Table 2 Actions required because of treatment-emergent diarrhea (safety population)
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Withdrawn from study, N (%) | 23 (1.6) | 0 |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) |