Inferences About Drug Safety in Phase III Trials in Oncology: Examples From Advanced Prostate Cancer.

ABSTRACT:

Background

Safety is a central consideration when choosing between multiple medications with similar efficacy. We aimed to evaluate whether adverse event (AE) profiles of 3 such drugs in advanced prostate cancer could be distinguished based on published literature.

Methods

We assessed consistency in AE reporting, AE risk in placebo arms, and methodology used for risk estimates and quantification of statistical uncertainty in randomized placebo-controlled phase III trials of apalutamide, enzalutamide, and darolutamide in advanced prostate cancer.

Results

Seven included clinical trials enrolled a total of 9215 participants (range = 1051-1715 per trial) across 3 prostate cancer disease states. Within disease states, baseline patient characteristics appeared similar betwe

SUBMITTER: Drago JZ 

PROVIDER: S-EPMC8096372 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature