Table 2.
AE overview.
| Cohort | DL1 molibresib 60 mg + FUL 500 mg (n = 94) | DL2 molibresib 80 mg + FUL 500 mg (n = 29) | Total (N = 123) |
|---|---|---|---|
| Any AE, n (%) | 94 (100) | 29 (100) | 123 (100) |
| AE related to study treatment | 90 (96) | 29 (100) | 119 (97) |
| AE leading to permanent discontinuation of study treatment | 14 (15) | 3 (10) | 17 (14) |
| AE leading to dose reduction | 22 (23) | 13 (45) | 35 (28) |
| AE leading to dose interruption/delay | 64 (68) | 22 (76) | 86 (70) |
| Any SAE, n (%) | 19 (20) | 8 (28) | 27 (22) |
| SAE related to study treatment | 11 (12) | 4 (14) | 15 (12) |
| Fatal SAE | 2 (2) | 0 | 2 (2) |
| Fatal SAE related to study treatment | 0 | 0 | 0 |
Abbreviations: AE, adverse event; DL, dosing level; FUL, fulvestrant; SAE; serious adverse event.