Table 3.
Adverse Event | Any Grade | Grade 3/4 |
---|---|---|
Any AE | 55 (47.0%) | 8 (6.8%) |
Hypothyroidism | 9 (7.7%) | 0 |
Fatigue | 5 (4.3%) | 0 |
Skin rash | 5 (4.3%) | 2 (1.7%) |
Anemia | 4 (3.4%) | 1 (0.9%) |
AST/ALT elevated | 3 (2.6%) | 1 (0.9%) |
Nausea | 3 (2.6%) | 0 |
Abdominal pain | 3 (2.6%) | 0 |
Dyspnea | 3 (2.6%) | 0 |
Colitis | 2 (1.7%) | 1 (0.9%) |
Neutropenia | 2 (1.7%) | 1 (0.9%) |
Thrombocytopenia | 2 (1.7%) | 0 |
Hyperphosphatemia | 2 (1.7%) | 0 |
Hypoalbuminemia | 2 (1.7%) | 0 |
Renal insufficiency | 2 (1.7%) | 0 |
Cough | 2 (1.7%) | 0 |
Hyperthyroidism | 1 (0.9%) | 0 |
Pneumonitis with pulmonary edema | 1 (0.9%) | 1 (0.9%) |
Constipation | 1 (0.9%) | 0 |
Vomiting | 1 (0.9%) | 0 |
Dizziness | 1 (0.9%) | 0 |
Guillain-Barré syndrome | 1 (0.9%) | 1 (0.9%) |
Any AE leading to discontinuation | ||
Guillain-Barre syndrome | 1 | 1 |
Colitis | 1 | 1 |
Pneumonitis with pulmonary edema | 1 | 1 |
AE, adverse events; AST, aspartate aminotransferase; ALT, alanine aminotransferase.