Table IV.
Hematological and non-hematological adverse events (total number of regorafenib administrations was 58).
| Dose groups | ||||||
|---|---|---|---|---|---|---|
| Adverse events | Total (n=20) | 160 mg (n=8) | 120 mg (n=12) | |||
| Hematological | Any | Grade 3 | Any | Grade 3 | Any | Grade 3 |
| Leukocytopenia | 6 (30.0) | 2 (25.0) | 4 (33.3) | |||
| Neutropenia | 4 (20.0) | 1 (5.0) | 2 (25.0) | 1 (25.0) | 2 (16.7) | |
| Anemia | 5 (25.0) | 3 (37.5) | 2 (16.7) | |||
| Thrombocytopenia | 2 (10.0) | 1 (12.5) | 1 (8.3) | |||
| Increased AST | 5 (25.0) | 2 (25.0) | 3 (25.0) | |||
| Increased ALT | 6 (30.0) | 3 (75.0) | 3 (25.0) | |||
| Increased γ-GT | 5 (25.0) | 3 (75.0) | 2 (16.7) | |||
| Hyperbilirubinemia | 2 (10.0) | 1 (12.5) | 1 (8.3) | |||
| Increased LDH | 5 (25.0) | 3 (37.5) | 2 (16.7) | |||
| Increased ALP | 2 (10.0) | 1 (12.5) | 1 (8.3) | |||
| Electrolyte disorders | ||||||
| Hyponatremia | 2 (10.0) | 1 (12.5) | 1 (8.3) | |||
| Hypokalemia | 1 (5.0) | 1 (8.3) | ||||
| Non-hematological | ||||||
| Gastrointestinal disorder | ||||||
| Nausea/vomiting | 3 (15.0) | 2 (25.0) | 1 (8.3) | |||
| Anorexia | 4 (20.0) | 3 (37.5) | 1 (8.3) | |||
| Diarrhea | 1 (5.0) | 1 (12.5) | ||||
| Stomatitis | 6 (30.0) | 3 (37.5) | 3 (25.0) | |||
| Small intestinal hemorrhage | 1 (12.5) | 1 (12.5) | 1 (12.5) | |||
| General disorders | ||||||
| General fatigue | 9 (45.0) | 6 (75.0) | 3 (25.0) | |||
| Alopecia | 3 (15.0) | 2 (25.0) | 1 (8.3) | |||
| Skin and subcutaneous disorders | ||||||
| HFSR | 18 (90.0) | 8 (40.0) | 8 (100.0) | 6 (75.0) | 10 (83.3) | 2 (16.7) |
| Nervous system disorders | ||||||
| Peripheral sensory neuropathy | 2 (10.0) | 1 (12.5) | 1 (8.3) | |||
| Hypertension | 4 (20.0) | 1 (5.0) | 2 (25.0) | 2 (16.7) | 1 (8.3) | |
AST, aspartate aminotransferase; ALT, alanine aminotransferase; γ-GT, γ-glutamyl transpeptidase; LDH, lactate dehydrogenase; ALP, alkaline phosphatase; HFSR, hand-foot skin reaction.