Table 3.
Adverse Events.*
| Event | Trial L1 | Trial L2 | ||||
|---|---|---|---|---|---|---|
| Placebo (N = 127) | Relugolix Combination Therapy (N = 128) | Delayed Relugolix Combination Therapy (N = 132) | Placebo (N = 129) | Relugolix Combination Therapy (N = 126) | Delayed Relugolix Combination Therapy (N = 126) | |
| number of participants with event (percent) | ||||||
| Any adverse event | 84 (66) | 79 (62) | 96 (73) | 76 (59) | 76 (60) | 90 (71) |
| Adverse event leading to discontinuation | 5 (4) | 7 (5) | 16 (12) | 6 (5) | 3 (2) | 14 (11) |
| Serious adverse event | 2 (2) | 7 (5) | 3 (2) | 4 (3) | 1 (1) | 2 (2) |
| Adverse event reported in >5% of participants in any group | ||||||
| Hot flash | 10 (8) | 14 (11) | 47 (36) | 5 (4) | 7 (6) | 44 (35) |
| Headache | 19 (15) | 14 (11) | 14 (11) | 15 (12) | 11 (9) | 28 (22) |
| Hypertension | 0 | 7 (5) | 3 (2) | 4 (3) | 5 (4) | 7 (6) |
| Arthralgia | 4 (3) | 4 (3) | 7 (5) | 4 (3) | 1 (1) | 8 (6) |
| Cough | 7 (6) | 1 (1) | 0 | 4 (3) | 0 | 1 (1) |
| Nausea | 6 (5) | 4 (3) | 5 (4) | 10 (8) | 6 (5) | 4 (3) |
| Upper respiratory tract infection | 3 (2) | 1 (1) | 7 (5) | 7 (5) | 6 (5) | 3 (2) |
| Anemia | 6 (5) | 4 (3) | 0 | 8 (6) | 2 (2) | 2 (2) |
| Fatigue | 5 (4) | 4 (3) | 6 (5) | 2 (2) | 1 (1) | 7 (6) |
*
Adverse events were coded with the use of the Medical Dictionary for Regulatory Activities, version 22.0. The severity of adverse events was evaluated by the investigator according to the National Cancer Institute Common Terminology for Adverse Events, version 5.0. No group in either trial had an incidence of hyperhidrosis or night sweats of more than 3%. There were no deaths in either trial.