Table 3.
Treatment-related AEs with maximum CTC grade ≥3, in cycle 1 and all cycles. The numbers of patients are shown for grades 3 and 4 AEs separately, and for all grades
| Figitumumab dose level | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6 mg/kg (n = 6) | 10 mg/kg (n = 7) | 20 mg/kg (n = 6) | ||||||||||||||||
| Cycle 1 | All cycles | Cycle 1 | All cycles | Cycle 1 | All cycles | |||||||||||||
| All | G3 | G4 | All | G3 | G4 | All | G3 | G4 | All | G3 | G4 | All | G3 | G4 | All | G3 | G4 | |
| AEs, hematologic | ||||||||||||||||||
| Anemia | 4 | 0 | 0 | 5 | 0 | 0 | 3 | 0 | 0 | 3 | 1 | 0 | 4 | 0 | 0 | 5 | 1 | 0 |
| Leukopenia | 6 | 0 | 0 | 6 | 1 | 0 | 6 | 1 | 0 | 6 | 1 | 0 | 5 | 0 | 0 | 6 | 2 | 0 |
| Neutropenia | 6 | 2a | 3 | 6 | 0 | 5 | 6 | 1 | 2 | 6 | 3 | 2 | 5 | 2 | 1 | 6 | 2 | 4 |
| Thrombocytopenia | 4 | 0 | 1 | 5 | 0 | 1 | 5 | 0 | 1 | 5 | 0 | 1 | 4 | 1 | 0 | 6 | 1 | 1 |
| AEs, non-hematologic | ||||||||||||||||||
| Anorexia | 2 | 1 | 0 | 3 | 2 | 0 | 5 | 0 | 0 | 6 | 0 | 0 | 5 | 0 | 0 | 5 | 0 | 0 |
| Diarrhea | 3 | 0 | 0 | 3 | 0 | 0 | 1 | 0 | 0 | 2 | 1 | 0 | 3 | 0 | 0 | 4 | 0 | 0 |
| Hyperkalemia | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hypermagnesemia | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hypersensitivity | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hyperuricemia | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 2 | 0 | 1 | 2 | 0 | 1 | 2 | 0 | 1 |
| Hyponatremia | 2 | 1 | 0 | 2 | 1 | 0 | 1 | 1 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 3 | 1 | 0 |
| Peripheral sensory neuropathy | 3 | 0 | 0 | 5 | 0 | 0 | 4 | 0 | 0 | 5 | 0 | 0 | 2 | 0 | 0 | 6 | 1 | 0 |
| Vomiting | 1 | 0 | 0 | 2 | 1 | 0 | 2 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
AE adverse event, All all grades, CTC Common Terminology Criteria, G grade
aTwo patients with grade 3 neutropenia during cycle 1 experienced worsening of symptoms to grade 4 after cycle 2