Table 5.
Safety summary of atezolizumab plus bevacizumab, safety-evaluable population
| Atezolizumab + bevacizumab |
|||
|---|---|---|---|
| <65 (n = 171) | ≥65 to <75 (n = 105) | ≥75 (n = 53) | |
| Median treatment duration, months (range) | Atezo = 7.7 (0–28) | Atezo = 9.2 (0–26) | Atezo = 7.8 (0–24) |
| Bev = 6.9 (0–28) | Bev = 8.4 (0–26) | Bev = 6.7 (0–24) | |
| Median dose intensity (%) (range) | Atezo = 97.0 (66–104) | Atezo = 95.0 (64–102) | Atezo = 97.0 (75–100) |
| Bev = 96.0 (27–104) | Bev = 95.0 (39–101) | Bev = 94.0 (58–100) | |
| All-grade AEs, any cause, n (%) | 165 (96.5) | 104 (99.0) | 53 (100) |
| AEs related to any study treatment | 150 (87.7) | 88 (83.8) | 46 (86.8) |
| AEs related to atezolizumab | 137 (80.1) | 82 (78.1) | 45 (84.9) |
| AEs related to bevacizumab | 136 (79.5) | 79 (75.2) | 39 (73.6) |
| Grade 3–4 AEs, n (%) | 100 (58.5) | 69 (65.7) | 38 (71.7) |
| Treatment-related grade 3–4 AEs | 68 (39.8) | 46 (43.8) | 29 (54.7) |
| SAEs, n (%) | 76 (44.4) | 54 (51.4) | 30 (56.6) |
| Treatment-related SAEs | 36 (21.1) | 24 (22.9) | 16 (30.2) |
| Grade 5 AEs, n (%) | 11 (6.4) | 7 (6.7) | 5 (9.4) |
| Treatment-related grade 5 AEs | 2 (1.2) | 2 (1.9) | 2 (3.8) |
| AEs leading to withdrawal from any component, n (%) | 31 (18.1) | 29 (27.6) | 12 (22.6) |
| AEs leading to withdrawal from atezolizumab, n (%) | 16 (9.4) | 14 (13.3) | 9 (17.0) |
| AEs leading to withdrawal from bevacizumab, n (%) | 29 (17.0) | 29 (27.6) | 11 (20.8) |
| AEs leading to withdrawal from both components, n (%) | 13 (7.6) | 13 (12.4) | 8 (15.1) |
| AEs leading to dose interruption of any study treatment, n (%) | 93 (54.4) | 67 (63.8) | 35 (66.0) |
AE, adverse event; atezo, atezolizumab; bev, bevacizumab; SAE, serious adverse event.