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Table 1 Summary 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

Variable Neratinib
(N = 1408)
Placebo
(N = 1408)
Any treatment-emergent diarrhea, N (%) 1343 (95.4) 499 (35.4)
Drug-related diarrhea, N (%) 1330 (94.5) 411 (29.2)
Serious events,a N (%) 22 (1.6) 1 (0.1)
Maximum toxicity, N (%)
 Grade 1 323 (22.9) 382 (27.1)
 Grade 2 458 (32.5) 94 (6.7)
 Grade 3 561 (39.8) 23 (1.6)
 Grade 4 1 (0.1) 0
Outcome of last diarrhea episode, N (%)   
 Resolved 1276 (90.6) 483 (34.3)
 Persistedb 67 (4.8) 16 (1.1)
Median (IQR) time to first onset of diarrhea, days
 Any grade 2 (2–4) 18 (4–82)
 Grade ≥ 2 5 (2–15) 90 (17–189)
 Grade ≥ 3 8 (4–33) 124 (21–257)
Median (IQR) duration of diarrhea per event, days
 Any grade 2 (1–3) 2 (1–3)
 Grade ≥ 2 1 (1–2) 2 (1–2)
 Grade ≥ 3 2 (1–3) 2 (1–4)
Median (IQR) cumulative duration of diarrhea per patient,c days
 Any grade 59 (14–164) 6 (2–34)
 Grade ≥ 2 10 (5–27) 3 (2–7)
 Grade ≥ 3 5 (2–9) 2 (1–5)
Median (IQR) episodes per patient, n
 Any grade 8 (3–27) 2 (1–6)
 Grade ≥ 2 3 (1–8) 1 (1–2)
 Grade ≥ 3 2 (1–3) 1 (1–1)
  1. IQR interquartile range, SD standard deviation
  2. aDefined as any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), or resulted in congenital anomaly/birth defect
  3. bPersisted beyond 28 days after the last dose of study drug
  4. cDefined as the sum of the durations of all episodes of diarrhea of the grade specified