Characteristics and management of diarrhea TEAEs
| Parameter . | Total (n = 465) . |
|---|---|
| Median time to first event (range), d | 2.0 (1-1330) |
| Median duration of an event* (range), d | 2.0 (1-1510) |
| Diarrhea resolved, n (%) | 387 (83) |
| Diarrhea management, n (%) | |
| Received dose reduction | 26 (6) |
| Received dose interruption | 65 (14) |
| No rechallenge | 1 (2) |
| Rechallenge | 64 (99) |
| Successful rechallenge† | 62 (97) |
| Unsuccessful rechallenge‡ | 2 (3) |
| Received concurrent medication | 304 (65) |
| Permanent treatment discontinuation due to diarrhea§ | 6/570 (1) |
| Parameter . | Total (n = 465) . |
|---|---|
| Median time to first event (range), d | 2.0 (1-1330) |
| Median duration of an event* (range), d | 2.0 (1-1510) |
| Diarrhea resolved, n (%) | 387 (83) |
| Diarrhea management, n (%) | |
| Received dose reduction | 26 (6) |
| Received dose interruption | 65 (14) |
| No rechallenge | 1 (2) |
| Rechallenge | 64 (99) |
| Successful rechallenge† | 62 (97) |
| Unsuccessful rechallenge‡ | 2 (3) |
| Received concurrent medication | 304 (65) |
| Permanent treatment discontinuation due to diarrhea§ | 6/570 (1) |
Event defined based on start to stop of diarrhea with no grade change; any change in grade represents a new event.
Successful rechallenge includes patients who did not experience subsequent/persistent diarrhea (n = 8) or experienced subsequent diarrhea that did not lead to treatment discontinuation (n = 54).
Unsuccessful rechallenge indicates treatment discontinuation due to diarrhea following rechallenge with bosutinib.
Includes patients with no rechallenge or unsuccessful rechallenge following dose interruption, as well as those who discontinued treatment because of diarrhea without dose interruption.