Table 2.
Treatment-related adverse events: worst grade per patient in all cycles in at least 10% of all patients, n (%)
| Adverse event | Gradea | Total | ||||
|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | ||
| Blood and lymphatic system disorders | ||||||
| Hypertension | 3 (16.7) | 1 (5.6) | 2 (11.1) | 0 | 0 | 6 (33.3) |
| Vaginal hemorrhage | 2 (11.1) | 0 | 0 | 0 | 0 | 2 (11.1) |
| Endocrine disorders | ||||||
| Hypothyroidism | 7 (38.9) | 0 | 0 | 0 | 0 | 7 (38.9) |
| Metabolism and nutrition disorders | ||||||
| Hypertriglyceridemia | 5 (27.8) | 1 (5.6) | 0 | 0 | 0 | 6 (33.3) |
| Decreased appetite | 0 | 2 (11.1) | 0 | 0 | 0 | 2 (11.1) |
| Respiratory, thoracic, and mediastinal disorders | ||||||
| Dysphonia | 2 (11.1) | 0 | 0 | 0 | 0 | 2 (11.1) |
| Gastrointestinal disorders | ||||||
| Nausea | 4 (22.2) | 0 | 0 | 0 | 0 | 4 (22.2) |
| Abdominal pain | 2 (11.1) | 0 | 0 | 0 | 0 | 2 (11.1) |
| Diarrhea | 2 (11.1) | 1 (5.6) | 0 | 0 | 0 | 3 (16.7) |
| Mouth ulceration | 1 (5.6) | 1 (5.6) | 0 | 0 | 0 | 2 (11.1) |
| Renal and urinary disorders | ||||||
| Proteinuria | 8 (44.4) | 0 | 0 | 0 | 0 | 8 (44.4) |
| Hematuria | 7 (38.9) | 0 | 0 | 0 | 0 | 7 (38.9) |
| Skin and subcutaneous tissue disorders | ||||||
| Rash | 1 (5.6) | 1 (5.6) | 0 | 0 | 0 | 2 (11.1) |
| Palmar-plantar erythrodysesthesia syndrome | 1 (5.6) | 1 (5.6) | 0 | 0 | 0 | 2 (11.1) |
| General disorders and administration site conditions | ||||||
| Fatigue | 7 (38.9) | 4 (22.2) | 0 | 0 | 0 | 11 (61.1) |
| Lab examinations | ||||||
| Leucopenia | 2 (11.1) | 1 (5.6) | 0 | 0 | 0 | 3 (16.7) |
| ALT increased | 2 (11.1) | 0 | 0 | 0 | 0 | 2 (11.1) |
| Amylase increased | 3 (16.7) | 1 (5.6) | 0 | 0 | 0 | 4 (22.2) |
| Conjugated bilirubin increased | 5 (27.8) | 0 | 0 | 0 | 0 | 5 (27.8) |
| Neutropenia | 2 (11.1) | 0 | 2 (11.1) | 0 | 0 | 4 (22.2) |
| AST increased | 3 (16.7) | 0 | 0 | 0 | 0 | 3 (16.7) |
| Hyperbilirubinemia | 2 (11.1) | 0 | 0 | 0 | 0 | 2 (11.1) |
| Unconjugated bilirubin increased | 2 (11.1) | 0 | 0 | 0 | 0 | 2 (11.1) |
| Blood urea increased | 2 (11.1) | 0 | 0 | 0 | 0 | 2 (11.1) |
| Thrombocytopenia | 2 (11.1) | 0 | 0 | 0 | 0 | 2 (11.1) |
Patients with multiple events in the same category are counted only once in that category; patients with events in more than one category are counted once in each of those categories
ALT alanine amino-transferase, AST aspartate amino-transferase
aGraded per National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0