ADAE
Subject Identifier for the Study
Study Site Identifier
Description of Planned Arm
Planned Arm Code
Description of Actual Arm
Actual Arm Code
Age Units
Pooled Age Group 1
Pooled Age Group 1 (N)
Pooled Age Group 2
Pooled Age Group 2 (N)
Pooled Age Group 3
Pooled Age Group 3 (N)
Pooled Age Group 4
Pooled Age Group 4 (N)
Race (N)
Sex (N)
Ethnicity
Ethnicity (N)
Analysis Race
Analysis Race (N)
Date of First Exposure to Treatment
Time of First Exposure to Treatment
Datetime of First Exposure to Treatment
Date of Last Exposure to Treatment
Time of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Actual Treatment for Period 01
Actual Treatment for Period 01 (N)
Planned Treatment for Period 01
Planned Treatment for Period 01 (N)
Vaccination Date 01
Vaccination Time 01
Vaccination Date 02
Vaccination Time 02
Safety Population Flag
Cohort Group
Cohort Group (N)
Actual Dosing Level
Actual Dosing Level (N)
Planned Dosing Level
Planned Dosing Level (N)
Vaccination 01
Vaccination 02
Date of Unblinding or Visit at 1MPD2
Date of Unblinding or Visit at 6MPD2
Randomized Population Flag
Study Phase
Study Phase (N)
Phase 3 30k Subjects Flag
Baseline SARS-CoV-2 Status
Treatment Unblinded Date
Vaccination Unplanned
Vaccination 03
Vaccination 04
Vaccination Date Unplanned
Vaccination Date 03
Vaccination Date 04
Vaccination Time 03
Vaccination Time 04
Date of Visit at 1M after Vax3/4
Date of Visit at 6M after Vax3/4
Actual Treatment for Period 02
Actual Treatment for Period 02 (N)
Planned Treatment for Period 02
Planned Treatment for Period 02 (N)
HIV Positive Subjects Flag
FU to 6MPD2
End Of Open Label Treatment D/C Date
Double Blinded Follow-up Censor Date
Crossover Dose1 Censor Date
PD1 FU Time in Days: to Unblinding
Post Xover D1 FUTM in Days: to Cutoff
Unblinding FUTM in Days: to Cutoff
PD1 FU Time in Days: to Cutoff
Age at Vaccination 01
Datetime of First Exposure in Period 01
Datetime of Last Exposure in Period 01
Datetime of First Exposure in Period 02
Datetime of Last Exposure in Period 02
Vaccination Unplanned in Period 02
Vaccination Date Unplanned in Period 02
Date of Dose 3 or Visit at 6MPD2
Pooled Race Group 1
Pooled Race Group 1 (N)
Study Identifier
Unique Subject Identifier
Sequence Number
Category for Adverse Event
Sponsor-Defined Identifier
Reported Term for the Adverse Event
Dictionary-Derived Term
Body System or Organ Class Code
Body System or Organ Class
Lowest Level Term
Lowest Level Term Code
Preferred Term Code
High Level Term
High Level Term Code
High Level Group Term
High Level Group Term Code
Primary System Organ Class
Primary System Organ Class Code
Start Date/Time of Adverse Event
Study Day of Start of Adverse Event
End Date/Time of Adverse Event
Study Day of End of Adverse Event
End Relative to Reference Time Point
End Reference Time Point
Standard Toxicity Grade
Dictionary Name and Version
Discontinued due to AE
Analysis Start Date
Analysis Start Date Imputation Flag
Analysis Start Relative Day
Analysis Start Time
Analysis Start Date/Time
Analysis End Date
Analysis End Relative Day
Analysis End Time
Analysis End Date/Time
Analysis Duration (N)
Analysis Duration Units
Serious Event
Congenital Anomaly or Birth Defect
Persist or Signif Disability/Incapacity
Results in Death
Requires or Prolongs Hospitalization
Is Life Threatening
Other Medically Important Serious Event
Is AE a Result of a Medication Error
Causality
Relationship to Non-Study Treatment
Event Due to Other Specify
Action Taken with Study Treatment
Concomitant Medication Given
Was a Non-Drug Treatment given
Outcome of Adverse Event
Discontinued because of this AE
Reference ID
Causality (N)
Analysis Causality
Analysis Causality (N)
Standard Toxicity Grade (N)
Analysis Toxicity Grade
Analysis Toxicity Grade (N)
Medication Error Associated With AE
Time Post Dose
Vaccine Studies AE Immediate flag
Period
Period (C)
Period Start Date
Period Start Time
Period Start Date/Time
Period End Date
Period End Time
Period End Date/Time
Vaccine Phase
Vaccine Phase(N)
Within Reporting Window Flag
Pre-treatment Flag
AE Occured after Which Vaccination
Date/Time of Last change
New AE Reported post EUA snapshot Flag
AE data change post EUA snapshot