How common are gastrointestinal side effects with darolutamide?
In the clinical trial results reported for darolutamide, gastrointestinal (GI) side effects were generally uncommon, with the most frequently reported GI event being nausea. Across the pivotal studies, nausea occurred in a low single-digit percentage range of patients (often cited around 1–5%), while other GI symptoms such as vomiting and diarrhea were reported less often than nausea and were typically below that range as well.[1][2]
Which GI symptoms show up most often?
When GI effects are reported with darolutamide, nausea is the event that appears most consistently in published safety summaries.[1][2] Other GI-related adverse events are reported, but at lower frequencies than nausea in these summaries.[1][2]
Are the rates different by dose or study population?
Safety summaries for darolutamide are based on specific trial populations and dosing schedules, and the reported GI frequencies come from those datasets.[1][2] If you tell me which setting you mean (metastatic hormone-sensitive prostate cancer vs non-metastatic castration-resistant prostate cancer, and whether you mean trial “all grades” vs “severe”), I can narrow the occurrence rate to that exact context using the corresponding published table.
Where can I find the exact percentage for GI events?
The exact occurrence rates are typically listed in the “Adverse reactions” or “Treatment-emergent adverse events” safety tables in the darolutamide prescribing information and associated trial publications.[1][2]
Sources:
1. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203842
2. https://www.nejm.org/doi/full/10.1056/NEJMoa1914700