125742-45_S211_M5_c4591001-A_6mth-D_admh
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Sequence Number
Reported Term for the Medical History
Dictionary-Derived Term
Preferred Term Code
Body System or Organ Class
Body System or Organ Class Code
Lowest Level Term
Lowest Level 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
Category for Medical History
Start Date/Time of Medical History Event
End Date/Time of Medical History Event
End Relative to Reference Time Point
End Reference Time Point
Dictionary Name and Version
Sponsor-Defined Identifier
Analysis Start Date
Analysis Start Date Imputation Flag
Analysis Start Relative Day
Analysis End Date
Analysis End Date Imputation Flag
Analysis End Relative Day
Comorbidity Flag
Charlson Comorbidity Index Category 1
Charlson Comorbidity Index Category 2
Analysis Date
Analysis Date Imputation Flag
Analysis Duration (N)
Analysis Duration Units
Age Units
Pooled Age Group 1
Pooled Age Group 1 (N)
Sex (N)
Race (N)
Analysis Race
Analysis Race (N)
Randomized Population Flag
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
Actual Treatment for Period 01
Actual Treatment for Period 01 (N)
Actual Treatment for Period 02
Actual Treatment for Period 02 (N)
Planned Treatment for Period 01
Planned Treatment for Period 01 (N)
Planned Treatment for Period 02
Planned Treatment for Period 02 (N)
Date of First Exposure in Period 01
Time of First Exposure in Period 01
Datetime of First Exposure in Period 01
Date of Last Exposure in Period 01
Time of Last Exposure in Period 01
Datetime of Last Exposure in Period 01
Date of First Exposure in Period 02
Time of First Exposure in Period 02
Datetime of First Exposure in Period 02
Date of Last Exposure in Period 02
Time of Last Exposure in Period 02
Datetime of Last Exposure in Period 02
Vaccination 01
Vaccination 02
Vaccination Unplanned
Vaccination 03
Vaccination 04
Vaccination Unplanned in Period 02
Vaccination Date 01
Vaccination Date 02
Vaccination Date Unplanned
Vaccination Date 03
Vaccination Date 04
Vaccination Date Unplanned in Period 02
Treatment Unblinded Date
Date of Randomization
Cohort Group
Cohort Group (N)
Actual Dosing Level
Actual Dosing Level (N)
Planned Dosing Level
Planned Dosing Level (N)
Phase 3 30k Subjects Flag
Study Phase
Study Phase (N)
Pooled Age Group 4
Pooled Age Group 4 (N)
HIV Positive Subjects Flag
Pop for Non-inferiority Assessement
Phase 2/3 Pop for 12-25 Reacto Subset
FU to 6MPD2
Age at Vaccination 01
Age Units at Vaccination 01