Nausea/Vomiting' and FATESTCD = 'SEV' Set to 'Fever' \|\| '(' \|\|VSSTRESU \|\|')' if source data are from VS and VSTESTCD in ('TEMP' 'VSALL') Set to FAOBJ \|\|' Longest Diameter (mm)' if source data are from FACE and FAOBJ in ('Erythema' 'Swelling') and FATEST contains 'Occurrence' and FAORRES='NO' Set to FAOBJ \|\| ' ' \|\| FATEST\|\| ' ' \|\| '(' \|\|FAORRESU \|\| ')' if source data are from FACE and FAOBJ in ('Erythema' 'Swelling') and FATEST='Longest Diameter' Set to FAOBJ otherwise. Note: Please add space between the VSTEST and VS unit. If the VSSTRESU is missing, use non-missing VSSTRESU) and assign AVAL=0 (see specs for AVAL)
AVALVLM		Analysis Value	float	8
	PARAMCD NOT IN ( "ERYTHDIA SWELLDIA" )		float	11		Derived Set to FACE.FASTRESN if source data are from FACE Set to VS.VSSTRESN if source data are from VS
	PARAMCD IN ( "ERYTHDIA SWELLDIA" )	Erythema Longest Diameter (mm) Swelling Longest Diameter (mm)	float	5		Derived Set to 0 If source data are from FACE and FAOBJ = 'Erythema' or 'Swelling' and FATEST='OCCURRENCE' and FAORRES='N' Set to FACE.FASTRESN, otherwise
AVALCVLM		Analysis Value (C)	text	100
	PARAMCD NOT IN ( "ERYTHDIA SWELLDIA" )		text	92		Derived Set to FACE.FASTRESC if source data are from FACE Set to VS.VSSTRESC if source data are from VS
	PARAMCD IN ( "ERYTHDIA SWELLDIA" )	Erythema Longest Diameter (mm) Swelling Longest Diameter (mm)	text	92		Derived Set to FACE.FASTRESC if source data are from FACE Set to VS.VSSTRESC if source data are from VS
ATOXGRVLM		Analysis Toxicity Grade	text	20	Analysis Toxicity Grade [9 Terms]	Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007)
	PARAMCD IN ( "ERYTHDIA SWELLDIA" )	Erythema Longest Diameter (mm) Swelling Longest Diameter (mm)	text	10		Derived Set to 'Grade 0' if .<AVAL < 25 mm or FASTRESC contains 'GRADE 0' Set to 'Grade 1' if AVAL = 25 - 50 mm or FASTRESC contains 'GRADE 1', Set to 'Grade 2' if AVAL = 51 - 100 mm or FASTRESC contains 'GRADE 2', Set to 'Grade 3' if AVAL > 100 mm or FASTRESC contains 'GRADE 3', Set to 'Grade 4' if FASTRESC contains 'GRADE 4',
	PARAMCD = "FEVER" (Fever (C))	Fever (C)	text	11		Derived Set to 'Grade 0' if .<AVAL < 38.0°C or FASTRESC contains 'GRADE 0' Set to 'Grade 1' if AVAL = 38.0 – 38.4°C or FASTRESC contains 'GRADE 1' Set to 'Grade 2' if AVAL = 38.5 – 38.9°C or FASTRESC contains 'GRADE 2' Set to 'Grade 3' if AVAL = 39.0 – 40.0°C or FASTRESC contains 'GRADE 3' Set to 'Grade 4' if AVAL > 40.0°C or FASTRESC contains 'GRADE 4'
	PARAMCD = "PAIN" (Pain)	Pain	text	10		Derived Set to 'Grade 0' if FASTRESC=’NONE’ or FASTRESC contains 'GRADE 0' Set to 'Grade 1' if FASTRESC='DOES NOT INTERFERE WITH ACTIVITY' or contains 'GRADE 1'; Set to 'Grade 2' if FASTRESC='REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR INTERFERES WITH ACTIVITY' or contains 'GRADE 2'; Set to 'Grade 3' if FASTRESC='ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY' or contains 'GRADE 3' Set to 'Grade 4' if FASTRESC contains 'GRADE 4'
	PARAMCD = "LYMPH" (Lymphadenopathy)	Lymphadenopathy	text	10		Derived Set to 'Grade 0' if FASTRESC='NONE' or FASTRESC contains 'GRADE 0' Set to 'Grade 1' if FASTRESC='DOES NOT INTERFERE WITH ACTIVITY' or FASTRESC contains 'GRADE 1' Set to 'Grade 2' if FASTRESC='REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR INTERFERES WITH SOME ACTIVITY' or FASTRESC contains 'GRADE 2' Set to 'Grade 3' if FASTRESC='ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY' or FASTRESC contains 'GRADE 3' Set to 'Grade 4' if FASTRESC contains 'GRADE 4'
	PARAMCD = "HEADACHE" (Headache)	Headache	text	10		Derived Set to 'Grade 0' if FASTRESC='NONE' or FASTRESC contains 'GRADE 0' Set to 'Grade 1' if FASTRESC='NO INTERFERENCE WITH ACTIVITY' or FASTRESC contains 'GRADE 1' Set to 'Grade 2' if FASTRESC='REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR SOME INTERFERENCE WITH ACTIVITY' or FASTRESC contains 'GRADE 2' Set to 'Grade 3' if FASTRESC='ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY' or FASTRESC contains 'GRADE 3' Set to 'Grade 4' if FASTRESC contains 'GRADE 4'
	PARAMCD IN ( "FATIGUE" (Fatigue), "MYALGIA" (Myalgia), "ARTHRALG" (Arthralgia) )	Fatigue, Myalgia, Arthralgia	text	10		Derived Set to 'Grade 0' if FASTRESC=NONE' or FASTRESC contains 'GRADE 0' Set to 'Grade 1' if FASTRESC='NO INTERFERENCE WITH ACTIVITY' or FASTRESC contains 'GRADE 1' Set to 'Grade 2' if FASTRESC='SOME INTERFERENCE WITH ACTIVITY' or FASTRESC contains 'GRADE 2' Set to 'Grade 3' if FASTRESC='SIGNIFICANT; PREVENTS DAILY ACTIVITY' or FASTRESC contains 'GRADE 3' Set to 'Grade 4' if FASTRESC contains 'GRADE 4'
	PARAMCD = "NAUSEA" (Nausea/Vomiting)	Nausea/Vomiting	text	10		Derived Set to 'Grade 0' if FASTRESC='NONE' or FASTRESC contains 'GRADE 0' Set to 'Grade 1' if FASTRESC= ‘NO INTERFERENCE WITH ACTIVITY OR 1-2 EPISODES/24 HOURS' or FASTRESC contains 'GRADE 1' Set to 'Grade 2' if FASTRESC='SOME INTERFERENCE WITH ACTIVITY OR >2 EPISODES/24 HOURS' or FASTRESC contains 'GRADE 2' Set to 'Grade 3' if FASTRESC='PREVENTS DAILY ACTIVITY, REQUIRES OUTPATIENT IV HYDRATION' or FASTRESC contains 'GRADE 3' Set to 'Grade 4' if FASTRESC contains 'GRADE 4'
	PARAMCD = "CHILLS" (Chills)	Chills	text	10		Derived Set to 'Grade 0' if FASTRESC='NONE' or FASTRESC contains 'GRADE 0' Set to 'Grade 1' if FASTRESC= 'NO INTERFERENCE WITH ACTIVITY' or contains 'GRADE 1'; Set to 'Grade 2' if FASTRESC= 'SOME INTERFERENCE WITH ACTIVITY NOT REQUIRING MEDICAL ATTENTION' or contains 'GRADE 2'; Set to 'Grade 3' if FASTRESC= 'PREVENTS DAILY ACTIVITY AND REQUIRES MEDICAL ATTENTION' or contains 'GRADE 3'; Set to 'Grade 4' if FASTRESC contains 'GRADE 4'
	PARAMCD = "RASH" (Rash)	Rash	text	10		Derived Set to 'Grade 0' if FASTRESC='GRADE 0 = NO RASH' or contains 'GRADE 0'; Set to 'Grade 1' if FASTRESC='GRADE 1 = LOCALIZED RASH, WITHOUT ASSOCIATED SYMPTOMS' or contains 'GRADE 1'; Set to 'Grade 2' if FASTRESC='GRADE 2 = MACULOPAPULAR RASH, COVERING 50% BODY SURFACE AREA WITH URTICARIA' or contains 'GRADE 2'; Set to 'Grade 3' if FASTRESC='GRADE 3 = GENERALIZED URTICARIAL, COVERING 50% BODY SURFACE AREA' or contains 'GRADE 3'; Set to 'Grade 4' if FASTRESC='GRADE 4 = GENERALIZED EXFOLIATIVE, ULCERATIVE OR BULLOUS DERMATITIS, E.G. STEVENS-JOHNSON SYNDROME OR ERYTHEMA MULTIFORME' or contains 'GRADE 4';
ATOXGRN		Analysis Toxicity Grade (N)	integer	8		Assigned 0 if ATOXGRL=Grade 0, 1 if ATOXGRL=Grade 1, 2 if ATOXGRL=Grade 2, 3 if ATOXGRL=Grade 3, 4 if ATOXGRL=Grade 4
ANL01FL		Analysis Flag 01	text	1	No Yes Response (Yes Only) • "Y"	Derived If PARAMCD is RASHOCC or LYMPHOCC: Set to 'Y' by selecting the first record with maximum non-missing AVALC (Y>N) per subject per PARAM per vaccination (ATPTREF) per ATPTGR1, i.e., the first available record per day If PARAMCD not in (RASHOCC or LYMPHOCC): Set to 'Y' for the first record with maximum non-missing ATOXGRN per subject per PARAM per vaccination (ATPTREF) per ATPTGR1, i.e., the first available record per day If there is two records per day and one from investigator and one from subject, select the one from subject (FAEVAL='STUDY SUBJECT')
ANL02FL		Analysis Flag 02	text	1	No Yes Response (Yes Only) • "Y"	Derived Y for the first record with maximum non-missing AVALC (Y>N) per subject per PARAM per vaccination (ATPTREF) per ATPT, i.e., the first available record per day. If there is two records per day and one from investigor and one from subject, select the one from subject (FAEVAL='STUDY SUBJECT') If PARAMCD not in (RASHOCC or LYMPHOCC): Y for the first record with maximum non-missing ATOXGRN per subject per PARAM per vaccination (ATPTREF) per ATPT, i.e., the first available record per day. If there is two records per day and one from investigor and one from subject, select the one from subject (FAEVAL='STUDY SUBJECT' or missing FAEVAL for FEVER)
CRIT1		Analysis Criterion 1	text	20		Derived Set to '> 102.6 degrees F' if CRIT1FL='Y'
CRIT1FL		Criterion 1 Evaluation Result Flag	text	1		Derived Set to 'Y' if PARAMCD='FEVER' and (9*AVAL/5)+32 > 102.6
CRIT2		Analysis Criterion 2	text	20		Derived Set to '> 103.1 degrees F' if CRIT2FL='Y'
CRIT2FL		Criterion 2 Evaluation Result Flag	text	1		Derived Set to 'Y' if PARAMCD='FEVER' and (9*AVAL/5)+32 > 103.1
CRIT3		Analysis Criterion 3	text	20		Derived Set to '> 103.6 degrees F' if CRIT3FL='Y'
CRIT3FL		Criterion 3 Evaluation Result Flag	text	1		Derived Set to 'Y' if PARAMCD='FEVER' and (9*AVAL/5)+32 > 103.6
CRIT4		Analysis Criterion 4	text	20		Derived Set to '> 104.1 degrees F' if CRIT4FL='Y'
CRIT4FL		Criterion 4 Evaluation Result Flag	text	1		Derived Set to 'Y' if PARAMCD='FEVER' and (9*AVAL/5)+32 > 104.1
FALOC		Location of the Finding About	text	34	Location of the Finding About [15 Terms]	Predecessor: FA.FALOC
FAEVAL		Evaluator	text	12	Evaluator • "INVESTIGATOR" • "STUDY SUBJECT"	Predecessor: FA.FAEVAL
LYMPHCOM		Lymphadenopathy Additional information	text	200		Derived Set to CO.COVAL where COREF=LYMPHCOM
LYMPHEVL		Lymphadenopathy evaluated?	text	1	No Yes Response (Yes Only) • "Y"	Derived Set to SUPPFACE.QVAL where SUPPFACE.QNAME='LYMPHEVL'
SRCOMM		Additional Relevant Rash Information	text	200		Derived Set to CO.COVAL where COREF=SRCOMMM
SREVLFL		Rash evaluated Flag	text	1	No Yes Response (Yes Only) • "Y"	Derived Set to SUPPFACE.QVAL where SUPPFACE.QNAME='SREVL'
SRCDOM		Source Data	text	20		Derived Set to FACE.DOMAIN if source data are from FACE Set to VS.DOMAIN if source data are from VS
SRCSEQ		Source Sequence Number	integer	8		Derived Set to FACE.FASEQ if source data are from FACE Set to VS.VSSEQ if source data are from VS
SRCVAR		Source Variable	text	50		Derived Set to 'FASTRESC' if source data are from FACE Set to 'VSSTRESN' if source data are from VS
MEDTAKP		Prevent Pain or Fever from Occurring	text	1	No Yes Response • "N" • "Y"	Derived Set to SUPPVS.QVAL where SUPPVS.QNAM='MEDTAKP'
MEDTAKT		Treat Pain or Fever already Occurred	text	1	No Yes Response • "N" • "Y"	Derived Set to SUPPVS.QVAL where SUPPVS.QNAM='MEDTAKT'
MEDTAK		Medication taken today for pain or fever	text	1	No Yes Response • "N" • "Y"	Derived Set to SUPPVS.QVAL where SUPPVS.QNAM='MEDTAK'
MAAEFL		Medically Attended Flag	text	1	No Yes Response • "N" • "Y"	Derived SUPPFACE.QVAL where SUPPFACE.QNAME='MAAEFL'

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Solicited AR post D7 Analysis Dataset (ADARP7D)

ADARP7D (Solicited AR post D7 Analysis Dataset) - BASIC DATA STRUCTURE Location: adarp7d.xpt
Variable	Where Condition	Label / Description	Type	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID		Study Identifier	text	14	Study Identifier • "mRNA-1273-P201"	Predecessor: ADSL.STUDYID
USUBJID		Unique Subject Identifier	text	25		Predecessor: ADSL.USUBJID
SUBJID		Subject Identifier for the Study	text	9		Predecessor: ADSL.SUBJID
SITEID		Study Site Identifier	text	5		Predecessor: ADSL.SITEID
COUNTRY		Country	text	3	Country • "USA"	Predecessor: ADSL.COUNTRY
AGE		Age	integer	8		Predecessor: ADSL.AGE
AGEU		Age Units	text	5		Predecessor: ADSL.AGEU
AGEGR1		Pooled Age Group 1	text	30	Pooled Age Group 1 • ">=18 and <55 Years" • ">=55 Years"	Predecessor: ADSL.AGEGR1
AGEGR1N		Pooled Age Group 1 (N)	integer	8		Predecessor: ADSL.AGEGR1N
AGEGR2		Pooled Age Group 2	text	19	Pooled Age Group 2 • ">=18 and <=22 Years" • ">=23 and <=25 Years" • ">25 and <55 Years" • ">=55 Years"	Predecessor: ADSL.AGEGR2
AGEGR2N		Pooled Age Group 2 (N)	integer	8		Predecessor: ADSL.AGEGR2N
SEX		Sex	text	1	Sex • "F" • "M"	Predecessor: ADSL.SEX
RACE		Race	text	41	Race [8 Terms]	Predecessor: ADSL.RACE
RACESPY		Race Specify	text	200		Predecessor: ADSL.RACESPY
ETHNIC		Ethnicity	text	22	Ethnicity • "HISPANIC OR LATINO" • "NOT HISPANIC OR LATINO" • "NOT REPORTED" • "UNKNOWN"	Predecessor: ADSL.ETHNIC
RANDFL		Randomized Population Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.RANDFL
SAFFL		Safety Population Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.SAFFL
FASBABFL		Full Analysis Set bAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASBABFL
FASNABFL		Full Analysis Set nAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASNABFL
PPBABFL		Per Protocol bAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBABFL
PPNABFL		Per Protocol nAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPNABFL
PPBD29FL		Per Protocol bAb Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBD29FL
PPBD57FL		Per Protocol bAb Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBD57FL
ADURN		Analysis Duration (N)	integer	8		Derived numeric part of ARRDENPT - numeric part of ARRDSTPT + 1
ANL01FL		Analysis Flag 01	text	1	No Yes Response (Yes Only) • "Y"	Derived Y for the first record with maximum non-missing ATOXGRN per subject per PARAM per vaccination (ATPTREF). If there is two records per day and one from investigor and one from subject, select the one from subject (FAEVAL='STUDY SUBJECT' or missing FAEVAL for FEVER) If PARAMCD =RASHOCC: Y for the first record with maximum non-missing AVALC (Y>N) per subject per PARAM per vaccination (ATPTREF). If there is two records per day and one from investigor and one from subject, select the one from subject (FAEVAL='STUDY SUBJECT')
SAR1FL		First Solicited Safety Population Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.SAR1FL
SAR2FL		Second Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAR2FL
SARAFL		Solicited Safety Population Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.SARAFL
ARRDENPT		End Timepoint from Most Recent Dose	text	6		Derived Set to FAAE.FATPT/VS.VSTPT based on the corresponding AENDT
ARRDSTPT		Start Timepoint from Most Recent Dose	text	5		Derived Set to FAAE.FATPT/VS.VSTPT based on the corresponding ASTDT
ATOXGRVLM		Analysis Toxicity Grade	text	7		Derived Grade 1 if AVAL = 25 - 50 mm or AVALC contains 'GRADE 1', Grade 2 if AVAL = 51 - 100 mm or AVALC contains 'GRADE 2', Grade 3 if AVAL > 100 mm or AVALC contains 'GRADE 3'; Grade 4 if AVALC contains 'GRADE 4'
	PARAMCD IN ( "ERYTHDIA SWELLDIA" )	Erythema Longest Diameter (mm) Swelling Longest Diameter (mm)	text	10		Derived Grade 1 if AVAL = 25 - 50 mm or AVALC contains 'GRADE 1', Grade 2 if AVAL = 51 - 100 mm or AVALC contains 'GRADE 2', Grade 3 if AVAL > 100 mm or AVALC contains 'GRADE 3'; Grade 4 if AVALC contains 'GRADE 4'
	PARAMCD = "FEVER"	Fever (C)	text	10		Derived Grade 1 if AVAL = 38.0 – 38.4°C or AVALC contains 'GRADE 1', Grade 2 if AVAL = >38.4 – 38.9°C or AVALC contains 'GRADE 2', Grade 3 if AVAL = 39.0 – 40.0°C or AVALC contains 'GRADE 3', Grade 4 if AVAL > 40.0°C or AVALC contains 'GRADE 4',
	PARAMCD = "PAIN" (Pain)	Pain	text	10		Derived Grade 1 if AVALC=’DOES NOT INTERFERE WITH ACTIVITY’ or contains 'GRADE 1'; Grade 2 if AVALC= ‘REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR INTERFERES WITH ACTIVITY’ or contains 'GRADE 2'; Grade 3 if AVALC= ‘ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3'; Grade 4 if AVALC contains 'GRADE 4'
	PARAMCD = "LYMPH" (Lymphadenopathy)	Lymphadenopathy	text	10		Derived Grade 1 if AVALC=’DOES NOT INTERFERE WITH ACTIVITY’ or contains 'GRADE 1'; Grade 2 if AVALC= ‘REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR INTERFERES WITH ACTIVITY’ or contains 'GRADE 2'; Grade 3 if AVALC= ‘ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3'; Grade 4 if AVALC contains 'GRADE 4'
	PARAMCD = "HEADACHE" (Headache)	Headache	text	10		Derived Grade 1 if AVALC=’NO INTERFERENCE WITH ACTIVITY or contains 'GRADE 1'’; Grade 2 if AVALC= ‘REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR SOME INTERFERERENCE WITH ACTIVITY’ or contains 'GRADE 2'; Grade 3 if AVALC= ‘ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3'; Grade 4 if AVALC contains 'GRADE 4'
	PARAMCD IN ( "FATIGUE" (Fatigue), "MYALGIA" (Myalgia), "ARTHRALG" (Arthralgia) )	Fatigue, Myalgia, Arthralgia	text	10		Derived Grade 1 if AVALC= 'NO INTERFERENCE WITH ACTIVITY' or contains 'GRADE 1'; Grade 2 if AVALC= ‘SOME INTERFERENCE WITH ACTIVITY’ or contains 'GRADE 2'; Grade 3 if AVALC= ‘SIGNIFICANT; PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3'; Grade 4 if AVALC contains 'GRADE 4'
	PARAMCD = "NAUSEA" (Nausea/Vomiting)	Nausea/Vomiting	text	10		Derived Grade 1 if AVALC= ‘NO INTERFERENCE WITH ACTIVITY OR 1-2 EPISODES/24 HOURS’ or contains 'GRADE 1'; Grade 2 if AVALC= ‘SOME INTERFERENCE WITH ACTIVITY OR >2 EPISODES/24 HOURS’ or contains 'GRADE 2'; Grade 3 if AVALC= ‘PREVENTS DAILY ACTIVITY, REQUIRES OUTPATIENT IV HYDRATION’ or contains 'GRADE 3'; Grade 4 if AVALC contains 'GRADE 4'
	PARAMCD = "CHILLS"	Chills	text	10		Derived Grade 1 if AVALC= ‘NO INTERFERENCE WITH ACTIVITY or contains 'GRADE 1'’; Grade 2 if AVALC= ‘SOME INTERFERENCE WITH ACTIVITY NOT REQUIRING MEDICAL ATTENTION’ or contains 'GRADE 2'; Grade 3 if AVALC= ‘PREVENTS DAILY ACTIVITY AND REQUIRES MEDICAL ATTENTION’ or contains 'GRADE 3'; Grade 4 if AVALC contains 'GRADE 4'
ATOXGRN		Analysis Toxicity Grade (N)	integer	8		Assigned
COMPLFL		Completers Population Flag	text	1		Predecessor: ADSL.COMPLFL
DVBABFL		Deviation Impact bAb Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DVBABFL
DVNABFL		Deviation Impact nAb Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DVNABFL
DOSE1FL		Vaccination 1 Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.DOSE1FL
DOSE2FL		Vaccination 2 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DOSE2FL
AVAL		Analysis Value	integer	8		Derived Set to corresponding FAAE.FASTRESN based on corresponding AVALC if the record is from FAAE IF PARAMCD in (ERYTHDIA, SWELLDIA); Set to corresponding VS.VSSTRESN based on corresponding AVALC if the record is from VS if PARAMCD=FEVER
COV19BL		Baseline COVID Infection	text	20	Baseline COVID Infection • "Detected" • "Not Detected"	Predecessor: ADSL.COV19BL
COV19FL		COVID Infection Flag	text	20	No Yes Response (No Only) • "N"	Predecessor: ADSL.COV19FL
SENTLFL		Sentinel Participant Flag	text	3	No Yes Response • "N" • "Y"	Predecessor: ADSL.SENTLFL
D29W7DFL		Day 29 Out of 7-Day Window Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.D29W7DFL
TRT01P		Planned Treatment for Period 01	text	25	Planned Treatment for Period 01 • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Predecessor: ADSL.TRT01P
TRT01PN		Planned Treatment for Period 01 (N)	integer	8		Predecessor: ADSL.TRT01PN
TRT01A		Actual Treatment for Period 01	text	25	Actual Treatment for Period 01 • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Predecessor: ADSL.TRT01A
TRT01AN		Actual Treatment for Period 01 (N)	integer	8		Predecessor: ADSL.TRT01AN
TR01SDT		Date of First Exposure in Period 01	integer	DATE9		Predecessor: ADSL.TR01SDT
TR01SDTM		Datetime of First Exposure in Period 01	integer	DATETIME20		Predecessor: ADSL.TR01SDTM
TR01EDT		Date of Last Exposure in Period 01	integer	DATE9		Predecessor: ADSL.TR01EDT
TR01EDTM		Datetime of Last Exposure in Period 01	integer	DATETIME20		Predecessor: ADSL.TR01EDTM
TRTSDTM		Datetime of First Exposure to Treatment	integer	DATETIME20		Predecessor: ADSL.TRTSDTM
TRTEDTM		Datetime of Last Exposure to Treatment	integer	DATETIME20		Predecessor: ADSL.TRTEDTM
DOSE2DT		Date of Dose 2	integer	DATE9		Predecessor: ADSL.DOSE2DT
DOS2DTM		Datetime of Dose 2	integer	DATETIME20		Predecessor: ADSL.DOS2DTM
TRTA		Actual Treatment	text	50	Actual Treatment • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Derived "If (.<ADSL.TR01SDTM<=ADTM <DOS2DTM) or (.<ADSL.TR01SDTM<=ADTM and ADSL.DOS2DTM is missing): 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'Day 1' ; 'mRNA-1273 50 ug' if EX.EXTRT='mRNA-1273' and 1) 0<EXDOSE<=75 where EX.VISIT contains 'Day 1', or 2) EXDOSTXT contains '>0-25', '>25-<50' or '>50-75' where EX.VISIT contains 'Day 1'; 'mRNA-1273 100 ug' if EX.EXTRT='mRNA-1273' and 1) EXDOSE>75 where EX.VISIT contains 'Day 1', or 2) EXDOSTXT contains '>75-<100' or '>100-125' or '>125' where EX.VISIT contains 'Day 1'; if .<ADSL.DOS2DTM<=ASTDTM: 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'Day 29' ; 'mRNA-1273 50 ug' if 1) EX.EXTRT='mRNA-1273' and 0<EXDOSE<=75 where EX.VISIT contains 'Day 29', or 2) EXDOSTXT contains '>0-25', '>25-<50' or '>50-75' where EX.VISIT contains 'Day 29'; 'mRNA-1273 100 ug' if EX.EXTRT='mRNA-1273' and 1) EXDOSE>75 where EX.VISIT contains 'Day 29', or 2) EXDOSTXT contains '>75-<100' or '>100-125' or '>125' where EX.VISIT contains 'Day 29'; if time part of ADTM, TR01SDTM, or DOS2DTM is missing, use ADT, TR01SDT, and DOSE2DT to replace ADTM, TR01SDTM, and DOS2DTM, respectively."
TRTAN		Actual Treatment (N)	integer	8		Assigned 1 if TRT01A=‘Placebo’, 2 if TRT01A=‘mRNA-1273 50 ug’, 3 if TRT01A=‘mRNA-1273 100 ug’"
ASEQ		Analysis Sequence Number	integer	8		Assigned Sort by USUBJID, PARCAT1, PARAMCD, ATPTREF and start from 1, increase by 1 for records within each subject
ASTDT		Analysis Start Date	integer	DATE9		Derived Per subject per vaccination (ATPTREF): Set to numeric date part of first FAAE.FADTC where FAOBJ='Erythema' and FATEST='Longest Diameter' and FASTRESN>=25 mm Set to numeric date part of first FAAE.FADTC where FAOBJ='Swelling' and FATEST='Longest Diameter' and FASTRESN>=25 mm Set to numeric date part of first VS.VSDTC where VSTESTCD='TEMP' and VSSTRESN>=38.0°C Set to numeric date part of first FAAE.FADTC where FAOBJ='Pain' and FASTRESC is not 'NONE' or missing Set to numeric date part of first FAAE.FADTC where FAOBJ='Underarm Gland Swelling or Tenderness' and FASTRESC is not 'NONE' or missing Set to numeric date part of first FAAE.FADTC where FAOBJ='Headache' and FASTRESC is not 'NONE' or missing Set to numeric date part of first FAAE.FADTC where FAOBJ='Fatigue' and FASTRESC is not 'NONE' or missing Set to numeric date part of first FAAE.FADTC where FAOBJ='Myalgia' and FASTRESC is not 'NONE' or missing Set to numeric date part of first FAAE.FADTC where FAOBJ='Arthralgia' and FASTRESC is not 'NONE' or missing Set to numeric date part of first FAAE.FADTC where FAOBJ='Nausea/Vomiting' and FASTRESC is not 'NONE' or missing Set to numeric date part of first FAAE.FADTC where FAOBJ='Chills' and FASTRESC is not 'NONE' or missing Set to numeric date part of first FAAE.FADTC where FAOBJ='Rash' and FASTRESC is 'Y'
ASTTM		Analysis Start Time	integer	TIME5		Derived Corresponding time part based on the derivation of ASTDT
ASTDTM		Analysis Start Datetime	integer	DATETIME20		Derived Concatenate ASTDT and ASTTM if both are non-missing
ASTDY		Analysis Start Relative Day	integer	8		Derived Set to ASTDT – ADSL.TR01SDT + 1
AENDT		Analysis End Date	integer	DATE9		Derived Per subject per vaccination (ATPTREF): Set to numeric date part of last FAAE.FADTC where FAOBJ='Erythema' and FATEST='Longest Diameter' and FASTRESN>=25 mm Set to numeric date part of last FAAE.FADTC where FAOBJ='Swelling' and FATEST='Longest Diameter' and FASTRESN>=25 mm Set to numeric date part of last VS.VSDTC where VSTESTCD='TEMP' and VSSTRESN>=38.0 C Set to numeric date part of last FAAE.FADTC where FAOBJ='Pain' and FASTRESC is not 'NONE' or missing Set to numeric date part of last FAAE.FADTC where FAOBJ='Underarm Gland Swelling or Tenderness' and FASTRESC is not 'NONE' or missing Set to numeric date part of last FAAE.FADTC where FAOBJ='Headache' and FASTRESC is not 'NONE' or missing Set to numeric date part of last FAAE.FADTC where FAOBJ='Fatigue' and FASTRESC is not 'NONE' or missing Set to numeric date part of last FAAE.FADTC where FAOBJ='Myalgia' and FASTRESC is not 'NONE' or missing Set to numeric date part of last FAAE.FADTC where FAOBJ='Arthralgia' and FASTRESC is not 'NONE' or missing Set to numeric date part of last FAAE.FADTC where FAOBJ='Nausea/Vomiting' and FASTRESC is not 'NONE' or missing Set to numeric date part of last FAAE.FADTC where FAOBJ='Chills' and FASTRESC is not 'NONE' or missing Set to numeric date part of last FAAE.FADTC where FAOBJ='Rash' and FASTRESC is 'Y'
AENTM		Analysis End Time	integer	TIME5		Derived Corresponding time part based on the derivation of AENDT
AENDTM		Analysis End Datetime	integer	DATETIME20		Derived Concatenate AENDT and AENTM if both are non-missing
AENDY		Analysis End Relative Day	integer	8		Derived Set to AENDT – ADSL.TR01SDT + 1
ATPTREF		Analysis Timepoint Reference	text	50	Analysis Timepoint Reference • "Vaccination 1" • "Vaccination 2"	Derived If source data are from FAAE: Set to 'Vaccination 1' if FAAE.FATPTREF contains 'DOSE 1' Set to 'Vaccination 2' if FAAE.FATPTREF contains 'DOSE 2' If source data are from VS: Set to 'Vaccination 1' if VS.VSTPTREF contains 'DOSE 1' Set to 'Vaccination 2' if VS.VSTPTREF contains 'DOSE 2'
DOSEROFL		Dosing Error Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DOSEROFL
FAEVAL		Evaluator	text	13		Predecessor: FAAE.FAEVAL
PARCAT1		Parameter Category 1	text	50	Solicited AR Category • "LOCAL" • "SYSTEMIC"	Derived If source data are from FACE: Set to 'LOCAL' if FASCAT=ADMINISTRATION SITE Set to FASCAT if FASCAT<>ADMINISTRATION SITE Set to VSSCAT if source data are from VS
PARCAT1N		Parameter Category 1 (N)	integer	8		Assigned 1 if PACAT1='LOCAL' 2 if PACAT1='SYSTEMIC'
PARAMCD		Parameter Code	text	8	Solicited AR post D7 Analysis Dataset Parameter Code [10 Terms]	Assigned RASHOCC if PARAM='Rash Occurrence', LYMPH if PARAM='Lymphadenopathy', PAIN if PARAM='Pain', ERYTHDIA if PARAM='Erythema Longest Diameter (mm)' SWELLDIA if PARAM='Swelling Longest Diameter (mm)', HEADACHE if PARAM='Headache', FATIGUE if PARAM='Fatigue', MYALGIA if PARAM='Myalgia', ARTHRALG if PARAM='Arthralgia', NAUSEA if PARAM='Nausea', CHILLS if PARAM='Chills', FEVER if PARAM='Fever (C)'
PARAM		Parameter	text	200		Derived Set to 'Rash'\|\|' '\|\|FATEST if source data are from FAAE and FAOBJ='Rash', and FATESTCD ne 'SEV' Set to 'Lymphadenopathy' if source data are from FAAE and FAOBJ='Underarm Gland Swelling or Tenderness' and FATESTCD = 'SEV' Set to 'Nausea/Vomiting' if source data are from FAAE and FAOBJ='Nausea' and FATESTCD = 'SEV' Set to FAOBJ\|\|' Longest Diameter (mm)' iff source data are from FAAE and FAOBJ in ('Erythema' 'Swelling') and FATEST='OCCURRENCE' and FAORRES='N' Set to 'FAOBJ'\|\|' '\|\|FATEST\|\|' '\|\|'('\|\|FAORRESU\|\|')' if source data are from FAAE and FAOBJ in ('Erythema' 'Swelling') and FATEST='Longest Diameter' Set to FAOBJ otherwise. Set to 'Fever'\|\|'('\|\|VSSTRESU\|\|')' if source data are from VS and VSTESTCD in ('TEMP' 'VSALL') Note: 1. Please add space between the VSTEST and VS unit. If the VSSTRESU is missing, use non-missing VSSTRESU 2. For each PARAM, keep only one record per subject per vaccination (ATPTREF)
FASNA2FL		FAS nAb 2 Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASNA2FL
AVALCVLM		Analysis Value (C)	text	94
	PARAMCD = "ERYTHDIA" (Erythema Longest Diameter (mm))	Erythema Longest Diameter (mm)	text	12		Derived Per subject per vaccination (ATPTREF) per FAEVAL, set to the corresponding FAAE.FASTRESC for the largest FASTRESN>=25 mm where FAOBJ='Erythema' and FATEST='Longest Diameter' or set to the highest order of FAAE.FASTRESC where FAOBJ='Erythema' and FATEST contains 'Intensity' (GRADE 1<GRADE 2<GRADE 3< GRADE 4) note: if there are records from both Longest diameter and intensity, choose the one with highest garde. if both fall in the same grade, use FASTRESC from FATEST='Longest Diameter'. 25-50 mm is corresponding to Grade 1, 51-100 mm is corresponding to Grade 2, and >100 mm is corresponding to Grade 3.
	PARAMCD = "SWELLDIA" (Swelling Longest Diameter (mm))	Swelling Longest Diameter (mm)	text	12		Derived Per subject per vaccination (ATPTREF) per FAEVAL, set to the corresponding FAAE.FASTRESC for the largest FASTRESN>=25 mm where FAOBJ='Swelling' and FATEST='Longest Diameter' or set to the highest order of FAAE.FASTRESC where FAOBJ='Swelling' and FATEST contains 'Intensity' (GRADE 1<GRADE 2<GRADE 3<GRADE 4) note: if there are records from both Longest diameter and intensity, choose the one with highest garde. if both fall in the same grade, use FASTRESC from FATEST='Longest Diameter'. 25-50 mm is corresponding to Grade 1, 51-100 mm is corresponding to Grade 2, and >100 mm is corresponding to Grade 3.
	PARAMCD = "FEVER"	Fever (C)	text	12		Derived Per subject per vaccination (ATPTREF) per FAEVAL, set to the corresponding VS.VSSTRESC for the largest VS.VSSTRESN>=38 C where VSTESTCD='TEMP' or set to the highest order of FAAE.FASTRESC where FAOBJ='Fever' (GRADE 1<GRADE 2<GRADE 3<GRADE 4) note: if there are records from both LVS and FAAE, choose the one with highest garde. if both fall in the same grade, use FAAE.FASTRESC. 38-38.4 C is corresponding to Grade 1, >38.4-38.9 C is corresponding to Grade 2, 39-40 C is corresponding to Grade 3, and >40 C is corresponding to Grade 4.
	PARAMCD = "PAIN" (Pain)	Pain	text	32		Derived Per subject per vaccination (ATPTREF) per FAEVAL, set to the highest order of FAAE.FASTRESC where FAOBJ='Pain' and FASTRESC is not 'NONE' or missing ’DOES NOT INTERFERE WITH ACTIVITY’ or contains 'GRADE 1'< ‘REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR INTERFERES WITH ACTIVITY’ or contains 'GRADE 2'< ‘ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3'
	PARAMCD = "LYMPH" (Lymphadenopathy)	Lymphadenopathy	text	32		Derived Per subject per vaccination (ATPTREF) per FAEVAL, set to the highest order of FAAE.FASTRESC where FAOBJ='Underarm Gland Swelling or Tenderness' and FASTRESC is not 'NONE' or missing ’DOES NOT INTERFERE WITH ACTIVITY’ or contains 'GRADE 1' < ‘REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR INTERFERES WITH SOME ACTIVITY’ or contains 'GRADE 2' < ‘ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3'
	PARAMCD = "HEADACHE" (Headache)	Headache	text	94		Derived Per subject per vaccination (ATPTREF) per FAEVAL, set to the highest order of FAAE.FASTRESC where FAOBJ='Headache' and FASTRESC is not 'NONE' or missing ’NO INTERFERENCE WITH ACTIVITY’ or contains 'GRADE 1'< ‘REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR SOME INTERFERERENCE WITH ACTIVITY’ or contains 'GRADE 2'< ‘ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3'
	PARAMCD = "FATIGUE" (Fatigue)	Fatigue	text	31		Derived "Per subject per vaccination (ATPTREF) per FAEVAL, set to the highest order of FAAE.FASTRESC where FAOBJ='Fatigue' and FASTRESC is not 'NONE' or missing 'NO INTERFERENCE WITH ACTIVITY' or contains 'GRADE 1'< ‘SOME INTERFERENCE WITH ACTIVITY’ or contains 'GRADE 2' <‘SIGNIFICANT; PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3'"
	PARAMCD = "MYALGIA" (Myalgia)	Myalgia	text	31		Derived Per subject per vaccination (ATPTREF) per FAEVAL, set to the highest order of FAAE.FASTRESC where FAOBJ='Myalgia' and FASTRESC is not 'NONE' or missing 'NO INTERFERENCE WITH ACTIVITY' or contains 'GRADE 1'< ‘SOME INTERFERENCE WITH ACTIVITY’ or contains 'GRADE 2' <‘SIGNIFICANT; PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3'
	PARAMCD = "ARTHRALG" (Arthralgia)	Arthralgia	text	31		Derived "Per subject per vaccination (ATPTREF) per FAEVAL, set to the highest order of FAAE.FASTRESC where FAOBJ='Arthralgia' and FASTRESC is not 'NONE' or missing 'NO INTERFERENCE WITH ACTIVITY' or contains 'GRADE 1' < ‘SOME INTERFERENCE WITH ACTIVITY’ or contains 'GRADE 2' <‘SIGNIFICANT; PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3'"
	PARAMCD = "NAUSEA" (Nausea/Vomiting)	Nausea/Vomiting	text	54		Derived Per subject per vaccination (ATPTREF) per FAEVAL, set to the highest order of FAAE.FASTRESC where FAOBJ='Nausea/Vomiting' and FASTRESC is not 'NONE' or missing ‘NO INTERFERENCE WITH ACTIVITY OR 1-2 EPISODES/24 HOURS’ or contains 'GRADE 1'< ‘SOME INTERFERENCE WITH ACTIVITY OR >2 EPISODES/24 HOURS’ or contains 'GRADE 2'< ‘PREVENTS DAILY ACTIVITY, REQUIRES OUTPATIENT IV HYDRATION’ or contains 'GRADE 3'
	PARAMCD = "CHILLS"	Chills	text	12		Derived Per subject per vaccination (ATPTREF) per FAEVAL, set to the highest order of FAAE.FASTRESC where FAOBJ='Chills' and FASTRESC is not 'NONE' or missing ‘NO INTERFERENCE WITH ACTIVITY’ or contains 'GRADE 1'< ‘SOME INTERFERENCE WITH ACTIVITY NOT REQUIRING MEDICAL ATTENTION’ or contains 'GRADE 2' < ‘PREVENTS DAILY ACTIVITY AND REQUIRES MEDICAL ATTENTION’ or contains 'GRADE 3'
MAAEFL		Medically Attended Flag	text	1		Derived For each PARAM, ATPTREF, FAEVAL, set to Y if there is one record in SUPPFAAE.QVAL where SUPPFAAE.QNAME='MAAEFL'
PN2D29FL		Per Protocol nAb 2 Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PN2D29FL
PN2D57FL		Per Protocol nAb 2 Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PN2D57FL
PPNAB2FL		PP nAb 2 Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPNAB2FL
PPND29FL		Per Protocol nAb Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPND29FL
PPND57FL		Per Protocol nAb Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPND57FL

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Solicited AR Summary Analysis Dataset (ADARSUM)

ADARSUM (Solicited AR Summary Analysis Dataset) - BASIC DATA STRUCTURE Location: adarsum.xpt
Variable	Where Condition	Label / Description	Type	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID		Study Identifier	text	14	Study Identifier • "mRNA-1273-P201"	Predecessor: ADSL.STUDYID
USUBJID		Unique Subject Identifier	text	25		Predecessor: ADSL.USUBJID
SUBJID		Subject Identifier for the Study	text	9		Predecessor: ADSL.SUBJID
SITEID		Study Site Identifier	text	5		Predecessor: ADSL.SITEID
COUNTRY		Country	text	3	Country • "USA"	Predecessor: ADSL.COUNTRY
AGE		Age	integer	8		Predecessor: ADSL.AGE
AGEU		Age Units	text	5		Predecessor: ADSL.AGEU
AGEGR1		Pooled Age Group 1	text	30	Pooled Age Group 1 • ">=18 and <55 Years" • ">=55 Years"	Predecessor: ADSL.AGEGR1
AGEGR1N		Pooled Age Group 1 (N)	integer	8		Predecessor: ADSL.AGEGR1N
AGEGR2		Pooled Age Group 2	text	19	Pooled Age Group 2 • ">=18 and <=22 Years" • ">=23 and <=25 Years" • ">25 and <55 Years" • ">=55 Years"	Predecessor: ADSL.AGEGR2
AGEGR2N		Pooled Age Group 2 (N)	integer	8		Predecessor: ADSL.AGEGR2N
SEX		Sex	text	1	Sex • "F" • "M"	Predecessor: ADSL.SEX
RACE		Race	text	41	Race [8 Terms]	Predecessor: ADSL.RACE
RACESPY		Race Specify	text	200		Predecessor: ADSL.RACESPY
ETHNIC		Ethnicity	text	22	Ethnicity • "HISPANIC OR LATINO" • "NOT HISPANIC OR LATINO" • "NOT REPORTED" • "UNKNOWN"	Predecessor: ADSL.ETHNIC
RANDFL		Randomized Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.RANDFL
SAFFL		Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAFFL
FASBABFL		Full Analysis Set bAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASBABFL
FASNABFL		Full Analysis Set nAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASNABFL
PPBABFL		Per Protocol bAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBABFL
PPNABFL		Per Protocol nAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPNABFL
PPBD29FL		Per Protocol bAb Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBD29FL
PPBD57FL		Per Protocol bAb Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBD57FL
PPND29FL		Per Protocol nAb Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPND29FL
PPND57FL		Per Protocol nAb Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPND57FL
SAR1FL		First Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAR1FL
SAR2FL		Second Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAR2FL
SARAFL		Solicited Safety Population Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.SARAFL
FASNA2FL		FAS nAb 2 Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASNA2FL
PPNAB2FL		PP nAb 2 Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPNAB2FL
PN2D29FL		Per Protocol nAb 2 Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PN2D29FL
PN2D57FL		Per Protocol nAb 2 Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PN2D57FL
COMPLFL		Completers Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.COMPLFL
DVBABFL		Deviation Impact bAb Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DVBABFL
DVNABFL		Deviation Impact nAb Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DVNABFL
DOSE1FL		Vaccination 1 Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.DOSE1FL
DOSE2FL		Vaccination 2 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DOSE2FL
DOSEROFL		Dosing Error Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DOSEROFL
COV19BL		Baseline COVID Infection	text	20	Baseline COVID Infection • "Detected" • "Not Detected"	Predecessor: ADSL.COV19BL
COV19FL		COVID Infection Flag	text	20	No Yes Response • "N" • "Y"	Predecessor: ADSL.COV19FL
SENTLFL		Sentinel Participant Flag	text	3	No Yes Response • "N" • "Y"	Predecessor: ADSL.SENTLFL
D29W7DFL		Day 29 Out of 7-Day Window Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.D29W7DFL
TRT01P		Planned Treatment for Period 01	text	25	Planned Treatment for Period 01 • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Predecessor: ADSL.TRT01P
TRT01PN		Planned Treatment for Period 01 (N)	integer	8		Predecessor: ADSL.TRT01PN
TRT01A		Actual Treatment for Period 01	text	25	Actual Treatment for Period 01 • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Predecessor: ADSL.TRT01A
TRT01AN		Actual Treatment for Period 01 (N)	integer	8		Predecessor: ADSL.TRT01AN
TR01SDT		Date of First Exposure in Period 01	integer	DATE9		Predecessor: ADSL.TR01SDT
TR01SDTM		Datetime of First Exposure in Period 01	integer	DATETIME20		Predecessor: ADSL.TR01SDTM
TR01EDT		Date of Last Exposure in Period 01	integer	DATE9		Predecessor: ADSL.TR01EDT
TR01EDTM		Datetime of Last Exposure in Period 01	integer	DATETIME20		Predecessor: ADSL.TR01EDTM
TRTSDTM		Datetime of First Exposure to Treatment	integer	DATETIME20		Predecessor: ADSL.TRTSDTM
TRTEDTM		Datetime of Last Exposure to Treatment	integer	DATETIME20		Predecessor: ADSL.TRTEDTM
DOSE2DT		Date of Dose 2	integer	DATE9		Predecessor: ADSL.DOSE2DT
DOS2DTM		Datetime of Dose 2	integer	DATETIME20		Predecessor: ADSL.DOS2DTM
TRTA		Actual Treatment	text	50	Actual Treatment • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Derived "If (.<ADSL.TR01SDTM<=ADTM <DOS2DTM) or (.<ADSL.TR01SDTM<=ADTM and ADSL.DOS2DTM is missing): 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'Day 1' ; 'mRNA-1273 50 ug' if EX.EXTRT='mRNA-1273' and 1) 0<EXDOSE<=75 where EX.VISIT contains 'Day 1', or 2) EXDOSTXT contains '>0-25', '>25-<50' or '>50-75' where EX.VISIT contains 'Day 1'; 'mRNA-1273 100 ug' if EX.EXTRT='mRNA-1273' and 1) EXDOSE>75 where EX.VISIT contains 'Day 1', or 2) EXDOSTXT contains '>75-<100' or '>100-125' or '>125' where EX.VISIT contains 'Day 1'; if .<ADSL.DOS2DTM<=ASTDTM: 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'Day 29' ; 'mRNA-1273 50 ug' if 1) EX.EXTRT='mRNA-1273' and 0<EXDOSE<=75 where EX.VISIT contains 'Day 29', or 2) EXDOSTXT contains '>0-25', '>25-<50' or '>50-75' where EX.VISIT contains 'Day 29'; 'mRNA-1273 100 ug' if EX.EXTRT='mRNA-1273' and 1) EXDOSE>75 where EX.VISIT contains 'Day 29', or 2) EXDOSTXT contains '>75-<100' or '>100-125' or '>125' where EX.VISIT contains 'Day 29'; if time part of ADTM, TR01SDTM, or DOS2DTM is missing, use ADT, TR01SDT, and DOSE2DT to replace ADTM, TR01SDTM, and DOS2DTM, respectively."
TRTAN		Actual Treatment (N)	integer	8		Assigned 1 if TRT01A=‘Placebo’, 2 if TRT01A=‘mRNA-1273 50 ug’, 3 if TRT01A=‘mRNA-1273 100 ug’"
ATPTREF		Analysis Timepoint Reference	text	50	Analysis Timepoint Reference • "Vaccination 1" • "Vaccination 2"	Derived Set to ADAR.ATPTREF if data from ADAR If source data are from FAAE, set to ‘Vaccination 1’ if FAAE.FATPTREF contains ‘DOSE 1’, set to ‘Vaccination 2’ if FAAE.FATPTREF contains ‘DOSE 2’. If source data are from VS, ‘Vaccination 1’ if VS.VSTPTREF contains ‘DOSE 1’, ‘Vaccination 2’ if VS.VSTPTREF contains ‘DOSE 2’
PARCAT1		Parameter Category 1	text	50	Solicited AR Category • "LOCAL" • "SYSTEMIC"	Derived Set to 'LOCAL' if PARAMCD in (LYMPHDUR, PAINDUR, ERYTHDUR, SWELLDUR, WLYMPH, WPAIN, WERYTH, WSWELL, WSLAR) Set to 'SYSTEMIC' if PARAMCD in (HEADADUR, FATIGDUR, MYALGDUR, ARTHRDUR, NAUSEDUR, CHILLDUR, FEVERDUR, RASHDUR, WHEAD, WFATIGUE, WMYALGIA, WARTHR, WNAUSEA, WCHILLS,WFEVER, WSSAR)
PARCAT1N		Parameter Category 1 (N)	integer	8		Assigned set to 'LOCAL' if PARAMCD in (LYMPHDUR PAINDUR ERYTHDUR SWELLDUR, WLYMPH, WPAIN, WERYTH, WSWELL, WSLAR) set to 'SYSTEMIC' if PARAMCD in (HEADADUR FATIGDUR MYALGDUR ARTHRDUR NAUSEDUR CHILLDUR FEVERDUR RASHDUR, WHEAD, WFATIGUE, WMYALGIA, WARTHR, WNAUSEA, WCHILLS,WFEVER, WSSAR)
PARAMCD		Parameter Code	text	8		Assigned see following reference link Additional ADaM Dataset Definition
PARAM		Parameter	text	200		Derived Assign the PARAM to each subject and each ATPTREF (i.e., Vaccination 1, Vaccination 2)
AVALVLM		Analysis Value	integer	8
	PARAMCD = "RASHDUR"	Number of Days for Rash	integer	1		Derived "1. Use ADAR data, count total number of records with AVALC='Y' per subject per vaccination (ATPTREF) where ADAR.PARAMCD='RASHOCC'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once. 2. Use FAAE data, count total number of records where FAOBJ='Rash' and FASTRESC is not 'N' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once. 3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) ."
	PARAMCD = "LYMPHDUR"	Number of Days for Lymphadenopathy	integer	1		Derived "1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD=' LYMPH '. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once. 2. Use FAAE data, count total number of records where FAOBJ='Underarm Gland Swelling or Tenderness' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once. 3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) ."
	PARAMCD = "PAINDUR"	Number of Days for Pain	integer	2		Derived "1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD=' PAIN '. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once. 2. Use FAAE data, count total number of records where FAOBJ='Pain' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once. 3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) ."
	PARAMCD = "ERYTHDUR"	Number of Days for Erythema	integer	2		Derived "1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='ERYTHDIA'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once. 2. Use FAAE data, count total number of records where (FAOBJ='Erythema' and FATEST='Longest Diameter' and FASTRESN>=25 mm) or (FAOBJ='Erythema' and FATEST contains 'Intensity' and FASTRESC contains GRADE 1, GRADE 2 or GRADE 3 or GRADE 4) per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once. 3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) ."
	PARAMCD = "SWELLDUR"	Number of Days for Swelling	integer	2		Derived "1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='SWELLDIA'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once. 2. Use FAAE data, count total number of records where (FAOBJ='Swelling' and FATEST='Longest Diameter' and FASTRESN>=25 mm) or (FAOBJ='Swelling' and FATEST contains 'Intensity' and FASTRESC contains GRADE 1, GRADE 2 or GRADE 3 or GRADE 4) per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once. 3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) ."
	PARAMCD = "HEADADUR"	Number of Days for Headache	integer	2		Derived "1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='HEADACHE'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once. 2. Use FAAE data, count total number of records where FAOBJ='Headache' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once. 3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) ."
	PARAMCD = "FATIGDUR"	Number of Days for Fatigue	integer	2		Derived "1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='FATIGUE'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once. 2. Use FAAE data, count total number of records where FAOBJ='Fatigue' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once. 3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) ."
	PARAMCD = "MYALGDUR"	Number of Days for Myalgia	integer	2		Derived "1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='MYALGIA'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once. 2. Use FAAE data, count total number of records where FAOBJ='Myalgia' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once. 3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) ."
	PARAMCD = "ARTHRDUR"	Number of Days for Arthralgia	integer	2		Derived 1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='ARTHRALG'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once. 2. Use FAAE data, count total number of records where FAOBJ='Arthralgia' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once. 3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) .
	PARAMCD = "NAUSEDUR"	Number of Days for Nausea	integer	1		Derived "1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='NAUSEA'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once. 2. Use FAAE data, count total number of records where FAOBJ='Nausea/Vomiting' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once. 3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) ."
	PARAMCD = "CHILLDUR"	Number of Days for Chills	integer	1		Derived 1.Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='CHILLS'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once. 2. Use FAAE data, count total number of records where FAOBJ='Chills' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once. 3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) .
	PARAMCD = "FEVERDUR"	Number of Days for Fever	integer	1		Derived "1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='FEVER'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once. 2. Use VS/FAAE data, count total number of records where (VSTESTCD='TEMP' and VSSTRESN>=38.0°C) or (FAAE.FAOBJ='Fever' and FASTRESC contains GRADE 1, GRADE 2, GRADE 3 or GRADE 4) per subject per vaccination (VSTPTREF/FATPTREF). If there are more than one record within same day (VSTPT/FATPT), subject and vaccination (VSTPTREF/FATPTREF), only count once. 3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/VSTPTREF/FATPTREF) ."
	PARAMCD = "HPRASDUR"	Number of Days for Rash by Health Provider	integer	1		Derived Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD=' RASH'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once
	PARAMCD = "HPLYMDUR"	Number of Days for Lymphadenopathy by Health Provider	integer	2		Derived Use ADAR data, count total number of records with AVALC='Y' per subject per vaccination (ATPTREF) where ADAR.PARAMCD='LYMPHOCC'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once
	PARAMCD = "ANYDUR"	Number of Days for Any Solicited AR	integer	2		Derived 1) Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD is not 'RASH', 'LYMPHOCC' ,''RASHOCC' or AVALC is Y where PARAMCD is 'RASHOCC'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once. 2) Use FAAE/VS data, count total number of records where (FAOBJ is ('Erythema', 'Swelling') and FATEST='Longest Diameter' and FASTRESN>=25 mm) or (FAOBJ is ('Erythema', 'Swelling') and FATEST contains 'Intensity' and FASTRESC contains GRADE 1, GRADE 2 or GRADE 3 or GRADE 4) or (FAAE.FAOBJ='Fever' and FASTRESC contains GRADE 1, GRADE 2, GRADE 3 or GRADE 4) or (for other FAOBJ and FASTRESC is not 'NONE', 'N' or missing) or (VSTESTCD='TEMP' and VSSTRESN>=38.0°C) per subject per vaccination (FATPTREF/VSTPTREF). If there are more than one record within same day (FATPT/VSTPT), subject and vaccination (FATPTREF/VSTPTREF), only count once. 3) sum of 1) and 2) by vaccination
	PARAMCD = "LOCDUR"	Number of Days for Local Solicited AR	integer	2		Derived "1) Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARCAT1 is 'LOCAL'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once. 2) Use FAAE data, count total number of records where (FAOBJ is ('Erythema', 'Swelling') and FATEST='Longest Diameter' and FASTRESN>=25 mm) or (FAOBJ is ('Erythema', 'Swelling') and FATEST contains 'Intensity' and FASTRESC contains GRADE 1, GRADE 2 or GRADE 3 or GRADE 4) or (FAOBJ is ('Pain', 'Underarm Gland Swelling or Tenderness') and FASTRESC is not 'NONE' or missing) per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once. 3) sum of 1) and 2) by vaccination"
	PARAMCD = "SYSDUR"	Number of Days for Systemic Solicited AR	integer	2		Derived "Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARCAT1 is 'SYSTEMIC' and ADAR.PARAMCD is not 'RASH', 'LYMPHOCC' ,''RASHOCC' or AVALC is Y where PARAMCD is 'RASHOCC'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once. 2) Use FAAE/VS data, count total number of records where (FASCAT='SYSTEMIC' and FASTRESC is not 'NONE', 'N' or missing) or (VSTESTCD='TEMP' and VSSTRESN>=38.0°C) per subject per vaccination (FATPTREF/VSTPTREF). If there are more than one record within same day (FATPT/VSTPT), subject and vaccination (FATPTREF/VSTPTREF), only count once. 3) sum of 1) and 2) by vaccination"
AVALCVLM		Analysis Value (C)	text	100
	PARAMCD IN ( "RASHOCYN", "LYMOCCYN" )		text	1		Derived Per subject per vaccination (ATPTREF), set to the maximum non-missing AVALC (Y>N) where PARAMCD is 'LYMPHOCC', 'RASHOCC'
	PARAMCD IN ( "WRASH", "WLYMPH", "WPAIN", "WERYTH", "WSWELL", "WHEAD", "WFATIGUE", "WMYALGIA", "WARTHR", "WNAUSEA", "WCHILLS", "WFEVER" )		text	94		Derived Set to AVALC of the record used to derive ATOXGR. Use the highest AVALC if multiple records
ATOXGRVLM		Analysis Toxicity Grade	text	20	Analysis Toxicity Grade [9 Terms]	Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007)
	PARAMCD = "WRASH"	Worst Analysis Toxicity Grade for Rash between Day 1 and Day 7	text	10		Derived Per subject per vaccination (ATPTREF): Set to the highest ATOXGR where ADAR.PARAMCD='RASH'
	PARAMCD = "WLYMPH"	Worst Analysis Toxicity Grade for Lymphadenopathy between Day 1 and Day 7	text	10		Derived Per subject per vaccination (ATPTREF): Set to the highest ATOXGR where ADAR.PARAMCD='LYMPH'
	PARAMCD = "WPAIN"	Worst Analysis Toxicity Grade for Pain between Day 1 and Day 7	text	10		Derived Per subject per vaccination (ATPTREF): Set to the highest ATOXGR where ADAR.PARAMCD='PAIN'
	PARAMCD = "WERYTH"	Worst Analysis Toxicity Grade for Erythema between Day 1 and Day 7	text	10		Derived Per subject per vaccination (ATPTREF): Set to the highest ATOXGR where ADAR.PARAMCD='ERYTHDIA'
	PARAMCD = "WSWELL"	Worst Analysis Toxicity Grade for Swelling between Day 1 and Day 7	text	10		Derived Per subject per vaccination (ATPTREF): Set to the highest ATOXGR where ADAR.PARAMCD='SWELLDIA'
	PARAMCD = "WHEAD"	Worst Analysis Toxicity Grade for Headache between Day 1 and Day 7	text	10		Derived Per subject per vaccination (ATPTREF): Set to the highest ATOXGR where ADAR.PARAMCD='HEADACHE'
	PARAMCD = "WFATIGUE"	Worst Analysis Toxicity Grade for Fatigue between Day 1 and Day 7	text	10		Derived Per subject per vaccination (ATPTREF): Set to the highest ATOXGR where ADAR.PARAMCD='FATIGUE'
	PARAMCD = "WMYALGIA"	Worst Analysis Toxicity Grade for Myalgia between Day 1 and Day 7	text	10		Derived Per subject per vaccination (ATPTREF): Set to the highest ATOXGR where ADAR.PARAMCD='MYALGIA'
	PARAMCD = "WARTHR"	Worst Analysis Toxicity Grade for Arthralgia between Day 1 and Day 7	text	10		Derived Per subject per vaccination (ATPTREF): Set to the highest ATOXGR where ADAR.PARAMCD='ARTHRALG'
	PARAMCD = "WNAUSEA"	Worst Analysis Toxicity Grade for Nausea between Day 1 and Day 7	text	10		Derived Per subject per vaccination (ATPTREF): Set to the highest ATOXGR where ADAR.PARAMCD='NAUSEA'
	PARAMCD = "WCHILLS"	Worst Analysis Toxicity Grade for Chills between Day 1 and Day 7	text	10		Derived Per subject per vaccination (ATPTREF): Set to the highest ATOXGR where ADAR.PARAMCD='CHILLS'
	PARAMCD = "WFEVER"	Worst Analysis Toxicity Grade for Fever between Day 1 and Day 7	text	10		Derived Per subject per vaccination (ATPTREF): Set to the highest ATOXGR where ADAR.PARAMCD='FEVER'
	PARAMCD = "WSAR"	Worst Analysis Toxicity Grade for Any Solicited AR between Day 1 and Day 7	text	10		Derived Per subject per vaccination (ATPTREF): Set to the highest ATOXGR where ADAR.PARAMCD is not 'RASH', 'LYMPHOCC', 'RASHOCC'
	PARAMCD = "WSLAR"	Worst Analysis Toxicity Grade for Any Solicited Local AR between Day 1 and Day 7	text	10		Derived Per subject per vaccination (ATPTREF): Set to the highest ATOXGR where ADAR.PARCAT1 is 'LOCAL'
	PARAMCD = "WSSAR"	Worst Analysis Toxicity Grade for Any Solicited Systemic AR between Day 1 and Day 7	text	10		Derived Per subject per vaccination (ATPTREF): Set to the highest ATOXGR where ADAR.PARCAT1 is 'SYSTEMIC' and ADAR.PARAMCD is not 'RASH', 'LYMPHOCC' ,''RASHOCC'
ATOXGRN		Analysis Toxicity Grade (N)	integer	8		Assigned 0 if ATOXGRH=Grade 0, 1 if ATOXGRH=Grade 1, 2 if ATOXGRH=Grade 2, 3 if ATOXGRH=Grade 3, 4 if ATOXGRH=Grade 4
SRCDOM		Source Data	text	4		Derived Set to 'ADAR' if PARAMCD does not contain 'DUR'
SRCSEQ		Source Sequence Number	integer	8		Derived Set to ADAR.ASEQ based on ATOXGR/AVALC derivation for PARAMCD does not contain 'DUR' and set to the smallest one if multiple records
SRCVAR		Source Variable	text	8		Derived Set to 'ATOXGR' if PARAM contains 'Worst'; Set to 'AVALC' if PARAMCD is 'RASHOCYN', 'LYMOCCYN'

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COVID-19 Analysis Dataset (ADCOV)

ADCOV (COVID-19 Analysis Dataset) - BASIC DATA STRUCTURE Location: adcov.xpt
Variable	Label / Description	Type	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	14	Study Identifier • "mRNA-1273-P201"	Predecessor: ADSL.STUDYID
USUBJID	Unique Subject Identifier	text	25		Predecessor: ADSL.USUBJID
SUBJID	Subject Identifier for the Study	text	9		Predecessor: ADSL.SUBJID
SITEID	Study Site Identifier	text	5		Predecessor: ADSL.SITEID
COUNTRY	Country	text	3	Country • "USA"	Predecessor: ADSL.COUNTRY
AGE	Age	integer	8		Predecessor: ADSL.AGE
AGEU	Age Units	text	5		Predecessor: ADSL.AGEU
AGEGR1	Pooled Age Group 1	text	30	Pooled Age Group 1 • ">=18 and <55 Years" • ">=55 Years"	Predecessor: ADSL.AGEGR1
AGEGR1N	Pooled Age Group 1 (N)	integer	8		Predecessor: ADSL.AGEGR1N
AGEGR2	Pooled Age Group 2	text	19	Pooled Age Group 2 • ">=18 and <=22 Years" • ">=23 and <=25 Years" • ">25 and <55 Years" • ">=55 Years"	Predecessor: ADSL.AGEGR2
AGEGR2N	Pooled Age Group 2 (N)	integer	8		Predecessor: ADSL.AGEGR2N
SEX	Sex	text	1	Sex • "F" • "M"	Predecessor: ADSL.SEX
RACE	Race	text	41	Race [8 Terms]	Predecessor: ADSL.RACE
RACESPY	Race Specify	text	200		Predecessor: ADSL.RACESPY
ETHNIC	Ethnicity	text	22	Ethnicity • "HISPANIC OR LATINO" • "NOT HISPANIC OR LATINO" • "NOT REPORTED" • "UNKNOWN"	Predecessor: ADSL.ETHNIC
RANDFL	Randomized Population Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.RANDFL
SAFFL	Safety Population Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.SAFFL
FASBABFL	Full Analysis Set bAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASBABFL
FASNABFL	Full Analysis Set nAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASNABFL
PPBABFL	Per Protocol bAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBABFL
PPNABFL	Per Protocol nAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPNABFL
PPBD29FL	Per Protocol bAb Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBD29FL
PPBD57FL	Per Protocol bAb Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBD57FL
PPND29FL	Per Protocol nAb Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPND29FL
PPND57FL	Per Protocol nAb Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPND57FL
SAR1FL	First Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAR1FL
SAR2FL	Second Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAR2FL
SARAFL	Solicited Safety Population Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.SARAFL
FASNA2FL	FAS nAb 2 Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASNA2FL
PPNAB2FL	PP nAb 2 Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPNAB2FL
PN2D29FL	Per Protocol nAb 2 Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PN2D29FL
PN2D57FL	Per Protocol nAb 2 Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PN2D57FL
COMPLFL	Completers Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.COMPLFL
DVBABFL	Deviation Impact bAb Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DVBABFL
DVNABFL	Deviation Impact nAb Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DVNABFL
DOSE1FL	Vaccination 1 Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.DOSE1FL
DOSE2FL	Vaccination 2 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DOSE2FL
DOSEROFL	Dosing Error Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DOSEROFL
COV19BL	Baseline COVID Infection	text	20	Baseline COVID Infection • "Detected" • "Not Detected"	Predecessor: ADSL.COV19BL
COV19FL	COVID Infection Flag	text	20	No Yes Response • "N" • "Y"	Predecessor: ADSL.COV19FL
SENTLFL	Sentinel Participant Flag	text	3	No Yes Response • "N" • "Y"	Predecessor: ADSL.SENTLFL
D29W7DFL	Day 29 Out of 7-Day Window Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.D29W7DFL
TRT01P	Planned Treatment for Period 01	text	25	Planned Treatment for Period 01 • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Predecessor: ADSL.TRT01P
TRT01PN	Planned Treatment for Period 01 (N)	integer	8		Predecessor: ADSL.TRT01PN
TRT01A	Actual Treatment for Period 01	text	25	Actual Treatment for Period 01 • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Predecessor: ADSL.TRT01A
TRT01AN	Actual Treatment for Period 01 (N)	integer	8		Predecessor: ADSL.TRT01AN
TR01SDT	Date of First Exposure in Period 01	integer	DATE9		Predecessor: ADSL.TR01SDT
TR01SDTM	Datetime of First Exposure in Period 01	integer	DATETIME20		Predecessor: ADSL.TR01SDTM
TR01EDT	Date of Last Exposure in Period 01	integer	DATE9		Predecessor: ADSL.TR01EDT
TR01EDTM	Datetime of Last Exposure in Period 01	integer	DATETIME20		Predecessor: ADSL.TR01EDTM
TRTSDTM	Datetime of First Exposure to Treatment	integer	DATETIME20		Predecessor: ADSL.TRTSDTM
TRTEDTM	Datetime of Last Exposure to Treatment	integer	DATETIME20		Predecessor: ADSL.TRTEDTM
DOSE2DT	Date of Dose 2	integer	DATE9		Predecessor: ADSL.DOSE2DT
DOS2DTM	Datetime of Dose 2	integer	DATETIME20		Predecessor: ADSL.DOS2DTM
ADT	Analysis Date	integer	DATE9		Derived Set to numeric date part of FAOT.FADTC if source data are from FAOT, Set to number date part of ER.ERDTC if source data are from ER, Set to number date part of SS.SSDTC if source data are from SS
ADY	Analysis Relative Day	integer	8		Derived Set to ADT - ADSL.TR01SDT + 1 if If ADT >= ADSL.TR01SDT, or Set to ADT - ADSL.TR01SDT if ADT < ADSL.TR01SDT
VISIT	Visit Name	text	28		Predecessor: DM.VISIT
VISITNUM	Visit Number	float	8		Predecessor: DM.VISITNUM
AVISIT	Analysis Visit	text	50		Derived If VISIT doesn't contain 'Unsched', set to 'Day xx' part of VISIT, If ADY>1 and VISIT contains 'Unsched', set AVISIT as follows: using the visit window below: If VISIT with 1<ADY<=11, then AVISIT = 'Day 8', else if VISIT with 12<=ADY<=22, then AVISIT = 'Day 15', else if VISIT with 23<=ADY<=32, then AVISIT = 'Day 29', else if VISIT with 33<=ADY<=39, then AVISIT = 'Day 36', else if VISIT with 40<=ADY<=50, then AVISIT = 'Day 43', else if VISIT with 51<=ADY<=133, then AVISIT = 'Day 57', else if VISIT with 134=<ADY<=301, then AVISIT = 'Day 209', else if VISIT with ADY>=302, then AVISIT = 'Day 394', After the steps above, sort data by AVISITN and ADY, set the unscheduled visit (i.e., VISIT contains 'Unsched') records to blank if AVISITN >any previous AVISITN AND ADY<=any previous ADY). For example, Scheduled Day 36 is with AVISITN=6 (Day 36) and ADY=42 and an unscheduled visit is with AVISITN=7 (Day 43) and ADY=40, set AVISIT to blank for this unscheduled visit
AVISITN	Analysis Visit (N)	integer	8		Assigned 1 if AVISIT = 'Baseline', 2 if AVISIT=Day 1, 3 if AVISIT=Day 8, 4 if AVISIT=Day 15, 5 if AVISIT=Day 29, 6 if AVISIT=Day 36, 7 if AVISIT=Day 43, 8 if AVISIT=Day 57
PARCAT1	Parameter Category 1	text	50	COVID-19 Parameter Category • "COVID-19 EXPOSURE" • "COVID-19 SYMPTOMS"	Derived Set to FAOT.FACAT if source data are from FAOT Set to ER.ERCAT if source data are from ER For data from SS, set to 'COVID-19 SYMPTOMS' if SSTESTCD='COVIDSYM' and 'COVID-19 EXPOSURE' if SSTESTCD='COVID'
PARAMCD	Parameter Code	text	8	COVID-19 Analysis Dataset Parameter Code [24 Terms]	Assigned 'DUR' if PARAM='Duration', 'EXPFAM' if PARAM='Family member', 'EXPHCF' if PARAM='Health Care Facility', 'EXPOTH' if PARAM='Other exposure', 'EXPSOC' if PARAM='Social setting', 'EXPTRAV' if PARAM='Travel', 'EXPWORK' if PARAM='Work', 'CONTACT' if PARAM='The participant had close contact with a person known to have SARS-CoV-2 infection or COVID-19', 'COUGH' if PARAM='Cough', 'SOB' if PARAM='Shortness of Breath', 'FEVER' if PARAM='Fever', 'SORETHRT' if PARAM='Sore Throat', 'CHESTTP' if PARAM='Chest Tightness/Pressure', 'HEADACHE' if PARAM='Headache', 'LETHARGY' if PARAM='Lethargy', 'MYALGIA' if PARAM='Myalgia', 'ANOSMIA' if PARAM='Anosmia', 'DYSGEUSI' if PARAM='Dysgeusia', 'CHILLS' if PARAM='Chills', 'REPTSHAK' if PARAM='Repeated Shaking with chills', 'OTHSYMPT' if PARAM='Other Symptoms', 'COVID' if PARAM='COVID-19'
PARAM	Parameter	text	200		Derived If PARCAT1='COVID-19 SYMPTOMS' set to FAOT.FAOBJ if PARCAT1='COVID-19 EXPOSURE' set to ER.ERTERM and create PARAM='Duration' if ERDUR is not missing per subject per ERDTC For data from SS, set to SSTEST Per subject per visit, if there are multiple records where PARAM='Other Symptoms', only keep one, and set FASEQ to the earliest FAOT.FASEQ.
AVAL	Analysis Value	integer	8		Derived Set to numeric part of ER.ERDUR
AVALC	Analysis Value (C)	text	50		Derived FAOT.FASTRESC if source data are from FAOT; ER.EROCCUR if source data are from ER; SS.SSSTRESC if source data are from SS; Set to numeric part of ER.ERDUR for PARAMCD=DUR and convert to character
T2FSYMP	Time from Last Exposure to First Symptom	integer	8		Derived Set 'Y' if subject with DS.DSDECOD countians 'ADVERSE EVENT' or 'AE' and the specified adverse event number match the AE.AESPID where DSCAT = DISPOSITION EVENT and DS.DSSCAT='END OF STUDY' Otherwise null
AWRANGE	Analysis Window Valid Relative Range	text	50		Assigned “<=1" for ‘Day 1’ “Day 2 - Day 11” for ‘Day 8’, “Day 12 - Day 22” for “Day 15”, “Day 23 – Day 32” for “Day 29”, “Day 33 – Day 39” for “Day 36”, “Day 40 - Day 50” for “Day 43”, “Day 51 – Day 133” for “Day 57”
AWTARGET	Analysis Window Target	integer	8		Assigned 2 for ‘Day 1’ 8 for ‘Day 8’, 15 for 'Day 15', 29 for 'Day 29', 36 for 'Day 36', 43 for 'Day 43', 57 for 'Day 57'
AWTDIFF	Analysis Window Diff from Target	integer	8		Derived Set to absolute value of (ADY - AWTARGET)
ANL01FL	Analysis Flag 01	text	1	No Yes Response (Yes Only) • "Y"	Derived Per subject per parameter and per AVISIT, set to ‘Y’ for the worst assessment (AVALC='Y'>'N') within the same visit to be considered first, if there are multiple with same AVALC then set 'Y' to the assessment at scheduled visit (i.e., VISIT doesn't contain "Unshed"). If there are 2 or more scheduled assessments at same visit, set to the last assessment
SYMPTDT	Estimated date of first symptoms	integer	DATE9		Derived Derive for records where PARAMCD='COVID' and AVALC='Y': use SUPPFAOT.QVAL where QNAM='SYMPTDTC'
EXPOSEDT	Estimated start date of exposure	integer	DATE9		Derived Derive for records where PARAMCD='CONTACT' and AVALC='Y': use ER.ERSTDTC
OTHSPY	Symptoms other	text	200		Derived If PARAMCD='OTHSYMPT' and AVALC='Y', then concatenate all the SUPPFAOT.QVAL where QNAM='SYMPOTH' with ', ' for that subject and visit; If PARAMCD='EXPOTH' and AVALC='Y', then set to SUPPER.QVAL where QNAM='EXPOSEOT'
SRCDOM	Source Data	text	20		Derived FAOT.DOMAIN if source data are from FAOT; ER.DOMAIN if source data are from ER; SS.DOMAIN if source data are from SS
SRCSEQ	Source Sequence Number	integer	8		Derived FAOT.FASEQ if source data are from FAOT; ER.ERSEQ if source data are from ER; SS.SSEQ if source data are from SS
SRCVAR	Source Variable	text	50		Derived Set to 'FASTRESC' if source data are from FAOT; Set to 'EROCCUR' if source data are from ER if PARAMCD is not 'DUR'; Set to 'ERDUR' if source data are from ER if PARAMCD is 'DUR'; Set to 'SSSTRESC' if source data are from SS

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Immunogenicity Analysis Dataset (ADIS)

ADIS (Immunogenicity Analysis Dataset) - BASIC DATA STRUCTURE Location: adis.xpt
Variable	Where Condition	Label / Description	Type	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID		Study Identifier	text	14	Study Identifier • "mRNA-1273-P201"	Predecessor: ADSL.STUDYID
USUBJID		Unique Subject Identifier	text	25		Predecessor: ADSL.USUBJID
SUBJID		Subject Identifier for the Study	text	9		Predecessor: ADSL.SUBJID
SITEID		Study Site Identifier	text	5		Predecessor: ADSL.SITEID
COUNTRY		Country	text	3	Country • "USA"	Predecessor: ADSL.COUNTRY
AGE		Age	integer	8		Predecessor: ADSL.AGE
AGEU		Age Units	text	5		Predecessor: ADSL.AGEU
AGEGR1		Pooled Age Group 1	text	30	Pooled Age Group 1 • ">=18 and <55 Years" • ">=55 Years"	Predecessor: ADSL.AGEGR1
AGEGR1N		Pooled Age Group 1 (N)	integer	8		Predecessor: ADSL.AGEGR1N
AGEGR2		Pooled Age Group 2	text	19	Pooled Age Group 2 • ">=18 and <=22 Years" • ">=23 and <=25 Years" • ">25 and <55 Years" • ">=55 Years"	Predecessor: ADSL.AGEGR2
AGEGR2N		Pooled Age Group 2 (N)	integer	8		Predecessor: ADSL.AGEGR2N
SEX		Sex	text	1	Sex • "F" • "M"	Predecessor: ADSL.SEX
RACE		Race	text	41	Race [8 Terms]	Predecessor: ADSL.RACE
RACESPY		Race Specify	text	200		Predecessor: ADSL.RACESPY
ETHNIC		Ethnicity	text	22	Ethnicity • "HISPANIC OR LATINO" • "NOT HISPANIC OR LATINO" • "NOT REPORTED" • "UNKNOWN"	Predecessor: ADSL.ETHNIC
RANDFL		Randomized Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.RANDFL
SAFFL		Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAFFL
FASBABFL		Full Analysis Set bAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASBABFL
FASNABFL		Full Analysis Set nAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASNABFL
PPBABFL		Per Protocol bAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBABFL
PPNABFL		Per Protocol nAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPNABFL
PPBD29FL		Per Protocol bAb Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBD29FL
PPBD57FL		Per Protocol bAb Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBD57FL
PPND29FL		Per Protocol nAb Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPND29FL
PPND57FL		Per Protocol nAb Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPND57FL
SAR1FL		First Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAR1FL
SAR2FL		Second Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAR2FL
SARAFL		Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SARAFL
FASNA2FL		FAS nAb 2 Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASNA2FL
PPNAB2FL		PP nAb 2 Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPNAB2FL
PN2D29FL		Per Protocol nAb 2 Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PN2D29FL
PN2D57FL		Per Protocol nAb 2 Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PN2D57FL
COMPLFL		Completers Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.COMPLFL
DVBABFL		Deviation Impact bAb Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DVBABFL
DVNABFL		Deviation Impact nAb Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DVNABFL
DOSE1FL		Vaccination 1 Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.DOSE1FL
DOSE2FL		Vaccination 2 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DOSE2FL
DOSEROFL		Dosing Error Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DOSEROFL
COV19BL		Baseline COVID Infection	text	20	Baseline COVID Infection • "Detected" • "Not Detected"	Predecessor: ADSL.COV19BL
COV19FL		COVID Infection Flag	text	20	No Yes Response • "N" • "Y"	Predecessor: ADSL.COV19FL
SENTLFL		Sentinel Participant Flag	text	3	No Yes Response • "N" • "Y"	Predecessor: ADSL.SENTLFL
D29W7DFL		Day 29 Out of 7-Day Window Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.D29W7DFL
TRT01P		Planned Treatment for Period 01	text	25	Planned Treatment for Period 01 • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Predecessor: ADSL.TRT01P
TRT01PN		Planned Treatment for Period 01 (N)	integer	8		Predecessor: ADSL.TRT01PN
TRT01A		Actual Treatment for Period 01	text	25	Actual Treatment for Period 01 • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Predecessor: ADSL.TRT01A
TRT01AN		Actual Treatment for Period 01 (N)	integer	8		Predecessor: ADSL.TRT01AN
TR01SDT		Date of First Exposure in Period 01	integer	DATE9		Predecessor: ADSL.TR01SDT
TR01SDTM		Datetime of First Exposure in Period 01	integer	DATETIME20		Predecessor: ADSL.TR01SDTM
TR01EDT		Date of Last Exposure in Period 01	integer	DATE9		Predecessor: ADSL.TR01EDT
TR01EDTM		Datetime of Last Exposure in Period 01	integer	DATETIME20		Predecessor: ADSL.TR01EDTM
TRTSDTM		Datetime of First Exposure to Treatment	integer	DATETIME20		Predecessor: ADSL.TRTSDTM
TRTEDTM		Datetime of Last Exposure to Treatment	integer	DATETIME20		Predecessor: ADSL.TRTEDTM
DOSE2DT		Date of Dose 2	integer	DATE9		Predecessor: ADSL.DOSE2DT
DOS2DTM		Datetime of Dose 2	integer	DATETIME20		Predecessor: ADSL.DOS2DTM
TRTA		Actual Treatment	text	50	Actual Treatment • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Derived "If (.<ADSL.TR01SDTM<=ADTM <DOS2DTM) or (.<ADSL.TR01SDTM<=ADTM and ADSL.DOS2DTM is missing): 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'Day 1' ; 'mRNA-1273 50 ug' if EX.EXTRT='mRNA-1273' and 1) 0<EXDOSE<=75 where EX.VISIT contains 'Day 1', or 2) EXDOSTXT contains '>0-25', '>25-<50' or '>50-75' where EX.VISIT contains 'Day 1'; 'mRNA-1273 100 ug' if EX.EXTRT='mRNA-1273' and 1) EXDOSE>75 where EX.VISIT contains 'Day 1', or 2) EXDOSTXT contains '>75-<100' or '>100-125' or '>125' where EX.VISIT contains 'Day 1'; if .<ADSL.DOS2DTM<=ASTDTM: 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'Day 29' ; 'mRNA-1273 50 ug' if 1) EX.EXTRT='mRNA-1273' and 0<EXDOSE<=75 where EX.VISIT contains 'Day 29', or 2) EXDOSTXT contains '>0-25', '>25-<50' or '>50-75' where EX.VISIT contains 'Day 29'; 'mRNA-1273 100 ug' if EX.EXTRT='mRNA-1273' and 1) EXDOSE>75 where EX.VISIT contains 'Day 29', or 2) EXDOSTXT contains '>75-<100' or '>100-125' or '>125' where EX.VISIT contains 'Day 29'; if time part of ADTM, TR01SDTM, or DOS2DTM is missing, use ADT, TR01SDT, and DOSE2DT to replace ADTM, TR01SDTM, and DOS2DTM, respectively."
TRTAN		Actual Treatment (N)	integer	8		Assigned 1 if TRT01A=‘Placebo’, 2 if TRT01A=‘mRNA-1273 50 ug’, 3 if TRT01A=‘mRNA-1273 100 ug’"
ISSEQ		Sequence Number	integer	8		Predecessor: IS.ISSEQ
ISDTC		Date/Time of Collection	datetime		ISO 8601	Predecessor: IS.ISDTC
ADT		Analysis Date	integer	DATE9		Derived Set to numeric date part of IS.ISDTC
ATM		Analysis Time	integer	TIME5		Derived Time part of IS.ISDTC
ADTM		Analysis Datetime	integer	DATETIME20		Derived Concatenate of ADT and ATM if both are available
ADY		Analysis Relative Day	integer	8		Derived Set to ADT - ADSL.TR01SDT + 1 if If ADT >= ADSL.TR01SDT, or Set to ADT - ADSL.TR01SDT if ADT < ADSL.TR01SDT
VISIT		Visit Name	text	28		Predecessor: IS.VISIT
VISITNUM		Visit Number	float	8		Predecessor: IS.VISITNUM
AVISIT		Analysis Visit	text	50		Derived If ABLFL='Y' then AVISIT='Baseline'; if ADY>1 and VISIT doesn't contain "UNSCHEDULE", set to 'Day xx' part of VISIT; ; if ADY>1 and VISIT contains "UNSCHED", set AVISIT as follows: using the visit window below: If VISIT with 1<ADY<=22, then AVISIT = ’Day 15’; else if VISIT with 23<=ADY<=36, then AVISIT = ’Day 29’; else if VISIT with 37<=ADY<=50, then AVISIT = ’Day 43’; else if VISIT with 51<=ADY<=133, then AVISIT = ’Day 57’; else if VISIT with 134=<ADY<=301, then AVISIT = ’Day 209’; else if VISIT with ADY>=302, then AVISIT = ’Day 394’;
AVISITN		Analysis Visit (N)	integer	8		Assigned 1 if AVISIT = 'Baseline', 2 if AVISIT=Day 1, 3 if AVISIT=Day 8, 4 if AVISIT=Day 15, 5 if AVISIT=Day 29, 6 if AVISIT=Day 36, 7 if AVISIT=Day 43, 8 if AVISIT=Day 57
PARCAT1		Parameter Category 1	text	50	Immunogenicity Parameter Category • "Serum SARS-CoV-2 Binding Antibodies" • "Serum SARS-CoV-2 Neutralizing Antibodies"	Derived Set to IS.ISCAT
PARAMCD		Parameter Code	text	8	Immunogenicity Analysis Dataset Parameter Code [8 Terms]	Assigned Set to ISTESTCD and create follow PARAMCDs if AVAL is not missing; L10PVN50, L10PVN80, L10MN50, LV58IGGS, LV58IGGN, LV58IGMS, LV58IG1S, LV58IG2S, LV58IG3S, LV58IG4S
PARAM		Parameter	text	50		Derived For PARCAT1='Serum SARS-CoV-2 Neutralizing Antibodies', set to ISTEST; For PARCAT1='Serum SARS-CoV-2 Binding Antibodies', if PARAMCD does not contain 'L10' then set to ISTEST " (" \|\|ISSTRESU\|\| ")" if ISSTRESU is non-missing for the test, or ISTEST if ISSTRESU is not available for the test; If PARAMCD contains 'L10' then assign PARAM based on PARAMCD: 'LOG10(PsVNT50)' if PARAMCD='L10PVN50'; 'LOG10(PsVNT80)' if PARAMCD='L10PVN80'; 'LOG10(MN50)' if PARAMCD='L10MN50'; 'LOG10(VAC58 Spike IgG Antibody)' if PARAMCD='LV58IGGS' 'LOG10(VAC58 Nucleocapsid IgG Antibody)' if PARAMCD='LV58IGGN'； 'LOG10(VAC58 Spike IgM Antibody)' if PARAMCD='LV58IGMS'； 'LOG10(VAC58 Spike IgG subclass 1)' if PARAMCD='LV58IG1S'； 'LOG10(VAC58 Spike IgG subclass 2)' if PARAMCD='LV58IG2S'； 'LOG10(VAC58 Spike IgG subclass 3)' if PARAMCD='LV58IG3S'； 'LOG10(VAC58 Spike IgG subclass 4)' if PARAMCD='LV58IG4S'
AVALVLM		Analysis Value	float	8
	PARAMCD IN ( "L10MNET" (LOG10(MN Endpoint Titer)), "L10MN50" (LOG10(MN50)), "LV58IGGS" (LOG10(VAC58 Spike IgG Antibody)), "LV58IGGN" (LOG10(VAC58 Nucleocapsid IgG Antibody)) )		float	12		Derived If ISSTRESC contains "<" or ISSTRESN<LOD or ISSTRESN<ISLLOQ, then set to LOG10(0.5* times ISLLOQ). If ISSTRESC contains ">" or ISSTRESN>ULOQ then set AVAL as LOG10(ULOQ). Otherwise set to LOG10(IS.ISSTRESN).
	PARAMCD IN ( "MNET" (MN Endpoint Titer), "MN50" (MN50), "V58IGGES" (VAC58 Spike IgG Antibody (ug/ml)), "V58IGGEN" (VAC58 Nucleocapsid IgG Antibody (AU/ml)) )		float	9		Derived If ISSTRESC contains "<" or ISSTRESN<LOD or ISSTRESN<ISLLOQ, then set AVAL as 0.5 times ISLLOQ. If ISSTRESC contains ">" or ISSTRESN>ULOQ then set AVAL as ULOQ. Otherwise set to IS.ISSTRESN.
ISSTRESC		Result or Finding in Standard Format	text	7		Predecessor: IS.ISSTRESC
BASE		Baseline Value	float	8		Derived AVAL where ABLFL = 'Y' for each SUBJID, PARCAT1 and PARAMCD
CHG		Change from Baseline	float	8		Derived AVAL-BASE for post-baseline records
R2BASE		Ratio to Baseline	float	8		Derived AVAL/BASE if both are available and BASE is not 0
AWRANGE		Analysis Window Valid Relative Range	text	20		Assigned “<=1 Pre-dose" for ‘Baseline’ “Day 2 – Day 22” for 'Day 15'; “Day 23 – Day 36” for 'Day 29'; “Day 37 – Day 50” for 'Day 43'; “Day 51 – Day 133” for 'Day 57';
AWTARGET		Analysis Window Target	integer	8		Assigned 1 for ‘Baseline’ 15 for 'Day 15'; 29 for 'Day 29'; 43 for 'Day 43'; 57 for 'Day 57';
AWTDIFF		Analysis Window Diff from Target	integer	8		Derived Set to absolute value of (ADY - AWTARGET)
ABLFL		Baseline Record Flag	text	1	No Yes Response (Yes Only) • "Y"	Derived Set to 'Y' by selecting the latest ADTM or ADT if time is not available with non-missing AVAL/AVALC on or before ADSL.TR01SDTM (TR01SDT if time part of TR01SDTM is missing) for each SUBJID, PARCAT1 and PARAMCD
ANL01FL		Analysis Flag 01	text	1	No Yes Response (Yes Only) • "Y"	Derived Set to 'Y' if ABLFL='Y', For post-baseline assessments where AVISITN is non-missing and result (AVAL) is non-missing, per subject per parameter and per AVISIT, Within an AVISIT, Set to ‘Y’ for the assessment at scheduled visit (i.e., VISIT doesn't contain "Unsched") or Set to ‘Y’ for the latest assessment if there are 2 or more assessments at scheduled visit, or Set to ‘Y’ for the latest assessment if there is no scheduled visit, or Set to 'Y' for the assessment closest to the target study day in the visit window or Set to 'Y' for the latest assessment If there are 2 or more assessments equal distance to the target study day
ANL02FL		Analysis Flag 02	text	1	No Yes Response (Yes Only) • "Y"	Derived Same as ANL01FL For PARCAT1='Serum SARS-CoV-2 Neutralizing Antibodies', only consider results from Set 1 LLOQ/ULOQ (MNET 40 and 1280, MN50 91.1 and 2031.87).
CRIT1		Analysis Criterion 1	text	100		Derived if CRIT1FL="Y" and PARAMCD is MNET, or MN50, then set to '>=2-fold Increase from Baseline'
CRIT1FL		Criterion 1 Evaluation Result Flag	text	1	No Yes Response (Yes Only) • "Y"	Derived 'Y' if PARAMCD is MNET or MN50 and post-baseline increase 2 times from the baseline value (R2BASE>=2)
CRIT2		Analysis Criterion 2	text	100		Derived if CRIT2FL="Y" and PARAMCD is MNET, or MN50, then set to '>=3-fold Increase from Baseline'
CRIT2FL		Criterion 2 Evaluation Result Flag	text	1	No Yes Response (Yes Only) • "Y"	Derived 'Y' if PARAMCD is MNET or MN50 and post-baseline increase 3 times from the baseline value (R2BASE>=3)
CRIT3		Analysis Criterion 3	text	100		Derived if CRIT3FL="Y" and PARAMCD is MNET or MN50, then set to '>=4-fold Increase from Baseline'
CRIT3FL		Criterion 3 Evaluation Result Flag	text	1	No Yes Response (Yes Only) • "Y"	Derived 'Y' if PARAMCD is MNET or MN50 and post-baseline increase 4 times from the baseline value (R2BASE>=4)
CRIT4		Analysis Criterion 4	text	100		Derived if CRIT4FL="Y" and PARAMCD is MNET, or MN50, then set to 'Seroconversion'
CRIT4FL		Criterion 4 Evaluation Result Flag	text	1	No Yes Response (Yes Only) • "Y"	Derived If PARAMCD is MNET or MN50, Derive when both baseline result (ISSTRESC where ABLF='Y') and post-baseline result (AVAL) are non-missing, set to 'Y' if baseline result ISSTRESC contains "<" or ISSTRESN<LOD or ISSTRESN<ISLLOQ and post-baseline >= LLOQ (AVAL>=ISLLOQ); or baseline result does not contain '<' and not less than LOD and not less than ISLLOQ and post-baseline increase 4 times from the baseline value (R2BASE>=4)
PPBABRFL		Per Protocol bAb Record-Level Flag	text	1	No Yes Response (Yes Only) • "Y"	Derived Set to 'Y' if PP_listing.PVSBABFL='Y' for PARCAT1='Serum SARS-CoV-2 Binding Antibodies' based on subject and visit (ADIS.AVISIT and pp_listing.VISITTPT).
PPNABRFL		Per Protocol nAb Record-Level Flag	text	1	No Yes Response (Yes Only) • "Y"	Derived Set to 'Y' if PP_listing.PVSNABFL='Y' for PARCAT1='Serum SARS-CoV-2 Neutralizing Antibodies' based on subject and visit (ADIS.AVISIT and pp_listing.VISITTPT).
PPBABRER		PP bAb Record-Level Exclusion Reason	text	200		Derived "Set to PP_list.PBABREAS for PARCAT1='Serum SARS-CoV-2 Binding Antibodies' based on subject and visit (ADIS.AVISIT and pp_list.VISITTPT). if subject has dosing error (ADSL.PPBABERS contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list if applicable"
PPNABRER		PP nAb Record-Level Exclusion Reason	text	200		Derived Set to PP_list.PNABREAS for PARCAT1='Serum SARS-CoV-2 Neutralizing Antibodies' based on subject and visit (ADIS.AVISIT and pp_list.VISITTPT). if subject has dosing error (ADSL.PPNABERS contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list if applicable
PPNA2RFL		PP nAb 2 Record-Level Flag	text	1	No Yes Response (Yes Only) • "Y"	Derived Set to 'Y' if ADSL.PPNAB2FL='Y' and PP_list2.PVSNABFL='Y' for PARCAT1='Serum SARS-CoV-2 Neutralizing Antibodies' based on subject and visit (ADIS.AVISIT and pp_list2.VISITTPT).
ISLLOQ		Lower Limit of Quantitation	float	8		Predecessor: IS.ISLLOQ
ULOQ		Upper Limit of Quantification	integer	8		Derived SUPPIS.QVAL where QNAM is 'ULOQ'
LOD		Limit of Detection	float	8		Derived SUPPIS.QVAL where QNAM is 'LOD'
ISNAM		Vendor Name	text	11		Predecessor: IS.ISNAM
ISSPEC		Specimen Type	text	5	Specimen Type • "SERUM"	Predecessor: IS.ISSPEC
DTYPE		Derivation Type	text	20	Derivation Type • "DERIVED" • "HALFLLOQ" • "ULOQ"	Derived Set to 'DERIVED' if PARAMCD contains 'L10' or 'LV58'
PARAMTYP		Parameter Type	text	7		Derived Set to 'DERIVED' if PARAMCD contains 'L10' or 'LV58'

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Laboratory Analysis Dataset (ADLB)

ADLB (Laboratory Analysis Dataset) - BASIC DATA STRUCTURE Location: adlb.xpt
Variable	Where Condition	Label / Description	Type	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID		Study Identifier	text	14	Study Identifier • "mRNA-1273-P201"	Predecessor: ADSL.STUDYID
USUBJID		Unique Subject Identifier	text	25		Predecessor: ADSL.USUBJID
SUBJID		Subject Identifier for the Study	text	9		Predecessor: ADSL.SUBJID
SITEID		Study Site Identifier	text	5		Predecessor: ADSL.SITEID
COUNTRY		Country	text	3	Country • "USA"	Predecessor: ADSL.COUNTRY
AGE		Age	integer	8		Predecessor: ADSL.AGE
AGEU		Age Units	text	5		Predecessor: ADSL.AGEU
AGEGR1		Pooled Age Group 1	text	30	Pooled Age Group 1 • ">=18 and <55 Years" • ">=55 Years"	Predecessor: ADSL.AGEGR1
AGEGR1N		Pooled Age Group 1 (N)	integer	8		Predecessor: ADSL.AGEGR1N
AGEGR2		Pooled Age Group 2	text	19	Pooled Age Group 2 • ">=18 and <=22 Years" • ">=23 and <=25 Years" • ">25 and <55 Years" • ">=55 Years"	Predecessor: ADSL.AGEGR2
AGEGR2N		Pooled Age Group 2 (N)	integer	8		Predecessor: ADSL.AGEGR2N
SEX		Sex	text	1	Sex • "F" • "M"	Predecessor: ADSL.SEX
RACE		Race	text	41	Race [8 Terms]	Predecessor: ADSL.RACE
RACESPY		Race Specify	text	200		Predecessor: ADSL.RACESPY
ETHNIC		Ethnicity	text	22	Ethnicity • "HISPANIC OR LATINO" • "NOT HISPANIC OR LATINO" • "NOT REPORTED" • "UNKNOWN"	Predecessor: ADSL.ETHNIC
RANDFL		Randomized Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.RANDFL
SAFFL		Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAFFL
FASBABFL		Full Analysis Set bAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASBABFL
FASNABFL		Full Analysis Set nAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASNABFL
PPBABFL		Per Protocol bAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBABFL
PPNABFL		Per Protocol nAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPNABFL
PPBD29FL		Per Protocol bAb Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBD29FL
PPBD57FL		Per Protocol bAb Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBD57FL
PPND29FL		Per Protocol nAb Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPND29FL
PPND57FL		Per Protocol nAb Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPND57FL
SAR1FL		First Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAR1FL
SAR2FL		Second Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAR2FL
SARAFL		Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SARAFL
FASNA2FL		FAS nAb 2 Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASNA2FL
PPNAB2FL		PP nAb 2 Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPNAB2FL
PN2D29FL		Per Protocol nAb 2 Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PN2D29FL
PN2D57FL		Per Protocol nAb 2 Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PN2D57FL
COMPLFL		Completers Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.COMPLFL
DVBABFL		Deviation Impact bAb Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DVBABFL
DVNABFL		Deviation Impact nAb Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DVNABFL
DOSE1FL		Vaccination 1 Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.DOSE1FL
DOSE2FL		Vaccination 2 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DOSE2FL
DOSEROFL		Dosing Error Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DOSEROFL
COV19BL		Baseline COVID Infection	text	20	Baseline COVID Infection • "Detected" • "Not Detected"	Predecessor: ADSL.COV19BL
COV19FL		COVID Infection Flag	text	20	No Yes Response • "N" • "Y"	Predecessor: ADSL.COV19FL
SENTLFL		Sentinel Participant Flag	text	3	No Yes Response • "N" • "Y"	Predecessor: ADSL.SENTLFL
D29W7DFL		Day 29 Out of 7-Day Window Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.D29W7DFL
TRT01P		Planned Treatment for Period 01	text	25	Planned Treatment for Period 01 • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Predecessor: ADSL.TRT01P
TRT01PN		Planned Treatment for Period 01 (N)	integer	8		Predecessor: ADSL.TRT01PN
TRT01A		Actual Treatment for Period 01	text	25	Actual Treatment for Period 01 • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Predecessor: ADSL.TRT01A
TRT01AN		Actual Treatment for Period 01 (N)	integer	8		Predecessor: ADSL.TRT01AN
TR01SDT		Date of First Exposure in Period 01	integer	DATE9		Predecessor: ADSL.TR01SDT
TR01SDTM		Datetime of First Exposure in Period 01	integer	DATETIME20		Predecessor: ADSL.TR01SDTM
TR01EDT		Date of Last Exposure in Period 01	integer	DATE9		Predecessor: ADSL.TR01EDT
TR01EDTM		Datetime of Last Exposure in Period 01	integer	DATETIME20		Predecessor: ADSL.TR01EDTM
TRTSDTM		Datetime of First Exposure to Treatment	integer	DATETIME20		Predecessor: ADSL.TRTSDTM
TRTEDTM		Datetime of Last Exposure to Treatment	integer	DATETIME20		Predecessor: ADSL.TRTEDTM
DOSE2DT		Date of Dose 2	integer	DATE9		Predecessor: ADSL.DOSE2DT
DOS2DTM		Datetime of Dose 2	integer	DATETIME20		Predecessor: ADSL.DOS2DTM
TRTA		Actual Treatment	text	50	Actual Treatment • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Derived If MDOSREF='Vaccination 1', set to: 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'Day 1' ; 'mRNA-1273 50 ug' if EX.EXTRT='mRNA-1273' and 0<EXDOSE<=75 where EX.VISIT contains 'Day 1'; 'mRNA-1273 100 ug' if EX.EXTRT='mRNA-1273' and EXDOSE>75 where EX.VISIT contains 'Day 1'; if MDOSREF='Vaccination 2', set to: 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'Day 29' ; 'mRNA-1273 50 ug' if EX.EXTRT='mRNA-1273' and 0<EXDOSE<=75 where EX.VISIT contains 'Day 29'; 'mRNA-1273 100 ug' if EX.EXTRT='mRNA-1273' and EXDOSE>75 where EX.VISIT contains 'Day 29';
TRTAN		Actual Treatment (N)	integer	8		Assigned 1 if TRT01A=‘Placebo’, 2 if TRT01A=‘mRNA-1273 50 ug’, 3 if TRT01A=‘mRNA-1273 100 ug’"
LBSEQ		Sequence Number	integer	8		Predecessor: LB.LBSEQ
LBDTC		Date/Time of Specimen Collection	datetime		ISO 8601	Predecessor: LB.LBDTC
ADT		Analysis Date	integer	DATE9		Derived Set to numeric date part of LB.LBDTC
ATM		Analysis Time	integer	TIME5		Derived Time part of LB.LBDTC
ADTM		Analysis Datetime	integer	DATETIME20		Derived Set to numeric date time of LBDTC if time part is not missing
ADY		Analysis Relative Day	integer	8		Derived Set to ADT - ADSL.TR01SDT + 1 if If ADT >= ADSL.TR01SDT, or Set to ADT - ADSL.TR01SDT if ADT < ADSL.TR01SDT
MDOSREF		Most Recent Dose Reference	text	25	Analysis Timepoint Reference • "Vaccination 1" • "Vaccination 2"	Derived If (.<ADSL.TR01SDTM<=ADTM <ADSL.DOS2DTM) or (.<ADSL.TR01SDTM<=ADTM and ADSL.DOS2DTM is missing), set to 'Vaccination 1'; if .<ADSL.DOS2DTM<=ADTM, set to 'Vaccination 2'; use date variables for comparison when time part is not available
MRDDY		Relative Day from Most Recent Dose	integer	8		Derived ADT – ADSL.TR01SDT+ 1 If MDOSREF='Vaccination 1', ADT – ADSL.DOSE2DT+ 1 If MDOSREF='Vaccination 2'.
VISIT		Visit Name	text	28		Predecessor: LB.VISIT
VISITNUM		Visit Number	float	8		Predecessor: LB.VISITNUM
AVISIT		Analysis Visit	text	50		Derived If ABLFL='Y', then AVISIT = 'Baseline', If ADY>1 and VISIT doesn't contain 'Unsched', set to 'Day xx' part of VISIT, if ADY>1 and VISIT contains 'Unsched', set AVISIT as follows: using the visit window below: If VISIT with 1<ADY<=43, then AVISIT = 'Day 29', Else If VISIT with 44<=ADY, then AVISIT = 'Day 57'
AVISITN		Analysis Visit (N)	integer	8		Assigned 1 if AVISIT = 'Baseline', 2 if AVISIT=Day 1, 3 if AVISIT=Day 8, 4 if AVISIT=Day 15, 5 if AVISIT=Day 29, 6 if AVISIT=Day 36, 7 if AVISIT=Day 43, 8 if AVISIT=Day 57
ASTAGE		Stage	text	30	Analysis Stage • "Follow up stage" • "Vaccination stage"	Derived For subjects who received 2 injections (DOSE1FL=’Y’ and DOSE2FL=’Y’), set to ‘Vaccination stage’ If .< ADSL.TR01SDTM <=ADTM and ADT<=earliest date of (date of Visit 7 (i.e. SV.SVSTDTC where SV.VISIT = 'Visit 7 Day 57'), ADSL.EOSDT, ADSL.DTHDT) ; set to 'Follow up stage' if ADT > non-missing date of Visit 7. If date of Visit 7, ADSL.EOSDT, and ADSL.DTHDT are all unavailable, set to ‘Vaccination stage’ for post baseline records. Else leave missing. For subjects who received only injection (DOSE1FL=’Y’ and DOSE2FL ne ’Y’), set to ‘Vaccination stage’ If .< ADSL.TR01SDTM <=ADTM and ADT<=earliest date of (date of Visit 4 (i.e. SV.SVSTDTC where SV.VISIT = 'Visit 4 Day 29'), ADSL.EOSDT, ADSL.DTHDT) ; set to 'Follow up stage' if ADT > non-missing date of Visit 4. If date of Visit 4, ADSL.EOSDT, and ADSL.DTHDT are all unavailable, set to ‘Vaccination stage’ for post baseline records. Else leave missing.
ASTAGEN		Stage (N)	integer	8		Assigned 1 if ASTAGE= Vaccination stage, 2 if ASTAGE= Follow up stage
PARCAT1		Parameter Category 1	text	50	Laboratory Parameter Category • "CHEMISTRY" • "COAGULATION" • "HEMATOLOGY" • "PREGNANCY TEST" • "SEROLOGY"	Derived Set to LB.LBCAT
PARAMCD		Parameter Code	text	8		Assigned Set to ECLIAHCG if LBCAT=CHEMISTRY and LBTESTCD=HCG and LBMETHOD=ELECTROCHEMILUMINESCENCE Set to CHEMIHCG if LBCAT=CHEMISTRY and LBTESTCD=HCG and LBMETHOD=CHEMILUMINESCENCE Set to U \|\| LBTESTCD If LBCAT=URINALYSIS Set to LBTESTCD if LBCAT ne URINALYSIS
PARAM		Parameter	text	100		Derived If LBCAT=CHEMISTRY and LBTESTCD=HCG and LBMETHOD='ELECTROCHEMILUMINESCENCE' or 'CHEMILUMINESCENCE', set to LBMETHOD\|\|' '\|\|LB.LBTEST\|\| ' (' \|\| LB.LBSTRESU \|\| ')' (please add space between LBMETHOD and LBTEST.) If LBCAT=URINALYSIS set to Urinary \|\| LB.LBTEST\|\| ' (' \|\| LB.LBSTRESU \|\| ')' if LBSTRESU is not blank If LBCAT ne URINALYSIS set to LB.LBTEST \|\| ' (' \|\| LB.LBSTRESU \|\| ')' if LBSTRESU is not blank If LBSTRESU is blank, set to LB.LBTEST appended with LBSTRESU from non-missing records in parenthesis. Note: Please add space between parameter and unit.
AVAL		Analysis Value	float	8		Derived LB.LBSTRESN If LBSTRESC contains '<', then take the value after '<', times 0.5 for AVAL. For example, if LBSTRESC="<3.4", then AVAL=1.7 If LBSTRESC contains '>', then take the value after '>' for AVAL. For example, if LBSTRESC=">75", then AVAL=75
BASE		Baseline Value	float	8		Derived Set to AVAL where ABLFL = 'Y' by USUBJID, PARCAT1, and PARAMCD
CHG		Change from Baseline	float	8		Derived AVAL-BASE for post-baseline records Note: post-baseline records are defined as any result where (ADTM > ADSL.TR01SDTM if time is available or ADY > 1 otherwise.
PCHG		Percent Change from Baseline	float	8		Derived (CHG/BASE)*100 if both are available and BASE is not 0
AWRANGE		Analysis Window Valid Relative Range	text	20		Assigned “<=1" for ‘Day 1’ “Day 2 - Day 11” for ‘Day 8’, “Day 12 - Day 22” for “Day 15”, “Day 23 – Day 32” for “Day 29”, “Day 33 – Day 39” for “Day 36”, “Day 40 - Day 50” for “Day 43”, “Day 51 – Day 133” for “Day 57”
AWTARGET		Analysis Window Target	integer	8		Assigned 2 for ‘Day 1’ 8 for ‘Day 8’, 15 for 'Day 15', 29 for 'Day 29', 36 for 'Day 36', 43 for 'Day 43', 57 for 'Day 57'
AWTDIFF		Analysis Window Diff from Target	integer	8		Derived Set to absolute value of (ADY - AWTARGET)
LBORNRLO		Reference Range Lower Limit in Orig Unit	text	4		Predecessor: LB.LBORNRLO
LBORNRHI		Reference Range Upper Limit in Orig Unit	text	5		Predecessor: LB.LBORNRHI
LBORRES		Result or Finding in Original Units	text	13		Predecessor: LB.LBORRES
LBORRESU		Original Units	text	9	Original Units [8 Terms]	Predecessor: LB.LBORRESU
LBTOXGR		Standard Toxicity Grade	text	1	Analysis Toxicity Grade [9 Terms]	Predecessor: LB.LBTOXGR
LBSTRESC		Character Result/Finding in Std Format	text	13		Predecessor: LB.LBSTRESC
ATOXGRLVLM		Analysis Toxicity Grade Low	text	20	Analysis Toxicity Grade [9 Terms]	Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007)
	PARAMCD = "HGB"	Hemoglobin (g/L)	text	10		Derived If AVAL is not missing and SEX=’F’, convert AVAL and CHG to g/dl (AVAL0.1, CHG0.1), then assign AVAL toxicity grading as follows: Set to 'Grade 1' if 11.0 – 12.0 Set to 'Grade 2' if 9.5 – 10.9 Set to 'Grade 3' if 8.0 – 9.4 Set to 'Grade 4' if < 8.0 Otherwise, set to Grade 0. assign CHG toxicity grading as follows: Set to 'Grade 1' if -1.5 to <0 Set to 'Grade 2' if -2 to -1.6 Set to 'Grade 3' if -5 to -2.1 Set to 'Grade 4' if < -5 Otherwise, set to 'Grade 0' Choose the higher grade between the two. If AVAL is not missing and SEX=’M’, convert AVAL and CHG to g/dl (AVAL0.1, CHG0.1), then assign AVAL toxicity grading as follows: Set to 'Grade 1' if 12.5 – 13.5 Set to 'Grade 2' if 10.5 – 12.4 Set to 'Grade 3' if 8.5 – 10.4 Set to 'Grade 4' if < 8.5 Otherwise, set to 'Grade 0' assign CHG toxicity grading as follows: Set to 'Grade 1' if -1.5 to <0 Set to 'Grade 2' if -2 to -1.6 Set to 'Grade 3' if -5 to -2.1 Set to 'Grade 4' if < -5 Otherwise, set to 'Grade 0' Choose the higher grade between the two.
	PARAMCD = "LYM"	Lymphocytes (10^9/L)	text	10		Derived If AVAL is not missing, convert AVAL to cell/mm3 (AVAL*1000), then assign AVAL toxicity grading as follows: Set to 'Grade 1' if 750 – 1,000 Set to 'Grade 2' if 500 – 749 Set to 'Grade 3' if 250 – 499 Set to 'Grade 4' if < 250 Otherwise, set to Grade '0'
	PARAMCD = "NEUT"	Neutrophils (10^9/L)	text	10		Derived If AVAL is not missing, convert AVAL to cell/mm3 (AVAL*1000), then assign AVAL toxicity grading as follows: Set to 'Grade 1' if 1,500 – 2,000 Set to 'Grade 2' if 1,000 – 1,499 Set to 'Grade 3' if 500 – 999 Set to 'Grade 4' if < 500 Otherwise, set to 'Grade 0'
	PARAMCD = "PLAT"	Platelets (10^9/L)	text	10		Derived If AVAL is not missing, convert AVAL to cell/mm3 (AVAL*1000), then assign AVAL toxicity grading as follows: Set to 'Grade 1' if 125,000 – 140,000 Set to 'Grade 2' if 100,000 – 124,000 Set to 'Grade 3' if 25,000 – 99,000 Set to 'Grade 4' if < 25,000 Otherwise, set to 'Grade 0'
	PARAMCD = "WBC"	Leukocytes (10^9/L)	text	10		Derived If AVAL is not missing, convert AVAL to cell/mm3 (AVAL*1000), then assign AVAL toxicity grading as follows: Set to 'Grade 1' if 2,500 – 3,500 Set to 'Grade 2' if 1,500 – 2,499 Set to 'Grade 3' if 1,000 – 1,499 Set to 'Grade 4' if < 1,000 Otherwise, set to 'Grade 0'
ATOXGRLN		Analysis Toxicity Grade Low (N)	integer	8		Assigned 0 if ATOXGRL=Grade 0, 1 if ATOXGRL=Grade 1, 2 if ATOXGRL=Grade 2, 3 if ATOXGRL=Grade 3, 4 if ATOXGRL=Grade 4
ATOXGRHVLM		Analysis Toxicity Grade High	text	20	Analysis Toxicity Grade [9 Terms]	Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007)
	PARAMCD = "UREAN"	Urea Nitrogen (mmol/L)	text	10		Derived If AVAL is not missing, then assign toxicity grading based on numeric version of LBORRES (mg/dL) as follows: Set to 'Grade 1' if 23-26 Set to 'Grade 2' if >26 -31 Set to 'Grade 3' if >31 Set to 'Grade 4' if requires dialysis pending Otherwise, set to Grade '0'
	PARAMCD = "CREAT"	Creatinine (umol/L)	text	10		Derived If AVAL is not missing, then assign toxicity grading based on numeric version of LBORRES (mg/dL) as follows: Set to 'Grade 1' if 1.5-1.7 Set to 'Grade 2' if >1.7 -2.0 Set to 'Grade 3' if >2.0 -2.5 Set to 'Grade 4' if > 2.5 or requires dialysis Otherwise, set to Set to 'Grade 0'
	PARAMCD = "ALP"	Alkaline Phosphatase (U/L)	text	10		Derived If AVAL is not missing, then assign AVAL toxicity grading as follows: Set to 'Grade 1' if 1.1 – 2.0 × ULN Set to 'Grade 2' if >2.0 – 3.0 × ULN Set to 'Grade 3' if >3.0 – 10 × ULN Set to 'Grade 4' if > 10 × ULN Otherwise, set to 'Grade 0' (ULN = upper limit of normal)
	PARAMCD = "ALT"	Alanine Aminotransferase (U/L)	text	10		Derived If AVAL is not missing, then assign AVAL toxicity grading as follows: Set to 'Grade 1' if 1.1 – 2.5 x ULN Set to 'Grade 2' if >2.5 – 5.0 × ULN Set to 'Grade 3' if >5.0 – 10 × ULN Set to 'Grade 4' if > 10 × ULN Otherwise, set to 'Grade 0' (ULN = upper limit of normal)
	PARAMCD = "AST"	Aspartate Aminotransferase (U/L)	text	10		Derived If AVAL is not missing, then assign AVAL toxicity grading as follows: Set to 'Grade 1' if 1.1 – 2.5 x ULN Set to 'Grade 2' if >2.5 – 5.0 × ULN Set to 'Grade 3' if >5.0 – 10 × ULN Set to 'Grade 4' if > 10 × ULN Otherwise, set to 'Grade 0' (ULN = upper limit of normal)
	PARAMCD = "BILI"	Bilirubin (umol/L)	text	10		Derived If AVAL is not missing and (ATOXGRHN>1 where PARAMCD=ALT or ATOXGRHN>1 where PARAMCD=AST), then assign AVAL toxicity grading as follows: Set to 'Grade 1' if 1.1 – 1.25 × ULN Set to 'Grade 2' if >1.25 – 1.5 × ULN Set to 'Grade 3' if >1.5 – 1.75 × ULN Set to 'Grade 4' if > 1.75 × ULN Otherwise, set to Grade '0' (ULN = upper limit of normal) If AVAL is not missing and (ATOXGRHN=0 where PARAMCD=ALT and ATOXGRHN=0 where PARAMCD=AST), then assign AVAL toxicity grading as follows: Set to 'Grade 1' if 1.1 – 1.5 × ULN Set to 'Grade 2' if >1.5 – 2.0 × ULN Set to 'Grade 3' if >2.0 – 3.0 × ULN Set to 'Grade 4' if > 3.0 × ULN Otherwise, set to Grade '0' (ULN = upper limit of normal)
	PARAMCD = "WBC"	Leukocytes (10^9/L)	text	10		Derived If AVAL is not missing, convert AVAL to cell/mm3 (AVAL*1000),, then assign AVAL toxicity grading as follows: Set to 'Grade 1' if 10,800 – 15,000 Set to 'Grade 2' if 1,5001 – 20,000 Set to 'Grade 3' if 20,001 – 25,000 Set to 'Grade 4' if > 25,000 Otherwise, set to 'Grade 0'
	PARAMCD = "EOS"	Eosinophils (10^9/L)	text	10		Derived If AVAL is not missing, convert AVAL to cell/mm3 (AVAL*1000), then assign AVAL toxicity grading as follows: Set to 'Grade 1' if 650 – 1,500 Set to 'Grade 2' if 1,501 – 5,000 Set to 'Grade 3' if > 5,000 Set to 'Grade 4' if pending Hypereosinophilic (Per medical review) Otherwise, set to 'Grade 0'
	PARAMCD = "PT"	Erythrocytes (10^12/L)	text	10		Derived If AVAL is not missing, then assign AVAL toxicity grading as follows: Set to 'Grade 1' if >1.0 – 1.10 × ULN (LB.LBSTNRHI) Set to 'Grade 2' if >1.10 – 1.20 × ULN Set to 'Grade 3' if >1.20 – 1.25 × ULN Set to 'Grade 4' if > 1.25 × ULN Otherwise, set to 'Grade 0' (ULN = upper limit of normal)
	PARAMCD = "APTT"	Activated Partial Thromboplastin Time (sec)	text	10		Derived If AVAL is not missing, then assign AVAL toxicity grading as follows: Set to 'Grade 1' if >1.0 – 1.2 × ULN Set to 'Grade 2' if >1.20 – 1.4 × ULN Set to 'Grade 3' if >1.40 – 1.5 × ULN Set to 'Grade 4' if > 1.5 × ULN Otherwise, set to Set to 'Grade 0' (ULN = upper limit of normal)
ATOXGRHN		Analysis Toxicity Grade High (N)	integer	8		Assigned 0 if ATOXGRH=Grade 0, 1 if ATOXGRH=Grade 1, 2 if ATOXGRH=Grade 2, 3 if ATOXGRH=Grade 3, 4 if ATOXGRH=Grade 4
BTOXGRL		Baseline Toxicity Grade Low	text	20	Analysis Toxicity Grade [9 Terms]	Derived Merge value of nonmissing ATOXGRL where ABLFL = 'Y' by USUBJID, PARCAT1, and PARAMCD
BTOXGRLN		Baseline Toxicity Grade Low (N)	integer	8		Assigned 0 if ATOXGRL=Grade 0, 1 if ATOXGRL=Grade 1, 2 if ATOXGRL=Grade 2, 3 if ATOXGRL=Grade 3, 4 if ATOXGRL=Grade 4
BTOXGRH		Baseline Toxicity Grade High	text	20	Analysis Toxicity Grade [9 Terms]	Derived Merge value of nonmissing ATOXGRH where ABLFL = 'Y' by USUBJID, PARCAT1, and PARAMCD
BTOXGRHN		Baseline Toxicity Grade High (N)	integer	8		Assigned 0 if ATOXGRH=Grade 0, 1 if ATOXGRH=Grade 1, 2 if ATOXGRH=Grade 2, 3 if ATOXGRH=Grade 3, 4 if ATOXGRH=Grade 4
ATOXDSCL		Analysis Toxicity Description Low	text	50		Derived Set to 'Hemoglobin Decreased' if PARAMCD='HGB' Set to 'Lymphocytes Decreased' if PARAMCD='LYM' Set to 'Neutrophils Decreased' if PARAMCD='NEUT' Set to 'Platelets Decreased' if PARAMCD='PLAT' Set to 'WBC Decreased' if PARAMCD='WBC'
ATOXDSCH		Analysis Toxicity Description High	text	50		Derived Set to 'Blood Urea Nitrogen Increased' if PARAMCD='UREAN' Set to 'Creatinine Increased' if PARAMCD='CREAT' Set to 'Alkaline Phosphatase Increased' if PARAMCD='ALP' Set to 'Alanine Aminotransferase Increased' if PARAMCD='ALT' Set to 'Aspartate Aminotransferase Increased' if PARAMCD='AST' Set to 'Bilirubin Increased' if PARAMCD='BILI' Set to 'WBC Increased' if PARAMCD='WBC' Set to 'Eosinophils Increased' if PARAMCD='EOS' Set to 'Prothrombin Time Increased' if PARAMCD='PT' Set to 'Activated Partial Thromboplastin Time Increased' if PARAMCD='APTT'
SHIFT1		Shift 1	text	50		Derived Only populate for post-baseline records If both of BTOXGRL and ATOXGRL are not missing, set to BTOXGRL\|\| ' to '\|\|ATOXGRL If either BTOXGRL or ATOXGRL is missing, set the missing BTOXGRL and ATOXGRL to 'UNK', then set to BTOXGRL\|\| ' to '\|\|ATOXGRL Note: post-baseline records are defined as any result where (ADTM > ADSL.TR01SDTM if time is available or ADY > 1 otherwise.
SHIFT2		Shift 2	text	50		Derived Only populate for post-baseline records If both of BTOXGRH and ATOXGRH are not missing, set to BTOXGRH\|\| ' to '\|\|ATOXGRH If either BTOXGRH or ATOXGRH is missing, set the missing BTOXGRH and ATOXGRH to 'UNK', then set to BTOXGRH\|\| ' to '\|\|ATOXGRH Note: post-baseline records are defined as any result where (ADTM > ADSL.TR01SDTM if time is available or ADY > 1 otherwise.
ANRIND		Analysis Reference Range Indicator	text	20	Analysis Reference Range Indicator • "ABNORMAL" • "HIGH" • "LOW" • "NORMAL"	Derived Set to LB.LBNRIND
BNRIND		Baseline Reference Range Indicator	text	20	Analysis Reference Range Indicator • "ABNORMAL" • "HIGH" • "LOW" • "NORMAL"	Derived Set up ANRIND where ABLFL = 'Y' by USUBJID, PARCAT1, and PARAMCD
ANRLO		Analysis Normal Range Lower Limit	float	8		Derived Set to LB.LBSTNRLO.
ANRHI		Analysis Normal Range Upper Limit	float	8		Derived Set to LB.LBSTNRHI.
CRIT1		Analysis Criterion 1	text	20		Derived Set to PARAMCD \|\|' <2 x ULN' if CRIT1FL='Y' and PARAMCD in (ALP); Set to PARAMCD \|\|' >=2 x ULN' if CRIT1FL='Y' and PARAMCD in (BILI); Set to PARAMCD \|\|' >3 x ULN' if CRIT1FL='Y' and PARAMCD in (ALT, AST)
CRIT1FL		Criterion 1 Evaluation Result Flag	text	1		Derived Set to 'Y' if If AVAL/ANRHI <2 and PARAMCD =ALP; Set to 'Y' if If AVAL/ANRHI >=2 and PARAMCD =BILI; Set to 'Y' if If AVAL/ANRHI >3 and PARAMCD in (ALT, AST);
ABLFL		Baseline Record Flag	text	1	No Yes Response (Yes Only) • "Y"	Derived Set to 'Y' by selecting the latest ADTM or ADT if time is not available with non-missing AVAL/ LBSTRESC on or before TR01SDTM (TR01SDT if time part of TR01SDTM is missing) for each SUBJID, PARCAT1 and PARAMCD. Note: If still multiple, selecting the records with the latest sequence number
ANL01FL		Analysis Flag 01	text	1	No Yes Response (Yes Only) • "Y"	Derived Set to 'Y' if ABLFL='Y', For post-baseline assessments where AVISITN is non-missing and result (AVAL) is non-missing, per subject per parameter and per AVISIT, Within an AVISIT, Set to ‘Y’ for the assessment at scheduled visit (i.e., VISIT doesn't contain "Unsched") or Set to ‘Y’ for the latest assessment if there are 2 or more assessments at scheduled visit, or Set to ‘Y’ for the latest assessment if there is no scheduled visit, or Set to 'Y' for the assessment closest to the target study day in the visit window or Set to 'Y' for the latest assessment If there are 2 or more assessments equal distance to the target study day
ANL02FL		Analysis Flag 02	text	1	No Yes Response (Yes Only) • "Y"	Derived Per subject per parameter, set to Y for the worst post-baseline toxicity grade (ATOXGRL) during vaccination stage (ASTAGEN=1) where ATOXDSCL is not missing using the following order: Grade 4> Grade 3>Grade 2>Grade 1>Grade 0. If there are more than one worst toxicity grades, then set to the first record.
ANL03FL		Analysis Flag 03	text	1	No Yes Response (Yes Only) • "Y"	Derived Per subject per parameter, set to Y for the worst post-baseline toxicity grade (ATOXGRH) during vaccination stage (ASTAGEN=1) where ATOXDSCH is not missing using the following order: Grade 4> Grade 3>Grade 2>Grade 1>Grade 0. If there are more than one worst toxicity grades, then set to the first record.
DTYPE		Derivation Type	text	20	Derivation Type • "DERIVED" • "HALFLLOQ" • "ULOQ"	Derived Set to 'HALFLLOQ' if LBSTRESC contains '<', Set to 'ULOQ' if LBSTRESC contains '>' Set to missing, otherwise

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Microbiology Analysis Dataset (ADMB)

ADMB (Microbiology Analysis Dataset) - BASIC DATA STRUCTURE Location: admb.xpt
Variable	Label / Description	Type	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	14	Study Identifier • "mRNA-1273-P201"	Predecessor: ADSL.STUDYID
USUBJID	Unique Subject Identifier	text	25		Predecessor: ADSL.USUBJID
SUBJID	Subject Identifier for the Study	text	9		Predecessor: ADSL.SUBJID
SITEID	Study Site Identifier	text	5		Predecessor: ADSL.SITEID
COUNTRY	Country	text	3	Country • "USA"	Predecessor: ADSL.COUNTRY
AGE	Age	integer	8		Predecessor: ADSL.AGE
AGEU	Age Units	text	5		Predecessor: ADSL.AGEU
AGEGR1	Pooled Age Group 1	text	30	Pooled Age Group 1 • ">=18 and <55 Years" • ">=55 Years"	Predecessor: ADSL.AGEGR1
AGEGR1N	Pooled Age Group 1 (N)	integer	8		Predecessor: ADSL.AGEGR1N
AGEGR2	Pooled Age Group 2	text	19	Pooled Age Group 2 • ">=18 and <=22 Years" • ">=23 and <=25 Years" • ">25 and <55 Years" • ">=55 Years"	Predecessor: ADSL.AGEGR2
AGEGR2N	Pooled Age Group 2 (N)	integer	8		Predecessor: ADSL.AGEGR2N
SEX	Sex	text	1	Sex • "F" • "M"	Predecessor: ADSL.SEX
RACE	Race	text	41	Race [8 Terms]	Predecessor: ADSL.RACE
RACESPY	Race Specify	text	200		Predecessor: ADSL.RACESPY
ETHNIC	Ethnicity	text	22	Ethnicity • "HISPANIC OR LATINO" • "NOT HISPANIC OR LATINO" • "NOT REPORTED" • "UNKNOWN"	Predecessor: ADSL.ETHNIC
RANDFL	Randomized Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.RANDFL
SAFFL	Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAFFL
FASBABFL	Full Analysis Set bAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASBABFL
FASNABFL	Full Analysis Set nAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASNABFL
PPBABFL	Per Protocol bAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBABFL
PPNABFL	Per Protocol nAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPNABFL
PPBD29FL	Per Protocol bAb Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBD29FL
PPBD57FL	Per Protocol bAb Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBD57FL
PPND29FL	Per Protocol nAb Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPND29FL
PPND57FL	Per Protocol nAb Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPND57FL
SAR1FL	First Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAR1FL
SAR2FL	Second Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAR2FL
SARAFL	Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SARAFL
FASNA2FL	FAS nAb 2 Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASNA2FL
PPNAB2FL	PP nAb 2 Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPNAB2FL
PN2D29FL	Per Protocol nAb 2 Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PN2D29FL
PN2D57FL	Per Protocol nAb 2 Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PN2D57FL
COMPLFL	Completers Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.COMPLFL
DVBABFL	Deviation Impact bAb Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DVBABFL
DVNABFL	Deviation Impact nAb Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DVNABFL
DOSE1FL	Vaccination 1 Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.DOSE1FL
DOSE2FL	Vaccination 2 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DOSE2FL
DOSEROFL	Dosing Error Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DOSEROFL
COV19BL	Baseline COVID Infection	text	20	Baseline COVID Infection • "Detected" • "Not Detected"	Predecessor: ADSL.COV19BL
COV19FL	COVID Infection Flag	text	20	No Yes Response • "N" • "Y"	Predecessor: ADSL.COV19FL
SENTLFL	Sentinel Participant Flag	text	3	No Yes Response • "N" • "Y"	Predecessor: ADSL.SENTLFL
TRT01P	Planned Treatment for Period 01	text	25	Planned Treatment for Period 01 • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Predecessor: ADSL.TRT01P
D29W7DFL	Day 29 Out of 7-Day Window Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.D29W7DFL
TRT01PN	Planned Treatment for Period 01 (N)	integer	8		Predecessor: ADSL.TRT01PN
TRT01A	Actual Treatment for Period 01	text	25	Actual Treatment for Period 01 • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Predecessor: ADSL.TRT01A
TRT01AN	Actual Treatment for Period 01 (N)	integer	8		Predecessor: ADSL.TRT01AN
TR01SDT	Date of First Exposure in Period 01	integer	DATE9		Predecessor: ADSL.TR01SDT
TR01SDTM	Datetime of First Exposure in Period 01	integer	DATETIME20		Predecessor: ADSL.TR01SDTM
TR01EDT	Date of Last Exposure in Period 01	integer	DATE9		Predecessor: ADSL.TR01EDT
TR01EDTM	Datetime of Last Exposure in Period 01	integer	DATETIME20		Predecessor: ADSL.TR01EDTM
TRTSDTM	Datetime of First Exposure to Treatment	integer	DATETIME20		Predecessor: ADSL.TRTSDTM
TRTEDTM	Datetime of Last Exposure to Treatment	integer	DATETIME20		Predecessor: ADSL.TRTEDTM
DOSE2DT	Date of Dose 2	integer	DATE9		Predecessor: ADSL.DOSE2DT
DOS2DTM	Datetime of Dose 2	integer	DATETIME20		Predecessor: ADSL.DOS2DTM
TRTA	Actual Treatment	text	50	Actual Treatment • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Derived "If (.<ADSL.TR01SDTM<=ADTM <DOS2DTM) or (.<ADSL.TR01SDTM<=ADTM and ADSL.DOS2DTM is missing): 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'Day 1' ; 'mRNA-1273 50 ug' if EX.EXTRT='mRNA-1273' and 1) 0<EXDOSE<=75 where EX.VISIT contains 'Day 1', or 2) EXDOSTXT contains '>0-25', '>25-<50' or '>50-75' where EX.VISIT contains 'Day 1'; 'mRNA-1273 100 ug' if EX.EXTRT='mRNA-1273' and 1) EXDOSE>75 where EX.VISIT contains 'Day 1', or 2) EXDOSTXT contains '>75-<100' or '>100-125' or '>125' where EX.VISIT contains 'Day 1'; if .<ADSL.DOS2DTM<=ASTDTM: 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'Day 29' ; 'mRNA-1273 50 ug' if 1) EX.EXTRT='mRNA-1273' and 0<EXDOSE<=75 where EX.VISIT contains 'Day 29', or 2) EXDOSTXT contains '>0-25', '>25-<50' or '>50-75' where EX.VISIT contains 'Day 29'; 'mRNA-1273 100 ug' if EX.EXTRT='mRNA-1273' and 1) EXDOSE>75 where EX.VISIT contains 'Day 29', or 2) EXDOSTXT contains '>75-<100' or '>100-125' or '>125' where EX.VISIT contains 'Day 29'; if time part of ADTM, TR01SDTM, or DOS2DTM is missing, use ADT, TR01SDT, and DOSE2DT to replace ADTM, TR01SDTM, and DOS2DTM, respectively."
TRTAN	Actual Treatment (N)	integer	8		Assigned
MBSEQ	Sequence Number	integer	8		Predecessor: MB.MBSEQ
MBDTC	Date/Time of Specimen Collection	datetime		ISO 8601	Predecessor: MB.MBDTC
ADT	Analysis Date	integer	DATE9		Derived Set to numeric date part of MB.MBDTC
ATM	Analysis Time	integer	TIME5		Derived Time part of MB.MBDTC
ADTM	Analysis Datetime	integer	DATETIME20		Derived Set to numeric date time of MBDTC if time part is not missing
ADY	Analysis Relative Day	integer	8		Derived Set to ADT - ADSL.TR01SDT + 1 if If ADT >= ADSL.TR01SDT, or Set to ADT - ADSL.TR01SDT if ADT < ADSL.TR01SDT
VISIT	Visit Name	text	28		Predecessor: MB.VISIT
VISITNUM	Visit Number	float	8		Predecessor: MB.VISITNUM
AVISIT	Analysis Visit	text	50		Derived "If ABLFL='Y' then AVISIT='Baseline'; if ADY>1 and VISITNUM is 5, 8, set to 'Day xx' part of VISIT; ; if ADY>1 and VISITNUM is not 5, 8, set AVISIT as follows: using the visit window below: If VISIT with 2<=ADY<=43, then AVISIT = ’Day 29’; else if VISIT with 44<=ADY<=70, then AVISIT = ’Day 57’; else if VISIT with 71<=ADY, then AVISIT = ’Day 71 or Beyond’; "
AVISITN	Analysis Visit (N)	integer	8		Assigned
PARCAT1	Parameter Category 1	text	50	Microbiology Parameter Category • "BIOFIRE" • "SARS-CoV-2"	Derived Set to MB.MBCAT
PARAMCD	Parameter Code	text	8	Microbiology Analysis Dataset Parameter Code [21 Terms]	Assigned MB.MBTESTCD
PARAM	Parameter	text	50		Derived Set to MB.MBTEST
AVALC	Analysis Value (C)	text	50		Derived Set to mixed case of MB.MBSTRESC; Set to 'Not Detected' if MBSTRESC is 'NOTDETECTED'
BASEC	Baseline Value (C)	text	50		Derived Set up AVALC where ABLFL = 'Y' for each SUBJID, PARCAT1 and PARAMCD
AWRANGE	Analysis Window Valid Relative Range	text	20		Assigned
AWTARGET	Analysis Window Target	integer	8		Assigned
AWTDIFF	Analysis Window Diff from Target	integer	8		Derived Set to absolute value of (ADY - AWTARGET)
ABLFL	Baseline Record Flag	text	1	No Yes Response (Yes Only) • "Y"	Derived Set to 'Y' for selecting the latest ADTM or ADT if time is not available with non-missing AVALC on or before ADSL.TR01SDTM (TR01SDT if time part of TR01SDTM is missing) for each SUBJID, PARCAT1 and PARAMCD. Note: ABLFL apply for non-local (LOCALFL is not 'Y') only
ANL01FL	Analysis Flag 01	text	1	No Yes Response (Yes Only) • "Y"	Derived Set to 'Y' if ABLFL='Y', For post-baseline assessments where AVISITN is non-missing and result (AVAL) is non-missing, per subject per parameter and per AVISIT, Within an AVISIT, Set to ‘Y’ for the assessment at scheduled visit (i.e., VISIT doesn't contain "Unsched") or Set to ‘Y’ for the latest assessment if there are 2 or more assessments at scheduled visit, or Set to ‘Y’ for the latest assessment if there is no scheduled visit, or Set to 'Y' for the assessment closest to the target study day in the visit window or Set to 'Y' for the latest assessment If there are 2 or more assessments equal distance to the target study day
MBSCAT	Subcategory for Microbiology Finding	text	19	Subcategory for Microbiology Finding • "NASOPHARYNGEAL SWAB" • "SWAB"	Predecessor: MB.MBSCAT
MBNAM	Vendor Name	text	38		Predecessor: MB.MBNAM
MBSPEC	Specimen Type	text	16	Specimen Type • "OTHER" • "SWABBED MATERIAL"	Predecessor: MB.MBSPEC
MBMETHOD	Method of Test or Examination	text	6	Method of Test or Examination • "RT-PCR"	Predecessor: MB.MBMETHOD
LOCALFL	Local Labs Flag	text	1	No Yes Response (Yes Only) • "Y"	Derived SUPPMB.QVAL where QNAM is 'LOCALFL'
LDTTYPE	Type of Diagnostic Test	text	200		Derived SUPPMB.QVAL where QNAM is 'LDTTYPE'
LDTSTOTH	Diagnostic Test Other, Specify	text	200		Derived SUPPMB.QVAL where QNAM is 'LDTSTOTH'

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Vital Signs Analysis Dataset (ADVS)

ADVS (Vital Signs Analysis Dataset) - BASIC DATA STRUCTURE Location: advs.xpt
Variable	Where Condition	Label / Description	Type	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID		Study Identifier	text	14	Study Identifier • "mRNA-1273-P201"	Predecessor: ADSL.STUDYID
USUBJID		Unique Subject Identifier	text	25		Predecessor: ADSL.USUBJID
SUBJID		Subject Identifier for the Study	text	9		Predecessor: ADSL.SUBJID
SITEID		Study Site Identifier	text	5		Predecessor: ADSL.SITEID
COUNTRY		Country	text	3	Country • "USA"	Predecessor: ADSL.COUNTRY
AGE		Age	integer	8		Predecessor: ADSL.AGE
AGEU		Age Units	text	5		Predecessor: ADSL.AGEU
AGEGR1		Pooled Age Group 1	text	30	Pooled Age Group 1 • ">=18 and <55 Years" • ">=55 Years"	Predecessor: ADSL.AGEGR1
AGEGR1N		Pooled Age Group 1 (N)	integer	8		Predecessor: ADSL.AGEGR1N
AGEGR2		Pooled Age Group 2	text	19	Pooled Age Group 2 • ">=18 and <=22 Years" • ">=23 and <=25 Years" • ">25 and <55 Years" • ">=55 Years"	Predecessor: ADSL.AGEGR2
AGEGR2N		Pooled Age Group 2 (N)	integer	8		Predecessor: ADSL.AGEGR2N
SEX		Sex	text	1	Sex • "F" • "M"	Predecessor: ADSL.SEX
RACE		Race	text	41	Race [8 Terms]	Predecessor: ADSL.RACE
RACESPY		Race Specify	text	200		Predecessor: ADSL.RACESPY
ETHNIC		Ethnicity	text	22	Ethnicity • "HISPANIC OR LATINO" • "NOT HISPANIC OR LATINO" • "NOT REPORTED" • "UNKNOWN"	Predecessor: ADSL.ETHNIC
RANDFL		Randomized Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.RANDFL
SAFFL		Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAFFL
FASBABFL		Full Analysis Set bAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASBABFL
FASNABFL		Full Analysis Set nAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASNABFL
PPBABFL		Per Protocol bAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBABFL
PPNABFL		Per Protocol nAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPNABFL
PPBD29FL		Per Protocol bAb Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBD29FL
PPBD57FL		Per Protocol bAb Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBD57FL
PPND29FL		Per Protocol nAb Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPND29FL
PPND57FL		Per Protocol nAb Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPND57FL
SAR1FL		First Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAR1FL
SAR2FL		Second Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAR2FL
SARAFL		Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SARAFL
FASNA2FL		FAS nAb 2 Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASNA2FL
PPNAB2FL		PP nAb 2 Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPNAB2FL
PN2D29FL		Per Protocol nAb 2 Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PN2D29FL
PN2D57FL		Per Protocol nAb 2 Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PN2D57FL
COMPLFL		Completers Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.COMPLFL
DVBABFL		Deviation Impact bAb Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DVBABFL
DVNABFL		Deviation Impact nAb Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DVNABFL
DOSE1FL		Vaccination 1 Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.DOSE1FL
DOSE2FL		Vaccination 2 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DOSE2FL
DOSEROFL		Dosing Error Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DOSEROFL
COV19BL		Baseline COVID Infection	text	20	Baseline COVID Infection • "Detected" • "Not Detected"	Predecessor: ADSL.COV19BL
COV19FL		COVID Infection Flag	text	20	No Yes Response • "N" • "Y"	Predecessor: ADSL.COV19FL
SENTLFL		Sentinel Participant Flag	text	3	No Yes Response • "N" • "Y"	Predecessor: ADSL.SENTLFL
D29W7DFL		Day 29 Out of 7-Day Window Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.D29W7DFL
TRT01P		Planned Treatment for Period 01	text	25	Planned Treatment for Period 01 • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Predecessor: ADSL.TRT01P
TRT01PN		Planned Treatment for Period 01 (N)	integer	8		Predecessor: ADSL.TRT01PN
TRT01A		Actual Treatment for Period 01	text	25	Actual Treatment for Period 01 • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Predecessor: ADSL.TRT01A
TRT01AN		Actual Treatment for Period 01 (N)	integer	8		Predecessor: ADSL.TRT01AN
TR01SDT		Date of First Exposure in Period 01	integer	DATE9		Predecessor: ADSL.TR01SDT
TR01SDTM		Datetime of First Exposure in Period 01	integer	DATETIME20		Predecessor: ADSL.TR01SDTM
TR01EDT		Date of Last Exposure in Period 01	integer	DATE9		Predecessor: ADSL.TR01EDT
TR01EDTM		Datetime of Last Exposure in Period 01	integer	DATETIME20		Predecessor: ADSL.TR01EDTM
TRTSDTM		Datetime of First Exposure to Treatment	integer	DATETIME20		Predecessor: ADSL.TRTSDTM
TRTEDTM		Datetime of Last Exposure to Treatment	integer	DATETIME20		Predecessor: ADSL.TRTEDTM
DOSE2DT		Date of Dose 2	integer	DATE9		Predecessor: ADSL.DOSE2DT
DOS2DTM		Datetime of Dose 2	integer	DATETIME20		Predecessor: ADSL.DOS2DTM
TRTA		Actual Treatment	text	50	Actual Treatment • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Derived If MDOSREF='Vaccination 1', set to: 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'Day 1' ; 'mRNA-1273 50 ug' if EX.EXTRT='mRNA-1273' and 0<EXDOSE<=75 where EX.VISIT contains 'Day 1'; 'mRNA-1273 100 ug' if EX.EXTRT='mRNA-1273' and EXDOSE>75 where EX.VISIT contains 'Day 1'; if MDOSREF='Vaccination 2', set to: 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'Day 29' ; 'mRNA-1273 50 ug' if EX.EXTRT='mRNA-1273' and 0<EXDOSE<=75 where EX.VISIT contains 'Day 29'; 'mRNA-1273 100 ug' if EX.EXTRT='mRNA-1273' and EXDOSE>75 where EX.VISIT contains 'Day 29';
TRTAN		Actual Treatment (N)	integer	8		Assigned
VSSEQ		Sequence Number	integer	8		Predecessor: VS.VSSEQ
VSDTC		Date/Time of Measurements	datetime		ISO 8601	Predecessor: VS.VSDTC
ADT		Analysis Date	integer	DATE9		Derived Set to numeric date part of VS.VSDTC
ATM		Analysis Time	integer	TIME5		Derived Time part of VS.VSDTC converted to numeric
ADTM		Analysis Datetime	integer	DATETIME20		Derived Set to numeric date time of VSDTC if time part is not missing
ADY		Analysis Relative Day	integer	8		Derived Set to ADT - ADSL.TR01SDT + 1 if If ADT >= ADSL.TR01SDT, or Set to ADT - ADSL.TR01SDT if ADT < ADSL.TR01SDT
MDOSREF		Most Recent Dose Reference	text	25	Analysis Timepoint Reference • "Vaccination 1" • "Vaccination 2"	Derived If (.<ADSL.TR01SDTM<=ADTM <ADSL.DOS2DTM) or (.<ADSL.TR01SDTM<=ADTM and ADSL.DOS2DTM is missing), set to 'Vaccination 1'; if .<ADSL.DOS2DTM<=ADTM, set to 'Vaccination 2'; use date variables for comparison when time part is not available
MRDDY		Relative Day from Most Recent Dose	integer	8		Derived ADT – ADSL.TR01SDT+ 1 If MDOSREF='Vaccination 1', ADT – ADSL.DOSE2DT+ 1 If MDOSREF='Vaccination 2'.
VISIT		Visit Name	text	28		Predecessor: VS.VISIT
VISITNUM		Visit Number	float	8		Predecessor: VS.VISITNUM
AVISIT		Analysis Visit	text	50		Derived If ABLFL='Y', then AVISIT = 'Baseline', if VISIT=Visit 1 Day 1 and VSTPT='POST DOSE' then AVISIT='Day 1', if ADY>1 and VISIT doesn't contain 'Unsched', set to 'Day xx' part of VISIT, if ADY>1 and VISIT contains 'Unsched', set AVISIT as follows: using the visit window below: If VISIT with 1<ADY<=11, then AVISIT = 'Day 8', else if VISIT with 12<=ADY<=22, then AVISIT = 'Day 15', else if VISIT with 23<=ADY<=32, then AVISIT = 'Day 29', else if VISIT with 33<=ADY<=39, then AVISIT = 'Day 36', else if VISIT with 40<=ADY<=50, then AVISIT = 'Day 43', else if VISIT with 51<=ADY<=133, then AVISIT = 'Day 57', else if VISIT with 134=<ADY<=301, then AVISIT = 'Day 209', else if VISIT with ADY>=302, then AVISIT = 'Day 394', After the steps above, sort data by AVISITN and ADY, set the unscheduled visit (i.e., VISIT contains 'Unsched') records to blank if AVISITN >any previous AVISITN AND ADY<=any previous ADY). For example, Scheduled Day 36 is with AVISITN=6 (Day 36) and ADY=42 and an unscheduled visit is with AVISITN=7 (Day 43) and ADY=40, set AVISIT to blank for this unscheduled visit
AVISITN		Analysis Visit (N)	integer	8		Assigned
VSTPT		Planned Time Point Name	text	49	Planned Time Point Name • "POST-DOSE" • "PRE-DOSE"	Predecessor: VS.VSTPT
ASTAGE		Stage	text	30	Analysis Stage • "Follow up stage" • "Vaccination stage"	Derived For subjects who received 2 injections (DOSE1FL=’Y’ and DOSE2FL=’Y’), set to ‘Vaccination stage’ If .< ADSL.TR01SDTM <=ADTM and ADT<=earliest date of (date of Visit 7 (i.e. SV.SVSTDTC where SV.VISIT = 'Visit 7 Day 57'), ADSL.EOSDT, ADSL.DTHDT) ; set to 'Follow up stage' if ADT > non-missing date of Visit 7. If date of Visit 7, ADSL.EOSDT, and ADSL.DTHDT are all unavailable, set to ‘Vaccination stage’ for post baseline records. Else leave missing. For subjects who received only injection (DOSE1FL=’Y’ and DOSE2FL ne ’Y’), set to ‘Vaccination stage’ If .< ADSL.TR01SDTM <=ADTM and ADT<=earliest date of (date of Visit 4 (i.e. SV.SVSTDTC where SV.VISIT = 'Visit 4 Day 29'), ADSL.EOSDT, ADSL.DTHDT) ; set to 'Follow up stage' if ADT > non-missing date of Visit 4. If date of Visit 4, ADSL.EOSDT, and ADSL.DTHDT are all unavailable, set to ‘Vaccination stage’ for post baseline records. Else leave missing.
ASTAGEN		Stage (N)	integer	8		Assigned
PARAMCD		Parameter Code	text	8	Vital Signs Analysis Dataset Parameter Code [8 Terms]	Assigned VS.VSTESTCD
PARAM		Parameter	text	50		Derived VS.VSTEST ' (' \|\|VSSTRESU\|\| ')' if VSSTRESU is non-missing, if VSSTRESU is missing, use the non-missing VSSTRESU from the same VSTEST
AVAL		Analysis Value	float	8		Derived Set to VS.VSSTRESN
VSSTRESC		Character Result/Finding in Std Format	text	5		Predecessor: VS.VSSTRESC
ABLFL		Baseline Record Flag	text	1	No Yes Response (Yes Only) • "Y"	Derived Set to 'Y' by selecting the latest ADTM or ADT if ATM is missing with non-missing AVAL/AVALC on or before TR01SDTM (TR01SDT if time part of TR01SDTM is missing) for each SUBJID and PARAMCD Note: exclude records where ADT is the same as TR01SDT and VSTPT^='PRE-DOSE'
BASE		Baseline Value	float	8		Derived Merge value of nonmissing AVAL where ABLFL = 'Y' by USUBJID and PARAMCD, Set to AVAL where ABLFL = 'Y'.
CHG		Change from Baseline	float	8		Derived For post baseline records only, if AVAL and BASE are both non-missing, set to AVAL - BASE Note: post-baseline records are defined as any result where (ADTM > ADSL.TR01SDTM if time is available, if time is not available use (ADY=1 and VSTPT^='PRE-DOSE') or ADY > 1).
PCHG		Percent Change from Baseline	float	8		Derived Set to 0 If CHG=0 ; else set to (CHG/BASE)*100 if BASE ne 0 , otherwise set to missing
ATOXGRLVLM		Analysis Toxicity Grade Low	text	10	Analysis Toxicity Grade [9 Terms]	Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007)
	PARAMCD = "PULSE" (Pulse Rate (beats/min))	Pulse Rate (beats/min)	text	8		Derived Assign AVAL toxicity grading as follows If AVAL is not missing: Set to 'Grade 1' if 50 – 54 Set to 'Grade 2' if 45 – 49 Set to 'Grade 3' if <45 Set to 'Grade 4' is based on medical input: Otherwise, set to 'Grade 0'
	PARAMCD = "SYSBP" (Systolic Blood Pressure (mmHg))	Systolic Blood Pressure (mmHg)	text	8		Derived Assign AVAL toxicity grading as follows If AVAL is not missing: Set to 'Grade 1' if 85 – 89 Set to 'Grade 2' if 80 – 84 Set to 'Grade 3' if <80 Set to 'Grade 4' is based on medical input: Otherwise, set to Grade '0'
ATOXGRLN		Analysis Toxicity Grade Low (N)	integer	8		Assigned 0 if ATOXGRL=Grade 0, 1 if ATOXGRL=Grade 1, 2 if ATOXGRL=Grade 2, 3 if ATOXGRL=Grade 3, 4 if ATOXGRL=Grade 4
ATOXGRHVLM		Analysis Toxicity Grade High	text	10	Analysis Toxicity Grade [9 Terms]	Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007)
	PARAMCD = "PULSE" (Pulse Rate (beats/min))	Pulse Rate (beats/min)	text	8		Derived Assign AVAL toxicity grading as follows If AVAL is not missing: Set to 'Grade 1' if 101 – 115 Set to 'Grade 2' if 116 – 130 Set to 'Grade 3' if >130 Set to 'Grade 4' is based on medical input: Otherwise, set to 'Grade 0'
	PARAMCD = "TEMP" (Temperature (C))	Temperature (C)	text	8		Derived Assign AVAL toxicity grading as follows If AVAL is not missing: Set to 'Grade 1' if 38.0 – 38.4 Set to 'Grade 2' if 38.5 – 38.9 Set to 'Grade 3' if 39.0 – 40.0 Set to 'Grade 4' if >40.0 Otherwise, set to 'Grade 0'
	PARAMCD = "DIABP" (Diastolic Blood Pressure (mmHg))	Diastolic Blood Pressure (mmHg)	text	8		Derived Assign AVAL toxicity grading as follows If AVAL is not missing: Set to 'Grade 1' if 91 – 95 Set to 'Grade 2' if 96 – 100 Set to 'Grade 3' if >100 Set to 'Grade 4' is based on medical input: Otherwise, set to 'Grade 0'
	PARAMCD = "SYSBP" (Systolic Blood Pressure (mmHg))	Systolic Blood Pressure (mmHg)	text	8		Derived Assign AVAL toxicity grading as follows If AVAL is not missing: Set to 'Grade 1' if 141 – 150 Set to 'Grade 2' if 151 – 155 Set to 'Grade 3' if >155 Set to 'Grade 4' is based on medical input: Otherwise, set to 'Grade 0'
	PARAMCD = "RESP" (Respiratory Rate (breaths/min))	Respiratory Rate (breaths/min)	text	8		Derived Assign AVAL toxicity grading as follows If AVAL is not missing: Set to 'Grade 1' if 17 – 20 Set to 'Grade 2' if 21 – 25 Set to 'Grade 3' if >25 Set to 'Grade 4' is based on medical input: Otherwise, set to 'Grade 0'
ATOXGRHN		Analysis Toxicity Grade High (N)	integer	8		Assigned 0 if ATOXGRH=Grade 0, 1 if ATOXGRH=Grade 1, 2 if ATOXGRH=Grade 2, 3 if ATOXGRH=Grade 3, 4 if ATOXGRH=Grade 4
BTOXGRL		Baseline Toxicity Grade Low	text	10	Analysis Toxicity Grade [9 Terms]	Derived Merge value of nonmissing ATOXGRL where ABLFL = 'Y' by USUBJID and PARAMCD;
BTOXGRLN		Baseline Toxicity Grade Low (N)	integer	8		Assigned
BTOXGRH		Baseline Toxicity Grade High	text	10	Analysis Toxicity Grade [9 Terms]	Derived Merge value of nonmissing ATOXGRH where ABLFL = 'Y' by USUBJID and PARAMCD;
BTOXGRHN		Baseline Toxicity Grade High (N)	integer	8		Assigned
ATOXDSCL		Analysis Toxicity Description Low	text	30		Derived Set to 'Bradycardia' if PARAMCD = 'PULSE'; Hypotension' if PARAMCD = 'SYSBP'
ATOXDSCH		Analysis Toxicity Description High	text	30		Derived Set to: 'Fever' if PARAMCD = 'TEMP'; 'Tachycardia' if PARAMCD = 'PULSE'; 'Systolic Hypertension' if PARAMCD = 'SYSBP'; 'Diastolic Hypertension' if PARAMCD = 'DIABP'; 'Respiratory Rate Increased' if PARAMCD = 'RESP'.
SHIFT1		Shift 1	text	20		Derived Only populate for post-baseline records If both of BTOXGRL and ATOXGRL are not missing, set to BTOXGRL\|\| ' to '\|\|ATOXGRL If either BTOXGRL or ATOXGRL is missing, set the missing BTOXGRL and ATOXGRL to 'UNK', then set to BTOXGRL\|\| ' to '\|\|ATOXGRL Note: post-baseline records are defined as any result where (ADTM > ADSL.TR01SDTM if time is available, if time is not available use (ADY=1 and VSTPT^='PRE-DOSE') or ADY > 1).
SHIFT2		Shift 2	text	20		Derived Only populate for post-baseline records If both of BTOXGRH and ATOXGRH are not missing, set to BTOXGRH\|\| ' to '\|\|ATOXGRH If either BTOXGRH or ATOXGRH is missing, set the missing BTOXGRH and ATOXGRH to 'UNK', then set to BTOXGRH\|\| ' to '\|\|ATOXGRH Note: post-baseline records are defined as any result where (ADTM > ADSL.TR01SDTM if time is available, if time is not available use (ADY=1 and VSTPT^='PRE-DOSE') or ADY > 1).
AWRANGE		Analysis Window Valid Relative Range	text	50		Assigned
AWTARGET		Analysis Window Target	integer	8		Assigned
AWTDIFF		Analysis Window Diff from Target	integer	8		Derived Set to absolute value of (ADY - AWTARGET)
ANL01FL		Analysis Flag 01	text	1	No Yes Response (Yes Only) • "Y"	Derived Set to 'Y' if ABLFL='Y', For post-baseline assessments where AVISITN is non-missing and result (AVAL) is non-missing, per subject per parameter and per AVISIT, Within an AVISIT, Set to ‘Y’ for the assessment at scheduled visit (i.e., VISIT doesn't contain "Unsched") or Set to ‘Y’ for the latest assessment if there are 2 or more assessments at scheduled visit, or Set to ‘Y’ for the latest assessment if there is no scheduled visit, or Set to 'Y' for the assessment closest to the target study day in the visit window or Set to 'Y' for the latest assessment If there are 2 or more assessments equal distance to the target study day
ANL02FL		Analysis Flag 02	text	1	No Yes Response (Yes Only) • "Y"	Derived Set to 'Y' by selecting the first worst toxicity grade (ATOXGRL Worst Case Order: Grade 4> Grade 3>Grade 2>Grade 1>Grade 0) by Subject, Parameter and Analysis Visit
ANL03FL		Analysis Flag 03	text	1	No Yes Response (Yes Only) • "Y"	Derived Set to 'Y' by selecting the first worst toxicity grade (ATOXGRH Worst Case Order: Grade 4> Grade 3>Grade 2>Grade 1>Grade 0) by Subject, Parameter and Analysis Visit
VSLOC		Location of Vital Signs Measurement	text	11	Location of Vital Signs Measurement • "ORAL CAVITY"	Predecessor: VS.VSLOC
VSLOCSP		Other Location, specify	text	200		Derived Set to SUPPCM.QVAL where QNAM='VSLOCSP'

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Adverse Event Analysis Dataset (ADAE)

ADAE (Adverse Event Analysis Dataset) - OCCURRENCE DATA STRUCTURE Location: adae.xpt
Variable	Label / Description	Type	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	14	Study Identifier • "mRNA-1273-P201"	Predecessor: ADSL.STUDYID
USUBJID	Unique Subject Identifier	text	25		Predecessor: ADSL.USUBJID
SUBJID	Subject Identifier for the Study	text	9		Predecessor: ADSL.SUBJID
SITEID	Study Site Identifier	text	5		Predecessor: ADSL.SITEID
COUNTRY	Country	text	3	Country • "USA"	Predecessor: ADSL.COUNTRY
AGE	Age	integer	8		Predecessor: ADSL.AGE
AGEU	Age Units	text	5		Predecessor: ADSL.AGEU
AGEGR1	Pooled Age Group 1	text	30	Pooled Age Group 1 • ">=18 and <55 Years" • ">=55 Years"	Predecessor: ADSL.AGEGR1
AGEGR1N	Pooled Age Group 1 (N)	integer	8		Predecessor: ADSL.AGEGR1N
AGEGR2	Pooled Age Group 2	text	19	Pooled Age Group 2 • ">=18 and <=22 Years" • ">=23 and <=25 Years" • ">25 and <55 Years" • ">=55 Years"	Predecessor: ADSL.AGEGR2
AGEGR2N	Pooled Age Group 2 (N)	integer	8		Predecessor: ADSL.AGEGR2N
SEX	Sex	text	1	Sex • "F" • "M"	Predecessor: ADSL.SEX
RACE	Race	text	41	Race [8 Terms]	Predecessor: ADSL.RACE
RACESPY	Race Specify	text	200		Predecessor: ADSL.RACESPY
ETHNIC	Ethnicity	text	22	Ethnicity • "HISPANIC OR LATINO" • "NOT HISPANIC OR LATINO" • "NOT REPORTED" • "UNKNOWN"	Predecessor: ADSL.ETHNIC
RANDFL	Randomized Population Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.RANDFL
SAFFL	Safety Population Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.SAFFL
FASBABFL	Full Analysis Set bAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASBABFL
FASNABFL	Full Analysis Set nAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASNABFL
PPBABFL	Per Protocol bAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBABFL
PPNABFL	Per Protocol nAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPNABFL
PPBD29FL	Per Protocol bAb Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBD29FL
PPBD57FL	Per Protocol bAb Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBD57FL
PPND29FL	Per Protocol nAb Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPND29FL
PPND57FL	Per Protocol nAb Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPND57FL
SAR1FL	First Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAR1FL
SAR2FL	Second Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAR2FL
SARAFL	Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SARAFL
FASNA2FL	FAS nAb 2 Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASNA2FL
PPNAB2FL	PP nAb 2 Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPNAB2FL
PN2D29FL	Per Protocol nAb 2 Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PN2D29FL
PN2D57FL	Per Protocol nAb 2 Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PN2D57FL
COMPLFL	Completers Population Flag	text	1		Predecessor: ADSL.COMPLFL
DVBABFL	Deviation Impact bAb Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DVBABFL
DVNABFL	Deviation Impact nAb Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DVNABFL
DOSE1FL	Vaccination 1 Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.DOSE1FL
DOSE2FL	Vaccination 2 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DOSE2FL
DOSEROFL	Dosing Error Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DOSEROFL
COV19BL	Baseline COVID Infection	text	20	Baseline COVID Infection • "Detected" • "Not Detected"	Predecessor: ADSL.COV19BL
COV19FL	COVID Infection Flag	text	20	No Yes Response • "N" • "Y"	Predecessor: ADSL.COV19FL
SENTLFL	Sentinel Participant Flag	text	3	No Yes Response • "N" • "Y"	Predecessor: ADSL.SENTLFL
D29W7DFL	Day 29 Out of 7-Day Window Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.D29W7DFL
TRT01P	Planned Treatment for Period 01	text	25	Planned Treatment for Period 01 • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Predecessor: ADSL.TRT01P
TRT01PN	Planned Treatment for Period 01 (N)	integer	8		Predecessor: ADSL.TRT01PN
TRT01A	Actual Treatment for Period 01	text	25	Actual Treatment for Period 01 • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Predecessor: ADSL.TRT01A
TRT01AN	Actual Treatment for Period 01 (N)	integer	8		Predecessor: ADSL.TRT01AN
TR01SDT	Date of First Exposure in Period 01	integer	DATE9		Predecessor: ADSL.TR01SDT
TR01SDTM	Datetime of First Exposure in Period 01	integer	DATETIME20		Predecessor: ADSL.TR01SDTM
TR01EDT	Date of Last Exposure in Period 01	integer	DATE9		Predecessor: ADSL.TR01EDT
TR01EDTM	Datetime of Last Exposure in Period 01	integer	DATETIME20		Predecessor: ADSL.TR01EDTM
TRTSDTM	Datetime of First Exposure to Treatment	integer	DATETIME20		Predecessor: ADSL.TRTSDTM
TRTEDTM	Datetime of Last Exposure to Treatment	integer	DATETIME20		Predecessor: ADSL.TRTEDTM
DOSE2DT	Date of Dose 2	integer	DATE9		Predecessor: ADSL.DOSE2DT
DOS2DTM	Datetime of Dose 2	integer	DATETIME20		Predecessor: ADSL.DOS2DTM
AELNKGRP	Link Group ID	text	4		Predecessor: AE.AELNKGRP
TRTAN	Actual Treatment (N)	integer	8		Assigned 1 if TRT01A=‘Placebo’, 2 if TRT01A=‘mRNA-1273 50 ug’, 3 if TRT01A=‘mRNA-1273 100 ug’"
AESPID	Sponsor-Defined Identifier	text	3		Predecessor: AE.AESPID
AESEQ	Sequence Number	integer	8		Predecessor: AE.AESEQ
AECAT	Category for Adverse Event	text	14	Category for Adverse Event • "ADVERSE EVENT" • "REACTOGENICITY"	Predecessor: AE.AECAT
AETERM	Reported Term for the Adverse Event	text	70		Predecessor: AE.AETERM
AEDECOD	Dictionary-Derived Term	text	33	Medical Dictionary for Regulatory Activities MedDRA 23.0	Predecessor: AE.AEDECOD
AEBODSYS	Body System or Organ Class	text	67	Medical Dictionary for Regulatory Activities MedDRA 23.0	Predecessor: AE.AEBODSYS
AEBDSYCD	Body System or Organ Class Code	integer	8	Medical Dictionary for Regulatory Activities MedDRA 23.0	Predecessor: AE.AEBDSYCD
AELLT	Lowest Level Term	text	31	Medical Dictionary for Regulatory Activities MedDRA 23.0	Predecessor: AE.AELLT
AELLTCD	Lowest Level Term Code	integer	8	Medical Dictionary for Regulatory Activities MedDRA 23.0	Predecessor: AE.AELLTCD
AEPTCD	Preferred Term Code	integer	8	Medical Dictionary for Regulatory Activities MedDRA 23.0	Predecessor: AE.AEPTCD
AEHLT	High Level Term	text	57	Medical Dictionary for Regulatory Activities MedDRA 23.0	Predecessor: AE.AEHLT
AEHLTCD	High Level Term Code	integer	8	Medical Dictionary for Regulatory Activities MedDRA 23.0	Predecessor: AE.AEHLTCD
AEHLGT	High Level Group Term	text	55	Medical Dictionary for Regulatory Activities MedDRA 23.0	Predecessor: AE.AEHLGT
AEHLGTCD	High Level Group Term Code	integer	8	Medical Dictionary for Regulatory Activities MedDRA 23.0	Predecessor: AE.AEHLGTCD
AESOC	Primary System Organ Class	text	67	Medical Dictionary for Regulatory Activities MedDRA 23.0	Predecessor: AE.AESOC
AESOCCD	Primary System Organ Class Code	integer	8	Medical Dictionary for Regulatory Activities MedDRA 23.0	Predecessor: AE.AESOCCD
AESTDTC	Start Date/Time of Adverse Event	datetime		ISO 8601	Predecessor: AE.AESTDTC
AEENDTC	End Date/Time of Adverse Event	datetime		ISO 8601	Predecessor: AE.AEENDTC
AESTDY	Study Day of Start of Adverse Event	integer	8		Predecessor: AE.AESTDY
AEENDY	Study Day of End of Adverse Event	integer	8		Predecessor: AE.AEENDY
AEENRF	End Relative to Reference Period	text	7		Predecessor: AE.AEENRF
ASTDT	Analysis Start Date	integer	DATE9		Derived Date part of AESTDTC convert to numeric. If AESTDTC is partial or missing, apply the following imputation rule: -If only DAY is missing: If the AE end date (AEENDTC) is after the date of first vaccination (ADSL.TR01SDT) or is missing AND the start month and year of the AE (AESTDTC) coincide with the start month and year of the first vaccination (ADSL.TR01SDT), use the date of first vaccination for ASTDT and time of first vaccination for ASTTM; Otherwise, use the first day of the month; -If DAY and Month are both missing: If the AE end date is after the date of first vaccination or is missing AND the start year of the AE coincides with the start year of the first vaccination, use the date of first vaccination; Otherwise, use the first day of the year; -If DAY, Month and Year are all missing, the date will not be imputed. "
ASTTM	Analysis Start Time	integer	TIME5		Derived Time part of AESTDTC and ASTDT for imputation. If ASTDT is imputed and is set to the first vaccination day while time part of AESTDTC not missing, reset ASTTM to the time of first vaccination.
ASTDTM	Analysis Start Date/Time	integer	DATETIME20		Derived Concatenate ASTDT and ASTTM if both are non-missing
ASTDTF	Analysis Start Date Imputation Flag	text	1		Derived M if year is present and month is imputed; D if only day is imputed; Otherwise null.
ASTTMF	Analysis Start Time Imputation Flag	text	1		Derived H if time is imputed based on ASTTM derivation; Otherwise null.
ASTDY	Analysis Start Relative Day	integer	8		Derived ASTDT – ADSL.TR01SDT + 1 if ASTDT >= TR01SDT, else ASTDT – ADSL.TR01SDT if ASTDT< TR01SDT.
AENDT	Analysis End Date	integer	DATE9		Derived Set to numeric date part of AEENDTC
AENTM	Analysis End Time	integer	TIME5		Derived Set to numeric time part of AEENDTC
AENDTM	Analysis End Date/Time	integer	DATETIME20		Derived Concatenate AENDT and AENTM if both are non-missing
ASTAGE	Stage	text	20	Analysis Stage • "Follow up stage" • "Vaccination stage"	Derived ‘Vaccination stage’ If .< ADSL.TR01SDTM <=ASTDTM and ASTDT<= ADSL.TR01EDT+27, if time part of TR01SDTM or time part of ASTDTM is missing, use TR01SDT and ASTDT. ‘Follow up stage’ if ASTDT> ADSL.TR01EDT+27
ASTAGEN	Stage (N)	integer	8		Assigned 1 if ASTAGE= Vaccination stage, 2 if ASTAGE= Follow up stage
AEDUR	Duration of Adverse Event	durationDatetime		ISO 8601	Predecessor: AE.AEDUR
MDOSREF	Most Recent Dose Reference	text	50	Analysis Timepoint Reference • "Vaccination 1" • "Vaccination 2"	Derived Set to 'Vaccination 1' if AE.AEREFID contains 'DOSE 1'； Set to 'Vaccination 2' if AE.AEREFID contains 'DOSE 2'
MRDSTDY	Relative Start Day from Most Recent Dose	integer	8		Derived Set to (the largest integer less than or equal to (ASTDTM – ADSL.TR01SDTM)/(246060)) + 1 If MDOSREF='Vaccination 1', set to (the largest integer less than or equal to (ASTDTM – ADSL.DOS2DTM)/(246060)) + 1 If MDOSREF='Vaccination 2'. if time part of ASTDTM is missing, use ASTDT to replace ASTDTM and calculate as follows: ASTDT – ADSL.TR01SDT+ 1 If MDOSREF='Vaccination 1', ASTDT – ADSL.DOSE2DT+ 1 If MDOSREF='Vaccination 2'. (For example, ADSL.TR01SDTM is on 01Mar2020 at 2 pm, the ASTDTM is on 02Mar2020 at 8 am, the MRDSTDY will be Day 1 with MDOSREF='Vaccination 1'. ADSL.TR01SDTM is on 01Mar2020 at 2 pm, the ASTDTM is on 02Mar2020 at 5 pm, the MRDSTDY will be Day 2 with MDOSREF='Vaccination 1'. )
MRDENDY	Relative End Day from Most Recent Dose	integer	8		Derived Set to (the largest integer less than or equal to (AENDTM – ADSL.TR01SDTM)/(246060)) + 1 If MDOSREF='Vaccination 1', set to (the largest integer less than or equal to (AENDTM – ADSL.DOS2DTM)/(246060)) + 1 If MDOSREF='Vaccination 2'. if time part of AENDTM is missing, use AENDT to replace AEENDTM and calculate as follows: AENDT – ADSL.TR01SDT+ 1 If MDOSREF='Vaccination 1', AENDT – ADSL.DOSE2DT+ 1 If MDOSREF='Vaccination 2'. (For example, ADSL.TR01SDTM is on 01Mar2020 at 2 pm, the AENDTM is on 02Mar2020 at 8 am, the MRDENDY will be Day 1 with MDOSREF='Vaccination 1'. ADSL.TR01SDTM is on 01Mar2020 at 2 pm, the AENDTM is on 02Mar2020 at 5 pm, the MRDENDY will be Day 2 with MDOSREF='Vaccination 1'. )
TRTEMFL	Treatment Emergent Analysis Flag	text	1	No Yes Response (Yes Only) • "Y"	Derived "Y" if .< ADSL.TR01SDTM <= ASTDTM, or (if ASTDT missing and .< ADSL.TR01SDTM <= AENDTM) or both ASTDT and AENDT missing. If time is not available, use TR01SDT, ASTDT and AENDT.
AEMAFL	Medically-Attended Flag	text	20	No Yes Response • "N" • "Y"	Derived Set to SUPPAE.QVAL where SUPPAE.QNAM=AEMAFL
D28FL	AE Through 28 Days Analysis Flag	text	1	No Yes Response (Yes Only) • "Y"	Derived Set to 'Y' if non-missing MRDSTDY<=28; Blank otherwise.
AEDISFL	Leading to Study Discontinuation Flag	text	1		Derived Set 'Y' if subject with DS.DSDECOD countians 'ADVERSE EVENT' or 'AE' and the specified adverse event number match the AE.AESPID where DSCAT = DISPOSITION EVENT and DS.DSSCAT='END OF STUDY' Otherwise null
AESOFL	Solicited Adverse Reaction?	text	1	No Yes Response • "N" • "Y"	Derived Set to SUPPAE.QVAL where SUPPAE.QNAM='AESOFL'
AESER	Serious Event	text	1	No Yes Response • "N" • "Y"	Predecessor: AE.AESER
AESCONG	Congenital Anomaly or Birth Defect	text	1	No Yes Response (No Only) • "N"	Predecessor: AE.AESCONG
AESDISAB	Persist or Signif Disability/Incapacity	text	1	No Yes Response (No Only) • "N"	Predecessor: AE.AESDISAB
AESDTH	Results in Death	text	1	No Yes Response (No Only) • "N"	Predecessor: AE.AESDTH
AESHOSP	Requires or Prolongs Hospitalization	text	1	No Yes Response • "N" • "Y"	Predecessor: AE.AESHOSP
AESLIFE	Is Life Threatening	text	1	No Yes Response • "N" • "Y"	Predecessor: AE.AESLIFE
AESMIE	Other Medically Important Serious Event	text	1	No Yes Response (No Only) • "N"	Predecessor: AE.AESMIE
AEREL	Causality	text	14	Causality • "NOT APPLICABLE" • "NOT RELATED" • "RELATED"	Predecessor: AE.AEREL
AERELNST	Relationship to Non-Study Treatment	text	14	Relationship to Non-Study Treatment • "NOT APPLICABLE" • "NOT RELATED" • "RELATED"	Predecessor: AE.AERELNST
AREL	Analysis Causality	text	20	Analysis Causality • "NOT APPLICABLE" • "NOT RELATED" • "RELATED"	Derived Set to AEREL.
ARELN	Analysis Causality (N)	integer	8		Assigned 1 if AREL= 'NOT RELATED', 2 if AREL= 'RELATED', 3 If AREL= 'NOT APPLICABLE'
AETOXGR	Standard Toxicity Grade	text	1		Predecessor: AE.AETOXGR
AESEV	Severity/Intensity	text	8	Severity/Intensity Scale for Adverse Events • "MILD" • "MODERATE" • "SEVERE"	Predecessor: AE.AESEV
ATOXGR	Analysis Toxicity Grade	text	20	Adverse Event Toxicity Grade • "Grade 1" • "Grade 2" • "Grade 3" • "Grade 4"	Derived Set to 'Grade 1' if AETOXGR='1'; Set to 'Grade 2’ if AETOXGR='2'; Set to ‘Grade 3’ if AETOXGR='3'; Set to ‘Grade 4’ if AETOXGR='4';
ATOXGRN	Analysis Toxicity Grade (N)	integer	8		Assigned 0 if ATOXGR=Grade 0, 1 if ATOXGR=Grade 1, 2 if ATOXGR=Grade 2, 3 if ATOXGR=Grade 3, 4 if ATOXGR=Grade 4
ASEV	Analysis Severity/Intensity	text	20	Analysis Severity/Intensity • "Grade 1/Mild" • "Grade 2/Moderate" • "Grade 3/Severe" • "Grade 4"	Derived Concatenate ATOXGR and Mixed case of AESEV with '/', eg, Grade 1/Mild; Set to ATOXGR if ATOXGR is 'Grade 4'
ASEVN	Analysis Severity/Intensity (N)	integer	8		Assigned 1 if ASEV = 'Grade 1/Mild' 2 if ASEV = 'Grade 2/Moderate' 3 if ASEV = 'Grade 4/Severe' 4 if AESEV='Grade 4'
TOXGGR1	Pooled Toxicity Grade Group 1	text	20		Derived Pooled grouping of toxicity grade for analysis: <3 when .<ATOXGRN <3; >=3 when ATOXGRN >=3;
TOXGGR1N	Pooled Toxicity Grade 1 (N)	integer	8		Assigned 1 if TOXGGR1= '<3', 2 if TOXGGR1= '>=3'
AEACN	Action Taken with Study Treatment	text	16	Action Taken with Study Treatment • "DOSE DELAYED" • "DOSE NOT CHANGED" • "DRUG WITHDRAWN" • "NOT APPLICABLE"	Predecessor: AE.AEACN
AEACNOTH	Other Action Taken	text	45		Predecessor: AE.AEACNOTH
AEOUT	Outcome of Adverse Event	text	26	Outcome of Adverse Event • "NOT RECOVERED/NOT RESOLVED" • "RECOVERED/RESOLVED" • "RECOVERING/RESOLVING" • "UNKNOWN"	Predecessor: AE.AEOUT
AEOUTSP	Recovered/Resolved with Sequelae,Spec	text	200		Derived Set to SUPPAE.QVAL where SUPPAE.QNAM=AEOUTSP
AEHSTDTC	Hospital Admission Date	text	20		Derived HO.HOSTDTC where HOTERM='HOSPITAL' based on AESPID and HOSPID
AEHENDTC	Hospital Discharge Date	text	20		Derived HO.HOENDTC where HOTERM='HOSPITAL' based on AESPID and HOSPID
ICUAD	Admitted to ICU	text	20		Derived HO.HOOCCUR where HOTERM='ADMITTED TO ICU' based on AESPID and HOSPID
ICUDAY	Duration of Healthcare Encounter	text	200		Derived HO.HODUR where HOTERM='ADMITTED TO ICU' based on AESPID and HOSPID
AEREFID	Reference ID	text	25		Predecessor: AE.AEREFID

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Concomitant Medication Analysis Dataset (ADCM)

ADCM (Concomitant Medication Analysis Dataset) - OCCURRENCE DATA STRUCTURE Location: adcm.xpt
Variable	Label / Description	Type	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	14	Study Identifier • "mRNA-1273-P201"	Predecessor: ADSL.STUDYID
USUBJID	Unique Subject Identifier	text	25		Predecessor: ADSL.USUBJID
SUBJID	Subject Identifier for the Study	text	9		Predecessor: ADSL.SUBJID
SITEID	Study Site Identifier	text	5		Predecessor: ADSL.SITEID
COUNTRY	Country	text	3	Country • "USA"	Predecessor: ADSL.COUNTRY
AGE	Age	integer	8		Predecessor: ADSL.AGE
AGEU	Age Units	text	5		Predecessor: ADSL.AGEU
AGEGR1	Pooled Age Group 1	text	30	Pooled Age Group 1 • ">=18 and <55 Years" • ">=55 Years"	Predecessor: ADSL.AGEGR1
AGEGR1N	Pooled Age Group 1 (N)	integer	8		Predecessor: ADSL.AGEGR1N
AGEGR2	Pooled Age Group 2	text	19	Pooled Age Group 2 • ">=18 and <=22 Years" • ">=23 and <=25 Years" • ">25 and <55 Years" • ">=55 Years"	Predecessor: ADSL.AGEGR2
AGEGR2N	Pooled Age Group 2 (N)	integer	8		Predecessor: ADSL.AGEGR2N
SEX	Sex	text	1	Sex • "F" • "M"	Predecessor: ADSL.SEX
RACE	Race	text	41	Race [8 Terms]	Predecessor: ADSL.RACE
RACESPY	Race Specify	text	200		Predecessor: ADSL.RACESPY
ETHNIC	Ethnicity	text	22	Ethnicity • "HISPANIC OR LATINO" • "NOT HISPANIC OR LATINO" • "NOT REPORTED" • "UNKNOWN"	Predecessor: ADSL.ETHNIC
RANDFL	Randomized Population Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.RANDFL
SAFFL	Safety Population Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.SAFFL
FASBABFL	Full Analysis Set bAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASBABFL
FASNABFL	Full Analysis Set nAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASNABFL
PPBABFL	Per Protocol bAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBABFL
PPNABFL	Per Protocol nAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPNABFL
PPBD29FL	Per Protocol bAb Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBD29FL
PPBD57FL	Per Protocol bAb Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBD57FL
PPND29FL	Per Protocol nAb Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPND29FL
PPND57FL	Per Protocol nAb Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPND57FL
SAR1FL	First Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAR1FL
SAR2FL	Second Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAR2FL
SARAFL	Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SARAFL
FASNA2FL	FAS nAb 2 Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASNA2FL
PPNAB2FL	PP nAb 2 Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPNAB2FL
PN2D29FL	Per Protocol nAb 2 Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADLS.PN2D29FL
PN2D57FL	Per Protocol nAb 2 Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PN2D57FL
COMPLFL	Completers Population Flag	text	1	No Yes Response (No Only) • "N"	Predecessor: ADSL.COMPLFL
DVBABFL	Deviation Impact bAb Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DVBABFL
DVNABFL	Deviation Impact nAb Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DVNABFL
DOSE1FL	Vaccination 1 Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.DOSE1FL
DOSE2FL	Vaccination 2 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DOSE2FL
DOSEROFL	Dosing Error Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DOSEROFL
COV19BL	Baseline COVID Infection	text	20	Baseline COVID Infection • "Detected" • "Not Detected"	Predecessor: ADSL.COV19BL
COV19FL	COVID Infection Flag	text	20	No Yes Response • "N" • "Y"	Predecessor: ADSL.COV19FL
SENTLFL	Sentinel Participant Flag	text	3	No Yes Response • "N" • "Y"	Predecessor: ADSL.SENTLFL
D29W7DFL	Day 29 Out of 7-Day Window Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.D29W7DFL
TRT01P	Planned Treatment for Period 01	text	25	Planned Treatment for Period 01 • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Predecessor: ADSL.TRT01P
TRT01PN	Planned Treatment for Period 01 (N)	integer	8		Predecessor: ADSL.TRT01PN
TRT01A	Actual Treatment for Period 01	text	25	Actual Treatment for Period 01 • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Predecessor: ADSL.TRT01A
TRT01AN	Actual Treatment for Period 01 (N)	integer	8		Predecessor: ADSL.TRT01AN
TR01SDT	Date of First Exposure in Period 01	integer	DATE9		Predecessor: ADSL.TR01SDT
TR01SDTM	Datetime of First Exposure in Period 01	integer	DATETIME20		Predecessor: ADSL.TR01SDTM
TR01EDT	Date of Last Exposure in Period 01	integer	DATE9		Predecessor: ADSL.TR01EDT
TR01EDTM	Datetime of Last Exposure in Period 01	integer	DATETIME20		Predecessor: ADSL.TR01EDTM
TRTSDTM	Datetime of First Exposure to Treatment	integer	DATETIME20		Predecessor: ADSL.TRTSDTM
TRTEDTM	Datetime of Last Exposure to Treatment	integer	DATETIME20		Predecessor: ADSL.TRTEDTM
DOSE2DT	Date of Dose 2	integer	DATE9		Predecessor: ADSL.DOSE2DT
DOS2DTM	Datetime of Dose 2	integer	DATETIME20		Predecessor: ADSL.DOS2DTM
CMSEQ	Sequence Number	integer	8		Predecessor: CM.CMSEQ
CMCAT	Category for Medication	text	44	Category for Medication • "Prior/Concomitant Medication and Vaccination"	Predecessor: CM.CMCAT
CMTRT	Reported Name of Drug, Med, or Therapy	text	137		Predecessor: CM.CMTRT
CMDECOD	Standardized Medication Name	text	189		Predecessor: CM.CMDECOD
CMINDC	Indication	text	83		Predecessor: CM.CMINDC
CMDOSE	Dose per Administration	float	8		Predecessor: CM.CMDOSE
CMDOSU	Dose Units	text	7	Dose Units [9 Terms]	Predecessor: CM.CMDOSU
CMUOTHSP	Dose Unit Other Specficiation	text	200		Derived Set to SUPPCM.QVAL where QNAM='CMUOTHSP'
CMDOSFRQ	Dosing Frequency per Interval	text	10	Dosing Frequency per Interval [11 Terms]	Predecessor: CM.CMDOSFRQ
CMFOTHSP	Dose Frequency Specification	text	200		Derived Set to SUPPCM.QVAL where QNAM='CMFOTHSP'
CMROUTE	Route of Administration	text	13	Route of Administration [12 Terms]	Predecessor: CM.CMROUTE
CMROTHSP	Dose Route Other Specification	text	200		Derived Set to SUPPCM.QVAL where QNAM='CMROTHSP'
CMSTDTC	Start Date/Time of Medication	text	10		Predecessor: CM.CMSTDTC
CMENDTC	End Date/Time of Medication	text	10		Predecessor: CM.CMENDTC
CMSTDY	Study Day of Start of Medication	integer	8		Predecessor: CM.CMSTDY
CMENDY	Study Day of End of Medication	integer	8		Predecessor: CM.CMENDY
CMENRTPT	End Relative to Reference Time Point	text	7		Predecessor: CM.CMENRTPT
CMSOLFL	Medication Taken for Solicited Event	text	1	No Yes Response • "N" • "Y"	Derived SUPPCM.QVAL when QNAM='CMSOL'
ASTDT	Analysis Start Date	integer	DATE9		Derived Convert date part of CM.CMSTDTC to numeric if day, month, and year are all present; -If only DAY is missing: If the CM end date (CMENDTC) is after the date of first vaccination (ADSL.TR01SDT) or is missing AND the start month and year of the CM (CMSTDTC) coincide with the start month and year of the first vaccination (ADSL.TR01SDT), use the date of first vaccination; Otherwise, use the first day of the month; -If DAY and Month are both missing: If the CM end date is after the date of first vaccination or is missing AND the start year of the CM coincides with the start year of the first vaccination, use the date of first vaccination Otherwise, use the first day of the year; -If DAY, Month and Year are all missing, the date will not be imputed. blank otherwise Note: if CMENDTC is partial: If only day is missing, month and year coincide with or after the month and year of TR01SDT, treat CMENDTC as after TR01SDT, otherwise treat CMENDTC as before TR01SDT. If month is missing (regardless of day is missing or not), if year coincides with or after the year of TR01SDT, treat CMENDTC as after TR01SDT, otherwise treat CMENDTC as before TR01SDT. If year is missing (regardles of day and month), treat CMENDTC as after TR01SDT.
ASTDTF	Analysis Start Date Imputation Flag	text	1		Derived "D" if only the day is imputed; "M" if the day and the month are imputed
ASTDY	Analysis Start Relative Day	integer	8		Derived ASTDT - TR01SDT + 1 if ASTDT >= TR01SDT, else ASTDT - TR01SDT if ASTDT < TR01SDT
AENDT	Analysis End Date	integer	DATE9		Derived Set to numeric date part of CM.CMENDTC if day, month, and year are all present If day and month are both missing, AENDT is whichever is earliest of the following: 31DECYYYY, EOSDT, or DTHDT; If only day is missing, AENDT is whichiever is earliest of the following: EOSDT, DTHDT, or xxMMMYYYY where xx is the last day of the month; blank otherwise
AENDTF	Analysis End Date Imputation Flag	text	1		Derived Set to 'D' if only the day is imputed Set to 'M' if the day and the month are imputed
AENDY	Analysis End Relative Day	integer	8		Derived Set to AENDT - TR01SDT + 1 if AENDT >= TR01SDT Set to ASTDT - TR01SDT if AENDT < TR01SDT
MDOSREF	Most Recent Dose Reference	text	50	Analysis Timepoint Reference • "Vaccination 1" • "Vaccination 2"	Derived If (.<TR01SDT<=ASTDT <DOSE2DT) or (.<TR01SDT<=ASTDT and DOSE2DT missing), set to 'Vaccination 1'; if .<DOSE2DT<=ASTDT , set to 'Vaccination 2';
MRDSTDY	Relative Start Day from Most Recent Dose	integer	8		Derived If MDOSREF='Vaccination 1' set to ASTDT – TR01SDT+ 1 If MDOSREF='Vaccination 2' set to ASTDT – DOS2DT+ 1
CMMOI1FL	Modified Indication 1 Result Flag	text	1	No Yes Response (Yes Only) • "Y"	Derived Set to 'Y' If CMINDC contians 'Prophylax' AND CMDECOD contains 'PARACETAMOL', 'DIPHENHYDRAMINE HYDROCHLORIDE;PARACETAMOL', 'IBUPROFEN', 'DIPHENHYDRAMINE CITRATE;IBUPROFEN', 'DIPHENHYDRAMINE HYDROCHLORIDE', IBUPROFEN', 'NAPROXEN SODIUM', 'DEXTROMETHORPHAN HYDROBROMIDE' 'GUAIFENESIN', 'PARACETAMOL' 'PSEUDOEPHEDRINE HYDROCHLORIDE', 'DEXTROMETHORPHAN HYDROBROMIDE;DOXYLAMINE SUCCINATE', 'EPHEDRINE SULFATE', 'ETHANOL', 'PARACETAMOL', 'ACETYLSALICYLIC ACID;CAFFEINE', 'PARACETAMOL'
CMMOI2FL	Modified Indication 2 Result Flag	text	1	No Yes Response (Yes Only) • "Y"	Derived 'Y' If CMDECOD contains 'PARACETAMOL', 'DIPHENHYDRAMINE HYDROCHLORIDE;PARACETAMOL', 'IBUPROFEN', 'DIPHENHYDRAMINE CITRATE;IBUPROFEN', 'DIPHENHYDRAMINE HYDROCHLORIDE', 'IBUPROFEN', 'NAPROXEN SODIUM', 'DEXTROMETHORPHAN HYDROBROMIDE', 'GUAIFENESIN', 'PARACETAMOL;PSEUDOEPHEDRINE HYDROCHLORIDE'; 'DEXTROMETHORPHAN HYDROBROMIDE;DOXYLAMINE SUCCINATE;EPHEDRINE SULFATE;ETHANOL;PARACETAMOL'; 'ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL'
PREFL	Pre-treatment Flag	text	1	No Yes Response (Yes Only) • "Y"	Derived Set to 'Y' if ASTDT < TR01SDT or ASTDT is missing; missing otherwise
ONTRTFL	On Treatment Record Flag	text	1	No Yes Response (Yes Only) • "Y"	Derived Set to 'Y' if (ASTDT <= TR01EDT + 28 days) and (AENDT >= TR01SDT or AENDT is missing); or if ASTDT is missing and (AENDT >= TR01SDT or AENDT is missing); missing otherwise
FUPFL	Follow-up Flag	text	1	No Yes Response (Yes Only) • "Y"	Derived Set to 'Y' if AENDT > TR01EDT + 28 days or AENDT is missing missing otherwise
ATCLEV1T	ATC Level 1	text	200		Derived Set to SUPPCM.QVAL where QNAM='ATCLEV1T'
ATCLEV2T	ATC Level 2	text	200		Derived Set to SUPPCM.QVAL where QNAM='ATCLEV2T'
ATCLEV3T	ATC Level 3	text	200		Derived Set to SUPPCM.QVAL where QNAM='ATCLEV3T'
ATCLEV4T	ATC Level 4	text	200		Derived Set to SUPPCM.QVAL where QNAM='ATCLEV4T'

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Deviation Analysis Dataset (ADDV)

ADDV (Deviation Analysis Dataset) - OCCURRENCE DATA STRUCTURE Location: addv.xpt
Variable	Label / Description	Type	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	14	Study Identifier • "mRNA-1273-P201"	Predecessor: ADSL.STUDYID
USUBJID	Unique Subject Identifier	text	25		Predecessor: ADSL.USUBJID
SUBJID	Subject Identifier for the Study	text	9		Predecessor: ADSL.SUBJID
SITEID	Study Site Identifier	text	5		Predecessor: ADSL.SITEID
COUNTRY	Country	text	3	Country • "USA"	Predecessor: ADSL.COUNTRY
AGE	Age	integer	8		Predecessor: ADSL.AGE
AGEU	Age Units	text	5		Predecessor: ADSL.AGEU
AGEGR1	Pooled Age Group 1	text	30	Pooled Age Group 1 • ">=18 and <55 Years" • ">=55 Years"	Predecessor: ADSL.AGEGR1
AGEGR1N	Pooled Age Group 1 (N)	integer	8		Predecessor: ADSL.AGEGR1N
AGEGR2	Pooled Age Group 2	text	19	Pooled Age Group 2 • ">=18 and <=22 Years" • ">=23 and <=25 Years" • ">25 and <55 Years" • ">=55 Years"	Predecessor: ADSL.AGEGR2
AGEGR2N	Pooled Age Group 2 (N)	integer	8		Predecessor: ADSL.AGEGR2N
SEX	Sex	text	1	Sex • "F" • "M"	Predecessor: ADSL.SEX
RACE	Race	text	41	Race [8 Terms]	Predecessor: ADSL.RACE
RACESPY	Race Specify	text	200		Predecessor: ADSL.RACESPY
ETHNIC	Ethnicity	text	22	Ethnicity • "HISPANIC OR LATINO" • "NOT HISPANIC OR LATINO" • "NOT REPORTED" • "UNKNOWN"	Predecessor: ADSL.ETHNIC
RANDFL	Randomized Population Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.RANDFL
SAFFL	Safety Population Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.SAFFL
FASBABFL	Full Analysis Set bAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASBABFL
FASNABFL	Full Analysis Set nAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASNABFL
PPBABFL	Per Protocol bAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBABFL
PPNABFL	Per Protocol nAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPNABFL
PPBD29FL	Per Protocol bAb Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBD29FL
PPBD57FL	Per Protocol bAb Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBD57FL
PPND29FL	Per Protocol nAb Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPND29FL
PPND57FL	Per Protocol nAb Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPND57FL
SAR1FL	First Solicited Safety Population Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.SAR1FL
SAR2FL	Second Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAR2FL
SARAFL	Solicited Safety Population Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.SARAFL
FASNA2FL	FAS nAb 2 Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASNA2FL
PPNAB2FL	PP nAb 2 Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPNAB2FL
PN2D29FL	Per Protocol nAb 2 Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PN2D29FL
PN2D57FL	Per Protocol nAb 2 Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PN2D57FL
COMPLFL	Completers Population Flag	text	1		Predecessor: ADSL.COMPLFL
DVBABFL	Deviation Impact bAb Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DVBABFL
DVNABFL	Deviation Impact nAb Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DVNABFL
DOSE1FL	Vaccination 1 Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.DOSE1FL
DOSE2FL	Vaccination 2 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DOSE2FL
DOSEROFL	Dosing Error Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DOSEROFL
COV19BL	Baseline COVID Infection	text	20		Predecessor: ADSL.COV19BL
COV19FL	COVID Infection Flag	text	20	No Yes Response • "N" • "Y"	Predecessor: ADSL.COV19FL
SENTLFL	Sentinel Participant Flag	text	3	No Yes Response • "N" • "Y"	Predecessor: ADSL.SENTLFL
D29W7DFL	Day 29 Out of 7-Day Window Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.D29W7DFL
TRT01P	Planned Treatment for Period 01	text	25	Planned Treatment for Period 01 • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Predecessor: ADSL.TRT01P
TRT01PN	Planned Treatment for Period 01 (N)	integer	8		Predecessor: ADSL.TRT01PN
TRT01A	Actual Treatment for Period 01	text	25	Actual Treatment for Period 01 • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Predecessor: ADSL.TRT01A
TRT01AN	Actual Treatment for Period 01 (N)	integer	8		Predecessor: ADSL.TRT01AN
TR01SDT	Date of First Exposure in Period 01	integer	DATE9		Predecessor: ADSL.TR01SDT
TR01SDTM	Datetime of First Exposure in Period 01	integer	DATETIME20		Predecessor: ADSL.TR01SDTM
TR01EDT	Date of Last Exposure in Period 01	integer	DATE9		Predecessor: ADSL.TR01EDT
TR01EDTM	Datetime of Last Exposure in Period 01	integer	DATETIME20		Predecessor: ADSL.TR01EDTM
TRTSDTM	Datetime of First Exposure to Treatment	integer	DATETIME20		Predecessor: ADSL.TRTSDTM
TRTEDTM	Datetime of Last Exposure to Treatment	integer	DATETIME20		Predecessor: ADSL.TRTEDTM
DOSE2DT	Date of Dose 2	integer	DATE9		Predecessor: ADSL.DOSE2DT
DOS2DTM	Datetime of Dose 2	integer	DATETIME20		Predecessor: ADSL.DOS2DTM
DVSEQ	Sequence Number	integer	8		Predecessor: DV.DVSEQ
DVCAT	Category for Protocol Deviation	text	18		Predecessor: DV.DVCAT
DVSCAT	Subcategory for Protocol Deviation	text	28	Subcategory for Protocol Deviation [11 Terms]	Predecessor: DV.DVSCAT
DVSTDTC	Start Date/Time of Deviation	date		ISO 8601	Predecessor: DV.DVSTDTC
DVSTDY	Study Day of Start of Deviation	integer	8		Predecessor: DV.DVSTDY
DVTERM	Protocol Deviation Term	text	199		Predecessor: DV.DVTERM
DVTERM1	Protocol Deviation Term 1	text	129		Derived Set to SUPPDV.QVAL where SUPPDV.QNAM='DVTERM1'
DVTERM2	Protocol Deviation Term 2	text	199		Derived Set to SUPPDV.QVAL where SUPPDV.QNAM='DVTERM2'
DVTERM3	Protocol Deviation Term 3	text	115		Derived Set to SUPPDV.QVAL where SUPPDV.QNAM='DVTERM3'
DVSIG	Significant Protocol Deviation	text	15		Derived Set to SUPPDV.QVAL where SUPPDV.QNAM='DVSIG'

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Treatment Exposure Analysis Dataset (ADEX)

ADEX (Treatment Exposure Analysis Dataset) - OCCURRENCE DATA STRUCTURE Location: adex.xpt
Variable	Label / Description	Type	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	14	Study Identifier • "mRNA-1273-P201"	Predecessor: ADSL.STUDYID
USUBJID	Unique Subject Identifier	text	25		Predecessor: ADSL.USUBJID
SUBJID	Subject Identifier for the Study	text	9		Predecessor: ADSL.SUBJID
SITEID	Study Site Identifier	text	5		Predecessor: ADSL.SITEID
COUNTRY	Country	text	3	Country • "USA"	Predecessor: ADSL.COUNTRY
AGE	Age	integer	8		Predecessor: ADSL.AGE
AGEU	Age Units	text	5		Predecessor: ADSL.AGEU
AGEGR1	Pooled Age Group 1	text	30	Pooled Age Group 1 • ">=18 and <55 Years" • ">=55 Years"	Predecessor: ADSL.AGEGR1
AGEGR1N	Pooled Age Group 1 (N)	integer	8		Predecessor: ADSL.AGEGR1N
AGEGR2	Pooled Age Group 2	text	19	Pooled Age Group 2 • ">=18 and <=22 Years" • ">=23 and <=25 Years" • ">25 and <55 Years" • ">=55 Years"	Predecessor: ADSL.AGEGR2
AGEGR2N	Pooled Age Group 2 (N)	integer	8		Predecessor: ADSL.AGEGR2N
SEX	Sex	text	1	Sex • "F" • "M"	Predecessor: ADSL.SEX
RACE	Race	text	41	Race [8 Terms]	Predecessor: ADSL.RACE
RACESPY	Race Specify	text	200		Predecessor: ADSL.RACESPY
ETHNIC	Ethnicity	text	22	Ethnicity • "HISPANIC OR LATINO" • "NOT HISPANIC OR LATINO" • "NOT REPORTED" • "UNKNOWN"	Predecessor: ADSL.ETHNIC
RANDFL	Randomized Population Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.RANDFL
SAFFL	Safety Population Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.SAFFL
FASBABFL	Full Analysis Set bAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASBABFL
FASNABFL	Full Analysis Set nAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASNABFL
PPBABFL	Per Protocol bAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBABFL
PPNABFL	Per Protocol nAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPNABFL
PPBD29FL	Per Protocol bAb Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBD29FL
PPBD57FL	Per Protocol bAb Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBD57FL
PPND29FL	Per Protocol nAb Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPND29FL
PPND57FL	Per Protocol nAb Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPND57FL
SAR1FL	First Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAR1FL
SAR2FL	Second Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAR2FL
SARAFL	Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SARAFL
FASNA2FL	FAS nAb 2 Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASNA2FL
PPNAB2FL	PP nAb 2 Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPNAB2FL
PN2D29FL	Per Protocol nAb 2 Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PN2D29FL
PN2D57FL	Per Protocol nAb 2 Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PN2D57FL
COMPLFL	Completers Population Flag	text	1	No Yes Response (No Only) • "N"	Predecessor: ADSL.COMPLFL
DVBABFL	Deviation Impact bAb Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DVBABFL
DVNABFL	Deviation Impact nAb Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DVNABFL
DOSE1FL	Vaccination 1 Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.DOSE1FL
DOSE2FL	Vaccination 2 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DOSE2FL
DOSEROFL	Dosing Error Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DOSEROFL
COV19BL	Baseline COVID Infection	text	20	Baseline COVID Infection • "Detected" • "Not Detected"	Predecessor: ADSL.COV19BL
COV19FL	COVID Infection Flag	text	20	No Yes Response • "N" • "Y"	Predecessor: ADSL.COV19FL
SENTLFL	Sentinel Participant Flag	text	3	No Yes Response • "N" • "Y"	Predecessor: ADSL.SENTLFL
D29W7DFL	Day 29 Out of 7-Day Window Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.D29W7DFL
TRT01P	Planned Treatment for Period 01	text	25	Planned Treatment for Period 01 • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Predecessor: ADSL.TRT01P
TRT01PN	Planned Treatment for Period 01 (N)	integer	8		Predecessor: ADSL.TRT01PN
TRT01A	Actual Treatment for Period 01	text	25	Actual Treatment for Period 01 • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Predecessor: ADSL.TRT01A
TRT01AN	Actual Treatment for Period 01 (N)	integer	8		Predecessor: ADSL.TRT01AN
TR01SDT	Date of First Exposure in Period 01	integer	DATE9		Predecessor: ADSL.TR01SDT
TR01SDTM	Datetime of First Exposure in Period 01	integer	DATETIME20		Predecessor: ADSL.TR01SDTM
TR01EDT	Date of Last Exposure in Period 01	integer	DATE9		Predecessor: ADSL.TR01EDT
TR01EDTM	Datetime of Last Exposure in Period 01	integer	DATETIME20		Predecessor: ADSL.TR01EDTM
TRTSDTM	Datetime of First Exposure to Treatment	integer	DATETIME20		Predecessor: ADSL.TRTSDTM
TRTEDTM	Datetime of Last Exposure to Treatment	integer	DATETIME20		Predecessor: ADSL.TRTEDTM
DOSE2DT	Date of Dose 2	integer	DATE9		Predecessor: ADSL.DOSE2DT
DOS2DTM	Datetime of Dose 2	integer	DATETIME20		Predecessor: ADSL.DOS2DTM
ASEQ	Analysis Sequence Number	integer	8		Assigned
EXTRT	Name of Treatment	text	9	Name of Treatment • "PLACEBO" • "mRNA-1273"	Predecessor: EX.EXTRT
EXDOSE	Dose	integer	8		Predecessor: EX.EXDOSE
EXDOSU	Dose Units	text	2	Dose Units • "ug"	Predecessor: EX.EXDOSU
EXDOSTXT	Dose Description	text	13		Predecessor: EX.DOSTXT
EXDOSFRM	Dose Form	text	9	Dose Form • "INJECTION"	Predecessor: EX.EXDOSFRM
EXDOSFRQ	Dosing Frequency per Interval	text	4	Dosing Frequency per Interval • "ONCE"	Predecessor: EX.EXDOSFRQ
EXROUTE	Route of Administration	text	13	Route of Administration • "INTRAMUSCULAR"	Predecessor: EX.EXROUTE
EXLOC	Location of Dose Administration	text	3	Location of Dose Administration • "ARM"	Predecessor: EX.EXLOC
EXLAT	Laterality	text	5	Laterality • "LEFT" • "RIGHT"	Predecessor: EX.EXLAT
EXSTDTC	Start Date/Time of Treatment	datetime		ISO 8601	Predecessor: EX.EXSTDTC
EXENDTC	End Date/Time of Treatment	datetime		ISO 8601	Predecessor: EX.EXENDTC
EXSTDY	Study Day of Start of Treatment	integer	8		Predecessor: EX.EXSTDY
VISIT	Visit Name	text	25		Predecessor: EX.VISIT if source data are from EX; EC.VISIT if source data are from EC/SUPPEC
VISITNUM	Visit Number	integer	8		Predecessor: EX.VISITNUM if source data are from EX; EC.VISITNUM if source data are from EC/SUPPEC
ASTDT	Analysis Start Date	integer	DATE9		Derived Date part of EX.EXSTDTC
AENDT	Analysis End Date	integer	DATE9		Derived Date part of EX.EXENDTC
DOSEYNFL	Study Treatment Occurrence Flag	text	1	No Yes Response • "N" • "Y"	Derived Set to 'Y' if EXSTDTC is not missing. Set to 'N' if EXSTDTC is missing and EC.ECOCCUR='N'
NDOSERS	Reason Study Treatment not Given	text	200	Reason Study Treatment not Given [8 Terms]	Derived Set to EC.ECREASOC
SRCDOM	Source Data	text	20		Derived EX.DOMAIN if source data are from EX; EC.DOMAIN if source data are from EC
SRCSEQ	Source Sequence Number	integer	8		Derived EX.EXSEQ if source data are from EX; EC.ECSEQ if source data are from EC

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Medical Hisotry Analysis Dataset (ADMH)

ADMH (Medical Hisotry Analysis Dataset) - OCCURRENCE DATA STRUCTURE Location: admh.xpt
Variable	Label / Description	Type	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	14	Study Identifier • "mRNA-1273-P201"	Predecessor: ADSL.STUDYID
USUBJID	Unique Subject Identifier	text	25		Predecessor: ADSL.USUBJID
SUBJID	Subject Identifier for the Study	text	9		Predecessor: ADSL.SUBJID
SITEID	Study Site Identifier	text	5		Predecessor: ADSL.SITEID
COUNTRY	Country	text	3	Country • "USA"	Predecessor: ADSL.COUNTRY
AGE	Age	integer	8		Predecessor: ADSL.AGE
AGEU	Age Units	text	5		Predecessor: ADSL.AGEU
AGEGR1	Pooled Age Group 1	text	18	Pooled Age Group 1 • ">=18 and <55 Years" • ">=55 Years"	Predecessor: ADSL.AGEGR1
AGEGR1N	Pooled Age Group 1 (N)	integer	8		Predecessor: ADSL.AGEGR1N
AGEGR2	Pooled Age Group 2	text	19	Pooled Age Group 2 • ">=18 and <=22 Years" • ">=23 and <=25 Years" • ">25 and <55 Years" • ">=55 Years"	Predecessor: ADSL.AGEGR2
AGEGR2N	Pooled Age Group 2 (N)	integer	8		Predecessor: ADSL.AGEGR2N
SEX	Sex	text	1	Sex • "F" • "M"	Predecessor: ADSL.SEX
RACE	Race	text	41	Race [8 Terms]	Predecessor: ADSL.RACE
RACESPY	Race Specify	text	39		Predecessor: ADSL.RACESPY
ETHNIC	Ethnicity	text	22	Ethnicity • "HISPANIC OR LATINO" • "NOT HISPANIC OR LATINO" • "NOT REPORTED" • "UNKNOWN"	Predecessor: ADSL.ETHNIC
RANDFL	Randomized Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.RANDFL
SAFFL	Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAFFL
FASBABFL	Full Analysis Set bAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASBABFL
FASNABFL	Full Analysis Set nAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASNABFL
PPBABFL	Per Protocol bAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBABFL
PPNABFL	Per Protocol nAb Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPNABFL
PPBD29FL	Per Protocol bAb Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBD29FL
PPBD57FL	Per Protocol bAb Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPBD57FL
PPND29FL	Per Protocol nAb Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPND29FL
PPND57FL	Per Protocol nAb Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPND57FL
SAR1FL	First Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAR1FL
SAR2FL	Second Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SAR2FL
SARAFL	Solicited Safety Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SARAFL
FASNA2FL	FAS nAb 2 Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.FASNA2FL
PPNAB2FL	PP nAb 2 Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PPNAB2FL
PN2D29FL	Per Protocol nAb 2 Day 29 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PN2D29FL
PN2D57FL	Per Protocol nAb 2 Day 57 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.PN2D57FL
COMPLFL	Completers Population Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.COMPLFL
DVBABFL	Deviation Impact bAb Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DVBABFL
DVNABFL	Deviation Impact nAb Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DVNABFL
DOSE1FL	Vaccination 1 Flag	text	1	No Yes Response (Yes Only) • "Y"	Predecessor: ADSL.DOSE1FL
DOSE2FL	Vaccination 2 Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DOSE2FL
DOSEROFL	Dosing Error Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.DOSEROFL
COV19BL	Baseline COVID Infection	text	12	Baseline COVID Infection • "Detected" • "Not Detected"	Predecessor: ADSL.COV19BL
COV19FL	COVID Infection Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.COV19FL
SENTLFL	Sentinel Participant Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.SENTLFL
D29W7DFL	Day 29 Out of 7-Day Window Flag	text	1	No Yes Response • "N" • "Y"	Predecessor: ADSL.D29W7DFL
TRT01P	Planned Treatment for Period 01	text	16	Planned Treatment for Period 01 • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Predecessor: ADSL.TRT01P
TRT01PN	Planned Treatment for Period 01 (N)	integer	8		Predecessor: ADSL.TRT01PN
TRT01A	Actual Treatment for Period 01	text	16	Actual Treatment for Period 01 • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Predecessor: ADSL.TRT01A
TRT01AN	Actual Treatment for Period 01 (N)	integer	8		Predecessor: ADSL.TRT01AN
TR01SDT	Date of First Exposure in Period 01	integer	DATE9.		Predecessor: ADSL.TR01SDT
TR01SDTM	Datetime of First Exposure in Period 01	integer	DATETIME20.		Predecessor: ADSL.TR01SDTM
TR01EDT	Date of Last Exposure in Period 01	integer	DATE9.		Predecessor: ADSL.TR01EDT
TR01EDTM	Datetime of Last Exposure in Period 01	integer	DATETIME20.		Predecessor: ADSL.TR01EDTM
TRTSDTM	Datetime of First Exposure to Treatment	integer	DATETIME20.		Predecessor: ADSL.TRTSDTM
TRTEDTM	Datetime of Last Exposure to Treatment	integer	DATETIME20.		Predecessor: ADSL.TRTEDTM
DOSE2DT	Date of Dose 2	integer	DATE9.		Predecessor: ADSL.DOSE2DT
DOS2DTM	Datetime of Dose 2	integer	DATETIME20.		Predecessor: ADSL.DOS2DTM
MHSEQ	Sequence Number	integer	8		Predecessor: MH.MHSEQ
MHCAT	Category for Medical History	text	7		Predecessor: MH.MHCAT
MHTERM	Reported Term for the Medical History	text	74		Predecessor: MH.MHTERM
MHBODSYS	Body System or Organ Class	text	67		Predecessor: MH.MHBODSYS
MHDECOD	Dictionary-Derived Term	text	40		Predecessor: MH.MHDECOD
MHSTDTC	Start Date/Time of Medical History Event	text	10		Predecessor: MH.MHSTDTC
MHENDTC	End Date/Time of Medical History Event	text	10		Predecessor: MH.MHENDTC
MHENRTPT	End Relative to Reference Time Point	text	7		Predecessor: MH.MHENRTPT
MHSTDY	Study Day of Start of Observation	integer	8		Predecessor: MH.MHSTDY
MHENDY	Study Day of End of Observation	integer	8		Predecessor: MH.MHENDY

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Action Taken with Study Treatment [C66767]

Permitted Value (Code)
DOSE DELAYED [*]
DOSE NOT CHANGED [C49504]
DRUG WITHDRAWN [C49502]
NOT APPLICABLE [C48660]

* Extended Value

Category for Adverse Event

Permitted Value (Code)
ADVERSE EVENT
REACTOGENICITY

Outcome of Adverse Event

Permitted Value (Code)
NOT RECOVERED/NOT RESOLVED
RECOVERED/RESOLVED
RECOVERING/RESOLVING
UNKNOWN

Causality

Permitted Value (Code)
NOT APPLICABLE
NOT RELATED
RELATED

Relationship to Non-Study Treatment

Permitted Value (Code)
NOT APPLICABLE
NOT RELATED
RELATED

Severity/Intensity Scale for Adverse Events [C66769]

Permitted Value (Code)
MILD [C41338]
MODERATE [C41339]
SEVERE [C41340]

Analysis Causality

Permitted Value (Code)
NOT APPLICABLE
NOT RELATED
RELATED

Analysis Severity/Intensity

Permitted Value (Code)
Grade 1/Mild
Grade 2/Moderate
Grade 3/Severe
Grade 4

Adverse Event Toxicity Grade

Permitted Value (Code)
Grade 1
Grade 2
Grade 3
Grade 4

Evaluator [C78735]

Permitted Value (Code)
INVESTIGATOR [C25936]
STUDY SUBJECT [C41189]

Location of the Finding About

Permitted Value (Code)
CHEST AND ABDOMEN
LEFT ARM AT INJECTION SITE
LEFT CHEEK
LEFT DELTOID (INJECTION SITE)
LEFT FOREARM AND RIGHT UPPER THIGH
LEFT TORSO REGION
NO RASH
RASH ON RIGHT KNEE NON-URTICARIAL
FOREHEAD AND ACROSS UPPER BACK
INJECTION SITE- RIGHT ARM.
NO RASH PER PI, RIGHT THIGH
NO RASH SUBJECT ENTERED YES IN ERROR
REPORTED AS REDNESS AND DISCOLORATION AT INJ SITE
RIGHT HIP
UNKNOWN

Solicited AR Category

Permitted Value (Code)
LOCAL
SYSTEMIC

Analysis Toxicity Grade

Permitted Value (Code)
Grade 0
Grade 1
Grade 2
Grade 3
Grade 4
1
2
3
4

Solicited AR post D7 Analysis Dataset Parameter Code

Permitted Value (Code)	Display Value (Decode)
ARTHRALG	Arthralgia
FATIGUE	Fatigue
HEADACHE	Headache
LYMPH	Lymphadenopathy
MYALGIA	Myalgia
NAUSEA	Nausea/Vomiting
PAIN	Pain
RASHOCC	Rash Occurrence
ERYTHDIA	Erythema Longest Diameter (mm)
SWELLDIA	Swelling Longest Diameter (mm)

Solicited AR Analysis Dataset Parameter Code

Permitted Value (Code)	Display Value (Decode)
ARTHRALG	Arthralgia
CHILLS	Chills
ERYTHDIA	Erythema Longest Diameter (mm)
FATIGUE	Fatigue
FEVER	Fever (C)
HEADACHE	Headache
LYMPH	Lymphadenopathy
LYMPHOCC	Lymphadenopathy Occurrence
MEDATTEN	Receive Medical Attention?
MYALGIA	Myalgia
NAUSEA	Nausea/Vomiting
PAIN	Pain
RASH	Rash
RASHOCC	Rash Occurrence
SWELLDIA	Swelling Longest Diameter (mm)

Category for Medication

Permitted Value (Code)
Prior/Concomitant Medication and Vaccination

Dosing Frequency per Interval

Permitted Value (Code)
BID
EVERY WEEK
ONCE
OTHER
PRN
QD
QID
QM
QOD
TID
UNKNOWN

Dose Units

Permitted Value (Code)
CAPSULE
IU
OTHER
PUFF
TABLET
g
mL
mg
ug

Route of Administration

Permitted Value (Code)
INTRAMUSCULAR
INTRAOCULAR
INTRAVENOUS
INTRAVENOUS BOLUS
NASAL
ORAL
OTHER
RECTAL
SUBCUTANEOUS
TOPICAL
TRANSDERMAL
VAGINAL

COVID-19 Parameter Category

Permitted Value (Code)
COVID-19 EXPOSURE
COVID-19 SYMPTOMS

COVID-19 Analysis Dataset Parameter Code

Permitted Value (Code)	Display Value (Decode)
ANOSMIA	Anosmia
CHESTTP	Chest Tightness/Pressure
CHILLS	Chills
CONTACT	The participant had close contact with a person known to have SARS-CoV-2 infection or COVID-19
COUGH	Cough
COVID	COVID-19
COVIDSYM	Participant COVID-19 Symptomatic
DUR	Duration
DYSGEUSI	Dysgeusia
EXPCOVID	Exposed to COVID-19
EXPFAM	Family member
EXPHCF	Health Care Facility
EXPOTH	Other exposure
EXPSOC	Social setting
EXPTRAV	Travel
EXPWORK	Work
FEVER	Fever
HEADACHE	Headache
LETHARGY	Lethargy
MYALGIA	Myalgia
OTHSYMPT	Other Symptoms
REPTSHAK	Repeated Shaking with chills
SOB	Shortness of Breath
SORETHRT	Sore Throat

Subcategory for Protocol Deviation

Permitted Value (Code)
Concomitant Medication
Exclusion Criteria
ICF Process/Timing
Inclusion Criteria
Informed Consent
Inv Record Keeping Source Docs
Missing Endpoint Assessments
Study Procedures/Assessments
Study Treatment Admin/Dispense
Study Treatment Compliance
Visit Scheduling

Dose Form

Permitted Value (Code)
INJECTION

Dosing Frequency per Interval

Permitted Value (Code)
ONCE

Dose Units

Permitted Value (Code)
ug

Laterality [C99073]

Permitted Value (Code)
LEFT [C25229]
RIGHT [C25228]

Location of Dose Administration

Permitted Value (Code)
ARM

Route of Administration

Permitted Value (Code)
INTRAMUSCULAR

Name of Treatment

Permitted Value (Code)
PLACEBO
mRNA-1273

Reason Study Treatment not Given

Permitted Value (Code)
Lost To Follow-Up
Other, PATIENT HAD POSITIVE NASAL SWAB RESULTS
Other, SUBJECT TESTED POSITIVE FOR COVID-19 NO VACCINE GIVEN ONLY FOLLOWING FOR SAFETY
PHYSICIAN AE
Physician Decision, THE VACCINE WAS NOT GIVEN AS THE PATIENT HAD BEEN RECENTLY HOSPITALIZED FOR COMMUNITY ACQUIRED PNEUMONIA AND THE ISSUE HAD NOT RESOLVED.
Physician withheld dose due to Adverse Event
WITHDRAWAL OF CONSENT
Withdrawal of Consent by Participant

Specimen Type [C78734]

Permitted Value (Code)
SERUM [C13325]

Immunogenicity Parameter Category

Permitted Value (Code)
Serum SARS-CoV-2 Binding Antibodies
Serum SARS-CoV-2 Neutralizing Antibodies

Immunogenicity Analysis Dataset Parameter Code

Permitted Value (Code)	Display Value (Decode)
L10MN50	LOG10(MN50)
L10MNET	LOG10(MN Endpoint Titer)
LV58IGGN	LOG10(VAC58 Nucleocapsid IgG Antibody)
LV58IGGS	LOG10(VAC58 Spike IgG Antibody)
MN50	MN50
MNET	MN Endpoint Titer
V58IGGEN	VAC58 Nucleocapsid IgG Antibody (AU/ml)
V58IGGES	VAC58 Spike IgG Antibody (ug/ml)

Analysis Reference Range Indicator

Permitted Value (Code)
ABNORMAL
HIGH
LOW
NORMAL

Original Units

Permitted Value (Code)
%
Seconds
U/L
g/dL
mIU/mL
mg/dL
x 10^3/uL
x 10^6/uL

Laboratory Parameter Category

Permitted Value (Code)
CHEMISTRY
COAGULATION
HEMATOLOGY
PREGNANCY TEST
SEROLOGY

Method of Test or Examination

Permitted Value (Code)
RT-PCR

Subcategory for Microbiology Finding

Permitted Value (Code)
NASOPHARYNGEAL SWAB
SWAB

Specimen Type [C78734]

Permitted Value (Code)
OTHER [*]
SWABBED MATERIAL [C150895]

* Extended Value

Microbiology Parameter Category

Permitted Value (Code)
BIOFIRE
SARS-CoV-2

Microbiology Analysis Dataset Parameter Code

Permitted Value (Code)	Display Value (Decode)
B30854A	Adenovirus
B30854B	Bordetella pertussis
B30854D	Chlamydophila pneumoniae
B30854E	Coronavirus 229E
B30854F	Coronavirus HKU1
B30854G	Coronavirus NL63
B30854H	Coronavirus OC43
B30854I	Human metapneumovirus
B30854J	Human Rhinovirus/Enterovirus
B30854K	Influenza A
B30854L	Influenza A subtype H1
B30854M	Influenza A subtype H1/2009
B30854N	Influenza A subtype H3
B30854O	Influenza B
B30854P	Mycoplasma pneumoniae
B30854Q	Parainfluenza Virus 1
B30854R	Parainfluenza Virus 2
B30854S	Parainfluenza Virus 3
B30854T	Parainfluenza Virus 4
B30854U	Respiratory Syncytial Virus
SARSCOV2	Severe Acute Resp Syndrome Coronavirus 2

Pooled Age Group 1

Permitted Value (Code)
>=18 and <55 Years
>=55 Years

Pooled Age Group 2

Permitted Value (Code)
>=18 and <=22 Years
>=23 and <=25 Years
>25 and <55 Years
>=55 Years

Country

Permitted Value (Code)
USA

Baseline COVID Infection

Permitted Value (Code)
Detected
Not Detected

Reason for Discontinuation from Study

Permitted Value (Code)
Withdrawal of Consent (COVID-19 Non-Infection Related)
Lost to Follow-Up

Reason for Discontinuation of Treatment

Permitted Value (Code)
Adverse Event (COVID-19 Infection)
Adverse Event (Other)
Lost to Follow-Up
Other
Withdrawal of Consent (COVID-19 Non-Infection Related)

Ethnicity

Permitted Value (Code)
HISPANIC OR LATINO
NOT HISPANIC OR LATINO
NOT REPORTED
UNKNOWN

Study Identifier

Permitted Value (Code)
mRNA-1273-P201

Actual Treatment for Period 01

Permitted Value (Code)
Placebo
mRNA-1273 100 ug
mRNA-1273 50 ug

Screen Failure Reason

Permitted Value (Code)
Cohort Full
Inclusion/Exclusion
Other
Withdrew Consent

Analysis Stage

Permitted Value (Code)
Follow up stage
Vaccination stage

Location of Vital Signs Measurement

Permitted Value (Code)
ORAL CAVITY

Planned Time Point Name

Permitted Value (Code)
POST-DOSE
PRE-DOSE

Vital Signs Analysis Dataset Parameter Code

Permitted Value (Code)	Display Value (Decode)
BMI	Body Mass Index (kg/m2)
DIABP	Diastolic Blood Pressure (mmHg)
HEIGHT	Height (cm)
PULSE	Pulse Rate (beats/min)
RESP	Respiratory Rate (breaths/min)
SYSBP	Systolic Blood Pressure (mmHg)
TEMP	Temperature (C)
WEIGHT	Weight (kg)

Analysis Timepoint Reference

Permitted Value (Code)
Vaccination 1
Vaccination 2

Description of Planned Arm

Permitted Value (Code)
Placebo
mRNA-1273 100 ug
mRNA-1273 50 ug

Derivation Type [C81224]

Permitted Value (Code)
DERIVED [*]
HALFLLOQ [C170546]
ULOQ [C170544]

* Extended Value

No Yes Response (No Only) [C66742]

Permitted Value (Code)
N [C49487]

No Yes Response [C66742]

Permitted Value (Code)
N [C49487]
Y [C49488]

Race [C74457]

Permitted Value (Code)
AMERICAN INDIAN OR ALASKA NATIVE [C41259]
ASIAN [C41260]
BLACK OR AFRICAN AMERICAN [C16352]
MULTIPLE [*]
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER [C41219]
NOT REPORTED [C43234]
OTHER [*]
WHITE [C41261]

* Extended Value

Sex [C66731]

Permitted Value (Code)
F [C16576]
M [C20197]

Planned Treatment for Period 01

Permitted Value (Code)
Placebo
mRNA-1273 100 ug
mRNA-1273 50 ug

Actual Treatment

Permitted Value (Code)
Placebo
mRNA-1273 100 ug
mRNA-1273 50 ug

No Yes Response (Yes Only) [C66742]

Permitted Value (Code)
Y [C49488]

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External Dictionaries

External Dictionaries
Reference Name	External Dictionary	Dictionary Version
Medical Dictionary for Regulatory Activities	MedDRA	23.0

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Methods

Methods
Method	Type	Description
AEDISFL	Computation	Set 'Y' if subject with DS.DSDECOD countians 'ADVERSE EVENT' or 'AE' and the specified adverse event number match the AE.AESPID where DSCAT = DISPOSITION EVENT and DS.DSSCAT='END OF STUDY' Otherwise null
AEHENDTC	Computation	HO.HOENDTC where HOTERM='HOSPITAL' based on AESPID and HOSPID
AEHSTDTC	Computation	HO.HOSTDTC where HOTERM='HOSPITAL' based on AESPID and HOSPID
AEMAFL	Computation	Set to SUPPAE.QVAL where SUPPAE.QNAM=AEMAFL
AENDT	Computation	Set to numeric date part of AEENDTC
AENDTM	Computation	Concatenate AENDT and AENTM if both are non-missing
AENTM	Computation	Set to numeric time part of AEENDTC
AEOUTSP	Computation	Set to SUPPAE.QVAL where SUPPAE.QNAM=AEOUTSP
AESOFL	Computation	Set to SUPPAE.QVAL where SUPPAE.QNAM='AESOFL'
AREL	Computation	Set to AEREL.
ASEV	Computation	Concatenate ATOXGR and Mixed case of AESEV with '/', eg, Grade 1/Mild; Set to ATOXGR if ATOXGR is 'Grade 4'
ASTAGE	Computation	‘Vaccination stage’ If .< ADSL.TR01SDTM <=ASTDTM and ASTDT<= ADSL.TR01EDT+27, if time part of TR01SDTM or time part of ASTDTM is missing, use TR01SDT and ASTDT. ‘Follow up stage’ if ASTDT> ADSL.TR01EDT+27
ASTDT	Imputation	Date part of AESTDTC convert to numeric. If AESTDTC is partial or missing, apply the following imputation rule: -If only DAY is missing: If the AE end date (AEENDTC) is after the date of first vaccination (ADSL.TR01SDT) or is missing AND the start month and year of the AE (AESTDTC) coincide with the start month and year of the first vaccination (ADSL.TR01SDT), use the date of first vaccination for ASTDT and time of first vaccination for ASTTM; Otherwise, use the first day of the month; -If DAY and Month are both missing: If the AE end date is after the date of first vaccination or is missing AND the start year of the AE coincides with the start year of the first vaccination, use the date of first vaccination; Otherwise, use the first day of the year; -If DAY, Month and Year are all missing, the date will not be imputed. "
ASTDTF	Computation	M if year is present and month is imputed; D if only day is imputed; Otherwise null.
ASTDTM	Computation	Concatenate ASTDT and ASTTM if both are non-missing
ASTDY	Computation	ASTDT – ADSL.TR01SDT + 1 if ASTDT >= TR01SDT, else ASTDT – ADSL.TR01SDT if ASTDT< TR01SDT.
ASTTM	Imputation	Time part of AESTDTC and ASTDT for imputation. If ASTDT is imputed and is set to the first vaccination day while time part of AESTDTC not missing, reset ASTTM to the time of first vaccination.
ASTTMF	Computation	H if time is imputed based on ASTTM derivation; Otherwise null.
ATOXGR	Computation	Set to 'Grade 1' if AETOXGR='1'; Set to 'Grade 2’ if AETOXGR='2'; Set to ‘Grade 3’ if AETOXGR='3'; Set to ‘Grade 4’ if AETOXGR='4';
D28FL	Computation	Set to 'Y' if non-missing MRDSTDY<=28; Blank otherwise.
ICUAD	Computation	HO.HOOCCUR where HOTERM='ADMITTED TO ICU' based on AESPID and HOSPID
ICUDAY	Computation	HO.HODUR where HOTERM='ADMITTED TO ICU' based on AESPID and HOSPID
MDOSREF	Computation	Set to 'Vaccination 1' if AE.AEREFID contains 'DOSE 1'； Set to 'Vaccination 2' if AE.AEREFID contains 'DOSE 2'
MRDENDY	Computation	Set to (the largest integer less than or equal to (AENDTM – ADSL.TR01SDTM)/(246060)) + 1 If MDOSREF='Vaccination 1', set to (the largest integer less than or equal to (AENDTM – ADSL.DOS2DTM)/(246060)) + 1 If MDOSREF='Vaccination 2'. if time part of AENDTM is missing, use AENDT to replace AEENDTM and calculate as follows: AENDT – ADSL.TR01SDT+ 1 If MDOSREF='Vaccination 1', AENDT – ADSL.DOSE2DT+ 1 If MDOSREF='Vaccination 2'. (For example, ADSL.TR01SDTM is on 01Mar2020 at 2 pm, the AENDTM is on 02Mar2020 at 8 am, the MRDENDY will be Day 1 with MDOSREF='Vaccination 1'. ADSL.TR01SDTM is on 01Mar2020 at 2 pm, the AENDTM is on 02Mar2020 at 5 pm, the MRDENDY will be Day 2 with MDOSREF='Vaccination 1'. )
MRDSTDY	Computation	Set to (the largest integer less than or equal to (ASTDTM – ADSL.TR01SDTM)/(246060)) + 1 If MDOSREF='Vaccination 1', set to (the largest integer less than or equal to (ASTDTM – ADSL.DOS2DTM)/(246060)) + 1 If MDOSREF='Vaccination 2'. if time part of ASTDTM is missing, use ASTDT to replace ASTDTM and calculate as follows: ASTDT – ADSL.TR01SDT+ 1 If MDOSREF='Vaccination 1', ASTDT – ADSL.DOSE2DT+ 1 If MDOSREF='Vaccination 2'. (For example, ADSL.TR01SDTM is on 01Mar2020 at 2 pm, the ASTDTM is on 02Mar2020 at 8 am, the MRDSTDY will be Day 1 with MDOSREF='Vaccination 1'. ADSL.TR01SDTM is on 01Mar2020 at 2 pm, the ASTDTM is on 02Mar2020 at 5 pm, the MRDSTDY will be Day 2 with MDOSREF='Vaccination 1'. )
TOXGGR1	Computation	Pooled grouping of toxicity grade for analysis: <3 when .<ATOXGRN <3; >=3 when ATOXGRN >=3;
TRTA	Computation	If MDOSREF='Vaccination 1', set to: 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'Day 1' ; 'mRNA-1273 50 ug' if EX.EXTRT='mRNA-1273' and 0<EXDOSE<=75 where EX.VISIT contains 'Day 1'; 'mRNA-1273 100 ug' if EX.EXTRT='mRNA-1273' and EXDOSE>75 where EX.VISIT contains 'Day 1'; if MDOSREF='Vaccination 2', set to: 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'Day 29' ; 'mRNA-1273 50 ug' if EX.EXTRT='mRNA-1273' and 0<EXDOSE<=75 where EX.VISIT contains 'Day 29'; 'mRNA-1273 100 ug' if EX.EXTRT='mRNA-1273' and EXDOSE>75 where EX.VISIT contains 'Day 29';
TRTEMFL	Computation	"Y" if .< ADSL.TR01SDTM <= ASTDTM, or (if ASTDT missing and .< ADSL.TR01SDTM <= AENDTM) or both ASTDT and AENDT missing. If time is not available, use TR01SDT, ASTDT and AENDT.
PPBD29ER	Computation	Only for subjects with RANDFL='Y' and PPBD29FL='N': Set to PP_list.PBABREAS where VISITTPT='Day 29'. if subejct has dosing error (ADSL.PPBABERS contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list if applicable
ADT	Computation	Set to numeric date part of FACE.FADTC if source data are from FACE Set to number date part of VS.VSDTC if source data are from VS
ADTM	Computation	Set to numeric date time of FACE.FADTC if time part is not missing for data is from FACE Set to numeric date time of VS.VSDTC if time part is not missing for data is from VS
ADY	Computation	Set to FACE.FADY if source data are from FACE Set to VS.VSDY if source data are from VS
ANL01FL	Computation	If PARAMCD is RASHOCC or LYMPHOCC: Set to 'Y' by selecting the first record with maximum non-missing AVALC (Y>N) per subject per PARAM per vaccination (ATPTREF) per ATPTGR1, i.e., the first available record per day If PARAMCD not in (RASHOCC or LYMPHOCC): Set to 'Y' for the first record with maximum non-missing ATOXGRN per subject per PARAM per vaccination (ATPTREF) per ATPTGR1, i.e., the first available record per day If there is two records per day and one from investigator and one from subject, select the one from subject (FAEVAL='STUDY SUBJECT')
ANL02FL	Computation	Y for the first record with maximum non-missing AVALC (Y>N) per subject per PARAM per vaccination (ATPTREF) per ATPT, i.e., the first available record per day. If there is two records per day and one from investigor and one from subject, select the one from subject (FAEVAL='STUDY SUBJECT') If PARAMCD not in (RASHOCC or LYMPHOCC): Y for the first record with maximum non-missing ATOXGRN per subject per PARAM per vaccination (ATPTREF) per ATPT, i.e., the first available record per day. If there is two records per day and one from investigor and one from subject, select the one from subject (FAEVAL='STUDY SUBJECT' or missing FAEVAL for FEVER)
ATM	Computation	Set to numeric time part of FACE.FADTC If source data are from FACE Set to numeric time part of VS.VSDTC if source data are from VS
ATPT	Computation	If source data are from FACE and FAEVAL='STUDY SUBJECT', set to FACE.CRFTMPT, If source data are from FACE and FAEVAL=''INVESTIGATOR', set to FACE.FATPT, If source data are from VS, set to VS.VSTPT; Recode 'DAY 1' as 'DAY 1, AFTER VACCINATION (AT HOME)' if FAEVAL='INVESTIGATOR' and PARAMCD is not RASH and LYMPHOCC
ATPTGR1	Computation	Set to 'Day 1' if ATPT contains 'Day 1' Set to ATPT otherwise
ATPTREF	Computation	If source data are from FACE: Set to 'Vaccination 1' if FACE.FATPTREF contains 'DOSE 1' Set to 'Vaccination 2' if FACE.FATPTREF contains 'DOSE 2' If source data are from VS: Set to 'Vaccination 1' if VS.VSTPTREF contains 'DOSE 1' Set to 'Vaccination 2' if VS.VSTPTREF contains 'DOSE 2'
AVAL	Computation	Set to FACE.FASTRESN if source data are from FACE Set to VS.VSSTRESN if source data are from VS
AVAL	Computation	Set to 0 If source data are from FACE and FAOBJ = 'Erythema' or 'Swelling' and FATEST='OCCURRENCE' and FAORRES='N' Set to FACE.FASTRESN, otherwise
AVALC	Computation	Set to FACE.FASTRESC if source data are from FACE Set to VS.VSSTRESC if source data are from VS
AVALC	Computation	Set to FACE.FASTRESC if source data are from FACE Set to VS.VSSTRESC if source data are from VS
CHILLS	Computation	Set to 'Grade 0' if FASTRESC='NONE' or FASTRESC contains 'GRADE 0' Set to 'Grade 1' if FASTRESC= 'NO INTERFERENCE WITH ACTIVITY' or contains 'GRADE 1'; Set to 'Grade 2' if FASTRESC= 'SOME INTERFERENCE WITH ACTIVITY NOT REQUIRING MEDICAL ATTENTION' or contains 'GRADE 2'; Set to 'Grade 3' if FASTRESC= 'PREVENTS DAILY ACTIVITY AND REQUIRES MEDICAL ATTENTION' or contains 'GRADE 3'; Set to 'Grade 4' if FASTRESC contains 'GRADE 4'
CRIT1	Computation	Set to '> 102.6 degrees F' if CRIT1FL='Y'
CRIT1FL	Computation	Set to 'Y' if PARAMCD='FEVER' and (9*AVAL/5)+32 > 102.6
CRIT2	Computation	Set to '> 103.1 degrees F' if CRIT2FL='Y'
CRIT2FL	Computation	Set to 'Y' if PARAMCD='FEVER' and (9*AVAL/5)+32 > 103.1
CRIT3	Computation	Set to '> 103.6 degrees F' if CRIT3FL='Y'
CRIT3FL	Computation	Set to 'Y' if PARAMCD='FEVER' and (9*AVAL/5)+32 > 103.6
CRIT4	Computation	Set to '> 104.1 degrees F' if CRIT4FL='Y'
CRIT4FL	Computation	Set to 'Y' if PARAMCD='FEVER' and (9*AVAL/5)+32 > 104.1
ES	Computation	Set to 'Grade 0' if .<AVAL < 25 mm or FASTRESC contains 'GRADE 0' Set to 'Grade 1' if AVAL = 25 - 50 mm or FASTRESC contains 'GRADE 1', Set to 'Grade 2' if AVAL = 51 - 100 mm or FASTRESC contains 'GRADE 2', Set to 'Grade 3' if AVAL > 100 mm or FASTRESC contains 'GRADE 3', Set to 'Grade 4' if FASTRESC contains 'GRADE 4',
FEVER	Computation	Set to 'Grade 0' if .<AVAL < 38.0°C or FASTRESC contains 'GRADE 0' Set to 'Grade 1' if AVAL = 38.0 – 38.4°C or FASTRESC contains 'GRADE 1' Set to 'Grade 2' if AVAL = 38.5 – 38.9°C or FASTRESC contains 'GRADE 2' Set to 'Grade 3' if AVAL = 39.0 – 40.0°C or FASTRESC contains 'GRADE 3' Set to 'Grade 4' if AVAL > 40.0°C or FASTRESC contains 'GRADE 4'
HEADACHE	Computation	Set to 'Grade 0' if FASTRESC='NONE' or FASTRESC contains 'GRADE 0' Set to 'Grade 1' if FASTRESC='NO INTERFERENCE WITH ACTIVITY' or FASTRESC contains 'GRADE 1' Set to 'Grade 2' if FASTRESC='REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR SOME INTERFERENCE WITH ACTIVITY' or FASTRESC contains 'GRADE 2' Set to 'Grade 3' if FASTRESC='ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY' or FASTRESC contains 'GRADE 3' Set to 'Grade 4' if FASTRESC contains 'GRADE 4'
LYMPH	Computation	Set to 'Grade 0' if FASTRESC='NONE' or FASTRESC contains 'GRADE 0' Set to 'Grade 1' if FASTRESC='DOES NOT INTERFERE WITH ACTIVITY' or FASTRESC contains 'GRADE 1' Set to 'Grade 2' if FASTRESC='REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR INTERFERES WITH SOME ACTIVITY' or FASTRESC contains 'GRADE 2' Set to 'Grade 3' if FASTRESC='ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY' or FASTRESC contains 'GRADE 3' Set to 'Grade 4' if FASTRESC contains 'GRADE 4'
LYMPHCOM	Computation	Set to CO.COVAL where COREF=LYMPHCOM
LYMPHEVL	Computation	Set to SUPPFACE.QVAL where SUPPFACE.QNAME='LYMPHEVL'
MAAEFL	Computation	SUPPFACE.QVAL where SUPPFACE.QNAME='MAAEFL'
MEDTAK	Computation	Set to SUPPVS.QVAL where SUPPVS.QNAM='MEDTAK'
MEDTAKP	Computation	Set to SUPPVS.QVAL where SUPPVS.QNAM='MEDTAKP'
MEDTAKT	Computation	Set to SUPPVS.QVAL where SUPPVS.QNAM='MEDTAKT'
MUSCLE	Computation	Set to 'Grade 0' if FASTRESC=NONE' or FASTRESC contains 'GRADE 0' Set to 'Grade 1' if FASTRESC='NO INTERFERENCE WITH ACTIVITY' or FASTRESC contains 'GRADE 1' Set to 'Grade 2' if FASTRESC='SOME INTERFERENCE WITH ACTIVITY' or FASTRESC contains 'GRADE 2' Set to 'Grade 3' if FASTRESC='SIGNIFICANT; PREVENTS DAILY ACTIVITY' or FASTRESC contains 'GRADE 3' Set to 'Grade 4' if FASTRESC contains 'GRADE 4'
NAUSEA	Computation	Set to 'Grade 0' if FASTRESC='NONE' or FASTRESC contains 'GRADE 0' Set to 'Grade 1' if FASTRESC= ‘NO INTERFERENCE WITH ACTIVITY OR 1-2 EPISODES/24 HOURS' or FASTRESC contains 'GRADE 1' Set to 'Grade 2' if FASTRESC='SOME INTERFERENCE WITH ACTIVITY OR >2 EPISODES/24 HOURS' or FASTRESC contains 'GRADE 2' Set to 'Grade 3' if FASTRESC='PREVENTS DAILY ACTIVITY, REQUIRES OUTPATIENT IV HYDRATION' or FASTRESC contains 'GRADE 3' Set to 'Grade 4' if FASTRESC contains 'GRADE 4'
ADURN	Computation	numeric part of ARRDENPT - numeric part of ARRDSTPT + 1
AENDT	Computation	Per subject per vaccination (ATPTREF): Set to numeric date part of last FAAE.FADTC where FAOBJ='Erythema' and FATEST='Longest Diameter' and FASTRESN>=25 mm Set to numeric date part of last FAAE.FADTC where FAOBJ='Swelling' and FATEST='Longest Diameter' and FASTRESN>=25 mm Set to numeric date part of last VS.VSDTC where VSTESTCD='TEMP' and VSSTRESN>=38.0 C Set to numeric date part of last FAAE.FADTC where FAOBJ='Pain' and FASTRESC is not 'NONE' or missing Set to numeric date part of last FAAE.FADTC where FAOBJ='Underarm Gland Swelling or Tenderness' and FASTRESC is not 'NONE' or missing Set to numeric date part of last FAAE.FADTC where FAOBJ='Headache' and FASTRESC is not 'NONE' or missing Set to numeric date part of last FAAE.FADTC where FAOBJ='Fatigue' and FASTRESC is not 'NONE' or missing Set to numeric date part of last FAAE.FADTC where FAOBJ='Myalgia' and FASTRESC is not 'NONE' or missing Set to numeric date part of last FAAE.FADTC where FAOBJ='Arthralgia' and FASTRESC is not 'NONE' or missing Set to numeric date part of last FAAE.FADTC where FAOBJ='Nausea/Vomiting' and FASTRESC is not 'NONE' or missing Set to numeric date part of last FAAE.FADTC where FAOBJ='Chills' and FASTRESC is not 'NONE' or missing Set to numeric date part of last FAAE.FADTC where FAOBJ='Rash' and FASTRESC is 'Y'
AENDTM	Computation	Concatenate AENDT and AENTM if both are non-missing
AENDY	Computation	Set to AENDT – ADSL.TR01SDT + 1
AENTM	Computation	Corresponding time part based on the derivation of AENDT
ANL01FL	Computation	Y for the first record with maximum non-missing ATOXGRN per subject per PARAM per vaccination (ATPTREF). If there is two records per day and one from investigor and one from subject, select the one from subject (FAEVAL='STUDY SUBJECT' or missing FAEVAL for FEVER) If PARAMCD =RASHOCC: Y for the first record with maximum non-missing AVALC (Y>N) per subject per PARAM per vaccination (ATPTREF). If there is two records per day and one from investigor and one from subject, select the one from subject (FAEVAL='STUDY SUBJECT')
ARRDENPT	Computation	Set to FAAE.FATPT/VS.VSTPT based on the corresponding AENDT
ARRDSTPT	Computation	Set to FAAE.FATPT/VS.VSTPT based on the corresponding ASTDT
ARTHRALG	Computation	"Per subject per vaccination (ATPTREF) per FAEVAL, set to the highest order of FAAE.FASTRESC where FAOBJ='Arthralgia' and FASTRESC is not 'NONE' or missing 'NO INTERFERENCE WITH ACTIVITY' or contains 'GRADE 1' < ‘SOME INTERFERENCE WITH ACTIVITY’ or contains 'GRADE 2' <‘SIGNIFICANT; PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3'"
ASTDT	Computation	Per subject per vaccination (ATPTREF): Set to numeric date part of first FAAE.FADTC where FAOBJ='Erythema' and FATEST='Longest Diameter' and FASTRESN>=25 mm Set to numeric date part of first FAAE.FADTC where FAOBJ='Swelling' and FATEST='Longest Diameter' and FASTRESN>=25 mm Set to numeric date part of first VS.VSDTC where VSTESTCD='TEMP' and VSSTRESN>=38.0°C Set to numeric date part of first FAAE.FADTC where FAOBJ='Pain' and FASTRESC is not 'NONE' or missing Set to numeric date part of first FAAE.FADTC where FAOBJ='Underarm Gland Swelling or Tenderness' and FASTRESC is not 'NONE' or missing Set to numeric date part of first FAAE.FADTC where FAOBJ='Headache' and FASTRESC is not 'NONE' or missing Set to numeric date part of first FAAE.FADTC where FAOBJ='Fatigue' and FASTRESC is not 'NONE' or missing Set to numeric date part of first FAAE.FADTC where FAOBJ='Myalgia' and FASTRESC is not 'NONE' or missing Set to numeric date part of first FAAE.FADTC where FAOBJ='Arthralgia' and FASTRESC is not 'NONE' or missing Set to numeric date part of first FAAE.FADTC where FAOBJ='Nausea/Vomiting' and FASTRESC is not 'NONE' or missing Set to numeric date part of first FAAE.FADTC where FAOBJ='Chills' and FASTRESC is not 'NONE' or missing Set to numeric date part of first FAAE.FADTC where FAOBJ='Rash' and FASTRESC is 'Y'
ASTDTM	Computation	Concatenate ASTDT and ASTTM if both are non-missing
ASTDY	Computation	Set to ASTDT – ADSL.TR01SDT + 1
ASTTM	Computation	Corresponding time part based on the derivation of ASTDT
ATOXGR	Computation	Grade 1 if AVAL = 25 - 50 mm or AVALC contains 'GRADE 1', Grade 2 if AVAL = 51 - 100 mm or AVALC contains 'GRADE 2', Grade 3 if AVAL > 100 mm or AVALC contains 'GRADE 3'; Grade 4 if AVALC contains 'GRADE 4'
ATOXGR	Computation	Grade 1 if AVALC= ‘NO INTERFERENCE WITH ACTIVITY or contains 'GRADE 1'’; Grade 2 if AVALC= ‘SOME INTERFERENCE WITH ACTIVITY NOT REQUIRING MEDICAL ATTENTION’ or contains 'GRADE 2'; Grade 3 if AVALC= ‘PREVENTS DAILY ACTIVITY AND REQUIRES MEDICAL ATTENTION’ or contains 'GRADE 3'; Grade 4 if AVALC contains 'GRADE 4'
ATOXGR	Computation	Grade 1 if AVAL = 25 - 50 mm or AVALC contains 'GRADE 1', Grade 2 if AVAL = 51 - 100 mm or AVALC contains 'GRADE 2', Grade 3 if AVAL > 100 mm or AVALC contains 'GRADE 3'; Grade 4 if AVALC contains 'GRADE 4'
ATOXGR	Computation	Grade 1 if AVAL = 38.0 – 38.4°C or AVALC contains 'GRADE 1', Grade 2 if AVAL = >38.4 – 38.9°C or AVALC contains 'GRADE 2', Grade 3 if AVAL = 39.0 – 40.0°C or AVALC contains 'GRADE 3', Grade 4 if AVAL > 40.0°C or AVALC contains 'GRADE 4',
ATOXGR	Computation	Grade 1 if AVALC= 'NO INTERFERENCE WITH ACTIVITY' or contains 'GRADE 1'; Grade 2 if AVALC= ‘SOME INTERFERENCE WITH ACTIVITY’ or contains 'GRADE 2'; Grade 3 if AVALC= ‘SIGNIFICANT; PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3'; Grade 4 if AVALC contains 'GRADE 4'
ATOXGR	Computation	Grade 1 if AVALC=’NO INTERFERENCE WITH ACTIVITY or contains 'GRADE 1'’; Grade 2 if AVALC= ‘REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR SOME INTERFERERENCE WITH ACTIVITY’ or contains 'GRADE 2'; Grade 3 if AVALC= ‘ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3'; Grade 4 if AVALC contains 'GRADE 4'
ATOXGR	Computation	Grade 1 if AVALC= ‘NO INTERFERENCE WITH ACTIVITY OR 1-2 EPISODES/24 HOURS’ or contains 'GRADE 1'; Grade 2 if AVALC= ‘SOME INTERFERENCE WITH ACTIVITY OR >2 EPISODES/24 HOURS’ or contains 'GRADE 2'; Grade 3 if AVALC= ‘PREVENTS DAILY ACTIVITY, REQUIRES OUTPATIENT IV HYDRATION’ or contains 'GRADE 3'; Grade 4 if AVALC contains 'GRADE 4'
ATOXGR	Computation	Grade 1 if AVALC=’DOES NOT INTERFERE WITH ACTIVITY’ or contains 'GRADE 1'; Grade 2 if AVALC= ‘REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR INTERFERES WITH ACTIVITY’ or contains 'GRADE 2'; Grade 3 if AVALC= ‘ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3'; Grade 4 if AVALC contains 'GRADE 4'
ATPTREF	Computation	If source data are from FAAE: Set to 'Vaccination 1' if FAAE.FATPTREF contains 'DOSE 1' Set to 'Vaccination 2' if FAAE.FATPTREF contains 'DOSE 2' If source data are from VS: Set to 'Vaccination 1' if VS.VSTPTREF contains 'DOSE 1' Set to 'Vaccination 2' if VS.VSTPTREF contains 'DOSE 2'
AVAL	Computation	Set to corresponding FAAE.FASTRESN based on corresponding AVALC if the record is from FAAE IF PARAMCD in (ERYTHDIA, SWELLDIA); Set to corresponding VS.VSSTRESN based on corresponding AVALC if the record is from VS if PARAMCD=FEVER
CHILLS	Computation	Per subject per vaccination (ATPTREF) per FAEVAL, set to the highest order of FAAE.FASTRESC where FAOBJ='Chills' and FASTRESC is not 'NONE' or missing ‘NO INTERFERENCE WITH ACTIVITY’ or contains 'GRADE 1'< ‘SOME INTERFERENCE WITH ACTIVITY NOT REQUIRING MEDICAL ATTENTION’ or contains 'GRADE 2' < ‘PREVENTS DAILY ACTIVITY AND REQUIRES MEDICAL ATTENTION’ or contains 'GRADE 3'
ERYTHDIA	Computation	Per subject per vaccination (ATPTREF) per FAEVAL, set to the corresponding FAAE.FASTRESC for the largest FASTRESN>=25 mm where FAOBJ='Erythema' and FATEST='Longest Diameter' or set to the highest order of FAAE.FASTRESC where FAOBJ='Erythema' and FATEST contains 'Intensity' (GRADE 1<GRADE 2<GRADE 3< GRADE 4) note: if there are records from both Longest diameter and intensity, choose the one with highest garde. if both fall in the same grade, use FASTRESC from FATEST='Longest Diameter'. 25-50 mm is corresponding to Grade 1, 51-100 mm is corresponding to Grade 2, and >100 mm is corresponding to Grade 3.
FATIGUE	Computation	"Per subject per vaccination (ATPTREF) per FAEVAL, set to the highest order of FAAE.FASTRESC where FAOBJ='Fatigue' and FASTRESC is not 'NONE' or missing 'NO INTERFERENCE WITH ACTIVITY' or contains 'GRADE 1'< ‘SOME INTERFERENCE WITH ACTIVITY’ or contains 'GRADE 2' <‘SIGNIFICANT; PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3'"
FEVER	Computation	Per subject per vaccination (ATPTREF) per FAEVAL, set to the corresponding VS.VSSTRESC for the largest VS.VSSTRESN>=38 C where VSTESTCD='TEMP' or set to the highest order of FAAE.FASTRESC where FAOBJ='Fever' (GRADE 1<GRADE 2<GRADE 3<GRADE 4) note: if there are records from both LVS and FAAE, choose the one with highest garde. if both fall in the same grade, use FAAE.FASTRESC. 38-38.4 C is corresponding to Grade 1, >38.4-38.9 C is corresponding to Grade 2, 39-40 C is corresponding to Grade 3, and >40 C is corresponding to Grade 4.
HEADACHE	Computation	Per subject per vaccination (ATPTREF) per FAEVAL, set to the highest order of FAAE.FASTRESC where FAOBJ='Headache' and FASTRESC is not 'NONE' or missing ’NO INTERFERENCE WITH ACTIVITY’ or contains 'GRADE 1'< ‘REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR SOME INTERFERERENCE WITH ACTIVITY’ or contains 'GRADE 2'< ‘ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3'
LYMPH	Computation	Per subject per vaccination (ATPTREF) per FAEVAL, set to the highest order of FAAE.FASTRESC where FAOBJ='Underarm Gland Swelling or Tenderness' and FASTRESC is not 'NONE' or missing ’DOES NOT INTERFERE WITH ACTIVITY’ or contains 'GRADE 1' < ‘REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR INTERFERES WITH SOME ACTIVITY’ or contains 'GRADE 2' < ‘ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3'
MAAEFL	Computation	For each PARAM, ATPTREF, FAEVAL, set to Y if there is one record in SUPPFAAE.QVAL where SUPPFAAE.QNAME='MAAEFL'
MYALGIA	Computation	Per subject per vaccination (ATPTREF) per FAEVAL, set to the highest order of FAAE.FASTRESC where FAOBJ='Myalgia' and FASTRESC is not 'NONE' or missing 'NO INTERFERENCE WITH ACTIVITY' or contains 'GRADE 1'< ‘SOME INTERFERENCE WITH ACTIVITY’ or contains 'GRADE 2' <‘SIGNIFICANT; PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3'
NAUSEA	Computation	Per subject per vaccination (ATPTREF) per FAEVAL, set to the highest order of FAAE.FASTRESC where FAOBJ='Nausea/Vomiting' and FASTRESC is not 'NONE' or missing ‘NO INTERFERENCE WITH ACTIVITY OR 1-2 EPISODES/24 HOURS’ or contains 'GRADE 1'< ‘SOME INTERFERENCE WITH ACTIVITY OR >2 EPISODES/24 HOURS’ or contains 'GRADE 2'< ‘PREVENTS DAILY ACTIVITY, REQUIRES OUTPATIENT IV HYDRATION’ or contains 'GRADE 3'
PAIN	Computation	Per subject per vaccination (ATPTREF) per FAEVAL, set to the highest order of FAAE.FASTRESC where FAOBJ='Pain' and FASTRESC is not 'NONE' or missing ’DOES NOT INTERFERE WITH ACTIVITY’ or contains 'GRADE 1'< ‘REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR INTERFERES WITH ACTIVITY’ or contains 'GRADE 2'< ‘ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3'
PARAM	Computation	Set to 'Rash'\|\|' '\|\|FATEST if source data are from FAAE and FAOBJ='Rash', and FATESTCD ne 'SEV' Set to 'Lymphadenopathy' if source data are from FAAE and FAOBJ='Underarm Gland Swelling or Tenderness' and FATESTCD = 'SEV' Set to 'Nausea/Vomiting' if source data are from FAAE and FAOBJ='Nausea' and FATESTCD = 'SEV' Set to FAOBJ\|\|' Longest Diameter (mm)' iff source data are from FAAE and FAOBJ in ('Erythema' 'Swelling') and FATEST='OCCURRENCE' and FAORRES='N' Set to 'FAOBJ'\|\|' '\|\|FATEST\|\|' '\|\|'('\|\|FAORRESU\|\|')' if source data are from FAAE and FAOBJ in ('Erythema' 'Swelling') and FATEST='Longest Diameter' Set to FAOBJ otherwise. Set to 'Fever'\|\|'('\|\|VSSTRESU\|\|')' if source data are from VS and VSTESTCD in ('TEMP' 'VSALL') Note: 1. Please add space between the VSTEST and VS unit. If the VSSTRESU is missing, use non-missing VSSTRESU 2. For each PARAM, keep only one record per subject per vaccination (ATPTREF)
PARCAT1	Computation	If source data are from FACE: Set to 'LOCAL' if FASCAT=ADMINISTRATION SITE Set to FASCAT if FASCAT<>ADMINISTRATION SITE Set to VSSCAT if source data are from VS
SWELLDIA	Computation	Per subject per vaccination (ATPTREF) per FAEVAL, set to the corresponding FAAE.FASTRESC for the largest FASTRESN>=25 mm where FAOBJ='Swelling' and FATEST='Longest Diameter' or set to the highest order of FAAE.FASTRESC where FAOBJ='Swelling' and FATEST contains 'Intensity' (GRADE 1<GRADE 2<GRADE 3<GRADE 4) note: if there are records from both Longest diameter and intensity, choose the one with highest garde. if both fall in the same grade, use FASTRESC from FATEST='Longest Diameter'. 25-50 mm is corresponding to Grade 1, 51-100 mm is corresponding to Grade 2, and >100 mm is corresponding to Grade 3.
PAIN	Computation	Set to 'Grade 0' if FASTRESC=’NONE’ or FASTRESC contains 'GRADE 0' Set to 'Grade 1' if FASTRESC='DOES NOT INTERFERE WITH ACTIVITY' or contains 'GRADE 1'; Set to 'Grade 2' if FASTRESC='REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR INTERFERES WITH ACTIVITY' or contains 'GRADE 2'; Set to 'Grade 3' if FASTRESC='ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY' or contains 'GRADE 3' Set to 'Grade 4' if FASTRESC contains 'GRADE 4'
PARAM	Computation	Set to 'Rash Occurrence' if source data are from FACE and FAOBJ='Rash', and FATESTCD ne 'SEV' Set to 'Rash' if source data are from FACE and FAOBJ='Solicited Rash', and FATESTCD = 'SEV' Set to 'Lymphadenopathy' if source data are from FACE and FAOBJ='Underarm Gland Swelling or Tenderness' and FATESTCD = 'SEV' Set to 'Lymphadenopathy Occurrence' if source data are from FACE and FAOBJ='Lymphadenopathy' Set to 'Nausea/Vomiting' if source data are from FACE and FAOBJ='Nausea/Vomiting' and FATESTCD = 'SEV' Set to 'Fever' \|\| '(' \|\|VSSTRESU \|\|')' if source data are from VS and VSTESTCD in ('TEMP' 'VSALL') Set to FAOBJ \|\|' Longest Diameter (mm)' if source data are from FACE and FAOBJ in ('Erythema' 'Swelling') and FATEST contains 'Occurrence' and FAORRES='NO' Set to FAOBJ \|\| ' ' \|\| FATEST\|\| ' ' \|\| '(' \|\|FAORRESU \|\| ')' if source data are from FACE and FAOBJ in ('Erythema' 'Swelling') and FATEST='Longest Diameter' Set to FAOBJ otherwise. Note: Please add space between the VSTEST and VS unit. If the VSSTRESU is missing, use non-missing VSSTRESU) and assign AVAL=0 (see specs for AVAL)
PARCAT1	Computation	If source data are from FACE: Set to 'LOCAL' if FASCAT=ADMINISTRATION SITE Set to FASCAT if FASCAT<>ADMINISTRATION SITE Set to VSSCAT if source data are from VS Set to 'SYSTEMIC' if PARAMCD='RASH' Set to 'LOCAL' if PARAMCD='LYMPHOCC'
RASH	Computation	Set to 'Grade 0' if FASTRESC='GRADE 0 = NO RASH' or contains 'GRADE 0'; Set to 'Grade 1' if FASTRESC='GRADE 1 = LOCALIZED RASH, WITHOUT ASSOCIATED SYMPTOMS' or contains 'GRADE 1'; Set to 'Grade 2' if FASTRESC='GRADE 2 = MACULOPAPULAR RASH, COVERING 50% BODY SURFACE AREA WITH URTICARIA' or contains 'GRADE 2'; Set to 'Grade 3' if FASTRESC='GRADE 3 = GENERALIZED URTICARIAL, COVERING 50% BODY SURFACE AREA' or contains 'GRADE 3'; Set to 'Grade 4' if FASTRESC='GRADE 4 = GENERALIZED EXFOLIATIVE, ULCERATIVE OR BULLOUS DERMATITIS, E.G. STEVENS-JOHNSON SYNDROME OR ERYTHEMA MULTIFORME' or contains 'GRADE 4';
SRCDOM	Computation	Set to FACE.DOMAIN if source data are from FACE Set to VS.DOMAIN if source data are from VS
SRCOMM	Computation	Set to CO.COVAL where COREF=SRCOMMM
SRCSEQ	Computation	Set to FACE.FASEQ if source data are from FACE Set to VS.VSSEQ if source data are from VS
SRCVAR	Computation	Set to 'FASTRESC' if source data are from FACE Set to 'VSSTRESN' if source data are from VS
SREVLFL	Computation	Set to SUPPFACE.QVAL where SUPPFACE.QNAME='SREVL'
ANYDUR	Computation	1) Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD is not 'RASH', 'LYMPHOCC' ,''RASHOCC' or AVALC is Y where PARAMCD is 'RASHOCC'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once. 2) Use FAAE/VS data, count total number of records where (FAOBJ is ('Erythema', 'Swelling') and FATEST='Longest Diameter' and FASTRESN>=25 mm) or (FAOBJ is ('Erythema', 'Swelling') and FATEST contains 'Intensity' and FASTRESC contains GRADE 1, GRADE 2 or GRADE 3 or GRADE 4) or (FAAE.FAOBJ='Fever' and FASTRESC contains GRADE 1, GRADE 2, GRADE 3 or GRADE 4) or (for other FAOBJ and FASTRESC is not 'NONE', 'N' or missing) or (VSTESTCD='TEMP' and VSSTRESN>=38.0°C) per subject per vaccination (FATPTREF/VSTPTREF). If there are more than one record within same day (FATPT/VSTPT), subject and vaccination (FATPTREF/VSTPTREF), only count once. 3) sum of 1) and 2) by vaccination
ARTHRDUR	Computation	1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='ARTHRALG'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once. 2. Use FAAE data, count total number of records where FAOBJ='Arthralgia' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once. 3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) .
ATPTREF	Computation	Set to ADAR.ATPTREF if data from ADAR If source data are from FAAE, set to ‘Vaccination 1’ if FAAE.FATPTREF contains ‘DOSE 1’, set to ‘Vaccination 2’ if FAAE.FATPTREF contains ‘DOSE 2’. If source data are from VS, ‘Vaccination 1’ if VS.VSTPTREF contains ‘DOSE 1’, ‘Vaccination 2’ if VS.VSTPTREF contains ‘DOSE 2’
AVALC	Computation	Per subject per vaccination (ATPTREF), set to the maximum non-missing AVALC (Y>N) where PARAMCD is 'LYMPHOCC', 'RASHOCC'
AVALC	Computation	Set to AVALC of the record used to derive ATOXGR. Use the highest AVALC if multiple records
CHILLDUR	Computation	1.Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='CHILLS'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once. 2. Use FAAE data, count total number of records where FAOBJ='Chills' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once. 3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) .
ERYTHDUR	Computation	"1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='ERYTHDIA'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once. 2. Use FAAE data, count total number of records where (FAOBJ='Erythema' and FATEST='Longest Diameter' and FASTRESN>=25 mm) or (FAOBJ='Erythema' and FATEST contains 'Intensity' and FASTRESC contains GRADE 1, GRADE 2 or GRADE 3 or GRADE 4) per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once. 3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) ."
FATIGDUR	Computation	"1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='FATIGUE'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once. 2. Use FAAE data, count total number of records where FAOBJ='Fatigue' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once. 3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) ."
FEVERDUR	Computation	"1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='FEVER'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once. 2. Use VS/FAAE data, count total number of records where (VSTESTCD='TEMP' and VSSTRESN>=38.0°C) or (FAAE.FAOBJ='Fever' and FASTRESC contains GRADE 1, GRADE 2, GRADE 3 or GRADE 4) per subject per vaccination (VSTPTREF/FATPTREF). If there are more than one record within same day (VSTPT/FATPT), subject and vaccination (VSTPTREF/FATPTREF), only count once. 3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/VSTPTREF/FATPTREF) ."
HEADADUR	Computation	"1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='HEADACHE'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once. 2. Use FAAE data, count total number of records where FAOBJ='Headache' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once. 3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) ."
HPLYMDUR	Computation	Use ADAR data, count total number of records with AVALC='Y' per subject per vaccination (ATPTREF) where ADAR.PARAMCD='LYMPHOCC'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once
HPRASDUR	Computation	Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD=' RASH'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once
LOCDUR	Computation	"1) Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARCAT1 is 'LOCAL'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once. 2) Use FAAE data, count total number of records where (FAOBJ is ('Erythema', 'Swelling') and FATEST='Longest Diameter' and FASTRESN>=25 mm) or (FAOBJ is ('Erythema', 'Swelling') and FATEST contains 'Intensity' and FASTRESC contains GRADE 1, GRADE 2 or GRADE 3 or GRADE 4) or (FAOBJ is ('Pain', 'Underarm Gland Swelling or Tenderness') and FASTRESC is not 'NONE' or missing) per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once. 3) sum of 1) and 2) by vaccination"
LYMPHDUR	Computation	"1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD=' LYMPH '. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once. 2. Use FAAE data, count total number of records where FAOBJ='Underarm Gland Swelling or Tenderness' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once. 3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) ."
MYALGDUR	Computation	"1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='MYALGIA'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once. 2. Use FAAE data, count total number of records where FAOBJ='Myalgia' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once. 3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) ."
NAUSEDUR	Computation	"1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='NAUSEA'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once. 2. Use FAAE data, count total number of records where FAOBJ='Nausea/Vomiting' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once. 3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) ."
PAINDUR	Computation	"1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD=' PAIN '. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once. 2. Use FAAE data, count total number of records where FAOBJ='Pain' and FASTRESC is not 'NONE' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once. 3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) ."
PARAM	Computation	Assign the PARAM to each subject and each ATPTREF (i.e., Vaccination 1, Vaccination 2)
PARCAT1	Computation	Set to 'LOCAL' if PARAMCD in (LYMPHDUR, PAINDUR, ERYTHDUR, SWELLDUR, WLYMPH, WPAIN, WERYTH, WSWELL, WSLAR) Set to 'SYSTEMIC' if PARAMCD in (HEADADUR, FATIGDUR, MYALGDUR, ARTHRDUR, NAUSEDUR, CHILLDUR, FEVERDUR, RASHDUR, WHEAD, WFATIGUE, WMYALGIA, WARTHR, WNAUSEA, WCHILLS,WFEVER, WSSAR)
RASHDUR	Computation	"1. Use ADAR data, count total number of records with AVALC='Y' per subject per vaccination (ATPTREF) where ADAR.PARAMCD='RASHOCC'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once. 2. Use FAAE data, count total number of records where FAOBJ='Rash' and FASTRESC is not 'N' or missing per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once. 3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) ."
SRCDOM	Computation	Set to 'ADAR' if PARAMCD does not contain 'DUR'
SRCSEQ	Computation	Set to ADAR.ASEQ based on ATOXGR/AVALC derivation for PARAMCD does not contain 'DUR' and set to the smallest one if multiple records
SRCVAR	Computation	Set to 'ATOXGR' if PARAM contains 'Worst'; Set to 'AVALC' if PARAMCD is 'RASHOCYN', 'LYMOCCYN'
SWELLDUR	Computation	"1. Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARAMCD='SWELLDIA'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once. 2. Use FAAE data, count total number of records where (FAOBJ='Swelling' and FATEST='Longest Diameter' and FASTRESN>=25 mm) or (FAOBJ='Swelling' and FATEST contains 'Intensity' and FASTRESC contains GRADE 1, GRADE 2 or GRADE 3 or GRADE 4) per subject per vaccination (FATPTREF). If there are more than one record within same day (FATPT), subject and vaccination (FATPTREF), only count once. 3. calculate the sum of the number of records from steps 1 and 2 per subject per vaccination (ATPTREF/FATPTREF) ."
SYSDUR	Computation	"Use ADAR data, count total number of records with ATOXGRN>0 per subject per vaccination (ATPTREF) where ADAR.PARCAT1 is 'SYSTEMIC' and ADAR.PARAMCD is not 'RASH', 'LYMPHOCC' ,''RASHOCC' or AVALC is Y where PARAMCD is 'RASHOCC'. If there are more than one record within same day (ATPTGR1), subject and vaccination (ATPTREF), only count once. 2) Use FAAE/VS data, count total number of records where (FASCAT='SYSTEMIC' and FASTRESC is not 'NONE', 'N' or missing) or (VSTESTCD='TEMP' and VSSTRESN>=38.0°C) per subject per vaccination (FATPTREF/VSTPTREF). If there are more than one record within same day (FATPT/VSTPT), subject and vaccination (FATPTREF/VSTPTREF), only count once. 3) sum of 1) and 2) by vaccination"
WARTHR	Computation	Per subject per vaccination (ATPTREF): Set to the highest ATOXGR where ADAR.PARAMCD='ARTHRALG'
WCHILLS	Computation	Per subject per vaccination (ATPTREF): Set to the highest ATOXGR where ADAR.PARAMCD='CHILLS'
WERYTH	Computation	Per subject per vaccination (ATPTREF): Set to the highest ATOXGR where ADAR.PARAMCD='ERYTHDIA'
WFATIGUE	Computation	Per subject per vaccination (ATPTREF): Set to the highest ATOXGR where ADAR.PARAMCD='FATIGUE'
WFEVER	Computation	Per subject per vaccination (ATPTREF): Set to the highest ATOXGR where ADAR.PARAMCD='FEVER'
WHEAD	Computation	Per subject per vaccination (ATPTREF): Set to the highest ATOXGR where ADAR.PARAMCD='HEADACHE'
WLYMPH	Computation	Per subject per vaccination (ATPTREF): Set to the highest ATOXGR where ADAR.PARAMCD='LYMPH'
WMYALGIA	Computation	Per subject per vaccination (ATPTREF): Set to the highest ATOXGR where ADAR.PARAMCD='MYALGIA'
WNAUSEA	Computation	Per subject per vaccination (ATPTREF): Set to the highest ATOXGR where ADAR.PARAMCD='NAUSEA'
WPAIN	Computation	Per subject per vaccination (ATPTREF): Set to the highest ATOXGR where ADAR.PARAMCD='PAIN'
WRASH	Computation	Per subject per vaccination (ATPTREF): Set to the highest ATOXGR where ADAR.PARAMCD='RASH'
WSAR	Computation	Per subject per vaccination (ATPTREF): Set to the highest ATOXGR where ADAR.PARAMCD is not 'RASH', 'LYMPHOCC', 'RASHOCC'
WSLAR	Computation	Per subject per vaccination (ATPTREF): Set to the highest ATOXGR where ADAR.PARCAT1 is 'LOCAL'
WSSAR	Computation	Per subject per vaccination (ATPTREF): Set to the highest ATOXGR where ADAR.PARCAT1 is 'SYSTEMIC' and ADAR.PARAMCD is not 'RASH', 'LYMPHOCC' ,''RASHOCC'
WSWELL	Computation	Per subject per vaccination (ATPTREF): Set to the highest ATOXGR where ADAR.PARAMCD='SWELLDIA'
AENDT	Imputation	Set to numeric date part of CM.CMENDTC if day, month, and year are all present If day and month are both missing, AENDT is whichever is earliest of the following: 31DECYYYY, EOSDT, or DTHDT; If only day is missing, AENDT is whichiever is earliest of the following: EOSDT, DTHDT, or xxMMMYYYY where xx is the last day of the month; blank otherwise
AENDTF	Computation	Set to 'D' if only the day is imputed Set to 'M' if the day and the month are imputed
AENDY	Computation	Set to AENDT - TR01SDT + 1 if AENDT >= TR01SDT Set to ASTDT - TR01SDT if AENDT < TR01SDT
ASTDT	Imputation	Convert date part of CM.CMSTDTC to numeric if day, month, and year are all present; -If only DAY is missing: If the CM end date (CMENDTC) is after the date of first vaccination (ADSL.TR01SDT) or is missing AND the start month and year of the CM (CMSTDTC) coincide with the start month and year of the first vaccination (ADSL.TR01SDT), use the date of first vaccination; Otherwise, use the first day of the month; -If DAY and Month are both missing: If the CM end date is after the date of first vaccination or is missing AND the start year of the CM coincides with the start year of the first vaccination, use the date of first vaccination Otherwise, use the first day of the year; -If DAY, Month and Year are all missing, the date will not be imputed. blank otherwise Note: if CMENDTC is partial: If only day is missing, month and year coincide with or after the month and year of TR01SDT, treat CMENDTC as after TR01SDT, otherwise treat CMENDTC as before TR01SDT. If month is missing (regardless of day is missing or not), if year coincides with or after the year of TR01SDT, treat CMENDTC as after TR01SDT, otherwise treat CMENDTC as before TR01SDT. If year is missing (regardles of day and month), treat CMENDTC as after TR01SDT.
ASTDTF	Computation	"D" if only the day is imputed; "M" if the day and the month are imputed
ASTDY	Computation	ASTDT - TR01SDT + 1 if ASTDT >= TR01SDT, else ASTDT - TR01SDT if ASTDT < TR01SDT
ATCLEV1T	Computation	Set to SUPPCM.QVAL where QNAM='ATCLEV1T'
ATCLEV2T	Computation	Set to SUPPCM.QVAL where QNAM='ATCLEV2T'
ATCLEV3T	Computation	Set to SUPPCM.QVAL where QNAM='ATCLEV3T'
ATCLEV4T	Computation	Set to SUPPCM.QVAL where QNAM='ATCLEV4T'
CMFOTHSP	Computation	Set to SUPPCM.QVAL where QNAM='CMFOTHSP'
CMMOI1FL	Computation	Set to 'Y' If CMINDC contians 'Prophylax' AND CMDECOD contains 'PARACETAMOL', 'DIPHENHYDRAMINE HYDROCHLORIDE;PARACETAMOL', 'IBUPROFEN', 'DIPHENHYDRAMINE CITRATE;IBUPROFEN', 'DIPHENHYDRAMINE HYDROCHLORIDE', IBUPROFEN', 'NAPROXEN SODIUM', 'DEXTROMETHORPHAN HYDROBROMIDE' 'GUAIFENESIN', 'PARACETAMOL' 'PSEUDOEPHEDRINE HYDROCHLORIDE', 'DEXTROMETHORPHAN HYDROBROMIDE;DOXYLAMINE SUCCINATE', 'EPHEDRINE SULFATE', 'ETHANOL', 'PARACETAMOL', 'ACETYLSALICYLIC ACID;CAFFEINE', 'PARACETAMOL'
CMMOI2FL	Computation	'Y' If CMDECOD contains 'PARACETAMOL', 'DIPHENHYDRAMINE HYDROCHLORIDE;PARACETAMOL', 'IBUPROFEN', 'DIPHENHYDRAMINE CITRATE;IBUPROFEN', 'DIPHENHYDRAMINE HYDROCHLORIDE', 'IBUPROFEN', 'NAPROXEN SODIUM', 'DEXTROMETHORPHAN HYDROBROMIDE', 'GUAIFENESIN', 'PARACETAMOL;PSEUDOEPHEDRINE HYDROCHLORIDE'; 'DEXTROMETHORPHAN HYDROBROMIDE;DOXYLAMINE SUCCINATE;EPHEDRINE SULFATE;ETHANOL;PARACETAMOL'; 'ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL'
CMROTHSP	Computation	Set to SUPPCM.QVAL where QNAM='CMROTHSP'
CMSOLFL	Computation	SUPPCM.QVAL when QNAM='CMSOL'
CMUOTHSP	Computation	Set to SUPPCM.QVAL where QNAM='CMUOTHSP'
FUPFL	Computation	Set to 'Y' if AENDT > TR01EDT + 28 days or AENDT is missing missing otherwise
MDOSREF	Computation	If (.<TR01SDT<=ASTDT <DOSE2DT) or (.<TR01SDT<=ASTDT and DOSE2DT missing), set to 'Vaccination 1'; if .<DOSE2DT<=ASTDT , set to 'Vaccination 2';
MRDSTDY	Computation	If MDOSREF='Vaccination 1' set to ASTDT – TR01SDT+ 1 If MDOSREF='Vaccination 2' set to ASTDT – DOS2DT+ 1
ONTRTFL	Computation	Set to 'Y' if (ASTDT <= TR01EDT + 28 days) and (AENDT >= TR01SDT or AENDT is missing); or if ASTDT is missing and (AENDT >= TR01SDT or AENDT is missing); missing otherwise
PREFL	Computation	Set to 'Y' if ASTDT < TR01SDT or ASTDT is missing; missing otherwise
ADT	Computation	Set to numeric date part of FAOT.FADTC if source data are from FAOT, Set to number date part of ER.ERDTC if source data are from ER, Set to number date part of SS.SSDTC if source data are from SS
ANL01FL	Computation	Per subject per parameter and per AVISIT, set to ‘Y’ for the worst assessment (AVALC='Y'>'N') within the same visit to be considered first, if there are multiple with same AVALC then set 'Y' to the assessment at scheduled visit (i.e., VISIT doesn't contain "Unshed"). If there are 2 or more scheduled assessments at same visit, set to the last assessment
AVAL	Computation	Set to numeric part of ER.ERDUR
AVALC	Computation	FAOT.FASTRESC if source data are from FAOT; ER.EROCCUR if source data are from ER; SS.SSSTRESC if source data are from SS; Set to numeric part of ER.ERDUR for PARAMCD=DUR and convert to character
AVISIT	Computation	If VISIT doesn't contain 'Unsched', set to 'Day xx' part of VISIT, If ADY>1 and VISIT contains 'Unsched', set AVISIT as follows: using the visit window below: If VISIT with 1<ADY<=11, then AVISIT = 'Day 8', else if VISIT with 12<=ADY<=22, then AVISIT = 'Day 15', else if VISIT with 23<=ADY<=32, then AVISIT = 'Day 29', else if VISIT with 33<=ADY<=39, then AVISIT = 'Day 36', else if VISIT with 40<=ADY<=50, then AVISIT = 'Day 43', else if VISIT with 51<=ADY<=133, then AVISIT = 'Day 57', else if VISIT with 134=<ADY<=301, then AVISIT = 'Day 209', else if VISIT with ADY>=302, then AVISIT = 'Day 394', After the steps above, sort data by AVISITN and ADY, set the unscheduled visit (i.e., VISIT contains 'Unsched') records to blank if AVISITN >any previous AVISITN AND ADY<=any previous ADY). For example, Scheduled Day 36 is with AVISITN=6 (Day 36) and ADY=42 and an unscheduled visit is with AVISITN=7 (Day 43) and ADY=40, set AVISIT to blank for this unscheduled visit
EXPOSEDT	Computation	Derive for records where PARAMCD='CONTACT' and AVALC='Y': use ER.ERSTDTC
OTHSPY	Computation	If PARAMCD='OTHSYMPT' and AVALC='Y', then concatenate all the SUPPFAOT.QVAL where QNAM='SYMPOTH' with ', ' for that subject and visit; If PARAMCD='EXPOTH' and AVALC='Y', then set to SUPPER.QVAL where QNAM='EXPOSEOT'
PARAM	Computation	If PARCAT1='COVID-19 SYMPTOMS' set to FAOT.FAOBJ if PARCAT1='COVID-19 EXPOSURE' set to ER.ERTERM and create PARAM='Duration' if ERDUR is not missing per subject per ERDTC For data from SS, set to SSTEST Per subject per visit, if there are multiple records where PARAM='Other Symptoms', only keep one, and set FASEQ to the earliest FAOT.FASEQ.
PARCAT1	Computation	Set to FAOT.FACAT if source data are from FAOT Set to ER.ERCAT if source data are from ER For data from SS, set to 'COVID-19 SYMPTOMS' if SSTESTCD='COVIDSYM' and 'COVID-19 EXPOSURE' if SSTESTCD='COVID'
SRCDOM	Computation	FAOT.DOMAIN if source data are from FAOT; ER.DOMAIN if source data are from ER; SS.DOMAIN if source data are from SS
SRCSEQ	Computation	FAOT.FASEQ if source data are from FAOT; ER.ERSEQ if source data are from ER; SS.SSEQ if source data are from SS
SRCVAR	Computation	Set to 'FASTRESC' if source data are from FAOT; Set to 'EROCCUR' if source data are from ER if PARAMCD is not 'DUR'; Set to 'ERDUR' if source data are from ER if PARAMCD is 'DUR'; Set to 'SSSTRESC' if source data are from SS
SYMPTDT	Computation	Derive for records where PARAMCD='COVID' and AVALC='Y': use SUPPFAOT.QVAL where QNAM='SYMPTDTC'
DVSIG	Computation	Set to SUPPDV.QVAL where SUPPDV.QNAM='DVSIG'
DVTERM1	Computation	Set to SUPPDV.QVAL where SUPPDV.QNAM='DVTERM1'
DVTERM2	Computation	Set to SUPPDV.QVAL where SUPPDV.QNAM='DVTERM2'
DVTERM3	Computation	Set to SUPPDV.QVAL where SUPPDV.QNAM='DVTERM3'
AENDT	Computation	Date part of EX.EXENDTC
ASTDT	Computation	Date part of EX.EXSTDTC
DOSEYNFL	Computation	Set to 'Y' if EXSTDTC is not missing. Set to 'N' if EXSTDTC is missing and EC.ECOCCUR='N'
NDOSERS	Computation	Set to EC.ECREASOC
SRCDOM	Computation	EX.DOMAIN if source data are from EX; EC.DOMAIN if source data are from EC
SRCSEQ	Computation	EX.EXSEQ if source data are from EX; EC.ECSEQ if source data are from EC
ABLFL	Computation	Set to 'Y' by selecting the latest ADTM or ADT if time is not available with non-missing AVAL/AVALC on or before ADSL.TR01SDTM (TR01SDT if time part of TR01SDTM is missing) for each SUBJID, PARCAT1 and PARAMCD
ADT	Computation	Set to numeric date part of IS.ISDTC
ADTM	Computation	Concatenate of ADT and ATM if both are available
ANL02FL	Computation	Same as ANL01FL For PARCAT1='Serum SARS-CoV-2 Neutralizing Antibodies', only consider results from Set 1 LLOQ/ULOQ (MNET 40 and 1280, MN50 91.1 and 2031.87).
ATM	Computation	Time part of IS.ISDTC
AVAL	Computation	If ISSTRESC contains "<" or ISSTRESN<LOD or ISSTRESN<ISLLOQ, then set to LOG10(0.5* times ISLLOQ). If ISSTRESC contains ">" or ISSTRESN>ULOQ then set AVAL as LOG10(ULOQ). Otherwise set to LOG10(IS.ISSTRESN).
AVAL	Computation	If ISSTRESC contains "<" or ISSTRESN<LOD or ISSTRESN<ISLLOQ, then set AVAL as 0.5 times ISLLOQ. If ISSTRESC contains ">" or ISSTRESN>ULOQ then set AVAL as ULOQ. Otherwise set to IS.ISSTRESN.
AVISIT	Computation	If ABLFL='Y' then AVISIT='Baseline'; if ADY>1 and VISIT doesn't contain "UNSCHEDULE", set to 'Day xx' part of VISIT; ; if ADY>1 and VISIT contains "UNSCHED", set AVISIT as follows: using the visit window below: If VISIT with 1<ADY<=22, then AVISIT = ’Day 15’; else if VISIT with 23<=ADY<=36, then AVISIT = ’Day 29’; else if VISIT with 37<=ADY<=50, then AVISIT = ’Day 43’; else if VISIT with 51<=ADY<=133, then AVISIT = ’Day 57’; else if VISIT with 134=<ADY<=301, then AVISIT = ’Day 209’; else if VISIT with ADY>=302, then AVISIT = ’Day 394’;
BASE	Computation	AVAL where ABLFL = 'Y' for each SUBJID, PARCAT1 and PARAMCD
CHG	Computation	AVAL-BASE for post-baseline records
CRIT1	Computation	if CRIT1FL="Y" and PARAMCD is MNET, or MN50, then set to '>=2-fold Increase from Baseline'
CRIT1FL	Computation	'Y' if PARAMCD is MNET or MN50 and post-baseline increase 2 times from the baseline value (R2BASE>=2)
CRIT2	Computation	if CRIT2FL="Y" and PARAMCD is MNET, or MN50, then set to '>=3-fold Increase from Baseline'
CRIT2FL	Computation	'Y' if PARAMCD is MNET or MN50 and post-baseline increase 3 times from the baseline value (R2BASE>=3)
CRIT3	Computation	if CRIT3FL="Y" and PARAMCD is MNET or MN50, then set to '>=4-fold Increase from Baseline'
CRIT3FL	Computation	'Y' if PARAMCD is MNET or MN50 and post-baseline increase 4 times from the baseline value (R2BASE>=4)
CRIT4	Computation	if CRIT4FL="Y" and PARAMCD is MNET, or MN50, then set to 'Seroconversion'
CRIT4FL	Computation	If PARAMCD is MNET or MN50, Derive when both baseline result (ISSTRESC where ABLF='Y') and post-baseline result (AVAL) are non-missing, set to 'Y' if baseline result ISSTRESC contains "<" or ISSTRESN<LOD or ISSTRESN<ISLLOQ and post-baseline >= LLOQ (AVAL>=ISLLOQ); or baseline result does not contain '<' and not less than LOD and not less than ISLLOQ and post-baseline increase 4 times from the baseline value (R2BASE>=4)
DTYPE	Computation	Set to 'DERIVED' if PARAMCD contains 'L10' or 'LV58'
LOD	Computation	SUPPIS.QVAL where QNAM is 'LOD'
PARAM	Computation	For PARCAT1='Serum SARS-CoV-2 Neutralizing Antibodies', set to ISTEST; For PARCAT1='Serum SARS-CoV-2 Binding Antibodies', if PARAMCD does not contain 'L10' then set to ISTEST " (" \|\|ISSTRESU\|\| ")" if ISSTRESU is non-missing for the test, or ISTEST if ISSTRESU is not available for the test; If PARAMCD contains 'L10' then assign PARAM based on PARAMCD: 'LOG10(PsVNT50)' if PARAMCD='L10PVN50'; 'LOG10(PsVNT80)' if PARAMCD='L10PVN80'; 'LOG10(MN50)' if PARAMCD='L10MN50'; 'LOG10(VAC58 Spike IgG Antibody)' if PARAMCD='LV58IGGS' 'LOG10(VAC58 Nucleocapsid IgG Antibody)' if PARAMCD='LV58IGGN'； 'LOG10(VAC58 Spike IgM Antibody)' if PARAMCD='LV58IGMS'； 'LOG10(VAC58 Spike IgG subclass 1)' if PARAMCD='LV58IG1S'； 'LOG10(VAC58 Spike IgG subclass 2)' if PARAMCD='LV58IG2S'； 'LOG10(VAC58 Spike IgG subclass 3)' if PARAMCD='LV58IG3S'； 'LOG10(VAC58 Spike IgG subclass 4)' if PARAMCD='LV58IG4S'
PARAMTYP	Computation	Set to 'DERIVED' if PARAMCD contains 'L10' or 'LV58'
PARCAT1	Computation	Set to IS.ISCAT
PPBABRER	Computation	"Set to PP_list.PBABREAS for PARCAT1='Serum SARS-CoV-2 Binding Antibodies' based on subject and visit (ADIS.AVISIT and pp_list.VISITTPT). if subject has dosing error (ADSL.PPBABERS contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list if applicable"
PPBABRFL	Computation	Set to 'Y' if PP_listing.PVSBABFL='Y' for PARCAT1='Serum SARS-CoV-2 Binding Antibodies' based on subject and visit (ADIS.AVISIT and pp_listing.VISITTPT).
PPNA2RFL	Computation	Set to 'Y' if ADSL.PPNAB2FL='Y' and PP_list2.PVSNABFL='Y' for PARCAT1='Serum SARS-CoV-2 Neutralizing Antibodies' based on subject and visit (ADIS.AVISIT and pp_list2.VISITTPT).
PPNABRER	Computation	Set to PP_list.PNABREAS for PARCAT1='Serum SARS-CoV-2 Neutralizing Antibodies' based on subject and visit (ADIS.AVISIT and pp_list.VISITTPT). if subject has dosing error (ADSL.PPNABERS contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list if applicable
PPNABRFL	Computation	Set to 'Y' if PP_listing.PVSNABFL='Y' for PARCAT1='Serum SARS-CoV-2 Neutralizing Antibodies' based on subject and visit (ADIS.AVISIT and pp_listing.VISITTPT).
R2BASE	Computation	AVAL/BASE if both are available and BASE is not 0
ULOQ	Computation	SUPPIS.QVAL where QNAM is 'ULOQ'
ABLFL	Computation	Set to 'Y' by selecting the latest ADTM or ADT if time is not available with non-missing AVAL/ LBSTRESC on or before TR01SDTM (TR01SDT if time part of TR01SDTM is missing) for each SUBJID, PARCAT1 and PARAMCD. Note: If still multiple, selecting the records with the latest sequence number
ADT	Computation	Set to numeric date part of LB.LBDTC
ADTM	Computation	Set to numeric date time of LBDTC if time part is not missing
ANL02FL	Computation	Per subject per parameter, set to Y for the worst post-baseline toxicity grade (ATOXGRL) during vaccination stage (ASTAGEN=1) where ATOXDSCL is not missing using the following order: Grade 4> Grade 3>Grade 2>Grade 1>Grade 0. If there are more than one worst toxicity grades, then set to the first record.
ANL03FL	Computation	Per subject per parameter, set to Y for the worst post-baseline toxicity grade (ATOXGRH) during vaccination stage (ASTAGEN=1) where ATOXDSCH is not missing using the following order: Grade 4> Grade 3>Grade 2>Grade 1>Grade 0. If there are more than one worst toxicity grades, then set to the first record.
ANRHI	Computation	Set to LB.LBSTNRHI.
ANRIND	Computation	Set to LB.LBNRIND
ANRLO	Computation	Set to LB.LBSTNRLO.
ASTAGE	Computation	For subjects who received 2 injections (DOSE1FL=’Y’ and DOSE2FL=’Y’), set to ‘Vaccination stage’ If .< ADSL.TR01SDTM <=ADTM and ADT<=earliest date of (date of Visit 7 (i.e. SV.SVSTDTC where SV.VISIT = 'Visit 7 Day 57'), ADSL.EOSDT, ADSL.DTHDT) ; set to 'Follow up stage' if ADT > non-missing date of Visit 7. If date of Visit 7, ADSL.EOSDT, and ADSL.DTHDT are all unavailable, set to ‘Vaccination stage’ for post baseline records. Else leave missing. For subjects who received only injection (DOSE1FL=’Y’ and DOSE2FL ne ’Y’), set to ‘Vaccination stage’ If .< ADSL.TR01SDTM <=ADTM and ADT<=earliest date of (date of Visit 4 (i.e. SV.SVSTDTC where SV.VISIT = 'Visit 4 Day 29'), ADSL.EOSDT, ADSL.DTHDT) ; set to 'Follow up stage' if ADT > non-missing date of Visit 4. If date of Visit 4, ADSL.EOSDT, and ADSL.DTHDT are all unavailable, set to ‘Vaccination stage’ for post baseline records. Else leave missing.
ATM	Computation	Time part of LB.LBDTC
ATOXDSCH	Computation	Set to 'Blood Urea Nitrogen Increased' if PARAMCD='UREAN' Set to 'Creatinine Increased' if PARAMCD='CREAT' Set to 'Alkaline Phosphatase Increased' if PARAMCD='ALP' Set to 'Alanine Aminotransferase Increased' if PARAMCD='ALT' Set to 'Aspartate Aminotransferase Increased' if PARAMCD='AST' Set to 'Bilirubin Increased' if PARAMCD='BILI' Set to 'WBC Increased' if PARAMCD='WBC' Set to 'Eosinophils Increased' if PARAMCD='EOS' Set to 'Prothrombin Time Increased' if PARAMCD='PT' Set to 'Activated Partial Thromboplastin Time Increased' if PARAMCD='APTT'
ATOXDSCL	Computation	Set to 'Hemoglobin Decreased' if PARAMCD='HGB' Set to 'Lymphocytes Decreased' if PARAMCD='LYM' Set to 'Neutrophils Decreased' if PARAMCD='NEUT' Set to 'Platelets Decreased' if PARAMCD='PLAT' Set to 'WBC Decreased' if PARAMCD='WBC'
ATOXGRH	Computation	If AVAL is not missing, then assign AVAL toxicity grading as follows: Set to 'Grade 1' if 1.1 – 2.0 × ULN Set to 'Grade 2' if >2.0 – 3.0 × ULN Set to 'Grade 3' if >3.0 – 10 × ULN Set to 'Grade 4' if > 10 × ULN Otherwise, set to 'Grade 0' (ULN = upper limit of normal)
ATOXGRH	Computation	If AVAL is not missing, then assign AVAL toxicity grading as follows: Set to 'Grade 1' if 1.1 – 2.5 x ULN Set to 'Grade 2' if >2.5 – 5.0 × ULN Set to 'Grade 3' if >5.0 – 10 × ULN Set to 'Grade 4' if > 10 × ULN Otherwise, set to 'Grade 0' (ULN = upper limit of normal)
ATOXGRH	Computation	If AVAL is not missing, then assign AVAL toxicity grading as follows: Set to 'Grade 1' if >1.0 – 1.2 × ULN Set to 'Grade 2' if >1.20 – 1.4 × ULN Set to 'Grade 3' if >1.40 – 1.5 × ULN Set to 'Grade 4' if > 1.5 × ULN Otherwise, set to Set to 'Grade 0' (ULN = upper limit of normal)
ATOXGRH	Computation	If AVAL is not missing, then assign AVAL toxicity grading as follows: Set to 'Grade 1' if 1.1 – 2.5 x ULN Set to 'Grade 2' if >2.5 – 5.0 × ULN Set to 'Grade 3' if >5.0 – 10 × ULN Set to 'Grade 4' if > 10 × ULN Otherwise, set to 'Grade 0' (ULN = upper limit of normal)
ATOXGRH	Computation	If AVAL is not missing and (ATOXGRHN>1 where PARAMCD=ALT or ATOXGRHN>1 where PARAMCD=AST), then assign AVAL toxicity grading as follows: Set to 'Grade 1' if 1.1 – 1.25 × ULN Set to 'Grade 2' if >1.25 – 1.5 × ULN Set to 'Grade 3' if >1.5 – 1.75 × ULN Set to 'Grade 4' if > 1.75 × ULN Otherwise, set to Grade '0' (ULN = upper limit of normal) If AVAL is not missing and (ATOXGRHN=0 where PARAMCD=ALT and ATOXGRHN=0 where PARAMCD=AST), then assign AVAL toxicity grading as follows: Set to 'Grade 1' if 1.1 – 1.5 × ULN Set to 'Grade 2' if >1.5 – 2.0 × ULN Set to 'Grade 3' if >2.0 – 3.0 × ULN Set to 'Grade 4' if > 3.0 × ULN Otherwise, set to Grade '0' (ULN = upper limit of normal)
ATOXGRH	Computation	If AVAL is not missing, then assign toxicity grading based on numeric version of LBORRES (mg/dL) as follows: Set to 'Grade 1' if 1.5-1.7 Set to 'Grade 2' if >1.7 -2.0 Set to 'Grade 3' if >2.0 -2.5 Set to 'Grade 4' if > 2.5 or requires dialysis Otherwise, set to Set to 'Grade 0'
ATOXGRH	Computation	If AVAL is not missing, convert AVAL to cell/mm3 (AVAL*1000), then assign AVAL toxicity grading as follows: Set to 'Grade 1' if 650 – 1,500 Set to 'Grade 2' if 1,501 – 5,000 Set to 'Grade 3' if > 5,000 Set to 'Grade 4' if pending Hypereosinophilic (Per medical review) Otherwise, set to 'Grade 0'
ATOXGRH	Computation	If AVAL is not missing, then assign AVAL toxicity grading as follows: Set to 'Grade 1' if >1.0 – 1.10 × ULN (LB.LBSTNRHI) Set to 'Grade 2' if >1.10 – 1.20 × ULN Set to 'Grade 3' if >1.20 – 1.25 × ULN Set to 'Grade 4' if > 1.25 × ULN Otherwise, set to 'Grade 0' (ULN = upper limit of normal)
ATOXGRH	Computation	If AVAL is not missing, then assign toxicity grading based on numeric version of LBORRES (mg/dL) as follows: Set to 'Grade 1' if 23-26 Set to 'Grade 2' if >26 -31 Set to 'Grade 3' if >31 Set to 'Grade 4' if requires dialysis pending Otherwise, set to Grade '0'
ATOXGRH	Computation	If AVAL is not missing, convert AVAL to cell/mm3 (AVAL*1000),, then assign AVAL toxicity grading as follows: Set to 'Grade 1' if 10,800 – 15,000 Set to 'Grade 2' if 1,5001 – 20,000 Set to 'Grade 3' if 20,001 – 25,000 Set to 'Grade 4' if > 25,000 Otherwise, set to 'Grade 0'
ATOXGRL	Computation	If AVAL is not missing and SEX=’F’, convert AVAL and CHG to g/dl (AVAL0.1, CHG0.1), then assign AVAL toxicity grading as follows: Set to 'Grade 1' if 11.0 – 12.0 Set to 'Grade 2' if 9.5 – 10.9 Set to 'Grade 3' if 8.0 – 9.4 Set to 'Grade 4' if < 8.0 Otherwise, set to Grade 0. assign CHG toxicity grading as follows: Set to 'Grade 1' if -1.5 to <0 Set to 'Grade 2' if -2 to -1.6 Set to 'Grade 3' if -5 to -2.1 Set to 'Grade 4' if < -5 Otherwise, set to 'Grade 0' Choose the higher grade between the two. If AVAL is not missing and SEX=’M’, convert AVAL and CHG to g/dl (AVAL0.1, CHG0.1), then assign AVAL toxicity grading as follows: Set to 'Grade 1' if 12.5 – 13.5 Set to 'Grade 2' if 10.5 – 12.4 Set to 'Grade 3' if 8.5 – 10.4 Set to 'Grade 4' if < 8.5 Otherwise, set to 'Grade 0' assign CHG toxicity grading as follows: Set to 'Grade 1' if -1.5 to <0 Set to 'Grade 2' if -2 to -1.6 Set to 'Grade 3' if -5 to -2.1 Set to 'Grade 4' if < -5 Otherwise, set to 'Grade 0' Choose the higher grade between the two.
ATOXGRL	Computation	If AVAL is not missing, convert AVAL to cell/mm3 (AVAL*1000), then assign AVAL toxicity grading as follows: Set to 'Grade 1' if 750 – 1,000 Set to 'Grade 2' if 500 – 749 Set to 'Grade 3' if 250 – 499 Set to 'Grade 4' if < 250 Otherwise, set to Grade '0'
ATOXGRL	Computation	If AVAL is not missing, convert AVAL to cell/mm3 (AVAL*1000), then assign AVAL toxicity grading as follows: Set to 'Grade 1' if 1,500 – 2,000 Set to 'Grade 2' if 1,000 – 1,499 Set to 'Grade 3' if 500 – 999 Set to 'Grade 4' if < 500 Otherwise, set to 'Grade 0'
ATOXGRL	Computation	If AVAL is not missing, convert AVAL to cell/mm3 (AVAL*1000), then assign AVAL toxicity grading as follows: Set to 'Grade 1' if 125,000 – 140,000 Set to 'Grade 2' if 100,000 – 124,000 Set to 'Grade 3' if 25,000 – 99,000 Set to 'Grade 4' if < 25,000 Otherwise, set to 'Grade 0'
ATOXGRL	Computation	If AVAL is not missing, convert AVAL to cell/mm3 (AVAL*1000), then assign AVAL toxicity grading as follows: Set to 'Grade 1' if 2,500 – 3,500 Set to 'Grade 2' if 1,500 – 2,499 Set to 'Grade 3' if 1,000 – 1,499 Set to 'Grade 4' if < 1,000 Otherwise, set to 'Grade 0'
AVAL	Computation	LB.LBSTRESN If LBSTRESC contains '<', then take the value after '<', times 0.5 for AVAL. For example, if LBSTRESC="<3.4", then AVAL=1.7 If LBSTRESC contains '>', then take the value after '>' for AVAL. For example, if LBSTRESC=">75", then AVAL=75
AVISIT	Computation	If ABLFL='Y', then AVISIT = 'Baseline', If ADY>1 and VISIT doesn't contain 'Unsched', set to 'Day xx' part of VISIT, if ADY>1 and VISIT contains 'Unsched', set AVISIT as follows: using the visit window below: If VISIT with 1<ADY<=43, then AVISIT = 'Day 29', Else If VISIT with 44<=ADY, then AVISIT = 'Day 57'
BASE	Computation	Set to AVAL where ABLFL = 'Y' by USUBJID, PARCAT1, and PARAMCD
BNRIND	Computation	Set up ANRIND where ABLFL = 'Y' by USUBJID, PARCAT1, and PARAMCD
BTOXGRH	Computation	Merge value of nonmissing ATOXGRH where ABLFL = 'Y' by USUBJID, PARCAT1, and PARAMCD
BTOXGRL	Computation	Merge value of nonmissing ATOXGRL where ABLFL = 'Y' by USUBJID, PARCAT1, and PARAMCD
CHG	Computation	AVAL-BASE for post-baseline records Note: post-baseline records are defined as any result where (ADTM > ADSL.TR01SDTM if time is available or ADY > 1 otherwise.
CRIT1	Computation	Set to PARAMCD \|\|' <2 x ULN' if CRIT1FL='Y' and PARAMCD in (ALP); Set to PARAMCD \|\|' >=2 x ULN' if CRIT1FL='Y' and PARAMCD in (BILI); Set to PARAMCD \|\|' >3 x ULN' if CRIT1FL='Y' and PARAMCD in (ALT, AST)
CRIT1FL	Computation	Set to 'Y' if If AVAL/ANRHI <2 and PARAMCD =ALP; Set to 'Y' if If AVAL/ANRHI >=2 and PARAMCD =BILI; Set to 'Y' if If AVAL/ANRHI >3 and PARAMCD in (ALT, AST);
DTYPE	Computation	Set to 'HALFLLOQ' if LBSTRESC contains '<', Set to 'ULOQ' if LBSTRESC contains '>' Set to missing, otherwise
MDOSREF	Computation	If (.<ADSL.TR01SDTM<=ADTM <ADSL.DOS2DTM) or (.<ADSL.TR01SDTM<=ADTM and ADSL.DOS2DTM is missing), set to 'Vaccination 1'; if .<ADSL.DOS2DTM<=ADTM, set to 'Vaccination 2'; use date variables for comparison when time part is not available
MRDDY	Computation	ADT – ADSL.TR01SDT+ 1 If MDOSREF='Vaccination 1', ADT – ADSL.DOSE2DT+ 1 If MDOSREF='Vaccination 2'.
PARAM	Computation	If LBCAT=CHEMISTRY and LBTESTCD=HCG and LBMETHOD='ELECTROCHEMILUMINESCENCE' or 'CHEMILUMINESCENCE', set to LBMETHOD\|\|' '\|\|LB.LBTEST\|\| ' (' \|\| LB.LBSTRESU \|\| ')' (please add space between LBMETHOD and LBTEST.) If LBCAT=URINALYSIS set to Urinary \|\| LB.LBTEST\|\| ' (' \|\| LB.LBSTRESU \|\| ')' if LBSTRESU is not blank If LBCAT ne URINALYSIS set to LB.LBTEST \|\| ' (' \|\| LB.LBSTRESU \|\| ')' if LBSTRESU is not blank If LBSTRESU is blank, set to LB.LBTEST appended with LBSTRESU from non-missing records in parenthesis. Note: Please add space between parameter and unit.
PARCAT1	Computation	Set to LB.LBCAT
PCHG	Computation	(CHG/BASE)*100 if both are available and BASE is not 0
SHIFT1	Computation	Only populate for post-baseline records If both of BTOXGRL and ATOXGRL are not missing, set to BTOXGRL\|\| ' to '\|\|ATOXGRL If either BTOXGRL or ATOXGRL is missing, set the missing BTOXGRL and ATOXGRL to 'UNK', then set to BTOXGRL\|\| ' to '\|\|ATOXGRL Note: post-baseline records are defined as any result where (ADTM > ADSL.TR01SDTM if time is available or ADY > 1 otherwise.
SHIFT2	Computation	Only populate for post-baseline records If both of BTOXGRH and ATOXGRH are not missing, set to BTOXGRH\|\| ' to '\|\|ATOXGRH If either BTOXGRH or ATOXGRH is missing, set the missing BTOXGRH and ATOXGRH to 'UNK', then set to BTOXGRH\|\| ' to '\|\|ATOXGRH Note: post-baseline records are defined as any result where (ADTM > ADSL.TR01SDTM if time is available or ADY > 1 otherwise.
ABLFL	Computation	Set to 'Y' for selecting the latest ADTM or ADT if time is not available with non-missing AVALC on or before ADSL.TR01SDTM (TR01SDT if time part of TR01SDTM is missing) for each SUBJID, PARCAT1 and PARAMCD. Note: ABLFL apply for non-local (LOCALFL is not 'Y') only
ADT	Computation	Set to numeric date part of MB.MBDTC
ADTM	Computation	Set to numeric date time of MBDTC if time part is not missing
ATM	Computation	Time part of MB.MBDTC
AVALC	Computation	Set to mixed case of MB.MBSTRESC; Set to 'Not Detected' if MBSTRESC is 'NOTDETECTED'
AVISIT	Computation	"If ABLFL='Y' then AVISIT='Baseline'; if ADY>1 and VISITNUM is 5, 8, set to 'Day xx' part of VISIT; ; if ADY>1 and VISITNUM is not 5, 8, set AVISIT as follows: using the visit window below: If VISIT with 2<=ADY<=43, then AVISIT = ’Day 29’; else if VISIT with 44<=ADY<=70, then AVISIT = ’Day 57’; else if VISIT with 71<=ADY, then AVISIT = ’Day 71 or Beyond’; "
AWTDIFF	Computation	Set to absolute value of (ADY - AWTARGET)
BASEC	Computation	Set up AVALC where ABLFL = 'Y' for each SUBJID, PARCAT1 and PARAMCD
LDTSTOTH	Computation	SUPPMB.QVAL where QNAM is 'LDTSTOTH'
LDTTYPE	Computation	SUPPMB.QVAL where QNAM is 'LDTTYPE'
LOCALFL	Computation	SUPPMB.QVAL where QNAM is 'LOCALFL'
PARAM	Computation	Set to MB.MBTEST
PARCAT1	Computation	Set to MB.MBCAT
AGEGR1	Computation	Based on SUPPDM.QVALwhere QNAM='COHORT': Set to '>=18 and <55 Years' if contains 'COHORT 1' Set to '>=55 Years' if COHORT contains 'COHORT 2'
AGEGR2	Computation	'Based on AGE: '>=18 and <=22 Years' if 18<=AGE<=22'; '>=23 and <=25 Years' if 23<=AGE<=25'; '>25 and <55 Years' if 25<AGE<55'; '>=55 Years' if COHORT contains 'COHORT 2'
BMIBL	Computation	Set to WEIGHTBL/(HEIGHTBL in meters)^2
CBNRS	Computation	Set to SUPPRP.QVAL where QNAM='CBRSN' and VISIT=Screening
CHILDBP	Computation	Set to RP.RPORRES where RPTESTCD is CHILDPOT and VISIT=Screening
COMPFL	Computation	Set to "Y" if USUBJID exists in DS where DSCAT ="DISPOSITION EVENT" and DS.DSSCAT ="END OF STUDY" and DSDECOD = "COMPLETED"; Set to "N" if USUBJID exists in DS where DSCAT = "DISPOSITION EVENT" and DS.DSSCAT = "END OF STUDY" and DSDECOD^= "COMPLETED".
COV19BL	Computation	Based on MB.MBSTRESC where MBTESTCD='SARSCOV2' and SUPPMB.QVAL is not 'Y' where QNAM is 'LOCALFL' and (MBDTC is before the first vaccination (DM.RFXSTDTC) or on the first vaccination date if time is not available: set to 'Not Detected' if 'NOTDETECTED' and 'Detected' if 'DETECTED'
COV19FL	Computation	"Set to 'Y' if there is one record in MB where MB.MBSTRESC is 'DETECTED' or 'POSITIVE' and MBTESTCD='SARSCOV2' or there is record in AE where AEDECOD is 'COVID-19', 'Asymptomatic COVID-19' or 'SARS-CoV-2 test positive'; Otherwise set to 'N' "
D29W7DFL	Computation	Set to 'Y' if DOSE2DT-TR01SDT+1>36; Otherwise set to 'N'
DCSREAS	Computation	Mixed case of DS.DSTERM where DSCAT='DISPOSITION EVENT' and DSSCAT='END OF STUDY' AND DSDECOD not in ('COMPLETED', 'AE COVID', 'ADVERSE EVENT (OTHER)', 'PHYSICIAN DESICION', 'WITHDRAWAL BY SUBJECT (OTHER)', 'WITHDRAWAL BY SUBJECT (COVID-19 NON-INFECTION RELATED)', 'PROTOCOL DEVIATION', 'OTHER'). Set to 'Adverse Event (COVID-19 Infection)' if DS.DSDECOD is 'AE COVID' Set to 'Adverse Event (Other)' if DS.DSDECOD is 'ADVERSE EVENT (OTHER)' Set to 'Physician Decision' if DS.DSDECOD is 'PHYSICIAN DESICION' Set to 'Withdrawal of Consent (Other)' if DS.DSDECOD is 'WITHDRAWAL BY SUBJECT (OTHER)' Set to 'Withdrawal of Consent (COVID-19 Non-Infection Related)' if DS.DSDECOD is 'WITHDRAWAL BY SUBJECT (COVID-19 NON-INFECTION RELATED)' Set to 'Protocol Deviation' if DS.DSDECOD is 'PROTOCOL DEVIATION' Set to 'Other' if DS.DSDECOD is 'OTHER'
DCSREASP	Computation	DS.DSTERM where DSCAT='DISPOSITION EVENT' and DSSCAT='END OF STUDY' AND DSDECOD in ('ADVERSE EVENT (OTHER)', 'PHYSICIAN DESICION', 'WITHDRAWAL BY SUBJECT (OTHER)', 'WITHDRAWAL BY SUBJECT (COVID-19 NON-INFECTION RELATED)', 'PROTOCOL DEVIATION', 'OTHER')
DCTREAS	Computation	Mixed case of DS.DSTERM where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' AND DSDECOD not in ('COMPLETED', 'AE COVID', 'ADVERSE EVENT (OTHER)', 'PHYSICIAN DESICION', 'WITHDRAWAL BY SUBJECT (OTHER)', 'WITHDRAWAL BY SUBJECT (COVID-19 NON-INFECTION RELATED)', 'PROTOCOL DEVIATION', 'OTHER'): Set to 'Adverse Event (COVID-19 Infection)' if DS.DSDECOD is 'AE COVID' Set to 'Adverse Event (Other)' if DS.DSDECOD is 'ADVERSE EVENT (OTHER)' Set to 'Physician Decision' if DS.DSDECOD is 'PHYSICIAN DESICION' Set to 'Withdrawal of Consent (Other)' if DS.DSDECOD is 'WITHDRAWAL BY SUBJECT (OTHER)' Set to 'Withdrawal of Consent (COVID-19 Non-Infection Related)' if DS.DSDECOD is 'WITHDRAWAL BY SUBJECT (COVID-19 NON-INFECTION RELATED)' Set to 'Protocol Deviation' if DS.DSDECOD is 'PROTOCOL DEVIATION' Set to 'Other' if DS.DSDECOD is 'OTHER'
DCTREASP	Computation	DS.DSTERM where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' AND DSDECOD in ('ADVERSE EVENT (OTHER)', 'PHYSICIAN DESICION', 'WITHDRAWAL BY SUBJECT (OTHER)', 'WITHDRAWAL BY SUBJECT (COVID-19 NON-INFECTION RELATED)', 'PROTOCOL DEVIATION', 'OTHER')
DOSE1FL	Computation	Set to 'Y' if USUBJID exists in EX with non-missing EXSTDTC where EX.VISIT contains 'Day 1'; Set to 'N' otherwise
DOSE2FL	Computation	Set to 'Y' if USUBJID exists in EX with non-missing EXSTDTC where EX.VISIT contains 'Day 29'; Set to 'N' otherwise
DOSEROFL	Computation	Set to 'Y' if subject received any dose (based on EX.EXTRT, EX.EXDOSE or EX.EXDOSTXT) which is different from the randomized arm (ARM); 'N' otherwise
DTHAUTOP	Computation	Set to SUPPDS.QVAL where QNAM='DTHAUTOP'
DTHDT	Computation	Set to DM.DTHDTC and convert to numeric
DVBABFL	Computation	Based on PP_LISTING, If a subject is excluded from subject-level PP set for bAb and has one record with PBABDVFL='Y', then set to 'Y'. Set to 'N' otherwise.
DVNABFL	Computation	Based on PP_LISTING, If a subject is excluded from subject-level PP set for nAb and has one record with PNABDVFL='Y', then set to 'Y'. set to 'N' otherwise.
FASBABFL	Computation	Set to 'Y' if 1. SAFFL='Y; and 2. Have at least one non-missing IS.ISSTRESC with ISCAT contains 'Serum SARS-CoV-2 Binding Antibodies' before the first vaccination (DM.RFSTDTC), and 3. Have at least one non-missing IS.ISSTRESC with ISCAT contains 'Serum SARS-CoV-2 Binding Antibodies' post the first vaccination
FASBABRS	Computation	Only for subjects with RANDFL='Y'. If SAFFL='N', set to 'Did not receive any study vaccination'; If SAFFL='Y' and FASBABFL='N', set to 'There were no immunogenicity results at baseline and at least one post-vaccination.'. blank otherwise.
FASNA2FL	Computation	Y' if 1. SAFFL='Y; and 2. Have at least one non-missing IS.ISSTRESC with ISCAT contains 'Serum SARS-CoV-2 Neutralizing Antibodies' on or before the date of the first vaccination (TR01SDT), and 3. Have at least one non-missing IS.ISSTRESC with ISCAT contains 'Serum SARS-CoV-2 Neutralizing Antibodies' post the date of first vaccination. 'N' otherwise.
FASNABFL	Computation	Set to 'Y' if 1. SAFFL='Y; and 2. Have at least one non-missing IS.ISSTRESC with ISCAT contains 'Serum SARS-CoV-2 Neutralizing Antibodies' before the first vaccination (DM.RFSTDTC), and 3. Have at least one non-missing IS.ISSTRESC with ISCAT contains 'Serum SARS-CoV-2 Neutralizing Antibodies' post the first vaccination
FASNABRS	Computation	Only for subjects with RANDFL='Y'. If SAFFL='N', set to 'Did not receive any study vaccination'; If SAFFL='Y' and FASNABFL='N', set to 'There were no immunogenicity results at baseline and at least one post-vaccination.' blank otherwise
HEIGHTBL	Computation	The last non-missing VS.VSSTRESN where VSTESTCD = “HEIGHT” and (VSDTC is before the first vaccination (DM.RFXSTDTC) or on the first vaccination date with VSTPT contains 'PRE-DOSE'.)
PN2D29ER	Computation	Only for subjects with RANDFL='Y' and PN2D29FL='N': Set to PP_list2.PNABREAS where VISITTPT='Day 29'. if subejct has dosing error (ADSL.PPNAB2ER contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list2 if applicable
PN2D29FL	Computation	set PP_LIST2.PVSNABFL where VISITTPT='Day 29'; set to 'N' if subject's actual doses is outside + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose (refer to PPBABFL)
PN2D57ER	Computation	Only for subjects with RANDFL='Y' and PN2D57FL='N': Set to PP_list2.PNABREAS where VISITTPT='Day 57'. if subejct has dosing error (ADSL.PPNAB2ER contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list2 if applicable
PN2D57FL	Computation	set PP_LIST2.PVSNABFL where VISITTPT='Day 57'; set to 'N' if subject's actual doses is outside + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose (refer to PPBABFL)
PPBABERS	Computation	"Only for subjects with RANDFL='Y' and PPBABFL='N': if subject is excluded due to dosing error as defined in PPBABFL then set to 'Dosing error' and concatenate the reasons from PP_list if the subject is also excluded due to other reasons. For exclusion based on PP_list, set to PP_list.PBABREAS and concatenate all unique reasons (Note: merge data by USUBJID)"
PPBABFL	Computation	"Subjects in FAS for bAb and 1. Complied with the injection schedule as defined in the protocol visit window, 2. don’t have COVID-19 infection at baseline, 3. don't have deviation impact bAb responses. 4. both actual doses are within + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose set to 'Y' if 1) for #1-3, based on PP_LIST, If a subject has one record with PVSBABFL='Y', and 2) for #4, a) both TRT01P and TRT01A are 'Placebo'; or b) both TRT01P and TRT01A are 'mRNA-1273 50 ug' and there is no record in EX where EXTRT is 'Placebo' or (EXTRT is 'mRNA-1273' and EXDOSTXT contains '>0-25', '>75-<100' or '>100-125', or '>125 or above'); or c) both TRT01P and TRT01A are 'mRNA-1273 100 ug' and there is no record in EX where EXTRT is 'Placebo' or (EXTRT is 'mRNA-1273' and EXDOSTXT contains '>0-25', '>25-<50' or >50-75', '>125 or above'); 'N' otherwise."
PPBD29FL	Computation	set PP_LIST.PVSBABFL where VISITTPT='Day 29'; set to 'N' if subject's actual doses is outside + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose (refer tp PPBABFL).
PPBD57ER	Computation	Only for subjects with RANDFL='Y' and PPBD57FL='N': Set to PP_list.PBABREAS where VISITTPT='Day 57'. if subejct has dosing error (ADSL.PPBABERS contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list if applicable
PPBD57FL	Computation	set PP_LIST.PVSBABFL where VISITTPT='Day 57'; set to 'N' if subject's actual doses is outside + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose (refer tp PPBABFL)
PPNAB2ER	Computation	Only for subjects with RANDFL='Y' and PPNAB2FL='N'. if subject is excluded due to dosing error as defined in PPNABFL then set to 'Dosing error' and concatenate the reasons from PP_list2 if the subject is also excluded due to other reasons. For exclusion based on PP_list2, set to PP_list2.PNABREAS and concatenate all unique reasons (Note: merge data by USUBJID)
PPNAB2FL	Computation	Subjects with FAS for nAb and 1. Complied with the injection schedule as defined in the protocol visit window, 2. don’t have COVID-19 infection at baseline, 3. don't have deviation impact nAb responses. 4. both actual doses are within + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose. set to 'Y' if 1) for #1-3, based on PP_LIST2, If a subject has one record with PVSNABFL='Y', and 2) for #4, a) both TRT01P and TRT01A are 'Placebo'; or b) both TRT01P and TRT01A are 'mRNA-1273 50 ug' and there is no record in EX where EXTRT is 'Placebo' or (EXTRT is 'mRNA-1273' and EXDOSTXT contains '>0-25', '>75-<100' or '>100-125', or '>125'); or c) both TRT01P and TRT01A are 'mRNA-1273 100 ug' and there is no record in EX where EXTRT is 'Placebo' or (EXTRT is 'mRNA-1273' and EXDOSTXT contains '>0-25', '>25-<50 ug' or >50-75', '>125'); 'N' otherwise.
PPNABERS	Computation	"Only for subjects with RANDFL='Y' and PPNABFL='N'. if subject is excluded due to dosing error as defined in PPNABFL then set to 'Dosing error' and concatenate the reasons from PP_list if the subject is also excluded due to other reasons. For exclusion based on PP_list, set to PP_list.PNABREAS and concatenate all unique reasons (Note: merge data by USUBJID)"
PPNABFL	Computation	"Subjects with FAS for nAb and 1. Complied with the injection schedule as defined in the protocol visit window, 2. don’t have COVID-19 infection at baseline, 3. don't have deviation impact nAb responses. 4. both actual doses are within + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose. set to 'Y' if 1) for #1-3, based on PP_LIST, If a subject has one record with PVSNABFL='Y', and 2) for #4, a) both TRT01P and TRT01A are 'Placebo'; or b) both TRT01P and TRT01A are 'mRNA-1273 50 ug' and there is no record in EX where EXTRT is 'Placebo' or (EXTRT is 'mRNA-1273' and EXDOSTXT contains '>0-25', '>75-<100' or '>100-125', or '>125'); or c) both TRT01P and TRT01A are 'mRNA-1273 100 ug' and there is no record in EX where EXTRT is 'Placebo' or (EXTRT is 'mRNA-1273' and EXDOSTXT contains '>0-25', '>25-<50 ug' or >50-75', '>125'); 'N' otherwise."
PPND29ER	Computation	Only for subjects with RANDFL='Y' and PPND29FL='N': Set to PP_list.PNABREAS where VISITTPT='Day 29'. if subejct has dosing error (ADSL.PPNABERS contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list if applicable
PPND29FL	Computation	set PP_LIST.PVSNABFL where VISITTPT='Day 29'; set to 'N' if subject's actual doses is outside + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose (refer to PPBABFL)
PPND57ER	Computation	Only for subjects with RANDFL='Y' and PPND57FL='N': Set to PP_list.PNABREAS where VISITTPT='Day 57'. if subejct has dosing error (ADSL.PPNABERS contains 'Dosing error') then set to 'Dosing error' and concatenate with the reason from PP_list if applicable
PPND57FL	Computation	set PP_LIST.PVSNABFL where VISITTPT='Day 57'; set to 'N' if subject's actual doses is outside + 25 ug (25 ug inclusive) / -25 ug (-25 ug exclusive) range from the planned vaccine dose (refer to PPBABFL)
PREVSCR	Computation	Set to SUPPDM.QVAL where QNAM='PREVSCR' per USUBJID
PROTVER	Computation	Set to SUPPDM.QVAL where QNAM is PROTVER
RACESPY	Computation	If RACE='OTHER' then set to SUPPDM.QVAL where QNAM is RACEOTH; If RACE='MULTIPLE' then set to SUPPDM.QVAL where QNAM is MULRACE
RANDDT	Computation	DS.DSSTDTC where DSTERM='RANDOMIZED' and DSCAT='PROTOCOL MILESTONE'
RANDFL	Computation	Set to 'Y' if USUBJID exists in DS where DSDECOD='RANDOMIZED' and DSSTDTC not missing and DSREFID not missing. Set to 'N' otherwise
RANDNUM	Computation	Set to DS.DSREFID
RFICDT	Computation	Date part of DM.RFICDTC
SAFEREAS	Computation	Only for subjects with RANDFL='Y'. Set to 'Did not receive any vaccination' if SAFFL='N'. blank otherwise
SAR1ERS	Computation	Only for subjects with RANDFL='Y'. If SAFFL='N', set to 'Did not receive any study vaccination'; If SAFFL='Y' and SAR1FL='N', set to 'Did not contribute any solicited AR data for Vaccination #1'. blank otherwise
SAR1FL	Computation	Set to 'Y' if both criteria met: 1. SAFFL='Y'; 2. Have at least one non-missing FAORRES where FATPTREF = 'DOSE 1' in FACE OR have at least one non-missing VSORRES where VSTPTREF = 'DOSE 1' and VSTEST contains "Temperature" where VSCAT contains "REACTOGENICITY" in VS; Set to 'N' otherwise.
SAR2ERS	Computation	Only for subjects with RANDFL='Y'. If SAFFL='N', set to 'Did not receive any study vaccination'; If SAFFL='Y' and DOSE2FL='N', set to 'Did not receive Vaccination #2'. If SAFFL='Y'and DOSE2FL='Y' and SAR2FL='N', set to 'Did not contribute any solicited AR data for Vaccination #2'. blank otherwise
SAR2FL	Computation	Set to 'Y' if all criteria met: 1. SAFFL='Y'; 2. Have at least one non-missing FAORRES where FATPTREF = 'DOSE 2' in FACE OR have at least one non-missing VSORRES where VSTPTREF = 'DOSE 2' and VSTEST contains "Temperature" where VSCAT contains "REACTOGENICITY" in VS; 3. DOSE2FL='Y'; Set to 'N' otherwise
SARAFL	Computation	Set to 'Y' if SAR1FL='Y' or SAR2FL='Y'
SENTLFL	Computation	Set to SUPPDM.QVAL where QNAM='SENTL'
CBNRS	Computation	Set to SUPPRP.QVAL where QNAM='CBRSN'
CHILDBP	Computation	Set to RP.RPORRES where RPTESTCD is CHILDPOTand VISIT=Screening
PREVSCR	Computation	Set to SUPPDM.QVAL where QNAM='PREVSCR' per USUBJID
PROTVER	Computation	Set to SUPPDM.QVAL where QNAM is PROTVER and VISIT=Screening
RACESPY	Computation	If RACE='OTHER' then set to SUPPDM.QVAL where QNAM is RACEOTH If RACE='MULTIPLE' then set to SUPPDM.QVAL where QNAM is MULRACE
RFICDT	Computation	Date part of DM.RFICDTC
SCFREAS	Computation	Mixed case of DS.DSTERM where DSCAT="DISPOSITION EVENT" and DSSCAT='SCREEN FAILURE' and DS.DSDECOD^='OTHER'. Set to 'Other' if DS.DSDECOD='OTHER' where DSCAT="DISPOSITION EVENT" and DSSCAT='SCREEN FAILURE'.
SCFREASP	Computation	Set to DS.DSTERM where SCFREAS='OTHER'
WEIGHTBL	Computation	The last non-missing VS.VSSTRESN where VSTESTCD = 'WEIGHT' and (VSDTC is before the first vaccination (DM.RFXSTDTC) or on the first vaccination date with VSTPT contains 'PRE-DOSE'.)
ABLFL	Computation	Set to 'Y' by selecting the latest ADTM or ADT if ATM is missing with non-missing AVAL/AVALC on or before TR01SDTM (TR01SDT if time part of TR01SDTM is missing) for each SUBJID and PARAMCD Note: exclude records where ADT is the same as TR01SDT and VSTPT^='PRE-DOSE'
ADT	Computation	Set to numeric date part of VS.VSDTC
ADTM	Computation	Set to numeric date time of VSDTC if time part is not missing
ANL02FL	Computation	Set to 'Y' by selecting the first worst toxicity grade (ATOXGRL Worst Case Order: Grade 4> Grade 3>Grade 2>Grade 1>Grade 0) by Subject, Parameter and Analysis Visit
ANL03FL	Computation	Set to 'Y' by selecting the first worst toxicity grade (ATOXGRH Worst Case Order: Grade 4> Grade 3>Grade 2>Grade 1>Grade 0) by Subject, Parameter and Analysis Visit
ASTAGE	Computation	For subjects who received 2 injections (DOSE1FL=’Y’ and DOSE2FL=’Y’), set to ‘Vaccination stage’ If .< ADSL.TR01SDTM <=ADTM and ADT<=earliest date of (date of Visit 7 (i.e. SV.SVSTDTC where SV.VISIT = 'Visit 7 Day 57'), ADSL.EOSDT, ADSL.DTHDT) ; set to 'Follow up stage' if ADT > non-missing date of Visit 7. If date of Visit 7, ADSL.EOSDT, and ADSL.DTHDT are all unavailable, set to ‘Vaccination stage’ for post baseline records. Else leave missing. For subjects who received only injection (DOSE1FL=’Y’ and DOSE2FL ne ’Y’), set to ‘Vaccination stage’ If .< ADSL.TR01SDTM <=ADTM and ADT<=earliest date of (date of Visit 4 (i.e. SV.SVSTDTC where SV.VISIT = 'Visit 4 Day 29'), ADSL.EOSDT, ADSL.DTHDT) ; set to 'Follow up stage' if ADT > non-missing date of Visit 4. If date of Visit 4, ADSL.EOSDT, and ADSL.DTHDT are all unavailable, set to ‘Vaccination stage’ for post baseline records. Else leave missing.
ATM	Computation	Time part of VS.VSDTC converted to numeric
ATOXDSCH	Computation	Set to: 'Fever' if PARAMCD = 'TEMP'; 'Tachycardia' if PARAMCD = 'PULSE'; 'Systolic Hypertension' if PARAMCD = 'SYSBP'; 'Diastolic Hypertension' if PARAMCD = 'DIABP'; 'Respiratory Rate Increased' if PARAMCD = 'RESP'.
ATOXDSCL	Computation	Set to 'Bradycardia' if PARAMCD = 'PULSE'; Hypotension' if PARAMCD = 'SYSBP'
ATOXGRH	Computation	Assign AVAL toxicity grading as follows If AVAL is not missing: Set to 'Grade 1' if 91 – 95 Set to 'Grade 2' if 96 – 100 Set to 'Grade 3' if >100 Set to 'Grade 4' is based on medical input: Otherwise, set to 'Grade 0'
ATOXGRH	Computation	Assign AVAL toxicity grading as follows If AVAL is not missing: Set to 'Grade 1' if 101 – 115 Set to 'Grade 2' if 116 – 130 Set to 'Grade 3' if >130 Set to 'Grade 4' is based on medical input: Otherwise, set to 'Grade 0'
ATOXGRH	Computation	Assign AVAL toxicity grading as follows If AVAL is not missing: Set to 'Grade 1' if 17 – 20 Set to 'Grade 2' if 21 – 25 Set to 'Grade 3' if >25 Set to 'Grade 4' is based on medical input: Otherwise, set to 'Grade 0'
ATOXGRH	Computation	Assign AVAL toxicity grading as follows If AVAL is not missing: Set to 'Grade 1' if 141 – 150 Set to 'Grade 2' if 151 – 155 Set to 'Grade 3' if >155 Set to 'Grade 4' is based on medical input: Otherwise, set to 'Grade 0'
ATOXGRH	Computation	Assign AVAL toxicity grading as follows If AVAL is not missing: Set to 'Grade 1' if 38.0 – 38.4 Set to 'Grade 2' if 38.5 – 38.9 Set to 'Grade 3' if 39.0 – 40.0 Set to 'Grade 4' if >40.0 Otherwise, set to 'Grade 0'
ATOXGRL	Computation	Assign AVAL toxicity grading as follows If AVAL is not missing: Set to 'Grade 1' if 50 – 54 Set to 'Grade 2' if 45 – 49 Set to 'Grade 3' if <45 Set to 'Grade 4' is based on medical input: Otherwise, set to 'Grade 0'
ATOXGRL	Computation	Assign AVAL toxicity grading as follows If AVAL is not missing: Set to 'Grade 1' if 85 – 89 Set to 'Grade 2' if 80 – 84 Set to 'Grade 3' if <80 Set to 'Grade 4' is based on medical input: Otherwise, set to Grade '0'
AVAL	Computation	Set to VS.VSSTRESN
AVISIT	Computation	If ABLFL='Y', then AVISIT = 'Baseline', if VISIT=Visit 1 Day 1 and VSTPT='POST DOSE' then AVISIT='Day 1', if ADY>1 and VISIT doesn't contain 'Unsched', set to 'Day xx' part of VISIT, if ADY>1 and VISIT contains 'Unsched', set AVISIT as follows: using the visit window below: If VISIT with 1<ADY<=11, then AVISIT = 'Day 8', else if VISIT with 12<=ADY<=22, then AVISIT = 'Day 15', else if VISIT with 23<=ADY<=32, then AVISIT = 'Day 29', else if VISIT with 33<=ADY<=39, then AVISIT = 'Day 36', else if VISIT with 40<=ADY<=50, then AVISIT = 'Day 43', else if VISIT with 51<=ADY<=133, then AVISIT = 'Day 57', else if VISIT with 134=<ADY<=301, then AVISIT = 'Day 209', else if VISIT with ADY>=302, then AVISIT = 'Day 394', After the steps above, sort data by AVISITN and ADY, set the unscheduled visit (i.e., VISIT contains 'Unsched') records to blank if AVISITN >any previous AVISITN AND ADY<=any previous ADY). For example, Scheduled Day 36 is with AVISITN=6 (Day 36) and ADY=42 and an unscheduled visit is with AVISITN=7 (Day 43) and ADY=40, set AVISIT to blank for this unscheduled visit
BASE	Computation	Merge value of nonmissing AVAL where ABLFL = 'Y' by USUBJID and PARAMCD, Set to AVAL where ABLFL = 'Y'.
BTOXGRH	Computation	Merge value of nonmissing ATOXGRH where ABLFL = 'Y' by USUBJID and PARAMCD;
BTOXGRL	Computation	Merge value of nonmissing ATOXGRL where ABLFL = 'Y' by USUBJID and PARAMCD;
CHG	Computation	For post baseline records only, if AVAL and BASE are both non-missing, set to AVAL - BASE Note: post-baseline records are defined as any result where (ADTM > ADSL.TR01SDTM if time is available, if time is not available use (ADY=1 and VSTPT^='PRE-DOSE') or ADY > 1).
MDOSREF	Computation	If (.<ADSL.TR01SDTM<=ADTM <ADSL.DOS2DTM) or (.<ADSL.TR01SDTM<=ADTM and ADSL.DOS2DTM is missing), set to 'Vaccination 1'; if .<ADSL.DOS2DTM<=ADTM, set to 'Vaccination 2'; use date variables for comparison when time part is not available
MRDDY	Computation	ADT – ADSL.TR01SDT+ 1 If MDOSREF='Vaccination 1', ADT – ADSL.DOSE2DT+ 1 If MDOSREF='Vaccination 2'.
PARAM	Computation	VS.VSTEST ' (' \|\|VSSTRESU\|\| ')' if VSSTRESU is non-missing, if VSSTRESU is missing, use the non-missing VSSTRESU from the same VSTEST
PCHG	Computation	Set to 0 If CHG=0 ; else set to (CHG/BASE)*100 if BASE ne 0 , otherwise set to missing
SHIFT	Computation	Only populate for post-baseline records If both of BTOXGRL and ATOXGRL are not missing, set to BTOXGRL\|\| ' to '\|\|ATOXGRL If either BTOXGRL or ATOXGRL is missing, set the missing BTOXGRL and ATOXGRL to 'UNK', then set to BTOXGRL\|\| ' to '\|\|ATOXGRL Note: post-baseline records are defined as any result where (ADTM > ADSL.TR01SDTM if time is available, if time is not available use (ADY=1 and VSTPT^='PRE-DOSE') or ADY > 1).
SHIFT2	Computation	Only populate for post-baseline records If both of BTOXGRH and ATOXGRH are not missing, set to BTOXGRH\|\| ' to '\|\|ATOXGRH If either BTOXGRH or ATOXGRH is missing, set the missing BTOXGRH and ATOXGRH to 'UNK', then set to BTOXGRH\|\| ' to '\|\|ATOXGRH Note: post-baseline records are defined as any result where (ADTM > ADSL.TR01SDTM if time is available, if time is not available use (ADY=1 and VSTPT^='PRE-DOSE') or ADY > 1).
VSLOCSP	Computation	Set to SUPPCM.QVAL where QNAM='VSLOCSP'
ADY	Computation	Set to ADT - ADSL.TR01SDT + 1 if If ADT >= ADSL.TR01SDT, or Set to ADT - ADSL.TR01SDT if ADT < ADSL.TR01SDT
ANL01FL	Computation	Set to 'Y' if ABLFL='Y', For post-baseline assessments where AVISITN is non-missing and result (AVAL) is non-missing, per subject per parameter and per AVISIT, Within an AVISIT, Set to ‘Y’ for the assessment at scheduled visit (i.e., VISIT doesn't contain "Unsched") or Set to ‘Y’ for the latest assessment if there are 2 or more assessments at scheduled visit, or Set to ‘Y’ for the latest assessment if there is no scheduled visit, or Set to 'Y' for the assessment closest to the target study day in the visit window or Set to 'Y' for the latest assessment If there are 2 or more assessments equal distance to the target study day
TRTA	Computation	"If (.<ADSL.TR01SDTM<=ADTM <DOS2DTM) or (.<ADSL.TR01SDTM<=ADTM and ADSL.DOS2DTM is missing): 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'Day 1' ; 'mRNA-1273 50 ug' if EX.EXTRT='mRNA-1273' and 1) 0<EXDOSE<=75 where EX.VISIT contains 'Day 1', or 2) EXDOSTXT contains '>0-25', '>25-<50' or '>50-75' where EX.VISIT contains 'Day 1'; 'mRNA-1273 100 ug' if EX.EXTRT='mRNA-1273' and 1) EXDOSE>75 where EX.VISIT contains 'Day 1', or 2) EXDOSTXT contains '>75-<100' or '>100-125' or '>125' where EX.VISIT contains 'Day 1'; if .<ADSL.DOS2DTM<=ASTDTM: 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'Day 29' ; 'mRNA-1273 50 ug' if 1) EX.EXTRT='mRNA-1273' and 0<EXDOSE<=75 where EX.VISIT contains 'Day 29', or 2) EXDOSTXT contains '>0-25', '>25-<50' or '>50-75' where EX.VISIT contains 'Day 29'; 'mRNA-1273 100 ug' if EX.EXTRT='mRNA-1273' and 1) EXDOSE>75 where EX.VISIT contains 'Day 29', or 2) EXDOSTXT contains '>75-<100' or '>100-125' or '>125' where EX.VISIT contains 'Day 29'; if time part of ADTM, TR01SDTM, or DOS2DTM is missing, use ADT, TR01SDT, and DOSE2DT to replace ADTM, TR01SDTM, and DOS2DTM, respectively."
DOS2DTM	Computation	Non-missing EX.EXSTDTC where EX.VISIT contains 'Day 29' and convert to numeric
DOSE2DT	Computation	Date part of non-missing EX.EXSTDTC where EX.VISIT contains 'Day 29' and convert to numeric
EOSDT	Computation	DS.DSSTDTC where DSCAT='DISPOSITION EVENT' and DSSCAT='END OF STUDY' and convert to numeric
EOSDY	Computation	EOSDT-TR01SDT+1 if EOSDT>=TR01SDT
EOSSTT	Computation	Set to 'COMPLETED' if COMPLFL='Y' Set to 'DISCONTINUED' if COMPLFL='N' Else set to 'ONGOING'.
EOTDT	Computation	DS.DSSTDTC where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' and convert to numeric
EOTDY	Computation	EOTDT-TR01SDT+1 if EOTDT>=TR01SDT
EOTSTT	Computation	Set to 'COMPLETED' if USUBJID exists in DS where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' AND DSDECOD='COMPLETED'. Set to 'DISCONTINUED' if USUBJID exists in DS where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' AND DSDECOD^='COMPLETED'. Else set to 'ONGOING'.
SAFFL	Computation	Set to "Y" if RANDFL="Y" AND USUBJID exists in EX with non-missing EXSTDTC. Set to "N" otherwise
TR01EDT	Computation	Date part of DM.RFXENDTC and convert to numeric
TR01EDTM	Computation	DM.RFXENDTC and convert to numeric
TR01SDT	Computation	Date part of DM.RFXSTDTC and convert to numeric
TR01SDTM	Computation	DM.RFXSTDTC and convert to numeric
TRT01A	Computation	Set to ACTARM if SAFFL='Y'
TRT01P	Computation	Set to ARM

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Analysis Results Metadata - Summary

Analysis Results Metadata - Detail

Datasets

Subject-Level Analysis Dataset (ADSL)

Screen Fail Subj-Level Analysis Dataset (ADSLSF)

Solicited AR Analysis Dataset (ADAR)

Solicited AR post D7 Analysis Dataset (ADARP7D)

Solicited AR Summary Analysis Dataset (ADARSUM)

COVID-19 Analysis Dataset (ADCOV)

Immunogenicity Analysis Dataset (ADIS)

Laboratory Analysis Dataset (ADLB)

Microbiology Analysis Dataset (ADMB)

Vital Signs Analysis Dataset (ADVS)

Adverse Event Analysis Dataset (ADAE)

Concomitant Medication Analysis Dataset (ADCM)

Deviation Analysis Dataset (ADDV)

Treatment Exposure Analysis Dataset (ADEX)

Medical Hisotry Analysis Dataset (ADMH)

CodeLists

External Dictionaries

Methods