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Table 4 Onset and resolution of diarrhea

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

  EP (n = 425) TPC (n = 406)
Number of patients with diarrheaa, n (%) 281 (66.1) 80 (19.7)
 Grade 1 177 (41.6) 52 (12.8)
 Grade 2 63 (14.8) 23 (5.7)
 Grade 3 41 (9.6) 5 (1.2)
Number of patients with diarrhea related to study druga, n (%) 268 (63.1) 51 (12.6)
 Grade 1 170 (40.0) 36 (8.9)
 Grade 2 59 (13.9) 11 (2.7)
 Grade 3 39 (9.2) 4 (1.0)
Onset of diarrhea grade 2 or higher, n (%)   
 Number of patients 104 28
 ≥60 days 72 (16.9 %) 13 (3.2 %)
 >60–90 days 10 (2.4 %) 8 (2.0 %)
 >90–150 days 11 (2.6 %) 4 (1.0 %)
 >150 days 11 (2.6 %) 3 (0.7 %)
Onset of diarrhea grade 3, n (%)   
 Number of patients 41 5
 ≥60 days 25 (5.9 %) 4 (1.0 %)
 >60–90 days 5 (1.2 %) 1 (0.2 %)
 >90–150 days 5 (1.2 %) 0
 >150 days 6 (1.4 %) 0
  1. aPatients were counted once within each summary level. If a patient had more than one occurrence of the same event, the patient was counted once at the highest grade