Inferences About Drug Safety in Phase 3 Trials in Advanced Prostate Cancer

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Inferences About Drug Safety in Phase 3 Trials in Advanced Prostate Cancer

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PUBLISHED: 11 SEPTEMBER 2020

The authors assessed the consistency in adverse event (AE) reporting across three randomized placebo-controlled phase 3 trials of apalutamide, enzalutamide, and darolutamide in advanced prostate cancer. They examined 7 trials with more than 9000 participants. There were 54 AEs in total; however, only 3 (fatigue, hypertension, and seizure) were reported by all 7 trials. The absolute risk of AEs in the placebo arms differed by more than twofold between trials. The variation was associated with visit frequency. The reporting of AEs was heterogenous across three randomized placebo-controlled phase 3 trials of apalutamide, enzalutamide, and darolutamide. This variation emphasizes the importance of improving the consistency in AE reporting across trials.