Summary of bleeding episodes by time after prophylactic BAX 855 infusions
| Cause of bleeding episode parameter . | Time since last prophylactic infusion . | ||||
|---|---|---|---|---|---|
| ≤24 h . | >24 to ≤48 h . | >48 to ≤72h . | >72 to ≤96 h . | >96 h . | |
| NA | |||||
| Number of infusions in analysis | 5907 | 5862 | 5763 | 4297 | 1338 |
| Spontaneous/ unknown | |||||
| Number of bleeding episodes | 26 | 40 | 42 | 25 | 24 |
| Bleeding episodes per prophylactic infusion | 0.0044 | 0.0068 | 0.0073 | 0.0058 | 0.0179 |
| Injury | |||||
| Number of bleeding episodes | 21 | 30 | 30 | 9 | 15 |
| Bleeding episodes per prophylactic infusion | 0.0036 | 0.0051 | 0.0052 | 0.0021 | 0.0112 |
| All | |||||
| Number of bleeding episodes | 47 | 70 | 72 | 34 | 39 |
| Bleeding episodes per prophylactic infusion | 0.0080 | 0.0119 | 0.0125 | 0.0079 | 0.0291 |
| Cause of bleeding episode parameter . | Time since last prophylactic infusion . | ||||
|---|---|---|---|---|---|
| ≤24 h . | >24 to ≤48 h . | >48 to ≤72h . | >72 to ≤96 h . | >96 h . | |
| NA | |||||
| Number of infusions in analysis | 5907 | 5862 | 5763 | 4297 | 1338 |
| Spontaneous/ unknown | |||||
| Number of bleeding episodes | 26 | 40 | 42 | 25 | 24 |
| Bleeding episodes per prophylactic infusion | 0.0044 | 0.0068 | 0.0073 | 0.0058 | 0.0179 |
| Injury | |||||
| Number of bleeding episodes | 21 | 30 | 30 | 9 | 15 |
| Bleeding episodes per prophylactic infusion | 0.0036 | 0.0051 | 0.0052 | 0.0021 | 0.0112 |
| All | |||||
| Number of bleeding episodes | 47 | 70 | 72 | 34 | 39 |
| Bleeding episodes per prophylactic infusion | 0.0080 | 0.0119 | 0.0125 | 0.0079 | 0.0291 |
A bleeding episode at more than 96 hours could occur only if the subject deviated from the protocol-specified infusion interval, as 96 hours was the maximum. The analysis was performed on the full analysis set, which included subjects with prophylactic infusion intervals for 5 days or longer.