ADaM day 1:
ADaM.ADAE stands for Adverse Event Analysis dataset :
This dataset is crucial for safety analysis in a new drug development progress as well as in post-market safety updates.
it contains the information of ADSL, AE, SUPPAE. The dataset ADAE captured adverse event’s name, length, start and end date, relation to the drugs, actions to resolve the adverse event, treatment emergent flag, and the adverse event serious level, which are all important for the drug’s safety concern.
key variables : aedecod, aeseq, aebodsys, teaefl, aestdt , aeendt, trtstd, trtendt，aerel, aeout, aetoxgr, aeacn, aeser
General Steps for Constructing ADAE dataset
Step 1. read in the Excel file for MedDRA coding (version 21)
Step 2. read in sdtm.AE for basic ae info (serious, ae toxicity grade)
Step 3. Merge sdtm.AE with ADSL for baseline patient info (demographic, death)
Step 4. Merge sdtm.AE with transposed sdtm.SUPPAE for exposure info (treatment group)
Step 5. Derive Variables: Treatment Emergency flag, AE start/End Date
Step 1. Extract MedDRA info:
MedDRA_PT=aedecod MedDRA_Code =ptcd
Step 5. Key variable explanation/derivation:
AEBODSYS: AE Body system and Organ Class
Some common examples:
AEDECOD: AE Dictionary-Derived Term
Under each body system organ class there are multiple AEDECOD to describe and differ the adverse event in great details:
Impute Missing AE start/end Date:
Given the Condition Non-missing treatment start date.
1.Missing Year, Month, and Day -> No imputation
2.Missing Month and Day -> Jan-01
3.Missing Day -> 01
if aestdtc ne '' and aestdt= . and trtsdt >. then do; if length(aestdc)=7 then do; aestdt =input(substr(aesdtc,1,7) || '-01',yymmdd10.); else if length(aestdc)=4 then do; aestdt =input(substr(aesdtc,1,4) || '-01-01',yymmdd10.); else aestdt=.; end;
AE duration/ ae relative day
aesdy= (aeendt – aestdt ) +1
We consider an adverse event as the treatment-emergent adverse event:
If an adverse event starts on/after the First dose or 28 days after the Last dose.
if (. < trtsdt <= aestdt <= trtedt + 28 )) then Teaefl = 'Y'; else TeaeFL = ' ';
Note: depends on different therapeutic areas, the definition of TEAE could be different, for example, Injection and Oral Drug.
💯AE toxicity grade: AETOXGR/ AETOXGRN by NCI CTCAE Criteria
Generally, there are 3-level of AE grade in most therapeutic area :
Mild (aetoxgrn=1), Moderate(aetoxgrn=2) , severe(aetoxgrn=3)
in Oncology/Hematology there are 5-level of AE grade:
Mild (aetoxgrn=1), Moderate(aetoxgrn=2) , severe(aetoxgrn=3) ,
Life-threatening(aetoxgrn=4) , Death(aetoxgrn=5)
AE Serious Event：value(AESER)
AE action : dose reduction, dose interruption, withdraw
AE outcome/Result: value(AEOUT)
AE Related : (Y/N) is the adverse event related to the drug?
value(AERELx): x:= the drug
Sample ADAE Dummy dataset:
ADAE is an important dataset for Safety analysis, it captured various kinds and level of adverse event for the particular drug.
Some studies might be more complex than others, which will involve more complicated treatment flag derivation and ae start/end day. In addition, there are might be additional request on Special interest event. some clinicians are interested in particular events.