Recurrent of Symptom Analysis Dataset
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Age Units
Strata Used for Randomization
Strata Used for Randomization (N)
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 Specify
Ethnicity
Randomized Population Flag
Full Analysis Set Population Flag
Safety Population Flag
First Solicited Safety Population Flag
Second Solicited Safety Population Flag
Solicited Safety Population Flag
Modified Intent to Treat Population Flag
Per-Protocol Population Flag
Random Immunogenicity Subcohort Flag
Per-Protocol Random Subcohort for IG
Case-Cohort IG Analysis Set Flag
Vaccination 1 Flag
Vaccination 2 Flag
OL Vaccination 1 Flag
OL Vaccination 2 Flag
Baseline RT-PCR Test
Baseline Elecsys Sars Cov-2 Assay
Baseline SARS-CoV-2 Status
Planned Treatment for Period 01
Planned Treatment for Period 01 (N)
Actual Treatment for Period 01
Actual Treatment for Period 01 (N)
Planned Treatment for Period 02
Planned Treatment for Period 02 (N)
Actual Treatment for Period 02
Actual Treatment for Period 02 (N)
Planned Sequence of Treatments
Planned Sequence of Treatments (N)
Actual Sequence of Treatments
Actual Sequence of Treatments (N)
Date of First Exposure to Treatment
Date of Last Exposure to 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
Date of Dose 2 in Blinded Phase
Datetime of Dose 2 in Blinded Phase
Date of First Exposure in Period 02
Datetime of First Exposure in Period 02
Date of Last Exposure in Period 02
Datetime of Last Exposure in Period 02
Date of Dose 2 in Open Label Phase
Datetime of Dose 2 in Open Label Phase
Date of Post-EUA Off-Study COVID Vaccine
Efficacy Date Cutoff Date
Period 01 Start Date
Period 01 End Date
Period 02 Start Date
Period 02 End Date
Period 01 Start Date for Safety Analysis
Period 01 End Date for Safety Analysis
Period 02 Start Date for Safety Analysis
Period 02 End Date for Safety Analysis
Risk Factor 1
Risk Factor 2
Risk Factor 3
Risk Factor 4
Risk Factor 5
Risk Factor 6
Strata from Verification Source
Strata from Verification Source (N)
Study Duration 3
Pooled Race Group 1
Pooled Race Group 1 (N)
Pooled Risk Group 1
Pooled Risk Group 1 (N)
Pooled Race and Ethnicity Group 1
Pooled Race and Ethnicity Group 1 (N)
COVID-19 Based on Adjudication Flag
Severe COVID-19 Based on Adj Flag
Parameter
Parameter Code
Event Sequence Number
Censor
Event or Censoring Description
Analysis Start Value
Analysis Value