Patient disposition
| . | Nilotinib, n = 134 . | Imatinib, n = 133 . |
|---|---|---|
| Remaining on study* | 129 (96.3) | 128 (96.2) |
| Remaining on treatment | 116 (86.6) | 118 (88.7) |
| Discontinued treatment† | 18 (13.4) | 15 (11.3) |
| Treatment failure‡ | 6 (4.5) | 3 (2.3) |
| Disease progression§ | 4 (3.0) | 6 (4.5) |
| Adverse events | 4 (3.0) | 2 (1.5) |
| Consent withdrawal|| | 4 (3.0) | 1 (0.8) |
| Lost to follow-up | 0 | 1 (0.8) |
| Protocol deviation | 0 | 1 (0.8) |
| Suboptimal response‡ | 0 | 1 (0.8) |
| . | Nilotinib, n = 134 . | Imatinib, n = 133 . |
|---|---|---|
| Remaining on study* | 129 (96.3) | 128 (96.2) |
| Remaining on treatment | 116 (86.6) | 118 (88.7) |
| Discontinued treatment† | 18 (13.4) | 15 (11.3) |
| Treatment failure‡ | 6 (4.5) | 3 (2.3) |
| Disease progression§ | 4 (3.0) | 6 (4.5) |
| Adverse events | 4 (3.0) | 2 (1.5) |
| Consent withdrawal|| | 4 (3.0) | 1 (0.8) |
| Lost to follow-up | 0 | 1 (0.8) |
| Protocol deviation | 0 | 1 (0.8) |
| Suboptimal response‡ | 0 | 1 (0.8) |
Values are n (%).
Patients on treatment or in follow-up (safety or survival) as of cutoff date.
Includes 1 patient in each arm who did not receive study drug.
Per investigator assessment (derived from modified 2009 European LeukemiaNet recommendations8 ).
As a reason for discontinuation, disease progression was defined per investigator judgment, as reported on the end of treatment case report form. Two additional patients in the nilotinib arm progressed to AP/BC on study but did not discontinue treatment due to disease progression (1 patient progressed during follow-up after treatment discontinuation; 1 patient remained on treatment despite progression [protocol deviation]).
At the time of discontinuation due to withdrawal of consent, 1 patient in the nilotinib arm had adverse events related to biochemical abnormalities (grade 1/2 elevations in bilirubin, alanine aminotransferase, and aspartate aminotransferase); the other 4 patients who discontinued due to withdrawal of consent did not have adverse events reported around the time of discontinuation.