Table 4 Safety profile of the patients who were given at least one dose of Pucotenlimab (N = 119)
All patients (N = 119) | Incidence (%) | |
|---|---|---|
TEAEs | 98.3 | |
TRAEs | 77.3 | |
TRAEs reported in ≥ 10% of patients | Any Grade | Grade ≥ 3 |
Thyroid function test abnormal | 26.1 | 0 |
Skin depigmentation | 21.0 | 0 |
Rash | 16.8 | 0.8 |
Aspartate aminotransferase increased | 15.1 | 1.7 |
Hyperlipidaemia | 13.4 | 2.5 |
Blood bilirubin increased | 12.6 | 1.7 |
Alanine aminotransferase increased | 12.6 | 0 |
hypothyroidism | 12.6 | 0 |
SAEs | 21.0 | |
Treatment-related SAEs | 9.2 | |
TEAEs of Grade ≥ 3 | 34.5 | |
TRAEs of Grade ≥ 3 | 15.1 | |
TEAEs leading to treatment interruption | 21.8 | |
TRAEs leading to treatment interruption | 14.3 | |
TEAEs leading to treatment discontinuation | 18.5 | |
TRAEs leading to treatment discontinuation | 6.7 | |
irAEs | 47.9 | |
irAEs reported in ≥ 1% of patients | Any Grade (%) | |
Skin depigmentation | 15.1% | |
Aspartate aminotransferase increased | 10.1% | |
Rash | 10.1% | |
Hypothyroidism | 10.1% | |
irSAEs | 9.2% | |