N/A
Completed N=5,565
Japanese Pradaxa PMS, Long Term
Source: ClinicalTrials.gov NCT03175198 ↗Enrolled (actual)
5,565
Serious AEs
7.6%
Results posted
Apr 2022
Primary outcomePrimary: Percentage of Patients With Suspected Adverse Drug Reactions (ADRs) — 10.69 Percentage of participants
Summary
The study objective is to confirm appropriate use and safety profile of Prazaxa® Capsules in real-world setting after the availability of idarucizumab
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Suspected Adverse Drug Reactions (ADRs) |
10.69 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female patients with nonvalvular atrial fibrillation who have never received Prazaxa® Capsules / dabigatran etexilate for preventing the occurrence of ischemic stroke and systemic embolism before enrolment in Japan
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT03175198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.