Table 2: Adverse events on study and reported relationship to study drug.

System organ classAdverse event (preferred term)Number of eventsCTC severity scaleRelationship
to study drug*
1234512345

Total numbers51251791814118
Blood and lymphatic disorders222
Lymphopenia222
Endocrine disorders111
Hyperglycemia111
Gastrointestinal disorders12525138
Abdominal pain111
Diarrhea42213
Gastritis2112
Nausea2112
Proctalgia111
Vomiting2211
General disorders and administration site reactions111
Fatigue111
Hepatobiliary disorder1054173
Hyperbilirubinemia1054173
Infections and infestations111
Bronchitis111
Investigations14851131
Alanine aminotransferase111
Aspartate aminotransferase222
Blood creatinine111
Blood alkaline phosphatase6426
Hemoglobin111
Platelet count2112
White blood count 111
Metabolism and nutrition disorders3123
Hypoalbuminemia111
Hypocalcemia111
Hypophosphatemia111
Musculoskeletal and connective tissue disorders222
Muscular weakness 111
Musculoskeletal chest pain 111
Respiratory, thoracic, and mediastinal disorders3123
Chest pain 2112
Pleural effusion111
Skin and subcutaneous disorders2211
Dermatitis acneiform111
Exfoliative rash111

*Relationship to study drug: 1: not related, 2: unlikely related, 3: possibly related, 4: probably related, and 5: definitely related.