Adverse Events Analysis
Format
A data frame with 107 columns:
- STUDYID
Study Identifier
- USUBJID
Unique Subject Identifier
- SUBJID
Subject Identifier for the Study
- SITEID
Study Site Identifier
- COUNTRY
Country
- DOMAIN
Domain Abbreviation
- RFSTDTC
Subject Reference Start Date/Time
- RFENDTC
Subject Reference End Date/Time
- RFXSTDTC
Date/Time of First Study Treatment
- RFXENDTC
Date/Time of Last Study Treatment
- RFPENDTC
Date/Time of End of Participation
- SCRFDT
Screen Failure Date
- FRVDT
Final Retrieval Visit Date
- DTHDTC
Date/Time of Death
- DTHADY
Relative Day of Death
- DTHFL
Subject Death Flag
- LDDTHELD
Elapsed Days from Last Dose to Death
- LDDTHGR1
Last Dose to Death - Days Elapsed Grp 1
- DTH30FL
Death Within 30 Days of Last Trt Flag
- DTHA30FL
Death After 30 Days from Last Trt Flag
- DTHDOM
Domain for Date of Death Collection
- DTHB30FL
Death Within 30 Days of First Trt Flag
- REGION1
Geographic Region 1
- DMDTC
Date/Time of Collection
- DMDY
Study Day of Collection
- AGE
Age
- AGEU
Age Units
- AGEGR1
Pooled Age Group 1
- SEX
Sex
- RACE
Race
- RACEGR1
Pooled Race Group 1
- ETHNIC
Ethnicity
- SAFFL
Safety Population Flag
- ARM
Description of Planned Arm
- ARMCD
Planned Arm Code
- ACTARM
Description of Actual Arm
- ACTARMCD
Actual Arm Code
- TRT01P
Planned Treatment for Period 01
- TRT01A
Actual Treatment for Period 01
- TRTSDT
Date of First Exposure to Treatment
- TRTSDTM
Datetime of First Exposure to Treatment
- TRTSTMF
Time of First Exposure Imput. Flag
- TRTEDT
Date of Last Exposure to Treatment
- TRTEDTM
Datetime of Last Exposure to Treatment
- TRTETMF
Time of Last Exposure Imput. Flag
- EOSSTT
End of Study Status
- EOSDT
End of Study Date
- RFICDTC
Date/Time of Informed Consent
- RANDDT
Date of Randomization
- LSTALVDT
Date Last Known Alive
- TRTDURD
Total Treatment Duration (Days)
- DTHDT
Date of Death
- DTHDTF
Date of Death Imputation Flag
- DTHCAUS
Cause of Death
- DTHCGR1
Cause of Death Reason 1
- AESEQ
Sequence Number
- AETERM
Reported Term for the Adverse Event
- AEDECOD
Dictionary-Derived Term
- AEBODSYS
Body System or Organ Class
- AEBDSYCD
Body System or Organ Class Code
- AELLT
Lowest Level Term
- AELLTCD
Lowest Level Term Code
- AEPTCD
Preferred Term Code
- AEHLT
High Level Term
- AEHLTCD
High Level Term Code
- AEHLGT
High Level Group Term
- AEHLGTCD
High Level Group Term Code
- AESOC
Primary System Organ Class
- AESOCCD
Primary System Organ Class Code
- AESTDTC
Start Date/Time of Adverse Event
- ASTDT
Analysis Start Date
- ASTDTM
Analysis Start Date/Time
- ASTDTF
Analysis Start Date Imputation Flag
- ASTTMF
Analysis Start Time Imputation Flag
- AEENDTC
End Date/Time of Adverse Event
- AENDT
Analysis End Date
- AENDTM
Analysis End Date/Time
- AENDTF
Analysis End Date Imputation Flag
- AENTMF
Analysis End Time Imputation Flag
- ASTDY
Analysis Start Relative Day
- AESTDY
Study Day of Start of Adverse Event
- AENDY
Analysis End Relative Day
- AEENDY
Study Day of End of Adverse Event
- ADURN
Analysis Duration (N)
- ADURU
Analysis Duration Units
- TRTEMFL
Treatment Emergent Analysis Flag
- AOCCIFL
1st Max Sev./Int. Occurrence Flag
- AESER
Serious Event
- AESDTH
Results in Death
- AESLIFE
Is Life Threatening
- AESHOSP
Requires or Prolongs Hospitalization
- AESDISAB
Persist or Signif Disability/Incapacity
- AESCONG
Congenital Anomaly or Birth Defect
- AESEV
Severity/Intensity
- ASEV
Analysis Severity/Intensity
- ASEVN
Analysis Severity/Intensity (N)
- AEREL
Causality
- AREL
Analysis Causality
- AEACN
Action Taken with Study Treatment
- AESPID
Sponsor-Defined Identifier
- AEOUT
Outcome of Adverse Event
- AESCAN
Involves Cancer
- AESOD
Occurred with Overdose
- AEDTC
Date/Time of Collection
- LDOSEDTM
End Date/Time of Last Dose
- DOSEON
Treatment Dose
- DOSEU
Treatment Dose Unit
Examples
data("adae")