Table 1 Treatment-emergent adverse events during long-term darolutamide treatment.
Treatment-emergent adverse events (TEAEs),a n (%) | Total: Darolutamide >2 years (n = 13) | Darolutamide >2 and ≤4 years (n = 7) | Darolutamide >4 years (n = 6) |
|---|---|---|---|
Any TEAE | 13 (100) | 7 (100) | 6 (100) |
Worst grade | |||
1 or 2 | 7 (54) | 6 (86) | 1 (17) |
3 | 6 (46) | 1 (14) | 5 (83) |
Serious TEAE | 6 (46) | 2 (29) | 4 (67) |
TEAE leading to discontinuation of darolutamide | 1 (8) | 1 (14) | 0 |
Any drug-related TEAE | 5 (38) | 3 (43) | 2 (33) |
Worst grade | |||
1 or 2 | 5 (38) | 3 (43) | 2 (33) |
3 | 0 | 0 | 0 |
Serious drug-related TEAE | 0 | 0 | 0 |
Drug-related TEAE leading to discontinuation of darolutamide | 0 | 0 | 0 |
Most common TEAEs (occurring in ≥3 patients)b | |||
Diarrhea | 5 (38) | 2 (29) | 3 (50) |
Abdominal pain | 4 (31) | 2 (29) | 2 (33) |
Nausea | 4 (31) | 2 (29) | 2 (33) |
Arthralgia | 3 (23) | 1 (14) | 2 (33) |
Fatigue | 3 (23) | 2 (29) | 1 (17) |
Hematuria | 3 (23) | 1 (14) | 2 (33) |
Influenza | 3 (23) | 1 (14) | 2 (33) |
