Table 3

Treatment-related adverse events (N=16 patients)

Any gradeGrade 3–4
Any12 (75.0%)4 (25.0%)
Serious3 (18.8%)2 (12.5%)
Led to discontinuation2 (12.5%)2 (12.5%)
Lead to death0 (0.0%)0 (0.0%)
>5% of Patients
Alanine aminotransferase increased3 (18.8%)1 (6.3%)
Anemia3 (18.8%)1 (6.3%)
Aspartate aminotransferase increased3 (18.8%)1 (6.3%)
Diarrhea3 (18.8%)1 (6.3%)
Fatigue3 (18.8%)0 (0%)
Hypothyroidism3 (18.8%)0 (0%)
Pneumonitis3 (18.8%)0 (0%)
Pruritus3 (18.8%)0 (0%)
Rash maculo-papular3 (18.8%)0 (0%)
Alkaline phosphatase increased2 (12.5%)1 (6.3%)
Hypokalemia2 (12.5%)1 (6.3%)
Neutrophil count decreased2 (12.5%)1 (6.3%)
Fever2 (12.5%)0 (0%)
Hyponatremia2 (12.5%)0 (0%)
Infusion-related reaction2 (12.5%)0 (0%)
Insomnia2 (12.5%)0 (0%)
Lipase increased2 (12.5%)0 (0%)
Lymphocyte count decreased2 (12.5%)0 (0%)
Nausea2 (12.5%)0 (0%)
Vomiting2 (12.5%)0 (0%)
Hepatobiliary disorders—other, specify: drug-induced hepatitis1 (6.3%)1 (6.3%)
Infections and infestations—other, specify: drug-induced hepatitis1 (6.3%)1 (6.3%)
Muscle weakness lower limb1 (6.3%)1 (6.3%)
Pneumothorax1 (6.3%)1 (6.3%)
Anorexia1 (6.3%)0 (0%)
Arthralgia1 (6.3%)0 (0%)
Back pain1 (6.3%)0 (0%)
Bone pain1 (6.3%)0 (0%)
Dry mouth1 (6.3%)0 (0%)
Dry skin1 (6.3%)0 (0%)
Dysgeusia1 (6.3%)0 (0%)
Dyspnea1 (6.3%)0 (0%)
Endocrine disorders—other, specify: ACTH increased1 (6.3%)0 (0%)
Gastrointestinal pain1 (6.3%)0 (0%)
Hepatobiliary disorders—other, specify: immune-mediated hepatitis1 (6.3%)0 (0%)
Hyperglycemia1 (6.3%)0 (0%)
Hyperthyroidism1 (6.3%)0 (0%)
Hypocalcemia1 (6.3%)0 (0%)
Neuralgia1 (6.3%)0 (0%)
Pain in extremity1 (6.3%)0 (0%)
Platelet count decreased1 (6.3%)0 (0%)
Pleural effusion1 (6.3%)0 (0%)
Rash acneiform1 (6.3%)0 (0%)
Serum amylase increased1 (6.3%)0 (0%)
Weight loss1 (6.3%)0 (0%)
Immune-mediated11 (68.8%)2 (12.5%)
Alanine aminotransferase increased3 (18.8%)1 (6.3%)
Aspartate aminotransferase increased3 (18.8%)1 (6.3%)
Diarrhea3 (18.8%)1 (6.3%)
Hypothyroidism3 (18.8%)0 (0%)
Pneumonitis3 (18.8%)0 (0%)
Pruritus3 (18.8%)0 (0%)
Rash maculo papular3 (18.8%)0 (0%)
Infusion-related reaction2 (12.5%)0 (0%)
Lipase increased2 (12.5%)0 (0%)
Arthralgia1 (6.3%)0 (0%)
Hyperthyroidism1 (6.3%)0 (0%)
Serum amylase increased1 (6.3%)0 (0%)