adae modified from pharmaverseadam
adaeA data frame with 1191 rows and 83 variables:
Unique Subject Identifier
Domain Abbreviation
Sequence Number
Reported Term for the Adverse Event
Dictionary-Derived Term
Body System or Organ Class
Body System or Organ Class Code
Lowest Level Term
Lowest Level Term Code
Preferred Term Code
High Level Term
High Level Term Code
High Level Group Term
High Level Group Term Code
Primary System Organ Class
Primary System Organ Class Code
Start Date/Time of Adverse Event
Analysis Start Date
Analysis Start Date/Time
Analysis Start Date Imputation Flag
Analysis Start Time Imputation Flag
End Date/Time of Adverse Event
Analysis End Date
Analysis End Date/Time
Analysis End Date Imputation Flag
Analysis End Time Imputation Flag
Analysis Start Relative Day
Study Day of Start of Adverse Event
Analysis End Relative Day
Study Day of End of Adverse Event
Analysis Duration (N)
Analysis Duration Units
Treatment Emergent Analysis Flag
1st Max Sev./Int. Occurrence Flag
Serious Event
Results in Death
Is Life Threatening
Requires or Prolongs Hospitalization
Persist or Signif Disability/Incapacity
Congenital Anomaly or Birth Defect
Severity/Intensity
Analysis Severity/Intensity
Analysis Severity/Intensity (N)
Causality
Analysis Causality
Action Taken with Study Treatment
Sponsor-Defined Identifier
Outcome of Adverse Event
Involves Cancer
Occurred with Overdose
Date/Time of Collection
End Date/Time of Last Dose
Treatment Dose at Record Start
Treatment Dose Units
Standard Toxicity Grade
Standard Toxicity Grade (N)
Day of Study Drug
Concomitant or Additional Trtmnt Given
Customized Query 01 Name
Customized Query 02 Name
Customized Query 03 Name
Other Medically Important Serious Event
Analysis Category 1
1st Occurrence within Subject Flag
1st Occurrence within Pref Term Flag
1st Occurrence of SOC Flag
1st TE Max Toxicity Grade Flag
Actual Treatment for Period 01
Safety Population Flag
Age
Sex
Race
Study Identifier
Pooled Age Group 1
Treatment Relative End Day
Planned Treatment for Period 01
Treatment Discontinued Flag
Prolongs Hospitalization
Requires Hospitalization
AESCAT
Standardized MedDRA Query 01 Name
Standardized MedDRA Query 02 Name
Standardized MedDRA Query 03 Name
adae adaeocmq adagocmq adcm addili adeg adex adexsum adlb adpc adsl adttesaf advs# nolint