| Post-Natal Age ≤7 Days | Post-Natal Age 8-28 Days | Total | |||
|---|---|---|---|---|---|
| GA ≤34 Weeks | GA >34 Weeks | GA ≤34 Weeks | GA >34 Weeks | ||
| Number PK Samples | |||||
| Number of Available Fresh Plasma PK Samples | 46 | 60 | 16 | 38 | 160 |
| Number of Non-Plasma PK Samples | 32 | 98 | 20 | 28 | 178 |
| Number of Available Fresh Plasma PK Samples Per Participant | |||||
| 1 | 2 (9.5%) | 2 (7.4%) | 3 (37.5%) | 6 (31.6%) | 13 (17.3%) |
| 2 | 15 (71.4%) | 19 (70.4%) | 2 (25.0%) | 9 (47.4%) | 45 (60.0%) |
| 3 | 2 (9.5%) | 4 (14.8%) | 3 (37.5%) | 2 (10.5%) | 11 (14.7%) |
| 4 | 2 (9.5%) | 2 (7.4%) | 0 | 2 (10.5%) | 6 (8.0%) |
| Number of Available Fresh Plasma PK Samples in Each Sampling Window | |||||
| After IV Dose/Flush | 14 (30.4%) | 14 (23.3%) | 3 (18.8%) | 7 (18.4%) | 38 (23.8%) |
| 1-4 Hours | 0 | 0 | 0 | 6 (15.8%) | 6 (3.8%) |
| 2-5 Hours | 2 (4.3%) | 10 (16.7%) | 0 | 2 (5.3%) | 14 (8.8%) |
| 2-8 Hours | 12 (26.1%) | 8 (13.3%) | 5 (31.3%) | 5 (13.2%) | 30 (18.8%) |
| 3-12 Hours | 1 (2.2%) | 0 | 1 (6.3%) | 0 | 2 (1.3%) |
| Elimination: 24-36 Hours | 4 (8.7%) | 4 (6.7%) | 0 | 1 (2.6%) | 9 (5.6%) |
| Window 3: Pre-Dose | 3 (6.5%) | 5 (8.3%) | 1 (6.3%) | 1 (2.6%) | 10 (6.3%) |
| Drawn Before End of Flush | 1 (2.2%) | 2 (3.3%) | 0 | 1 (2.6%) | 4 (2.5%) |
| Out-of-Window | 9 (19.6%) | 17 (28.3%) | 6 (37.5%) | 15 (39.5%) | 47 (29.4%) |
| Time Until Frozen for Evaluable Fresh Plasma PK Samples (minutes) | |||||
| N | 46 | 60 | 16 | 38 | 160 |
| Mean (SD) | 35.1 (13.7) | 31.5 (11.3) | 35.4 (20.2) | 42.7 (38.0) | 35.6 (22.2) |
| Median (Min-Max) | 33.0 (15.0 - 77.0) | 27.0 (15.0 - 60.0) | 30.0 (16.0 - 80.0) | 31.0 (15.0 - 236.0) | 30.0 (15.0 - 236.0) |
| Samples with Freeze Time > 60 Minutes | 2 (4.3%) | 0 | 2 (12.5%) | 6 (15.8%) | 10 (6.3%) |
Note: Sampling windows are presented in the CSR.
From: 14, TABLES REFERRED TO BUT NOT INCLUDED IN THE TEXT
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