Table 1.
Summary of AEs overall and those that occurred after ≥12 months of treatment in patients treated with avelumab in the JAVELIN Bladder 100 trial (data cut-off, 4 June 2021)69,72
| Patients, n (%) | Occurred at any time (n = 344)a | Occurred after ≥12 months of treatment (n = 118)b |
|---|---|---|
| AE of any grade | 338 (98.3) | 102 (86.4) |
| Grade ≥3 AE | 185 (53.8) | 56 (47.5) |
| TRAE of any grade | 269 (78.2) | 59 (50.0) |
| Grade ≥3 TRAE | 67 (19.5) | 14 (11.9) |
| Serious AE | 105 (30.5) | 28 (23.7) |
| Serious TRAE | 35 (10.2) | 6 (5.1) |
| AE leading to interruption of avelumab | 156 (45.3) | 43 (36.4) |
| AE leading to discontinuation | 49 (14.2) | 13 (11.0) |
| TRAE leading to discontinuation | 40 (11.6) | 12 (10.2) |
| AE leading to death | 7 (2.0) | 3 (2.5) |
| TRAE leading to death | 2 (0.6) | 1 (0.8) |
| irAE of any grade | 111 (32.3) | 27 (22.9) |
| Grade ≥3 irAE | 26 (7.6) | 5 (4.2) |
| irAE leading to discontinuation | 21 (6.1) | 5 (4.2) |
AE, adverse event; irAE, immune-related AE; TRAE, treatment-related AE.
a
All treated patients.
b
Patients with ≥12 months of treatment.