Table 3.
AEs reported irrespective of study treatment relationship by preferred term reported in ≥10% of patients.
| Preferred term, n (%) | All patients N = 48 |
|
|---|---|---|
| All grades | Grade ≥ 3 | |
| No. of patients with ≥1 event | 48 (100) | 29 (60.4) |
| Lipase increased | 14 (29.2) | 9 (18.8) |
| Fatigue | 14 (29.2) | 1 (2.1) |
| Nausea | 13 (27.1) | 0 |
| Diarrhea | 10 (20.8) | 1 (2.1) |
| Vomiting | 9 (18.8) | 3 (6.3) |
| Musculoskeletal paina | 9 (18.8) | 0 |
| Thrombocytopenia | 8 (16.7) | 7 (14.6) |
| Headache | 8 (16.7) | 1 (2.1) |
| Arthralgia | 8 (16.7) | 0 |
| Alanine aminotransferase increased | 7 (14.6) | 3 (6.3) |
| Abdominal pain | 7 (14.6) | 3 (6.3) |
| Cough | 7 (14.6) | 0 |
| Amylase increased | 6 (12.5) | 2 (4.2) |
| Back pain | 6 (12.5) | 1 (2.1) |
| Pruritus | 6 (12.5) | 0 |
| Aspartate aminotransferase increased | 6 (12.5) | 1 (2.1) |
| Hypertension | 5 (10.4) | 3 (6.3) |
| Anemia | 5 (10.4) | 3 (6.3) |
| Edema peripheral | 5 (10.4) | 2 (4.2) |
AE adverse event.
aMusculoskeletal pain includes preferred terms for musculoskeletal pain and pain in extremity.