Table 3 Results
Time | Phase 1 | Phase 3 | P value |
|---|---|---|---|
Mean administration time (min) [STD] | 73.6 [34.1] | 33.2 [14.2] | <.0001 |
Median administration time (min) [25–75% IQR] | 70.0 [55.0–95.0] | 30.0 [24.3–38.8] |  |
Pre reconstitution median time (min) [25–75% IQR] | 25.5 [12.8–34.5] | xxx |  |
Post reconstitution median time (min) [25–75% IQR] | 43.5 [31.0–60.0] | xxx |  |
Time | Phase 3 conform (82%) | Phase 3 Non-conform (18%) | P value |
Mean administration time (min) [STD] | 28 [7.8] | 56.9 [12.8] | 0.0002 |
Median administration time (min) [25–75% IQR] | 28.0 [24.0–33.5] | 58.0 [56.5–65.0] |  |
Pre reconstitution median time (min) [25–75% IQR] | 0 [0–0] | xxx |  |
Post reconstitution median time (min) [25–75% IQR] | 28.0 [24.0–33.5] | xxx |  |