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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