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. 2020 Aug 28;113(5):553–561. doi: 10.1093/jnci/djaa134

Table 3.

Conclusions about safety profiles as summarized in the main publications from each triala

Trial Assessment as per the "discussion" sections Conclusion
SPARTAN “Apalutamide was associated with higher rates of rash, fatigue, arthralgia, weight loss, falls, and fracture than placebo.” More AEs
PROSPER “Adverse events were more common with enzalutamide treatment than with placebo.” More AEs
ARAMIS “The safety data indicated no clinically relevant difference between darolutamide and placebo in the incidence of adverse events that occurred during the treatment period, including falls, fractures, seizures, cognitive disorders, and hypertension.” No difference
ARCHES “Enzalutamide was generally well tolerated, with a preliminary safety analysis seeming to be consistent with the safety profile of enzalutamide in previous clinical trials in CRPC.”
TITAN “The safety profile did not differ notably between the two groups, and health-related quality of life was preserved during apalutamide treatment.” No difference
PREVAIL “The benefit of enzalutamide was achieved with a favorable safety profile. Grade 3 or higher adverse events were more common in enzalutamide-treated patients than in placebo-treated patients (43% vs. 37%), a finding that was probably influenced by the fact that the safety-reporting period for the enzalutamide group was approximately 1 year longer than that for the placebo group.” More AEs
AFFIRM “The most common adverse events that were reported more frequently in the enzalutamide group included fatigue, diarrhea, and hot flashes.” More AEs
a

AE = adverse event; CRPC = castration-resistant prostate cancer.