Table 1. Baseline Participant Demographics and Disease Characteristics.
| Characteristics | Ponatinib (n = 164) | Imatinib (n = 81) |
|---|---|---|
| Age, y | ||
| Median (range) | 54 (19-82) | 52 (19-75) |
| ≥60, No. (%) | 61 (37.2) | 30 (37.0) |
| Sex, No. (%) | ||
| Female | 90 (54.9) | 43 (53.1) |
| Male | 74 (45.1) | 38 (46.9) |
| Eastern Cooperative Oncology Group performance status score, No. (%)a | ||
| 0 (Best) | 72 (43.9) | 33 (40.7) |
| 1 | 85 (51.8) | 43 (53.1) |
| 2 (Worst) | 7 (4.3) | 5 (6.2) |
| Central nervous system disease/extramedullary disease, No. (%)b | 10 (6.1) | 3 (3.7) |
| BCR::ABL1 dominant isoform, No. (%) | ||
| p190 | 114 (69.5) | 53 (65.4) |
| p210 | 40 (24.4) | 25 (30.9) |
| Atypical | 0 | 1 (1.2) |
| Undetermined or not testedc | 10 (6.1) | 2 (2.5) |
| Cardiovascular comorbidities, No. (%)d | ||
| ≥1 | 92 (56.4) | 52 (64.2) |
| ≥2 | 45 (27.6) | 27 (33.3) |
| Hypertensione | 58 (35.6) | 30 (37.0) |
| Diabetes | 39 (23.9) | 24 (29.6) |
| Obesityf | 33 (20.2) | 19 (23.5) |
| Dyslipidemiag | 29 (17.8) | 23 (28.4) |
| History of smokingh | 44 (27.0) | 26 (32.1) |
Eastern Cooperative Oncology Group performance status scores range from 0 to 5, with higher scores indicative of greater disability.
Extramedullary involvement included lymphadenopathy, splenomegaly, skin/gum infiltration, and testicular mass.
Undetermined indicates transcripts were assessed at the central laboratory, but transcript type was not determined. Not tested indicates samples were not received by the central laboratory.
Cardiovascular comorbidities were evaluated in the safety population (ponatinib, n = 163; imatinib, n = 81).
Hypertension was defined as having hypertension, systolic hypertension, or essential hypertension reported as a preferred term in the Standardised MedDRA Queries list for a patient’s medical history.
Obesity was defined as a baseline body mass index ≥30 (calculated as weight in kilograms divided by height in meters squared).
Dyslipidemia was defined as having hypertriglyceridemia, blood cholesterol increased, hypercholesterolemia, hyperlipidemia, dyslipidemia, or low-density lipoprotein increased reported as a preferred term in the Standardized MedDRA Queries list for a patient’s medical history.
History of smoking was not included as a cardiovascular comorbidity when calculating number of patients with multiple comorbidities.