Table 2.
Infusion compliance (safety analysis set)
| Pump-Assisted Volume Cohort | 25 mL (N = 15) | 40 mL (N = 2) | 50 mL (N = 11) | |
| Overall compliance (administered dose/planned dose, %) | ||||
| Mean (SD) | 100.3 (1.2) | 100.4 (1.3) | 100.4 (1.4) | |
| Median (min, max) | 100.0 (99.8, 104.5) | 100.1 (99.8, 104.5) | 100.0 (99.8, 104.5) | |
| Compliance level, n (%) | ||||
| < 90% | 0 | 0 | 0 | |
| ≥ 90% | 15 (100.0) | 12 (100.0) | 11 (100.0) | |
| Pump-Assisted Flow Rate Cohort | 25 mL/h (N = 18) | 50 mL/h (N = 14) | 75 mL/h (N = 13) | 100 mL/h (N = 12) |
| Overall compliance (administered dose/planned dose, %) | ||||
| Mean (SD) | 97.3 (10.7) | 98.1 (6.8) | 96.0 (8.8) | 98.5 (16.8) |
| Median (min, max) | 100.0 (54.5, 100.3) | 100.0 (74.7, 100.3) | 100.0 (75.0, 100.4) | 100.0 (50.1, 124.7) |
| Compliance level, n (%) | ||||
| < 90% | 1 (5.6) | 1 (7.1) | 2 (15.4) | 1 (8.3) |
| ≥ 90% | 17 (94.4) | 13 (92.9) | 11 (84.6) | 11 (91.7) |
SD standard deviation