Table 2.
Summary of treatment-emergent adverse events
| Relugolix | Placebo | ||||||
|---|---|---|---|---|---|---|---|
| 10 mg (n = 48) |
20 mg (n = 55) |
40 mg (n = 54) |
(n = 57) | ||||
| TEAEs, n | 105 | 143 | 145 | 99 | |||
| Patients with any TEAEs | 41 (85.4) | 53 (96.4) | 48 (88.9) | 40 (70.2) | |||
| Patients with drug-related TEAEs | 33 (68.8) | 50 (90.9) | 44 (81.5) | 23 (40.4) | |||
| Intensity of TEAEs | |||||||
| Mild | 36 (75.0) | 46 (83.6) | 45 (83.3) | 34 (59.6) | |||
| Moderate | 5 (10.4) | 7 (12.7) | 2 (3.7) | 6 (10.5) | |||
| Severe | 0 (0.0) | 0 (0.0) | 1 (1.9) | 0 (0.0) | |||
| TEAEs leading to study drug discontinuation | 0 (0.0) | 1 (1.8) | 0 (0.0) | 1 (1.8) | |||
| Serious TEAEs (%) | 0 (0.0) | 1 (1.8) | 1 (1.9) | 1 (1.8) | |||
| TEAEs occurring in ≥ 10% of patients in any group | |||||||
| Nasopharyngitis | 9 (18.8) | 4 (7.3) | 7 (13.0) | 16 (28.1) | |||
| Hot flushes | 2 (4.2) | 16 (29.1) | 21 (38.9) | 2 (3.5) | |||
| Irregular uterine bleeding | 13 (27.1) | 17 (30.9) | 15 (27.8) | 10 (17.5) | |||
| Heavy menstrual bleeding | 6 (12.5) | 13 (23.6) | 12 (22.2) | 4 (7.0) | |||
| Headache | 1 (2.1) | 8 (14.5) | 7 (13.0) | 1 (1.8) | |||
| Genital hemorrhage | 2 (4.2) | 6 (10.9) | 6 (11.1) | 2 (3.5) | |||
| Menstruation irregular | 12 (25.0) | 8 (14.5) | 3 (5.6) | 0 (0.0) | |||
Data are n (%) unless stated otherwise
TEAEs treatment-emergent adverse events