Treatment-emergent AEs by grade occurring in at least 10% of patients
| Preferred term . | All patients (N = 35) . | ||||
|---|---|---|---|---|---|
| Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | Total . | |
| Diarrhea | 15 (42.9%) | 9 (25.7%) | 3 (8.6%) | 0 | 27 (77.1%) |
| Nausea | 15 (42.9%) | 1 (2.9%) | 0 | 0 | 16 (45.7%) |
| Fatigue | 4 (11.4%) | 5 (14.3%) | 3 (8.6%) | 1 (2.9%) | 13 (37.1%) |
| Anemia | 0 | 3 (8.6%) | 6 (17.1%) | 3 (8.6%) | 12 (34.3%) |
| Vomiting | 8 (22.9%) | 3 (8.6%) | 0 | 0 | 11 (31.4%) |
| Abdominal pain | 5 (14.3%) | 2 (5.7%) | 2 (5.7%) | 0 | 9 (25.7%) |
| Pruritus | 6 (17.1%) | 1 (2.9%) | 1 (2.9%) | 0 | 8 (22.9%) |
| Thrombocytopenia | 1 (2.9%) | 0 | 5 (14.3%) | 2 (5.7%) | 8 (22.9%) |
| Decreased appetite | 4 (11.4%) | 3 (8.6%) | 0 | 0 | 7 (20.0%) |
| Dehydration | 1 (2.9%) | 3 (8.6%) | 2 (5.7%) | 0 | 6 (17.1%) |
| Dizziness | 5 (14.3%) | 1 (2.9%) | 0 | 0 | 6 (17.1%) |
| Flatulence | 6 (17.1%) | 0 | 0 | 0 | 6 (17.1%) |
| Aspartate aminotransferase increased | 3 (8.6%) | 0 | 2 (5.7%) | 0 | 5 (14.3%) |
| Bone pain | 4 (11.4%) | 1 (2.9%) | 0 | 0 | 5 (14.3%) |
| Dyspnea | 1 (2.9%) | 4 (11.4%) | 0 | 0 | 5 (14.3%) |
| Hyperuricemia | 3 (8.6%) | 0 | 1 (2.9%) | 1 (2.9%) | 5 (14.3%) |
| Insomnia | 5 (14.3%) | 0 | 0 | 0 | 5 (14.3%) |
| Alopecia | 4 (11.4%) | 0 | 0 | 0 | 4 (11.4%) |
| Asthenia | 2 (5.7%) | 1 (2.9%) | 1 (2.9%) | 0 | 4 (11.4%) |
| Constipation | 3 (8.6%) | 1 (2.9%) | 0 | 0 | 4 (11.4%) |
| Headache | 3 (8.6%) | 0 | 1 (2.9%) | 0 | 4 (11.4%) |
| Musculoskeletal pain | 2 (5.7%) | 2 (5.7%) | 0 | 0 | 4 (11.4%) |
| Pyrexia | 3 (8.6%) | 1 (2.9%) | 0 | 0 | 4 (11.4%) |
| Preferred term . | All patients (N = 35) . | ||||
|---|---|---|---|---|---|
| Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | Total . | |
| Diarrhea | 15 (42.9%) | 9 (25.7%) | 3 (8.6%) | 0 | 27 (77.1%) |
| Nausea | 15 (42.9%) | 1 (2.9%) | 0 | 0 | 16 (45.7%) |
| Fatigue | 4 (11.4%) | 5 (14.3%) | 3 (8.6%) | 1 (2.9%) | 13 (37.1%) |
| Anemia | 0 | 3 (8.6%) | 6 (17.1%) | 3 (8.6%) | 12 (34.3%) |
| Vomiting | 8 (22.9%) | 3 (8.6%) | 0 | 0 | 11 (31.4%) |
| Abdominal pain | 5 (14.3%) | 2 (5.7%) | 2 (5.7%) | 0 | 9 (25.7%) |
| Pruritus | 6 (17.1%) | 1 (2.9%) | 1 (2.9%) | 0 | 8 (22.9%) |
| Thrombocytopenia | 1 (2.9%) | 0 | 5 (14.3%) | 2 (5.7%) | 8 (22.9%) |
| Decreased appetite | 4 (11.4%) | 3 (8.6%) | 0 | 0 | 7 (20.0%) |
| Dehydration | 1 (2.9%) | 3 (8.6%) | 2 (5.7%) | 0 | 6 (17.1%) |
| Dizziness | 5 (14.3%) | 1 (2.9%) | 0 | 0 | 6 (17.1%) |
| Flatulence | 6 (17.1%) | 0 | 0 | 0 | 6 (17.1%) |
| Aspartate aminotransferase increased | 3 (8.6%) | 0 | 2 (5.7%) | 0 | 5 (14.3%) |
| Bone pain | 4 (11.4%) | 1 (2.9%) | 0 | 0 | 5 (14.3%) |
| Dyspnea | 1 (2.9%) | 4 (11.4%) | 0 | 0 | 5 (14.3%) |
| Hyperuricemia | 3 (8.6%) | 0 | 1 (2.9%) | 1 (2.9%) | 5 (14.3%) |
| Insomnia | 5 (14.3%) | 0 | 0 | 0 | 5 (14.3%) |
| Alopecia | 4 (11.4%) | 0 | 0 | 0 | 4 (11.4%) |
| Asthenia | 2 (5.7%) | 1 (2.9%) | 1 (2.9%) | 0 | 4 (11.4%) |
| Constipation | 3 (8.6%) | 1 (2.9%) | 0 | 0 | 4 (11.4%) |
| Headache | 3 (8.6%) | 0 | 1 (2.9%) | 0 | 4 (11.4%) |
| Musculoskeletal pain | 2 (5.7%) | 2 (5.7%) | 0 | 0 | 4 (11.4%) |
| Pyrexia | 3 (8.6%) | 1 (2.9%) | 0 | 0 | 4 (11.4%) |
Data are expressed as n (%). No grade 5 events occurred at ≥10% frequency. Source: supplemental Table 7.2.1.