Table 3.
Adverse Events Summary for the Overall mITT Population and the Metastatic Disease Population.
| Overall Population | Metastatic Population | |||||||
|---|---|---|---|---|---|---|---|---|
|
Relugolix
(N = 717) |
Leuprolide
(N = 357) |
Relugolix
(N = 290) |
Leuprolide
(N = 144) |
|||||
|
Any Grade
n (%) |
Grade ≥ 3
n (%) |
Any Grade
n (%) |
Grade ≥ 3
n (%) |
Any Grade
n (%) |
Grade ≥ 3
n (%) |
Any Grade
n (%) |
Grade ≥ 3
n (%) |
|
| Any adverse event | 664 (92.6) | 136 (19.0) | 330 (92.4) | 70 (19.6) | 268 (92.4) | 72 (24.8) | 129 (89.6) | 35 (24.3) |
| Serious adverse event | 89 (12.4) | — | 51 (14.3) | — | 49 (16.9) | — | 24 (16.7) | — |
| Fatal adverse event | 10 (1.4) | — | 11 (3.1) | — | 9 (3.1) | — | 7 (4.9) | — |
| Adverse events that occurred in >10% of patients in either group | ||||||||
| Hot flush | 386 (53.8) | 4 (0.6%) | 182 (51.0) | 0 | 146 (50.3) | 0 | 66 (45.8) | 0 |
| Fatigue | 158 (22.0) | 4 (0.6) | 68 (19.0) | 0 | 67 (23.1) | 2 (0.7) | 29 (20.1) | 0 |
| Arthralgia | 87 (12.1) | 2 (0.3) | 32 (9.0) | 0 | 47 (16.2) | 2 (0.7) | 13 (9.0) | 0 |
| Constipation | 91 (12.7) | 0 | 36 (10.1) | 0 | 45 (15.5) | 0 | 22 (15.3) | 0 |
| Hypertension | 61 (8.5) | 15 (2.1) | 37 (10.4) | 2 (0.6) | 34 (11.7) | 10 (3.4) | 14 (9.7) | 1 (0.7) |
| Nausea | 48 (6.7) | 0 | 16 (4.5) | 0 | 32 (11.0) | 0 | 10 (6.9) | 0 |
| Diarrhea | 82 (11.4) | 0 | 23 (6.4) | 0 | 29 (10.0) | 0 | 7 (4.9) | 0 |
| Back pain | 61 (8.5) | 3 (0.4) | 35 (9.8) | 3 (0.8) | 28 (9.7) | 2 (0.7) | 22 (15.3) | 3 (2.1) |
Abbreviations: MACE, major adverse cardiovascular event; SMQ, standardized MedDRA query. Adverse event grades are evaluated based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03. MedDRA Version 22.0.