Table 3.
Treatment-emergent adverse events.
| n (%) | Placebo |
Elagolix 300 mg BID |
Elagolix 300 mg BID + add-back therapy |
||||||
|---|---|---|---|---|---|---|---|---|---|
| Women with uterine fibroids and coexisting adenomyosis (N = 34) | Women with uterine fibroids without adenomyosis diagnosis at baseline (N = 161) | Overall pooled study population (N = 195) | Women with coexisting adenomyosis (N = 32) | Excluding women with adenomyosis (N = 167) | Overall pooled study population (N = 199) | Women with uterine fibroids and coexisting adenomyosis (N = 60) | Women with uterine fibroids without adenomyosis diagnosis at baseline (N = 332) | Overall pooled study population (N = 392) | |
| Any adverse event (AE) | 26 (76.5) | 104 (64.6) | 130 (66.7) | 26 (81.3) | 140 (83.8) | 166 (83.4) | 39 (65.0) | 243 (73.2) | 282 (71.9) |
| Any serious AE | 1 (2.9) | 5 (3.1) | 6 (3.1) | 1 (3.1) | 6 (3.6) | 7 (3.5) | 2 (3.3) | 8 (2.4) | 10 (2.6) |
| Any severe AE | 1 (2.9) | 9 (5.6) | 10 (5.1) | 2 (6.3) | 18 (10.8) | 20 (10.1) | 5 (8.3) | 31 (9.3) | 36 (9.2) |
| Any AE leading to study drug discontinuation | 3 (8.8) | 10 (6.2) | 13 (6.7) | 2 (6.3) | 20 (12.0) | 22 (11.1) | 5 (8.3) | 33 (9.9) | 38 (9.7) |
| Most common AEsa | |||||||||
| Hot flush | 2 (5.9) | 11 (6.8) | 13 (6.7) | 21 (65.6) | 87 (52.1) | 108 (54.3) | 11 (18.3) | 68 (20.5) | 79 (20.2) |
| Nausea | 2 (5.9) | 17 (10.6) | 19 (9.7) | 0 | 11 (6.6) | 11 (5.5) | 7 (11.7) | 30 (9.0) | 37 (9.4) |
| Headache | 3 (8.8) | 11 (6.8) | 14 (7.2) | 5 (15.6) | 25 (15.0) | 30 (15.1) | 4 (6.7) | 33 (9.9) | 37 (9.4) |
| Night sweats | 1 (2.9) | 7 (4.3) | 8 (4.1) | 8 (25.0) | 44 (26.3) | 52 (26.1) | 5 (8.3) | 29 (8.7) | 34 (8.7) |
| Fatigue | 0 | 7 (4.3) | 7 (3.6) | 0 | 4 (2.4) | 4 (2.0) | 4 (6.7) | 20 (6.0) | 24 (6.1) |
Note: Four women who were randomized and treated before the trial registration date were excluded from this analysis. Data are presented as n (%) or n.
a
MedDRA preferred terms in descending order for elagolix 300 mg BID plus add-back overall and then for subjects with adenomyosis. AE = adverse event; BID = twice daily.