Findings About Clinical Events Analysis
Format
A data frame with 61 columns:
- STUDYID
Study Identifier
- USUBJID
Unique Subject Identifier
- SUBJID
Subject Identifier for the Study
- SITEID
Study Site Identifier
- AGE
Age
- AGEU
Age Units
- SEX
Sex
- RACE
Race
- SAFFL
Safety Population Flag
- ARM
Description of Planned Arm
- ARMCD
Planned Arm Code
- ACTARM
Description of Actual Arm
- ACTARMCD
Actual Arm Code
- TRTSDT
Date of First Exposure to Treatment
- TRTSDTM
Datetime of First Exposure to Treatment
- TRTEDT
Date of Last Exposure to Treatment
- TRTEDTM
Datetime of Last Exposure to Treatment
- FATEST
Findings About Test Name
- FALNKID
Link ID
- FALNKGRP
Link Group ID
- FATESTCD
Findings About Test Short Name
- PARAMCD
Parameter Code
- PARAM
Parameter
- PARAMN
Parameter (N)
- FAOBJ
Object of the Observation
- PARCAT1
Parameter Category 1
- PARCAT2
Parameter Category 2
- AVALC
Analysis Value (C)
- AVAL
Analysis Value
- FASTAT
Completion Status
- FAREASND
Reason Not Performed
- FAEVAL
Evaluator
- EPOCH
Epoch
- ADT
Analysis Date
- ADTM
Analysis Datetime
- FAEVINTX
Evaluation Interval Text
- ADY
Analysis Relative Day
- ATPT
Analysis Timepoint
- ATPTN
Analysis Timepoint (N)
- ATPTREF
Analysis Timepoint Reference
- EXDOSE
Dose
- EXTRT
Name of Treatment
- EXSTDTC
Start Date/Time of Treatment
- EXENDTC
End Date/Time of Treatment
- TRTA
Actual Treatment
- TRTP
Planned Treatment
- APERIOD
Period
- APERSDT
Period Start Date
- APEREDT
Period End Date
- FAORRES
Result or Finding in Original Units
- TRT01P
Planned Treatment for Period 01
- TRT02P
Planned Treatment for Period 02
- TRT01A
Actual Treatment for Period 01
- TRT02A
Actual Treatment for Period 02
- VAX01DT
Vaccination Date 01
- VAX02DT
Vaccination Date 02
- EVENTFL
Event Value Flag
- EVENTDFL
Day Event Value Flag
- ANL01FL
Analysis Flag 01
- ANL02FL
Analysis Flag 02
- ANL03FL
Analysis Flag 03
Details
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 |
Examples
data("adface_vaccine")