Table 3.
Study treatment‐emergent adverse events a
| TEAE, n (%) | n = 23 | |
|---|---|---|
| Any grade | Grade ≥3 | |
| Any TEAE | 23 (100.0) | 16 (69.6) |
| Blood alkaline phosphatase increased | 11 (47.8) | 5 (21.7) |
| Fatigue | 10 (43.5) | 5 (21.7) |
| Aspartate aminotransferase increased | 10 (43.5) | 3 (13.0) |
| Headache | 9 (39.1) | 0 |
| Decreased appetite | 9 (39.1) | 0 |
| Alanine aminotransferase increased | 7 (30.4) | 2 (8.7) |
| Abdominal pain b | 6 (26.1) | 1 (4.3) |
| Edema peripheral | 6 (26.1) | 0 |
| Constipation | 6 (26.1) | 0 |
| Hypothyroidism | 6 (26.1) | 0 |
| Hyperbilirubinemia | 5 (21.7) | 2 (8.7) |
| Nausea | 5 (21.7) | 0 |
| Rash c | 5 (21.7) | 0 |
| Proteinuria | 4 (17.4) | 1 (4.3) |
| Dyspnea | 4 (17.4) | 0 |
| Diarrhea | 3 (13.0) | 2 (8.7) |
| Small intestinal obstruction | 3 (13.0) | 2 (8.7) |
| Gamma‐glutamyl transferase increased | 3 (13.0) | 2 (8.7) |
| Hypertension | 3 (13.0) | 2 (8.7) |
| Blood creatine phosphokinase increased | 3 (13.0) | 1 (4.3) |
| Dysphonia | 3 (13.0) | 0 (0.0) |
| Pruritus | 3 (13.0) | 0 (0.0) |
| Pyrexia | 3 (13.0) | 0 (0.0) |
| Somnolence | 3 (13.0) | 0 (0.0) |
| Vomiting | 3 (13.0) | 0 (0.0) |
| Supraventricular tachycardia | 2 (8.7) | 2 (8.7) |
a
Any grade occurring in two or more patients. Presented by preferred term.
b
Consolidated term including abdominal pain (4 patients), abdominal pain upper (1 patient), and hepatic pain (1 patient).
c
Consolidated term including maculopapular rash (3 patients), dermatitis (1 patient), and follicular rash (1 patient).
Abbreviation: TEAE, treatment‐emergent adverse event.