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. 2015 Jul 8;126(9):1078–1085. doi: 10.1182/blood-2015-03-630897

Table 3.

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

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.