Table 2.
Adverse Events at Least Possibly Related to Treatment (n=32 patients)
| Any Grade | Grade 3-5 | |||
|---|---|---|---|---|
| Treatment Related | ||||
| Any | 27 | 84.4% | 16 | 50.0% |
| Serious | 12 | 37.5% | 11 | 34.4% |
| Led to discontinuation | 10 | 31.3% | 8 | 25.0% |
| Led to deatd | 0 | 0.0% | 0 | 0.0% |
| Occurred in ≥5% of patients | ||||
| Fatigue | 9 | 28.1% | 1 | 3.1% |
| Nausea | 9 | 28.1% | 0 | 0.0% |
| Vomiting | 8 | 25.0% | 1 | 3.1% |
| Alkaline phosphatase increased | 7 | 21.9% | 2 | 6.3% |
| Anorexia | 7 | 21.9% | 0 | 0.0% |
| Lymphocyte count decreased | 5 | 15.6% | 1 | 3.1% |
| Platelet count decreased | 5 | 15.6% | 0 | 0.0% |
| Anemia | 4 | 12.5% | 2 | 6.3% |
| Dyspnea | 4 | 12.5% | 1 | 3.1% |
| Generalized muscle weakness | 4 | 12.5% | 0 | 0.0% |
| Weight loss | 4 | 12.5% | 0 | 0.0% |
| Hyperglycemia | 3 | 9.4% | 1 | 3.1% |
| Dizziness | 3 | 9.4% | 0 | 0.0% |
| Dry skin | 3 | 9.4% | 0 | 0.0% |
| Hypoalbuminemia | 3 | 9.4% | 0 | 0.0% |
| Neutrophil count decreased | 3 | 9.4% | 0 | 0.0% |
| White blood cell decreased | 3 | 9.4% | 0 | 0.0% |
| Autoimmune disorder | 2 | 6.3% | 2 | 6.3% |
| Sepsis | 2 | 6.3% | 2 | 6.3% |
| Acute kidney injury | 2 | 6.3% | 1 | 3.1% |
| Endocrine disorders-Other | 2 | 6.3% | 1 | 3.1% |
| Sinusitis | 2 | 6.3% | 1 | 3.1% |
| Blurred vision | 2 | 6.3% | 0 | 0.0% |
| Constipation | 2 | 6.3% | 0 | 0.0% |
| Dry mouth | 2 | 6.3% | 0 | 0.0% |
| Dysgeusia | 2 | 6.3% | 0 | 0.0% |
| Edema limbs | 2 | 6.3% | 0 | 0.0% |
| Fever | 2 | 6.3% | 0 | 0.0% |
| Hypertension | 2 | 6.3% | 0 | 0.0% |
| Hypocalcemia | 2 | 6.3% | 0 | 0.0% |
| Hypokalemia | 2 | 6.3% | 0 | 0.0% |
| Proteinuria | 2 | 6.3% | 0 | 0.0% |
| Skin/subq tissue ds-Other | 2 | 6.3% | 0 | 0.0% |
| Immune-mediated | ||||
| Any | 23 | 71.9% | 12 | 37.5% |
| Hypothyroidism | 10 | 31.3% | 0 | 0.0% |
| AST increased | 8 | 25.0% | 2 | 6.3% |
| Artdralgia | 7 | 21.9% | 1 | 3.1% |
| Diarrhea | 7 | 21.9% | 1 | 3.1% |
| Pruritus | 7 | 21.9% | 0 | 0.0% |
| Rash maculo-papular | 5 | 15.6% | 1 | 3.1% |
| ALT increased | 4 | 12.5% | 3 | 9.4% |
| Lipase increased | 3 | 9.4% | 2 | 6.3% |
| Hyperthyroidism | 3 | 9.4% | 0 | 0.0% |
| Infusion related reaction | 3 | 9.4% | 0 | 0.0% |
| Encephalopathy | 2 | 6.3% | 2 | 6.3% |
| Colitis | 2 | 6.3% | 1 | 3.1% |
| Pancreatitis | 2 | 6.3% | 1 | 3.1% |
| Retinopathy | 1 | 3.1% | 1 | 3.1% |
| Blood bilirubin increased | 1 | 3.1% | 0 | 0.0% |