Clinical SAS Interview question 25 - Detecting Treatment Emergent Adverse Events (TEAEs)

[@PrashanthJutur]

Treatment emergent :- Scenario 1(In Treatment):- Subject having adverse event in between the treatment (TRT1 - TRTEND). Scenario 2(Pre-Treatment) :- Subject having an event before treatment but it became worse while on going treatment . Scenario 3(Post-Treatment) :- Subject having event after the last dose in followup ,as per the SAP analysis we consider treatment emergent, if event occurs within 24 or 48 hrs . DERIVATION :- Adverse event start date(AESTDTC) less than equal to treatment start date(RFSTDTC) and Adverse event start date (AESTDTC) greater than equal to Adverse event end date(AENDTC) then TEAE = 'Y' ; else TEAE=' ' ;

[@MAbhikya]

Could you please show some code example too. Especially when severity increases after treatment. That would be very helpful

[@aswinip7579]

Pls make videos on SDTM also

[@merrychristmas1782]

If subject has started AE just on the same date when screening and treatment then how do you decide that AE happened due to treatment or it was pre AE?? Please suggest.

[@ClinicalSAS]

On the same day treatment and ae happen if time part collected we can chexk time as well

[@merrychristmas1782]

@@ClinicalSAS thanks