Table 2.
Characteristics of patients who developed VAEs vs those without VAEs
| Characteristic | n (%) | P | OR (95% CI) | |
|---|---|---|---|---|
| Patients with VAEs (n = 26) | Patients without VAEs (n = 194) | |||
| Male/female | 15/11 | 115/79 | .99 | 0.94 (0.4-2) |
| Age at nilotinib commencement, y | .014* | |||
| Median | 61 | 53 | ||
| Range | 37-80 | 21-91 | ||
| Duration of nilotinib therapy to time of first VAE, mo | NA | |||
| Median | 19 | |||
| Range | 1-68 | |||
| Mean no. of cardiovascular risk factors per patient | 1.7 | 0.9 | <.001 | |
| Individual cardiovascular risk factors | ||||
| Diabetes | 3 (12) | 19 (10) | .73 | 1.2 (0.3-4.3) |
| Hypertension | 12 (46) | 52 (26) | .06 | 2.3 (0.9-5.3) |
| Smoking history (former or current) | 14 (54) | 59 (30) | .025 | 2.7 (1.2-6.4) |
| History of VAEs | 5 (20) | 20 (10) | .19 | 2.1 (0.8-5.8) |
| Dyslipidemia | 8 (31) | 13 (7) | <.001* | 6.1 (2.2-17.2) |
| Line of therapy† | ||||
| First | 9 (35) | 67 (35) | .99 | |
| Second | 17 (65) | 95 (49) | .15 | |
| First-line therapy, imatinib | 17 | 90 | ||
| First-line therapy, dasatinib | 0 | 5 | ||
| Third | 0 (0) | 32 (16) | .018 | |
| Nilotinib dose at commencement, mg† | ||||
| 800 | 16 (62) | 90 (46) | .21 | |
| 600 | 10 (38) | 80 (41) | .84 | |
| 400 | 0 (0) | 15 (8) | .39 | |
| 300 | 0 (0) | 6 (3) | .99 | |
| 150 | 0 (0) | 2 (1) | .99 | |
| Data not available | 0 (0) | 1 (1) | .99 | |
NA, not applicable.
*
Significant (P < .05) on multivariate analysis.
†
Percentage indicates percentage of patients receiving that line or dose.