Table 3.
Rates and duration of neratinib-associated diarrhea with prophylaxis on the CONTROL trial (Ibrahim et al., 2017).
| Study | CONTROL | ExteNET | ||
|---|---|---|---|---|
|
| ||||
| Antidiarrheal prophylaxis | Loperamide (original + modified) | Budesonide + loperamide | Colestipol + loperamide | Loperamide pm |
| N (at data cut-off) | 137 | 64 | 26 | 1408 |
| Diarrhea, % | ||||
| Any grade | 77.4 | 79.7 | 57.7 | 95.4 |
| Grade 1 | 24.1 | 26.6 | 30.8 | 22.9 |
| Grade 2 | 22.6 | 29.7 | 15.4 | 32.5 |
| Grade 3 | 30.7 | 23.4 | 11.5 | 39.8 |
| Grade 4 | 0 | 0 | 0 | 0.1 |
| Median cumulative duration of diarrhea, days | ||||
| Any grade | 12.0 | 10.0 | 8.0 | 59.0 |
| Grade ≥2 | 4.0 | 3.0 | 2.0 | 10.0 |
| Grade ≥3 | 3.0 | 2.0 | 2.0 | 5.0 |
| Median episodes of diarrhea per patient, n | ||||
| Any grade | 2.0 | 4.0 | 3.0 | 8.0 |
| Grade ≥2 | 2.0 | 2.0 | 2.0 | 3.0 |
| Grade ≥3a | 1.0 | 1.0 | 2.0 | 2.0 |
| Median duration of neratinib treatment, months | 10.6 | 5.1 | 1.7 | 11.6 |
a
No grade 4 events in the CONTROL study; one grade 4 event in the ExteNET study.