Table 2.
Adverse events on study and reported relationship to study drug.
| System organ class | Adverse event (preferred term) | Number of events | CTC severity scale | Relationship to study drug* |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | 1 | 2 | 3 | 4 | 5 | |||
| Total numbers | 51 | 25 | 17 | 9 | 18 | 14 | 11 | 8 | ||||
| Blood and lymphatic disorders | 2 | 2 | 2 | |||||||||
| Lymphopenia | 2 | 2 | 2 | |||||||||
| Endocrine disorders | 1 | 1 | 1 | |||||||||
| Hyperglycemia | 1 | 1 | 1 | |||||||||
| Gastrointestinal disorders | 12 | 5 | 2 | 5 | 1 | 3 | 8 | |||||
| Abdominal pain | 1 | 1 | 1 | |||||||||
| Diarrhea | 4 | 2 | 2 | 1 | 3 | |||||||
| Gastritis | 2 | 1 | 1 | 2 | ||||||||
| Nausea | 2 | 1 | 1 | 2 | ||||||||
| Proctalgia | 1 | 1 | 1 | |||||||||
| Vomiting | 2 | 2 | 1 | 1 | ||||||||
| General disorders and administration site reactions | 1 | 1 | 1 | |||||||||
| Fatigue | 1 | 1 | 1 | |||||||||
| Hepatobiliary disorder | 10 | 5 | 4 | 1 | 7 | 3 | ||||||
| Hyperbilirubinemia | 10 | 5 | 4 | 1 | 7 | 3 | ||||||
| Infections and infestations | 1 | 1 | 1 | |||||||||
| Bronchitis | 1 | 1 | 1 | |||||||||
| Investigations | 14 | 8 | 5 | 1 | 13 | 1 | ||||||
| Alanine aminotransferase | 1 | 1 | 1 | |||||||||
| Aspartate aminotransferase | 2 | 2 | 2 | |||||||||
| Blood creatinine | 1 | 1 | 1 | |||||||||
| Blood alkaline phosphatase | 6 | 4 | 2 | 6 | ||||||||
| Hemoglobin | 1 | 1 | 1 | |||||||||
| Platelet count | 2 | 1 | 1 | 2 | ||||||||
| White blood count | 1 | 1 | 1 | |||||||||
| Metabolism and nutrition disorders | 3 | 1 | 2 | 3 | ||||||||
| Hypoalbuminemia | 1 | 1 | 1 | |||||||||
| Hypocalcemia | 1 | 1 | 1 | |||||||||
| Hypophosphatemia | 1 | 1 | 1 | |||||||||
| Musculoskeletal and connective tissue disorders | 2 | 2 | 2 | |||||||||
| Muscular weakness | 1 | 1 | 1 | |||||||||
| Musculoskeletal chest pain | 1 | 1 | 1 | |||||||||
| Respiratory, thoracic, and mediastinal disorders | 3 | 1 | 2 | 3 | ||||||||
| Chest pain | 2 | 1 | 1 | 2 | ||||||||
| Pleural effusion | 1 | 1 | 1 | |||||||||
| Skin and subcutaneous disorders | 2 | 2 | 1 | 1 | ||||||||
| Dermatitis acneiform | 1 | 1 | 1 | |||||||||
| Exfoliative rash | 1 | 1 | 1 | |||||||||
*Relationship to study drug: 1: not related, 2: unlikely related, 3: possibly related, 4: probably related, and 5: definitely related.