Table 2.
Baseline characteristics by treatment center.
| Total (n = 44) | Johns Hopkins Hospital (n = 24) | University of Maryland Medical Center (n = 20) | P-value* | |
|---|---|---|---|---|
| Sex, % female | 50 | 37.5 | 65 | 0.129 |
| Age, years, mean (range; SD) | 50.6 (20–87; 16.7) | 50.9 (20–83; 15.2) | 50.3 (23–87; 18.8) | 0.905 |
| Weight, kg, median (range) | 87.7 (52.2–228.5) | 85.2 (52.2–149.5) | 88.3 (61.7–228.5) | 0.962 |
| BMI, kg/m2, median (range) | 30.2 (18.1–62) | 27.5 (18.1–55.7) | 31.4 (22.5–62.0) | 0.311 |
| WHO Obesity Class | Underweight: 1 | Underweight: 1 | Underweight: 0 | |
| Normal: 7 | Normal: 4 | Normal: 3 | ||
| Overweight: 13 | Overweight: 10 | Overweight: 3 | ||
| Obese: 12 | Obese: 2 | Obese: 10 | ||
| Obese II: 3 | Obese II: 1 | Obese II: 2 | ||
| Obese III: 8 | Obese III: 6 | Obese III: 2 | ||
| Starting ATO dose, mg, median (range) | 12 (7.8–20) | 10.5 (7.8–17.0) | 13.0 (9.3–20.0) | 0.006 |
| Starting ATO dose > 10 mg, n (%) | 29 (65.9) | 12 (50.0) | 17 (85.0) | 0.025 |
| Dose, mg/kg, median (range) | 0.15 (0.067–0.157) | 0.144 (0.067–0.157) | 0.149 (0.088–0.157) | 0.015 |
| Baseline AST, IU/L, median (range) | 25 (11–155) | 21.5 (11–39) | 32.5 (15–155) | 0.003 |
| Baseline ALT, IU/L, median (range) | 26.5 (8–173) | 22.5 (8–47) | 35.5 (17–173) | 0.001 |
| Baseline TBILI, mg/dL, median (range) | 0.6 (0.2–3.2) | 0.6 (0.2–3.2) | 0.7 (0.2–1.5) | 0.222 |
| Baseline QTc, msec, median (range) | 415 (296–479) | 415 (381–453) | 416 (296–479) | 0.888 |
| Duration of induction, days, median (range) | 28 (3–67) | 28 (14–67) | 28 (3–34) | 0.953 |
| Cumulative ATO dose during induction mg, mean (range; SD) | 333.5 (140–540; 91.0) | 301.1 (140–514.4; 80.6) | 375.0 (240–540; 88.6) | 0.008 |
| Dose omissions for any reason, n | 6 | 4 | 2 | |
| Dose reductions for any reason, n | 3 | 2 | 1 | |
| CR after induction, n (%) | 41 (93.2) | 23 (95.8) | 18 (90) | 0.583 |
| Relapse, n | 0 | 0 | 0 | |
| Death, n | 3 | 1 | 2 |
WHO: World Health Organization.
*
P-values generated with Mann Whitney U test (non-parametric) and t-test (normally distributed).