Table 3.
Adverse events occurring in ≥10% of patients (N = 36)
| MedDRA preferred term | Treatment-emergent adverse events, n (%) |
Treatment-related adverse events, n (%)a | ||||
|---|---|---|---|---|---|---|
| Grade 1 or 2 | Grade 3 | Any gradeb | Grade 1 or 2 | Grade 3 | Any gradec | |
| Any event | 19 (53) | 15 (42) | 36 (100) | 29 (81) | 1 (3) | 30 (83) |
| Constipation | 15 (42) | 0 (0) | 15 (42) | 7 (19) | 0 (0) | 7 (19) |
| Anemia | 9 (25) | 2 (6) | 11 (31) | 2 (6) | 0 (0) | 2 (6) |
| Nausea | 11 (31) | 0 (0) | 11 (31) | 6 (17) | 0 (0) | 6 (17) |
| ALT increased | 9 (25) | 1 (3) | 10 (28) | 5 (14) | 0 (0) | 5 (14) |
| Dizziness | 10 (28) | 0 (0) | 10 (28) | 6 (17) | 0 (0) | 6 17) |
| Fatigue | 9 (25) | 1 (3) | 10 (28) | 4 (11) | 0 (0) | 4 (11) |
| Abdominal pain | 8 (22) | 1 (3) | 9 (25) | 1 (3) | 0 (0) | 1 (3) |
| Oedema peripheral | 9 (25) | 0 (0) | 9 (25) | 3 (8) | 0 (0) | 3 (8) |
| Weight increased | 7 (19) | 2 (6) | 9 (25) | 6 (17) | 1 (3) | 7 (19) |
| Diarrhea | 7 (19) | 1 (3) | 8 (22) | 1 (3) | 0 (0) | 1 (3) |
| Anxiety | 6 (17) | 1 (3) | 7 (19) | 1 (3) | 0 (0) | 1 (3) |
| Arthralgia | 7 (19) | 0 (0) | 7 (19) | 1 (3) | 0 (0) | 1 (3) |
| Back pain | 7 (19) | 0 (0) | 7 (19) | – | – | – |
| Headache | 7 (19) | 0 (0) | 7 (19) | 4 (11) | 0 (0) | 4 (11) |
| Myalgia | 7 (19) | 0 (0) | 7 (19) | 6 (17) | 0 (0) | 6 (17) |
| Pain in extremity | 7 (19) | 0 (0) | 7 (19) | 1 (3) | 0 (0) | 1 (3) |
| AST increased | 5 (14) | 1 (3) | 6 (17) | 5 (14) | 0 (0) | 5 (14) |
| Cough | 6 (17) | 0 (0) | 6 (17) | – | – | – |
| Abdominal distension | 5 (14) | 0 (0) | 5 (14) | 1 (3) | 0 (0) | 1 (3) |
| Dyspnea | 4 (11) | 1 (3) | 5 (14) | 2 (6) | 0 (0) | 2 (6) |
| Pain | 5 (14) | 0 (0) | 5 (14) | 2 (6) | 0 (0) | 2 (6) |
| Upper respiratory tract infection | 5 (14) | 0 (0) | 5 (14) | – | – | – |
| Vomiting | 5 (14) | 0 (0) | 5 (14) | 2 (6) | 0 (0) | 2 (6) |
| Abdominal pain upper | 4 (11) | 0 (0) | 4 (11) | 2 (6) | 0 (0) | 2 (6) |
| Insomnia | 4 (11) | 0 (0) | 4 (11) | – | – | – |
| Muscular weakness | 4 (11) | 0 (0) | 4 (11) | 1 (3) | 0 (0) | 1 (3) |
| Musculoskeletal chest pain | 4 (11) | 0 (0) | 4 (11) | – | – | – |
| Nasopharyngitis | 4 (11) | 0 (0) | 4 (11) | – | – | – |
ALT, alanine aminotransferase; AST, aspartate transaminase; MedDRA; medical dictionary for regulatory activities.
a
Dashes indicate AEs that were not reported to be treatment-related in any patients.
b
There were no grade 4 and 2 grade 5 treatment-emergent adverse events (malignant neoplasm progression and neurofibrosarcoma).
c
There were no grade 4 or 5 treatment-related adverse events.