Treatment-related adverse events (N=16 patients)
Any grade | Grade 3–4 | |
Any | 12 (75.0%) | 4 (25.0%) |
Serious | 3 (18.8%) | 2 (12.5%) |
Led to discontinuation | 2 (12.5%) | 2 (12.5%) |
Lead to death | 0 (0.0%) | 0 (0.0%) |
>5% of Patients | ||
Alanine aminotransferase increased | 3 (18.8%) | 1 (6.3%) |
Anemia | 3 (18.8%) | 1 (6.3%) |
Aspartate aminotransferase increased | 3 (18.8%) | 1 (6.3%) |
Diarrhea | 3 (18.8%) | 1 (6.3%) |
Fatigue | 3 (18.8%) | 0 (0%) |
Hypothyroidism | 3 (18.8%) | 0 (0%) |
Pneumonitis | 3 (18.8%) | 0 (0%) |
Pruritus | 3 (18.8%) | 0 (0%) |
Rash maculo-papular | 3 (18.8%) | 0 (0%) |
Alkaline phosphatase increased | 2 (12.5%) | 1 (6.3%) |
Hypokalemia | 2 (12.5%) | 1 (6.3%) |
Neutrophil count decreased | 2 (12.5%) | 1 (6.3%) |
Fever | 2 (12.5%) | 0 (0%) |
Hyponatremia | 2 (12.5%) | 0 (0%) |
Infusion-related reaction | 2 (12.5%) | 0 (0%) |
Insomnia | 2 (12.5%) | 0 (0%) |
Lipase increased | 2 (12.5%) | 0 (0%) |
Lymphocyte count decreased | 2 (12.5%) | 0 (0%) |
Nausea | 2 (12.5%) | 0 (0%) |
Vomiting | 2 (12.5%) | 0 (0%) |
Hepatobiliary disorders—other, specify: drug-induced hepatitis | 1 (6.3%) | 1 (6.3%) |
Infections and infestations—other, specify: drug-induced hepatitis | 1 (6.3%) | 1 (6.3%) |
Muscle weakness lower limb | 1 (6.3%) | 1 (6.3%) |
Pneumothorax | 1 (6.3%) | 1 (6.3%) |
Anorexia | 1 (6.3%) | 0 (0%) |
Arthralgia | 1 (6.3%) | 0 (0%) |
Back pain | 1 (6.3%) | 0 (0%) |
Bone pain | 1 (6.3%) | 0 (0%) |
Dry mouth | 1 (6.3%) | 0 (0%) |
Dry skin | 1 (6.3%) | 0 (0%) |
Dysgeusia | 1 (6.3%) | 0 (0%) |
Dyspnea | 1 (6.3%) | 0 (0%) |
Endocrine disorders—other, specify: ACTH increased | 1 (6.3%) | 0 (0%) |
Gastrointestinal pain | 1 (6.3%) | 0 (0%) |
Hepatobiliary disorders—other, specify: immune-mediated hepatitis | 1 (6.3%) | 0 (0%) |
Hyperglycemia | 1 (6.3%) | 0 (0%) |
Hyperthyroidism | 1 (6.3%) | 0 (0%) |
Hypocalcemia | 1 (6.3%) | 0 (0%) |
Neuralgia | 1 (6.3%) | 0 (0%) |
Pain in extremity | 1 (6.3%) | 0 (0%) |
Platelet count decreased | 1 (6.3%) | 0 (0%) |
Pleural effusion | 1 (6.3%) | 0 (0%) |
Rash acneiform | 1 (6.3%) | 0 (0%) |
Serum amylase increased | 1 (6.3%) | 0 (0%) |
Weight loss | 1 (6.3%) | 0 (0%) |
Immune-mediated | 11 (68.8%) | 2 (12.5%) |
Alanine aminotransferase increased | 3 (18.8%) | 1 (6.3%) |
Aspartate aminotransferase increased | 3 (18.8%) | 1 (6.3%) |
Diarrhea | 3 (18.8%) | 1 (6.3%) |
Hypothyroidism | 3 (18.8%) | 0 (0%) |
Pneumonitis | 3 (18.8%) | 0 (0%) |
Pruritus | 3 (18.8%) | 0 (0%) |
Rash maculo papular | 3 (18.8%) | 0 (0%) |
Infusion-related reaction | 2 (12.5%) | 0 (0%) |
Lipase increased | 2 (12.5%) | 0 (0%) |
Arthralgia | 1 (6.3%) | 0 (0%) |
Hyperthyroidism | 1 (6.3%) | 0 (0%) |
Serum amylase increased | 1 (6.3%) | 0 (0%) |