Safety summary for safety-evaluable patients in the main study and substudy
| . | Main study (N = 382) . | Substudy (n = 34) . | ||
|---|---|---|---|---|
| VenR (n = 194) . | BR (n = 188) . | Retreatment with VenR (n = 25) . | Crossed over to VenR (n = 9) . | |
| Total no. of patients with ≥1 AE, n (%) | 194 (100.0) | 185 (98.4) | 19 (76.0) | 9 (100.0) |
| Total no. of AEs | 2368 | 1877 | 60 | 26 |
| Total no. of deaths, n (%) | 60 (30.9) | 84 (44.7) | 8 (32.0) | 1 (11.1) |
| Total no. of patients withdrawn from study due to an AE, n (%) | 1 (0.5) | 0 | 0 | 0 |
| Total no. of patients with ≥1 AE with fatal outcome, n (%) | 18 (9.3) | 17 (9.0) | 1 (4.0) | 0 |
| Total no. of patients with ≥1 serious AE, n (%) | 101 (52.1) | 84 (44.7) | 13 (52.0) | 5 (55.6) |
| Total no. of patients with ≥1 related serious AE, n (%) | 44 (22.7) | 51 (27.1) | 4 (16.0) | 4 (44.4) |
| Total no. of patients with ≥1 AE leading to withdrawal from any treatment, n (%) | 37 (19.1) | 18 (9.6) | 2 (8.0) | 1 (11.1) |
| Total no. of patients with ≥1 AE leading to dose interruption, n (%) | 136 (70.1) | 76 (40.4) | 10 (40.0) | 8 (88.9) |
| Total no. of patients with ≥1 AE leading to dose reduction, n (%) | 30 (15.5) | 28 (14.9) | 2 (8.0) | 0 |
| Total no. of patients with ≥1 related AE, n (%) | 170 (87.6) | 170 (90.4) | 10 (40.0) | 7 (77.8) |
| Total no. of patients with ≥1 grade 3/4 AE, n (%) | 150 (77.3) | 121 (64.4) | 16 (64.0) | 8 (88.9) |
| . | Main study (N = 382) . | Substudy (n = 34) . | ||
|---|---|---|---|---|
| VenR (n = 194) . | BR (n = 188) . | Retreatment with VenR (n = 25) . | Crossed over to VenR (n = 9) . | |
| Total no. of patients with ≥1 AE, n (%) | 194 (100.0) | 185 (98.4) | 19 (76.0) | 9 (100.0) |
| Total no. of AEs | 2368 | 1877 | 60 | 26 |
| Total no. of deaths, n (%) | 60 (30.9) | 84 (44.7) | 8 (32.0) | 1 (11.1) |
| Total no. of patients withdrawn from study due to an AE, n (%) | 1 (0.5) | 0 | 0 | 0 |
| Total no. of patients with ≥1 AE with fatal outcome, n (%) | 18 (9.3) | 17 (9.0) | 1 (4.0) | 0 |
| Total no. of patients with ≥1 serious AE, n (%) | 101 (52.1) | 84 (44.7) | 13 (52.0) | 5 (55.6) |
| Total no. of patients with ≥1 related serious AE, n (%) | 44 (22.7) | 51 (27.1) | 4 (16.0) | 4 (44.4) |
| Total no. of patients with ≥1 AE leading to withdrawal from any treatment, n (%) | 37 (19.1) | 18 (9.6) | 2 (8.0) | 1 (11.1) |
| Total no. of patients with ≥1 AE leading to dose interruption, n (%) | 136 (70.1) | 76 (40.4) | 10 (40.0) | 8 (88.9) |
| Total no. of patients with ≥1 AE leading to dose reduction, n (%) | 30 (15.5) | 28 (14.9) | 2 (8.0) | 0 |
| Total no. of patients with ≥1 related AE, n (%) | 170 (87.6) | 170 (90.4) | 10 (40.0) | 7 (77.8) |
| Total no. of patients with ≥1 grade 3/4 AE, n (%) | 150 (77.3) | 121 (64.4) | 16 (64.0) | 8 (88.9) |