Subject-Level 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
Protocol Version
Childbearing Potential
Reason for No Childbearing Potential
Randomized Population Flag
Randomization Number
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
Completers Population 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
Baseline Height (cm)
Baseline Weight (kg)
Baseline BMI (kg/m2)
COVID Infection Flag
Sentinel Participant Flag
Day 29 Out of 7-Day Window Flag
Description of Planned Arm
Description of Actual Arm
Planned Treatment for Period 01
Planned Treatment for Period 01 (N)
Actual Treatment for Period 01
Actual Treatment for Period 01 (N)
Date of Informed Consent
Date of Randomization
Date/Time of First Study Treatment
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
End of Study Status
End of Study Date
End of Study Relative Day
Reason for Discontinuation from Study
Reason Spec for Discont from Study
End of Treatment Status
End of Treatment Date
End of Treatment Relative Day
Reason for Discontinuation of Treatment
Reason Specify for Discont of Treatment
Date of Death
Was autopsy performed?
Data Cutoff Date
Unblinded (Y/N)
Updated Informed Consent (Y/N)
Reason for Safety Set Exclusion
Reason for 1st Solicited Safety Set Exc
Reason for 2nd Solicited Safety Set Exc
Reason for BAB Full Analysis Set Exc
Reason for NAB Full Analysis Set Exc
Reason for BAB Per-Protocol Set Exc
Reason for nAb Per-Protocol Set Exc
Reason for bAb Per-Protocol Day 29 Exc
Reason for bAb Per-Protocol Day 57 Exc
Reason for bAb Per-Protocol Day 209 Exc
Reason for nAb Per-Protocol Day 29 Exc
Reason for nAb Per-Protocol Day 57 Exc
Reason for nAb Per-Protocol Day 209 Exc
Reason for nAb 2 Per-Protocol Set Exc
Reason for nAb 2 PP Day 29 Exc
Reason for nAb 2 PP Day 57 Exc
Reason for nAb 2 PP Day 209 Exc
Was this participant screened previously