Table 3 Grade 3 or above treatment-related TEAEs occurring in at least 4% of patients in the phase Ib and the phase II trials
Preferred term | Phase Ib N (%) | Phase II N (%) | |
|---|---|---|---|
(n=42) | Fruquintinib group (n=47) | Placebo group (n=24) | |
Hypertension | 9 (21.4) | 14 (29.8) | 0 |
HFSR | 4 (9.5) | 7 (14.9) | 0 |
Diarrhea | 4 (9.5) | 1 (2.1) | 0 |
Serum sodium decreased | 3 (7.1) | 0 | 0 |
Fatigue | 2 (4.8) | 2 (4.3) | 0 |
Chest pain | 2 (4.8) | 0 | 0 |
Blood bilirubin increased | 1 (2.4) | 2 (4.2) | 1 (4.2) |
AST increased | 0 | 1 (2.1) | 1 (4.2) |
Platelet count decreased | 0 | 1 (2.1) | 1 (4.2) |
Blood alkaline phosphatase increased | 0 | 0 | 2 (8.3) |
Myalgia | 0 | 0 | 1 (4.2) |
Coma hepatic | 0 | 0 | 1 (4.2) |
Infection | 0 | 0 | 1 (4.2) |