Table 2.
Management of Diarrhea Treatment-Emergent AEs (in Patients With ≥1 AE of Diarrhea)
| Parameter | Bosutinib (n = 173) | Imatinib (n = 65) |
|---|---|---|
| Median (range) time to first event, d | 3 (1–591) | 53 (1–1089) |
| Median (range) duration of an eventa d | ||
| Any grade | 3 (1–836) | 6 (1–854) |
| From grade 3/4 to grade 0/1 | 8 (2–103) | 9 (5–13) |
| Cumulative median (range) duration of an episodeb d | 37.0 (1–844) | 16.5 (1–878) |
| Diarrhea management, n (%) | ||
| Received concurrent medication only | 80 (46) | 20 (31) |
| Median (range) duration, d | 2 (1–741) | 4 (1–281) |
| Received dose reduction | 13 (8) | 0 |
| Received dose interruption | 37 (21) | 7 (11) |
| No rechallenge | 2 (5) | 0 |
| Rechallenge | 35 (95) | 7 (100) |
| Successful rechallengec | 35 (100) | 7 (100) |
| Unsuccessful rechallenge | 0 | 0 |
| Discontinued treatment because of diarrhea | 0 | 1/251 (<1) |
AE, adverse event.
a
Event defined based on start to stop of diarrhea with no grade change; any change in grade represents a new event.
b
Episode defined based on start to stop of diarrhea with resolution across grades.
c
Successful rechallenge includes patients who did not experience subsequent diarrhea (bosutinib, n = 9; imatinib, n = 3) or experienced subsequent diarrhea that did not lead to treatment discontinuation (bosutinib, n = 26; imatinib, n = 4).