To evaluate safety and effectiveness of Prizbind® for Intravenous Solution 2.5 g under Japanese clinical condition.
Study Type
OBSERVATIONAL
Enrollment
1,402
Prizbind®
Unnamed facility
Multiple Locations, Japan
Number of Patients With Adverse Drug Reactions (ADRs)
Adverse reaction was defined as a response to the medicinal product which was noxious and unintended. Number of participants with Adverse Drug Reactions (ADRs) is reported.
Time frame: From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT)
Maximum reversal of anticoagulation as measured by activated partial thromboplastin time (aPTT) is reported. Maximum reversal was calculated as:｛(predose aPTT - minimum postdose aPTT)/(predose aPTT - upper limit of normal (ULN))｝ × 100%. If calculated reversal is \> 100, it was set to 100.
Time frame: From the end of the first infusion up to 4 hours after the last infusion on Day 1.
Number of Patients in Each Category of Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT)
Number of patients in each category of maximum reversal of anticoagulation as measured by activated partial thromboplastin time (aPTT) is reported. Maximum reversal was calculated as:｛(predose aPTT - minimum postdose aPTT)/(predose aPTT - upper limit of normal (ULN))｝ × 100%. If calculated reversal is \> 100, it was set to 100. Maximum Reversal was categorized in the following 4 categories: 100% 80% \<= and \< 100% 50% \<= and \< 80% \< 50%
Time frame: From the end of the first infusion up to 4 hours after the last infusion on Day 1.
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