Adverse effects during and after cycles 1 and 2
| Event . | Standard treatment . | Bevacizumab 10 mg cohort . | Significance . | ||
|---|---|---|---|---|---|
| Cycle 1 . | Cycle 2 . | Cycle 1 . | Cycle 2 . | ||
| Maximal-grade side effect, no. of patients | P = .23, exact (both cycles together) | ||||
| Grade 2 | 6 | 7 | 7 | 3 | |
| Grade 3 | 61 | 46 | 61 | 39 | |
| Grade 4 | 16 | 10 | 13 | 22 | |
| Maximal-grade bleedings, no. of patients | P = .12, exact (both cycles together) | ||||
| Grade 2 | 5 | 4 | 7 | 5 | |
| Grade 3 | 3 | 2 | 5 | 4 | |
| Grade 4 | 2 | 0 | 1 | 3 | |
| SAEs, n | 18 | 10 | 26 | 37 | P = .043, χ2 |
| Outcome of SAEs in cycles 1 and 2, no of deaths | 13 (46%) | 22 (35%) | P = .465, χ2 | ||
| Outcome of SAEs in cycles 1 and 2, no of deaths or life-threatening events | 21 (75%) | 38 (60%) | P = .347, χ2 | ||
| Early death, n (%) | 8 (9%) | 6 (7%) | |||
| Nights in hospital, n (median) | |||||
| Cycle 1 | 28 | 29 | P = .448, K-W | ||
| Cycle 2 | 30 | 30 | P = .850, K-W | ||
| Platelet transfusions, n (median) | |||||
| Cycle 1 | 8 | 7 | P = .669, K-W | ||
| Cycle 2 | 9 | 9 | P = .612, K-W | ||
| Event . | Standard treatment . | Bevacizumab 10 mg cohort . | Significance . | ||
|---|---|---|---|---|---|
| Cycle 1 . | Cycle 2 . | Cycle 1 . | Cycle 2 . | ||
| Maximal-grade side effect, no. of patients | P = .23, exact (both cycles together) | ||||
| Grade 2 | 6 | 7 | 7 | 3 | |
| Grade 3 | 61 | 46 | 61 | 39 | |
| Grade 4 | 16 | 10 | 13 | 22 | |
| Maximal-grade bleedings, no. of patients | P = .12, exact (both cycles together) | ||||
| Grade 2 | 5 | 4 | 7 | 5 | |
| Grade 3 | 3 | 2 | 5 | 4 | |
| Grade 4 | 2 | 0 | 1 | 3 | |
| SAEs, n | 18 | 10 | 26 | 37 | P = .043, χ2 |
| Outcome of SAEs in cycles 1 and 2, no of deaths | 13 (46%) | 22 (35%) | P = .465, χ2 | ||
| Outcome of SAEs in cycles 1 and 2, no of deaths or life-threatening events | 21 (75%) | 38 (60%) | P = .347, χ2 | ||
| Early death, n (%) | 8 (9%) | 6 (7%) | |||
| Nights in hospital, n (median) | |||||
| Cycle 1 | 28 | 29 | P = .448, K-W | ||
| Cycle 2 | 30 | 30 | P = .850, K-W | ||
| Platelet transfusions, n (median) | |||||
| Cycle 1 | 8 | 7 | P = .669, K-W | ||
| Cycle 2 | 9 | 9 | P = .612, K-W | ||
K-W indicates Kruskal-Wallis.