Table 2.
Most commonly reported (≥10%) AEs (any cause)a
| AE | Grade 1, n (%) |
Grade 2, n (%) |
Grade 3, n (%) |
Grade 4, n (%) |
Total, n (%) |
|---|---|---|---|---|---|
| Diarrhea | 33 (43) | 13 (17) | 3 (4) | 0 | 49 (64) |
| Nausea | 42 (55) | 4 (5) | 1 (1) | 0 | 47 (61) |
| Fatigue | 21 (27) | 16 (21) | 0 | 1 (1) | 38 (49) |
| Vomiting | 29 (38) | 3 (4) | 1 (1) | 0 | 33 (43) |
| Decreased appetite | 23 (30) | 6 (8) | 0 | 1 (1) | 30 (39) |
| Abdominal pain | 13 (17) | 4 (5) | 3 (4) | 0 | 20 (26) |
| Constipation | 14 (18) | 3 (4) | 0 | 0 | 17 (22) |
| Hyperglycemia | 2 (3) | 9 (12) | 5 (6) | 1 (1) | 17 (22) |
| Rash | 8 (10) | 8 (10) | 1 (1) | 0 | 17 (22) |
| Weight decreased | 12 (16) | 5 (6) | 0 | 0 | 17 (22) |
| Back pain | 11 (14) | 3 (4) | 1 (1) | 0 | 15 (19) |
| Dyspnea | 10 (13) | 3 (4) | 2 (3) | 0 | 15 (19) |
| Dizziness | 12 (16) | 0 | 0 | 0 | 12 (16) |
| Pyrexia | 10 (13) | 2 (3) | 0 | 0 | 12 (16) |
| Urinary tract infection | 6 (8) | 6 (8) | 0 | 0 | 12 (16) |
| Cough | 9 (12) | 0 | 0 | 0 | 9 (12) |
| Peripheral edema | 9 (12) | 0 | 0 | 0 | 9 (12) |
| Headache | 7 (9) | 0 | 1 (1) | 1 (1) | 9 (12) |
| Dysgeusia | 7 (9) | 1 (1) | 0 | 0 | 8 (10) |
| Mucosal inflammation | 7 (9) | 1 (1) | 0 | 0 | 8 (10) |
Abbreviations: AE, adverse event.
a
By Common Terminology Criteria for Adverse Events (version 3.0).