Table 3 Summary of adverse events (overall study population)
Outcome | Number of patients (%) | ||
|---|---|---|---|
|  | N = 103 |  | |
All grades | Grade 3 or 4 | Grade 5 | |
TEAEs | 99 (96) | 38 (37) | 3 (3) |
Study drug-related TEAEs | 87 (84) | 16 (16) | 0 |
Related TEAEs with rate ≥ 10% |  |  |  |
Decreased white blood cell count | 17 (17) | 0 | 0 |
Asthenia | 17 (17) | 0 | 0 |
Rash | 16 (16) | 1 (1) | 0 |
Hypothyroidism | 16 (16) | 0 | 0 |
Hyperthyroidism | 12 (12) | 0 | 0 |
Decreased neutrophil count | 12 (12) | 1 (1) | 0 |
Anemia | 12 (12) | 5 (5) | 0 |
SAEs | 27 (26) | 20 (19) | 3 (3) |
Related SAEs | 10 (10) | 9 (9) | 0 |
Related TEAEs leading to discontinuation | 3 (3) | 3 (3) | 0 |
irAEs | 44 (43) | 8 (8) | 0 |
irAEs leading to discontinuation | 3 (3) | 3 (3) | 0 |
Injection site reactions | 9 (9) | 0 | 0 |
 Injection site pain | 2 (2) | 0 | 0 |
 Injection site reaction | 6 (6) | 0 | 0 |
 Injection site swelling | 1 (1) | 0 | 0 |