adaefmq.Rdadae modified from pharmaverseadam to include FDA Medical Query information
adaefmqA data frame with 1979 rows and 83 variables:
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Sponsor-Defined Identifier
Reported Term for the Adverse Event
Lowest Level Term
Lowest Level Term Code
AEDECOD
Preferred Term Code
High Level Term
High Level Term Code
High Level Group Term
High Level Group Term Code
Body System or Organ Class
Body System or Organ Class Code
Primary System Organ Class
Primary System Organ Class Code
Severity/Intensity
Serious Event
Action Taken with Study Treatment
Causality
Outcome of Adverse Event
Involves Cancer
Congenital Anomaly or Birth Defect
Persist or Signif Disability/Incapacity
Results in Death
Requires or Prolongs Hospitalization
Is Life Threatening
Occurred with Overdose
Date/Time of Collection
Start Date/Time of Adverse Event
End Date/Time of Adverse Event
Study Day of Start of Adverse Event
Study Day of End of Adverse Event
Analysis Start Date/Time
Analysis Start Date Imputation Flag
Analysis Start Time Imputation Flag
Analysis End Date/Time
Analysis End Date Imputation Flag
Analysis End Time Imputation Flag
Analysis Start Date
Analysis End Date
Analysis Start Relative Day
Analysis End Relative Day
Analysis Duration (N)
Analysis Duration Units
End Date/Time of Last Dose
Analysis Severity/Intensity
Analysis Causality
Treatment Emergent Analysis Flag
Analysis Severity/Intensity (N)
1st Max Sev./Int. Occurrence Flag
Standard Toxicity Grade
Standard Toxicity Grade (N)
Action Taken with Study Treatment
Day of Study Drug
Treatment Dose Units
Treatment Dose at Record Start
Concomitant or Additional Trtmnt Given
Customized Query 01 Name
Customized Query 02 Name
Customized Query 03 Name
Other Medically Important Serious Event
Serious Event
Causality
Outcome of Adverse Event
1st Occurence within Subject Flag
1st Occurence within Preferred Term Flag
1st Occurrence of SOC Flag
Actual Treatment for Period 01
Safety Population Flag
Age
Sex
Race
Race
Study Identifier
Pooled Age Group 1
Treatment Relative End Day
Planned Treatment for Period 01
Analysis Category 1
FMQNAM
FMQSOC
FMQCLASS
data from adae from pharmaverseadam and, FDA_FMW_Consolidated_List.rds and FDA_FMQ_References.rds
if (FALSE) { # \dontrun{
data("adaefmq")
} # }