adaefmq {pharmaverseadamjnj} | R Documentation |
adaefmq
Description
adae modified from pharmaverseadam to include FDA Medical Query information
Usage
adaefmq
Format
A data frame with 1979 rows and 81 variables:
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- AESEQ
Sequence Number
- AESPID
Sponsor-Defined Identifier
- AETERM
Reported Term for the Adverse Event
- AELLT
Lowest Level Term
- AELLTCD
Lowest Level Term Code
- AEDECOD
AEDECOD
- AEPTCD
Preferred Term Code
- AEHLT
High Level Term
- AEHLTCD
High Level Term Code
- AEHLGT
High Level Group Term
- AEHLGTCD
High Level Group Term Code
- AEBODSYS
Body System or Organ Class
- AEBDSYCD
Body System or Organ Class Code
- AESOC
Primary System Organ Class
- AESOCCD
Primary System Organ Class Code
- AESEV
Severity/Intensity
- AESER
Serious Event
- AEACN
Action Taken with Study Treatment
- AEREL
Causality
- AEOUT
Outcome of Adverse Event
- AESCAN
Involves Cancer
- AESCONG
Congenital Anomaly or Birth Defect
- AESDISAB
Persist or Signif Disability/Incapacity
- AESDTH
Results in Death
- AESHOSP
Requires or Prolongs Hospitalization
- AESLIFE
Is Life Threatening
- AESOD
Occurred with Overdose
- AEDTC
Date/Time of Collection
- AESTDTC
Start Date/Time of Adverse Event
- AEENDTC
End Date/Time of Adverse Event
- AESTDY
Study Day of Start of Adverse Event
- AEENDY
Study Day of End of Adverse Event
- ASTDTM
Analysis Start Date/Time
- ASTDTF
Analysis Start Date Imputation Flag
- ASTTMF
Analysis Start Time Imputation Flag
- AENDTM
Analysis End Date/Time
- AENDTF
Analysis End Date Imputation Flag
- AENTMF
Analysis End Time Imputation Flag
- ASTDT
Analysis Start Date
- AENDT
Analysis End Date
- ASTDY
Analysis Start Relative Day
- AENDY
Analysis End Relative Day
- ADURN
Analysis Duration (N)
- ADURU
Analysis Duration Units
- LDOSEDTM
End Date/Time of Last Dose
- ASEV
Analysis Severity/Intensity
- AREL
Analysis Causality
- TRTEMFL
Treatment Emergent Analysis Flag
- ASEVN
Analysis Severity/Intensity (N)
- AOCCIFL
1st Max Sev./Int. Occurrence Flag
- AETOXGR
Standard Toxicity Grade
- AETOXGRN
Standard Toxicity Grade (N)
- AEACN_DECODE
Action Taken with Study Treatment
- DOSEDY
Day of Study Drug
- DOSEU
Treatment Dose Units
- DOSEON
Treatment Dose at Record Start
- AECONTRT
Concomitant or Additional Trtmnt Given
- CQ01NAM
Customized Query 01 Name
- CQ02NAM
Customized Query 02 Name
- CQ03NAM
Customized Query 03 Name
- AESMIE
Other Medically Important Serious Event
- ACAT1
Analysis Category 1
- AESER_DECODE
Serious Event
- AEREL_DECODE
Causality
- AEOUT_DECODE
Outcome of Adverse Event
- AOCCFL
1st Occurance within Subject Flag
- AOCCPFL
1st Occurance within Preferred Term Flag
- AOCCSFL
1st Occurrence of SOC Flag
- TRT01A
Actual Treatment for Period 01
- SAFFL
Safety Population Flag
- AGE
Age
- SEX
Sex
- RACE
Race
- RACE_DECODE
Race
- STUDYID
Study Identifier
- AGEGR1
Pooled Age Group 1
- FMQNAM
FMQNAM
- FMQSOC
FMQSOC
- FMQCLASS
FMQCLASS
Source
data from adae from pharmaverseadam and, FDA_FMW_Consolidated_List.rds and FDA_FMQ_References.rds
See Also
adae
adaefmq
adcm
adeg
adex
adexsum
adlb
adsl
adttesaf
advs
# nolint
Examples
head(data("adaefmq"))