Table 3.
Adverse events.
| Placebo | Linzagolix 75 mg | Linzagolix 200 mg + ABT | |
|---|---|---|---|
| (N = 162) | (N = 160) | (N = 162) | |
| n (%) | n (%) | n (%) | |
| Any TEAE | 76 (46.9) | 75 (46.9) | 92 (56.8) |
| Severe TEAE | 2 (1.2) | 5 (3.1) | 3 (1.9) |
| Serious TEAE | 0 (0) | 1 (0.6) | 2 (1.2) |
| TEAE leading to permanent discontinuation of treatment | 4 (2.5) | 9 (5.6) | 5 (3.1) |
| TEAEs occurring in more than 5% of subjects in any linzagolix group | |||
| Headache | 13 (8.0) | 13 (8.1) | 17 (10.5) |
| Hot flush | 4 (2.5) | 12 (7.5) | 11 (6.8) |
| Fatigue | 4 (2.5) | 6 (3.8) | 11 (6.8) |
ABT: add-back therapy; LGX: linzagolix; TEAE: treatment-emergent adverse event.
For subjects not entering the follow-up or the extension period, AE are included in this summary up to 30 days after end of treatment. Only one subject (407016) not entering the follow-up or extension period reported 2 AE more than 30 days after end of treatment.