Skip to main content

Table 3 Summary of adverse events (safety population)

From: Safety and tolerability of etirinotecan pegol in advanced breast cancer: analysis of the randomized, phase 3 BEACON trial

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 %)
  1. TEAE treatment emergent adverse event, TESAE treatment emergent serious adverse event, TPC treatment of physician’s choice
  2. a P < 0.0001
  3. bAdverse event which is reported as the primary cause of death of the patient