Table 4.
Treatment-emergent adverse events (all-causality) occurring in ≥25% of patients who received ≥1 dose of study treatment (in either cohort, any grade).
| MedDRA preferred term | Cohort 1, (N = 26), n (%) | Cohort 2, (N = 28), n (%) | ||
|---|---|---|---|---|
| Any grade | Grade ≥ 3 | Any grade | Grade ≥ 3 | |
| Patients with ≥ 1 TEAE | 26 (100.0) | 18 (69.2) | 27 (96.4) | 17 (60.7) |
| Diarrhea | 22 (84.6) | 1 (3.8) | 22 (78.6) | 3 (10.7) |
| Fatigue | 13 (50.0) | 0 (0.0) | 15 (53.6) | 0 (0.0) |
| Headache | 2 (7.7) | 0 (0.0) | 14 (50.0) | 0 (0.0) |
| Neutropenia | 10 (38.5) | 8 (30.8) | 14 (50.0) | 8 (28.6) |
| Cough | 6 (23.1) | 0 (0.0) | 12 (42.9) | 0 (0.0) |
| Abdominal pain | 6 (23.1) | 0 (0.0) | 11 (39.3) | 1 (3.6) |
| Nausea | 10 (38.5) | 0 (0.0) | 11 (39.3) | 1 (3.6) |
| Pruritus | 7 (26.9) | 1 (3.8) | 11 (39.3) | 0 (0.0) |
| Decreased appetite | 6 (23.1) | 0 (0.0) | 10 (35.7) | 0 (0.0) |
| AST increased | 12 (46.2) | 9 (34.6) | 9 (32.1) | 5 (17.9) |
| Vomiting | 6 (23.1) | 0 (0.0) | 9 (32.1) | 1 (3.6) |
| Dyspnea | 8 (30.8) | 1 (3.8) | 8 (28.6) | 1 (3.6) |
| ALT increased | 14 (53.8) | 11 (42.3) | 7 (25.0) | 3 (10.7) |
| Anemia | 5 (19.2) | 2 (7.7) | 7 (25.0) | 1 (3.6) |
| Arthralgia | 4 (15.4) | 0 (0.0) | 7 (25.0) | 0 (0.0) |
| Rash | 5 (19.2) | 1 (3.8) | 7 (25.0) | 1 (3.6) |
| ILD/pneumonitisa | 3 (11.5) | 2 (7.7) | 4 (14.3) | 1 (3.6) |
ALT alanine aminotransferase, AST aspartate aminotransferase, ILD interstitial lung disease, N number of treated patients, n number of patients in category, TEAE treatment-emergent adverse event.
aThese events are adverse events of interest.