Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Sequence Number
Category for Medication
Subcategory for Medication
Start Date/Time of Medication
End Date/Time of Medication
Reported Name of Drug, Med, or Therapy
Standardized Medication Name
Standardized Medication Code
Pre-treatment Flag
On-Period Flag
On-Period 01 Flag
On-Period 02 Flag
Analysis Start Date
Analysis Start Date Imputation Flag
Analysis Start Relative Day
Analysis End Date
Analysis End Date Imputation Flag
Analysis End Relative Day
Medication Class
Medication Class Code
WHODrug preferred name
WHODrug preferred name1
ATC Level 1 Code
ATC Level 1 Text
ATC Level 2 Code
ATC Level 2 Text
ATC Level 3 Code
ATC Level 3 Text
ATC Level 4 Code
ATC Level 4 Text
ATC Level 5 Code
ATC Level 5 Text
Study Day of Start of Medication
Study Day of End of Medication
Dose per Administration
Route of Administration
Dose Description
Dose Units
Dosing Frequency per Interval
End Relative to Reference Time Point
End Reference Time Point
Dictionary Name and Version
Medication Class 1
Medication Class 2
Medication Class Code 1
Medication Class Code 2
Age Units
Sex (N)
Race (N)
Analysis Race
Analysis Race (N)
Safety Population Flag
Description of Planned Arm
Planned Arm Code
Description of Actual Arm
Actual Arm Code
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
Date of Unblinding or Visit at 1MPD2
Date of Unblinding or Visit at 6MPD2
Date of Visit at 1M after Vax4
Date of Visit at 6M after Vax4
Vaccination Date 01
Vaccination Date Unplanned
Vaccination Date 02
Vaccination Date 03
Vaccination Date 04
Cohort Group (N)
Cohort Group
Actual Dosing Level (N)
Actual Dosing Level
Planned Dosing Level (N)
Planned Dosing Level
Study Phase (N)
Study Phase
Treatment Unblinded Date
Multiply Enrolled Subjects
Phase 3 30k Subjects Flag
HIV Positive Subjects Flag
Age at Vaccination 01
Pooled Age Group 1
Pooled Age Group 1 (N)
Pooled Age Group 4
Pooled Age Group 4 (N)
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
Actual Treatment for Period 01
Actual Treatment for Period 01 (N)
Planned Treatment for Period 01
Planned Treatment for Period 01 (N)
Actual Treatment for Period 02
Actual Treatment for Period 02 (N)
Planned Treatment for Period 02
Planned Treatment for Period 02 (N)
Vaccination 01
Vaccination 02
Vaccination Unplanned
Vaccination 03
Vaccination 04
Vaccination Unplanned in Period 02
Vaccination Date Unplanned in Period 02
Phase 3 3000 Subjects Flag
Randomized Population Flag
Random - exclude Multi-Enrolloer
Safety - excld Multi-Enrolloer&HIV&IND
Safety - exclude Multi-Enrolloer&IND
Vaccine Phase
Vaccine Phase(N)
CM Occured after Which Vaccination