NCT02946931CompletedNot Applicable
The Drug Use-results Survey (All-Case Surveillance) on Prizbind® for Intravenous Solution 2.5 g in Japan
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 1,402
- Primary Endpoint
- Number of Patients With Adverse Drug Reactions (ADRs)
Study Overview
Brief Summary
To evaluate safety and effectiveness of Prizbind® for Intravenous Solution 2.5 g under Japanese clinical condition.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Prizbind® for Intravenous Solution
Patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.
Intervention: Prizbind® (Drug)
Outcomes
Primary Outcomes
Number of Patients With Adverse Drug Reactions (ADRs)
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.
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.
Secondary Outcomes
- Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT)(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)(From the end of the first infusion up to 4 hours after the last infusion on Day 1.)
Investigators
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