Assigned therapy and treatment discontinuations at follow-up of 24 months
| . | Cohort 1 . | Cohort 2 . | Total . | |||
|---|---|---|---|---|---|---|
| No. . | % . | No. . | % . | No. . | % . | |
| Imatinib assigned at 24 months, mg | 64 | 61 | 51 | 49 | 115 | 55 |
| 400 | 9 | 9 | 13 | 12 | 22 | 11 |
| 600 | 37 | 35 | 32 | 31 | 69 | 33 |
| 800 | 18 | 17 | 6 | 6 | 24 | 11 |
| Nilotinib assigned at 24 months | 25 | 24 | 38 | 36 | 63 | 30 |
| Withdrawn at or before 24 months | 16 | 15 | 16 | 15 | 32 | 15 |
| AE | 3 | 4 | 7 | 3 | ||
| Progression to AP/BC* | 2 | 3 | 5 | 2 | ||
| Death† | 3 | 3 | 1 | |||
| Therapeutic failure‡ | 4 | 3 | 7 | 3 | ||
| Other§ | 7 | 3 | 10 | 5 | ||
| . | Cohort 1 . | Cohort 2 . | Total . | |||
|---|---|---|---|---|---|---|
| No. . | % . | No. . | % . | No. . | % . | |
| Imatinib assigned at 24 months, mg | 64 | 61 | 51 | 49 | 115 | 55 |
| 400 | 9 | 9 | 13 | 12 | 22 | 11 |
| 600 | 37 | 35 | 32 | 31 | 69 | 33 |
| 800 | 18 | 17 | 6 | 6 | 24 | 11 |
| Nilotinib assigned at 24 months | 25 | 24 | 38 | 36 | 63 | 30 |
| Withdrawn at or before 24 months | 16 | 15 | 16 | 15 | 32 | 15 |
| AE | 3 | 4 | 7 | 3 | ||
| Progression to AP/BC* | 2 | 3 | 5 | 2 | ||
| Death† | 3 | 3 | 1 | |||
| Therapeutic failure‡ | 4 | 3 | 7 | 3 | ||
| Other§ | 7 | 3 | 10 | 5 | ||
Progression to AP/BC as a primary cause of withdrawal.
Death as primary cause of withdrawal.
Failure to achieve milestone responses or loss of response, aside from transformation to AP/BC.
The 10 patients in this category discontinued because of protocol violations: failure to comply with therapy (n = 3), withdrawal of consent (n = 3), pregnancy or failure to apply contraception (n = 3), or development of long QTc affecting ability to switch to nilotinib (n = 1).