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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