Table 3.
Primary safety end point: microbiological testing of the water from the holding bag
Visit | Total tests | Met specifications, n (%) | Did not meet specifications, n (%) | Missing resultsa, n (%) |
---|---|---|---|---|
All visits | 71 | 68 (95.8) | 0 (0) | 3 (4.2) |
Visit 1 (1.5% dextrose) | 23 | 23 (100.0) | 0 (0) | 0 (0) |
Visit 2 (2.5% dextrose) | 20 | 20 (100.0) | 0 (0) | 0 (0) |
Visit 3 (4.25% dextrose) | 14 | 13 (92.9) | 0 (0) | 1 (7.1) |
Visit 4 (1.5% dextrose) | 14 | 12 (85.7) | 0 (0) | 2 (14.3) |
Missing results comprised: (i) samples that were never collected and (ii) samples that were collected, but had at least 1 parameter that was not able to be analyzed.