Endpoint | Etirinotecan pegol (n = 425) | TPC (n = 406) |
---|---|---|
Patients with at least 1 TEAE, n | 417 (98.1 %) | 405 (99.8 %) |
Patients with at least 1 grade 3 or higher TEAEa, n | 204 (48.0 %) | 256 (63.1 %) |
Patients with at least 1 TEAE related to study drug, n | 394 (92.7 %) | 356 (87.7 %) |
Patients with at least 1 TEAE leading to study drug discontinuation | 47 (11.1 %) | 27 (6.7 %) |
Patients with AE(s) leading to deathb, n | 5 (1.2 %) | 8 (2.0 %) |
Patients with at least 1 TESAE, n | 128 (30.1 %) | 129 (31.8 %) |
Patients with at least 1 TESAE related to study drug, n | 52 (12.2 %) | 24 (5.9 %) |