TABLE 3.
Treatment-Emergent Adverse Events (safety analysis set)
| Adverse Event, No. of Patients (%) | Darolutamide + ADT (n = 445a) | Placebo + ADT (n = 221a) | ||
|---|---|---|---|---|
| Any adverse event | 405 (91.0) | 199 (90.0) | ||
| Serious adverse event | 105 (23.6) | 52 (23.5) | ||
| Grade 3 or 4 adverse event | 137 (30.8) | 67 (30.3) | ||
| Grade 5 adverse event | 21 (4.7) | 12 (5.4) | ||
| Adverse event leading to permanent discontinuation of study drug | 27 (6.1) | 20 (9.0) | ||
| Most common adverse events, occurring in ≥5% of patients in either group | Any grade | Grade 3 or 4 | Any grade | Grade 3 or 4 |
|---|---|---|---|---|
| Anemia | 91 (20.4) | 14 (3.1) | 39 (17.6) | 8 (3.6) |
| Arthralgia | 55 (12.4) | 5 (1.1) | 25 (11.3) | 0 |
| Urinary tract infection | 52 (11.7) | 8 (1.8) | 17 (7.7) | 1 (0.5) |
| Back pain | 43 (9.7) | 5 (1.1) | 23 (10.4) | 2 (0.9) |
| Increased aspartate aminotransferase | 43 (9.7) | 10 (2.2) | 17 (7.7) | 1 (0.5) |
| Constipation | 42 (9.4) | 0 | 16 (7.2) | 0 |
| Hot flush | 41 (9.2) | 0 | 16 (7.2) | 0 |
| Increased alanine aminotransferase | 40 (9.0) | 9 (2.0) | 18 (8.1) | 1 (0.5) |
| Pain in extremity | 38 (8.5) | 1 (0.2) | 20 (9.0) | 4 (1.8) |
| Hypertension | 38 (8.5) | 19 (4.3) | 19 (8.6) | 8 (3.6) |
| Bone pain | 33 (7.4) | 9 (2.0) | 27 (12.2) | 3 (1.4) |
| Increased weight | 33 (7.4) | 4 (0.9) | 17 (7.7) | 1 (0.5) |
| COVID-19 | 32 (7.2) | 1 (0.2) | 15 (6.8) | 2 (0.9) |
| Increased alkaline phosphatase | 30 (6.7) | 0 | 13 (5.9) | 3 (1.4) |
| Insomnia | 28 (6.3) | 0 | 6 (2.7) | 1 (0.5) |
| Hyperglycemia | 27 (6.1) | 1 (0.2) | 8 (3.6) | 0 |
| Fatigue | 25 (5.6) | 0 | 18 (8.1) | 1 (0.5) |
| Increased creatinine | 21 (4.7) | 2 (0.4) | 15 (6.8) | 0 |
| Headache | 18 (4.0) | 0 | 14 (6.3) | 2 (0.9) |
Abbreviations: ADT, androgen-deprivation therapy; COVID-19, coronavirus disease 2019.
a
Two patients who were randomly assigned to the placebo group but received darolutamide are analyzed in the darolutamide group for the safety analysis set.