Table 1 Summary of treatment-emergent diarrhea (safety population)
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) |