Concomitant Medication Analysis Dataset
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Age Units
Pooled Age Group 1
Pooled Age Group 1 (N)
Pooled Age Group 2
Pooled Age Group 2 (N)
Race Specify
Ethnicity
Randomized Population Flag
Safety Population Flag
Full Analysis Set bAb Population Flag
Full Analysis Set nAb Population Flag
Per Protocol bAb Population Flag
Per Protocol nAb Population Flag
Per Protocol bAb Day 29 Flag
Per Protocol bAb Day 57 Flag
Per Protocol bAb Day 209 Flag
Per Protocol nAb Day 29 Flag
Per Protocol nAb Day 57 Flag
Per Protocol nAb Day 209 Flag
First Solicited Safety Population Flag
Second Solicited Safety Population Flag
Solicited Safety Population Flag
FAS nAb 2 Population Flag
PP nAb 2 Population Flag
Per Protocol nAb 2 Day 29 Flag
Per Protocol nAb 2 Day 57 Flag
Per Protocol nAb 2 Day 209 Flag
Deviation Impact bAb Flag
Deviation Impact nAb Flag
Vaccination 1 Flag
Vaccination 2 Flag
Dosing Error Flag
Baseline COVID Infection
Baseline Elecsys SARS CoV-2 Assay
COVID Infection Flag
Sentinel Participant Flag
Day 29 Out of 7-Day Window Flag
Planned Treatment for Period 01
Planned Treatment for Period 01 (N)
Actual Treatment for Period 01
Actual Treatment for Period 01 (N)
Date of First Exposure in Period 01
Datetime of First Exposure in Period 01
Date of Last Exposure in Period 01
Datetime of Last Exposure in Period 01
Datetime of First Exposure to Treatment
Datetime of Last Exposure to Treatment
Date of Dose 2
Datetime of Dose 2
Sequence Number
Category for Medication
Reported Name of Drug, Med, or Therapy
Standardized Medication Name
Indication
Dose per Administration
Dose Units
Dose Unit Other Specficiation
Dosing Frequency per Interval
Dose Frequency Specification
Route of Administration
Dose Route Other Specification
Start Date/Time of Medication
End Date/Time of Medication
Study Day of Start of Medication
Study Day of End of Medication
End Relative to Reference Time Point
Medication Taken for Solicited Event
Analysis Start Date
Analysis Start Date Imputation Flag
Analysis Start Relative Day
Analysis End Date
Analysis End Date Imputation Flag
Analysis End Relative Day
Most Recent Dose Reference
Relative Start Day from Most Recent Dose
Modified Indication 1 Result Flag
Modified Indication 2 Result Flag
Pre-treatment Flag
On Treatment Record Flag
Follow-up Flag
ATC Level 1
ATC Level 2
ATC Level 3
ATC Level 4