Findings About Clinical Events Analysis
adface_vaccineA data frame with 61 columns:
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Age
Age Units
Sex
Race
Safety Population Flag
Description of Planned Arm
Planned Arm Code
Description of Actual Arm
Actual Arm Code
Planned Treatment
Actual Treatment
Planned Treatment for Period 01
Actual Treatment for Period 01
Planned Treatment for Period 02
Actual Treatment for Period 02
Date of First Exposure to Treatment
Datetime of First Exposure to Treatment
Date of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Period Start Date
Period End Date
Analysis Date
Analysis Datetime
Analysis Relative Day
Analysis Timepoint
Analysis Timepoint (N)
Analysis Timepoint Reference
Period
Parameter
Parameter Code
Parameter (N)
Parameter Category 1
Parameter Category 2
Analysis Value
Analysis Value (C)
Analysis Flag 01
Analysis Flag 02
Analysis Flag 03
Findings About Test Name
Link ID
Link Group ID
Findings About Test Short Name
Object of the Observation
Completion Status
Reason Not Performed
Evaluator
Epoch
Evaluation Interval Text
Dose
Name of Treatment
Start Date/Time of Treatment
End Date/Time of Treatment
Result or Finding in Original Units
Vaccination Date 01
Vaccination Date 02
Event Value Flag
Day Event Value Flag
Contains a set of 30 unique Parameter Codes and Parameters:
| PARAMCD | PARAM |
| DIARE | Redness diameter deltoid muscle left |
| DIASWEL | Swelling diameter deltoid muscle left |
| MAXREDN | Redness maximum severity deltoid muscle left |
| MAXSFAT | Fatigue maximum severity |
| MAXSHEA | Headache maximum severity |
| MAXSPIS | Pain at injection site maximum severity deltoid muscle left |
| MAXSWEL | Swelling maximum severity deltoid muscle left |
| MAXTEMP | Fever maximum temperature |
| MDIRE | Redness maximum diameter deltoid muscle left |
| MDISW | Swelling maximum diameter deltoid muscle left |
| MSEVNWJP | New or worsened joint pain maximum severity |
| MSEVNWMP | New or worsened muscle pain maximum severity |
| OCCHILLS | Chills occurrence indicator |
| OCCNWJP | New or worsened joint pain occurrence indicator |
| OCCNWMP | New or worsened muscle pain occurrence indicator |
| OCCVOM | Vomiting occurrence indicator |
| OCDIAR | Diarrhea occurrence indicator |
| OCFATIG | Fatigue occurrence indicator |
| OCFEVER | Fever occurrence indicator |
| OCHEAD | Headache occurrence indicator |
| OCINS | Swelling occurrence indicator deltoid muscle left |
| OCISR | Redness occurrence indicator deltoid muscle left |
| OCPIS | Pain at injection site occurrence indicator deltoid muscle left |
| SEVFAT | Fatigue severity/intensity |
| SEVHEAD | Headache severity/intensity |
| SEVNWJP | New or worsened joint pain severity/intensity |
| SEVNWMP | New or worsened muscle pain severity/intensity |
| SEVPIS | Pain at injection site severity/intensity deltoid muscle left |
| SEVREDN | Redness severity/intensity deltoid muscle left |
| SEVSWEL | Swelling severity/intensity deltoid muscle left |
None