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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=' ' ;
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Hello sir I am watching your classes it's very informative to me, thank you so much for giving us this much valuable classes . I have total Pharma experience, now I am trying for the job in clinical sector, could you please share me your email so that I can send my resume, thankyou
