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Table 4 Treatment-related adverse events occurring in mCRC patients during the study in the safety analysis set
| Adverse event | Famitinib group [cases (%)] (n = 99) | Placebo group [cases (%)] (n = 55) | ||
|---|---|---|---|---|
| Any grade | Grade 3–4 | Any grade | Grade 3–4 | |
| Any eventa | 92 (92.9) | 51 (51.5) | 42 (76.4) | 20 (36.4) |
| Clinical adverse event | ||||
| Hypertension | 38 (38.4) | 11 (11.1) | 4 (7.3) | 1 (1.8) |
| Hand-foot syndrome | 27 (27.3) | 10 (10.1) | 1 (1.8) | 0 (0.0) |
| Diarrhea | 15 (15.2) | 1 (1.0) | 3 (5.5) | 0 (0.0) |
| Fatigue | 14 (14.1) | 3 (3.0) | 9 (16.4) | 2 (3.6) |
| Rash | 8 (8.1) | 2 (2.0) | 0 (0.0) | 0 (0.0) |
| Hypothyroidism | 7 (7.1) | 0 (0.0) | 1 (1.8) | 0 (0.0) |
| Oral mucositis | 7 (7.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Nausea | 6 (6.1) | 0 (0.0) | 4 (7.3) | 1 (1.8) |
| Decrease appetite | 6 (6.1) | 0 (0.0) | 5 (9.1) | 0 (0.0) |
| Headache | 6 (6.1) | 1 (1.0) | 2 (3.6) | 1 (1.8) |
| Vomit | 5 (5.1) | 1 (1.0) | 2 (3.6) | 1 (1.8) |
| Dizziness | 5 (5.1) | 0 (0.0) | 2 (3.6) | 0 (0.0) |
| Backache | 3 (3.0) | 0 (0.0) | 3 (5.5) | 0 (0.0) |
| Abdominal distension | 2 (2.0) | 0 (0.0) | 3 (5.5) | 0 (0.0) |
| Cough | 2 (2.0) | 0 (0.0) | 5 (9.1) | 0 (0.0) |
| Laboratory abnormalities | ||||
| Proteinuria | 42 (42.4) | 6 (6.1) | 9 (16.4) | 0 (0.0) |
| Neutropenia | 41 (41.4) | 9 (9.1) | 1 (1.8) | 1 (1.8) |
| Leukopenia | 36 (36.4) | 3 (3.0) | 1 (1.8) | 0 (0.0) |
| Thrombocytopenia | 31 (31.3) | 10 (10.1) | 1 (1.8) | 1 (1.8) |
| Increased γ-GT | 20 (20.2) | 7 (7.1) | 11 (20.0) | 7 (12.7) |
| Increased ALT | 17 (17.2) | 3 (3.0) | 8 (14.5) | 1 (1.8) |
| Increased AST | 16 (16.2) | 2 (2.0) | 7 (12.7) | 0 (0.0) |
| Increased ALP | 14 (14.1) | 0 (0.0) | 6 (10.9) | 2 (3.6) |
| Hypercholesterolemia | 11 (11.1) | 0 (0.0) | 2 (3.6) | 0 (0.0) |
| Hypertriglyceridemia | 11 (11.1) | 0 (0.0) | 2 (3.6) | 0 (0.0) |
| Anemia | 7 (7.1) | 0 (0.0) | 4 (7.3) | 1 (1.8) |
| Increase bilirubin | 5 (5.1) | 1 (1.0) | 1 (1.8) | 0 (0.0) |
| Hyperglycemia | 1 (1.0) | 0 (0.0) | 3 (5.5) | 1 (1.8) |
