Table 2.
Incidence of treatment-emergent adverse events.
| TEAE, n (%) | Black subgroup | Overall populationa | ||
|---|---|---|---|---|
| Darolutamide + ADT + docetaxel (n = 26) |
Placebo + ADT + docetaxel (n = 28) |
Darolutamide + ADT + docetaxel (n = 652) |
Placebo + ADT + docetaxel (n = 650a) |
|
| Any | 26 (100.0) | 27 (96.4) | 649 (99.5) | 643 (98.9) |
| Worst grade | ||||
| Grade 1 or 2 | 8 (30.8) | 10 (35.7) | 190 (29.1) | 204 (31.4) |
| Grade 3 or 4 | 16 (61.5) | 17 (60.7) | 431 (66.1) | 413 (63.5) |
| Grade 5 | 2 (7.7) | 0 | 27 (4.1) | 26 (4.0) |
| Serious | 11 (42.3) | 7 (25.0) | 292 (44.8) | 275 (42.3) |
| Leading to discontinuation of: | ||||
| Darolutamide/placebo | 5 (19.2) | 4 (14.3) | 88 (13.5) | 69 (10.6) |
| Exposure-adjusted incidence rate, per 100 patient yearsb | 8.1 | 11.2 | 5.1 | 5.7 |
Data for the overall population are from the New England Journal of Medicine, Smith MR, Hussain M, Saad F, et al, Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer, volume 386, pages 1132-1142. Copyright © 2022 Massachusetts Medical Society. Reprinted with permission.
aThree randomized patients (all in the placebo group) were never treated and were excluded from the safety analysis set. One patient randomized to placebo but who received darolutamide was included in the darolutamide group for the safety analysis set.
bExposure-adjusted incidence rate is defined as the number of patients with a given TEAE divided by the total darolutamide/placebo treatment duration for all patients in years.
Abbreviations: ADT: androgen-deprivation therapy; TEAE: treatment-emergent adverse event.