Table 1.
Summary of TEAEs
| Relugolix | Leuprorelin (n = 80) | Placebo (n = 97) | |||
|---|---|---|---|---|---|
| 10 mg (n = 103) | 20 mg (n = 100) | 40 mg (n = 103) | |||
| Number of TEAEs | 334 | 365 | 407 | 334 | 263 |
| Patients with any TEAEs | 89 (86.4) | 96 (96.0) | 98 (95.1) | 78 (97.5) | 79 (81.4) |
| Patients with drug-related TEAEs | 68 (66.0) | 88 (88.0) | 91 (88.3) | 72 (90.0) | 38 (39.2) |
| Intensity of TEAEs | |||||
| Mild | 83 (80.6) | 82 (82.0) | 83 (80.6) | 64 (80.0) | 68 (70.1) |
| Moderate | 6 (5.8) | 14 (14.0) | 15 (14.6) | 14 (17.5) | 9 (9.3) |
| Severe | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (2.1) |
| TEAEs leading to study drug discontinuation | 1 (1.0) | 7 (7.0) | 2 (1.9) | 9 (11.3) | 6 (6.2) |
| Serious TEAEs | 0 (0.0) | 2 (2.0) | 0 (0.0) | 0 (0.0) | 5 (5.2) |
| TEAEs occurring in ≥ 10% of patients in any treatment group | |||||
| Nasopharyngitis | 31 (30.1) | 31 (31.0) | 31 (30.1) | 26 (32.5) | 32 (33.0) |
| Headache | 5 (4.9) | 12 (12.0) | 11 (10.7) | 11 (13.8) | 10 (10.3) |
| Metrorrhagia | 28 (27.2) | 36 (36.0) | 30 (29.1) | 32 (40.0) | 8 (8.2) |
| Menstruation irregular | 21 (20.4) | 21 (21.0) | 7 (6.8) | 5 (6.3) | 5 (5.2) |
| Menorrhagia | 11 (10.7) | 16 (16.0) | 15 (14.6) | 9 (11.3) | 5 (5.2) |
| Oligomenorrhea | 12 (11.7) | 12 (12.0) | 1 (1.0) | 0 (0.0) | 2 (2.1) |
| Genital hemorrhage | 3 (2.9) | 5 (5.0) | 7 (6.8) | 8 (10.0) | 2 (2.1) |
| Hyperhidrosis | 4 (3.9) | 11 (11.0) | 10 (9.7) | 10 (12.5) | 1 (1.0) |
| Hot flush | 12 (11.7) | 23 (23.0) | 55 (53.4) | 37 (46.3) | 8 (8.2) |
Data are n (%), unless otherwise stated
TEAE treatment-emergent adverse event