![]() Participant did not have an event or had an event outside risk period were censored at end of RP. In case of death, last contact date was death date. Last contact date was maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). The risk period (RP) was minimum of The risk period (RP) was the minimum of last contact date or last study treatment dose date + 28 days. ![]() Incidence rate was the total number of participants with admissible events divided by total (for all qualifying participants) time at risk for the cohort/treatment group of interest. Hepatic events (adjudicated) included drug-induced liver injury (DILI) - probable, highly likely and definite, DILI - listed separately, DILI - cases meeting classification and severity, participants with elevations of transaminase levels greater than (>) 1* upper limit of normal (ULN), greater than or equal to (>=) 3*ULN, >=5*ULN (based on laboratory values). Why Should I Register and Submit Results?.
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