Summary of AEs
| . | Cohort, n (%) . | ||
|---|---|---|---|
| 45 mg (n = 94) . | 30 mg (n = 94) . | 15 mg (n = 94) . | |
| TEAEs | |||
| Any TEAE | 94 (100) | 88 (93.6) | 89 (94.7) |
| Grade ≥3 TEAEs | 64 (68.1) | 58 (61.7) | 60 (63.8) |
| Serious TEAEs | 32 (34) | 24 (25.5) | 31 (33.0) |
| Grade 5 TEAEs | 2 (2.1) | 0 | 2 (2.1) |
| Dose modifications for TEAEs | |||
| Discontinuation | 18 (19.1) | 15 (16.0) | 13 (13.8) |
| Reduction | 43 (45.7) | 33 (35.1) | 30 (31.9) |
| Interruption | 67 (71.3) | 58 (61.7) | 55 (58.5) |
| TE-AOEs | |||
| Any AOE | 9 (9.6) | 5 (5.3) | 3 (3.2) |
| Serious TE-AOEs | 4 (4.3) | 4 (4.3) | 3 (3.2) |
| Grade ≥3 TE-AOEs | 5 (5.3) | 5 (5.3) | 3 (3.2) |
| Dose modifications for AOE | |||
| Discontinuation | 4 (4.3) | 3 (3.2) | 1 (1.1) |
| Reduction | 0 | 1 (1.1) | 0 |
| Interruption | 2 (2.1) | 3 (3.2) | 1 (1.1) |
| . | Cohort, n (%) . | ||
|---|---|---|---|
| 45 mg (n = 94) . | 30 mg (n = 94) . | 15 mg (n = 94) . | |
| TEAEs | |||
| Any TEAE | 94 (100) | 88 (93.6) | 89 (94.7) |
| Grade ≥3 TEAEs | 64 (68.1) | 58 (61.7) | 60 (63.8) |
| Serious TEAEs | 32 (34) | 24 (25.5) | 31 (33.0) |
| Grade 5 TEAEs | 2 (2.1) | 0 | 2 (2.1) |
| Dose modifications for TEAEs | |||
| Discontinuation | 18 (19.1) | 15 (16.0) | 13 (13.8) |
| Reduction | 43 (45.7) | 33 (35.1) | 30 (31.9) |
| Interruption | 67 (71.3) | 58 (61.7) | 55 (58.5) |
| TE-AOEs | |||
| Any AOE | 9 (9.6) | 5 (5.3) | 3 (3.2) |
| Serious TE-AOEs | 4 (4.3) | 4 (4.3) | 3 (3.2) |
| Grade ≥3 TE-AOEs | 5 (5.3) | 5 (5.3) | 3 (3.2) |
| Dose modifications for AOE | |||
| Discontinuation | 4 (4.3) | 3 (3.2) | 1 (1.1) |
| Reduction | 0 | 1 (1.1) | 0 |
| Interruption | 2 (2.1) | 3 (3.2) | 1 (1.1) |