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Table 2 Actions required because of treatment-emergent diarrhea (safety population)

From: Patterns of occurrence and implications of neratinib-associated diarrhea in patients with HER2-positive breast cancer: analyses from the randomized phase III ExteNET trial

Action Neratinib
(N = 1408)
Placebo
(N = 1408)
Hospitalization, N (%) 20 (1.4) 1 (0.1)
Withdrawn from study, N (%) 23 (1.6) 0
Discontinued study drug, N (%) 237 (16.8) 3 (0.2)
 Grade 1 60 (4.3) 0
 Grade 2 71 (5.0) 2 (0.1)
 Grade 3 106 (7.5) 1 (0.1)
Median (IQR) time to discontinuation, days 20 (9–56) 241 (147–305)
Dose reduction, N (%) 372 (26.4) 8 (0.6)
 Once 239 (17.0) 6 (0.4)
 Twice 96 (6.8) 1 (0.1)
 Three or more timesa 37 (2.6) 1 (0.1)
Median (IQR) time to dose reduction, days 19 (6–53) 99 (18–252)
Dose hold, N (%) 477 (33.9) 26 (1.8)
 Once 263 (18.7) 22 (1.6)
 Twice 97 (6.9) 2 (0.1)
 Three or more times 117 (8.3) 2 (0.1)
Median (IQR) time to dose hold, days 8 (3–29) 64 (19–239)
  1. IQR interquartile range
  2. aAlso included cases of dosing errors and dosing noncompliance