Table 4.
Summary of Adverse Events
| Characteristic | Responders |
Nonresponders |
||
|---|---|---|---|---|
| Placebo (n = 16) | Elagolix+add-back therapy (n = 278) | Placebo (n = 166) | Elagolix+add-back therapy (n = 89) | |
| All AEs | 12 (75.0) | 193 (69.4) | 112 (67.5) | 68 (76.4) |
| Severe AE | 2 (12.5) | 23 (8.3) | 8 (4.8) | 10 (11.2) |
| Serious AE | 0 | 9 (3.2) | 5 (3.0) | 0 |
| AE leading to treatment discontinuation | 1 (6.3) | 1 (0.4) | 12 (7.2) | 26 (29.2) |
| Most common AEs with elagolix+add-back therapy | ||||
| Hot flush | 3 (18.8) | 56 (20.1) | 10 (6.0) | 18 (20.2) |
| Nausea | 1 (6.3) | 21 (7.6) | 18 (10.8) | 12 (13.5) |
| Headache | 0 | 22 (7.9) | 13 (7.8) | 11 (12.4) |
| Fatigue | 0 | 17 (6.1) | 6 (3.6) | 7 (7.9) |
| Night sweats | 1 (6.3) | 25 (9.0) | 7 (4.2) | 6 (6.7) |
Data are n (%).
AE, adverse event.