Table 4.
Overview of treatment-emergent adverse events by concomitant statin use (safety population)
| Patients | Darolutamide (N = 954) | Placebo (N = 554) | ||
|---|---|---|---|---|
| Concomitant statin use | Concomitant statin use | |||
| Yes (n = 306) | No (n = 648) | Yes (n = 202) | No (n = 352) | |
| Any TEAE | 270 (88.2) | 524 (80.9) | 166 (82.2) | 260 (73.9) |
| Grade 1 | 73 (23.9) | 146 (22.5) | 51 (25.2) | 83 (23.6) |
| Grade 2 | 95 (31.0) | 207 (31.9) | 69 (34.2) | 97 (27.6) |
| Grade 3 | 76 (24.8) | 139 (21.5) | 36 (17.8) | 63 (17.9) |
| Grade 4 | 10 (3.3) | 11 (1.7) | 5 (2.5) | 4 (1.1) |
| SAE | 97 (31.7) | 140 (21.6) | 42 (20.8) | 69 (19.6) |
| Death | 16 (5.2) | 21 (3.2) | 5 (2.5) | 13 (3.7) |
| TEAE leading to dose modification | 51 (16.7) | 84 (13.0) | 20 (9.9) | 32 (9.1) |
| TEAE leading to discontinuation of study drug | 28 (9.2) | 57 (8.8) | 16 (7.9) | 32 (9.1) |
| Any drug-related TEAEa | 81 (26.5) | 177 (27.3) | 43 (21.3) | 67 (19.0) |
| Grade 1 | 42 (13.7) | 90 (13.9) | 31 (15.3) | 37 (10.5) |
| Grade 2 | 30 (9.8) | 68 (10.5) | 7 (3.5) | 19 (5.4) |
| Grade 3 | 8 (2.6) | 16 (2.5) | 4 (2.0) | 10 (2.8) |
| Grade 4 | 1 (0.3) | 2 (0.3) | 0 | 0 |
| Drug-related SAE | 3 (1.0) | 7 (1.1) | 3 (1.5) | 3 (0.9) |
| Drug-related death | 0 | 1 (0.2) | 1 (0.5) | 1 (0.3) |
| Drug-related TEAE leading to dose modification | 15 (4.9) | 34 (5.2) | 5 (2.5) | 9 (2.6) |
| Drug-related TEAE leading to discontinuation of study drug | 3 (1.0) | 12 (1.9) | 5 (2.5) | 8 (2.3) |
This analysis used data from the 17 January 2019 datacut. Data are presented as n (%)
TEAE treatment-emergent adverse event, SAE serious adverse event
aAccording to investigator’s assessment, with severity graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 [31]