Post-Marketing Surveillance of Prazaxa® on the Long-term Use in Patients With Nonvalvular Atrial Fibrillation

Boehringer Ingelheim6,772 enrolled

Overview

To investigate the safety and efficacy of long-term use of Prazaxa® Capsules in patients with nonvalvular atrial fibrillation for preventing the occurrence of ischemic stroke or systemic embolism (SEE).

Study Type

OBSERVATIONAL

Enrollment

6,772

Conditions

Atrial Fibrillation

Interventions

PrazaxaDRUG

Dabigatran etexilate

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion criteria: \- Patients with nonvalvular atrial fibrillation who have never received Prazaxa Capsules for preventing the occurrence of ischemic stroke and systemic embolism will be included. Exclusion criteria: \- None

Locations (1164)

Outcomes

Primary Outcomes

Frequency (Percentage) of Participants With Adverse Drug Reactions

Percentage of participants with adverse drug reactions (ADRs) is presented. An ADR is defined as an adverse event (AE) for which either the investigator or the sponsor (or both) assess the causal relationship to Prazaxa® Capsules either as "Related", "Probably related", or "Cannot be denied".

Time frame: Up to 104 weeks from first administration of study drug

Secondary Outcomes

Incidences of Stroke and Systemic Embolism (SEE)

Incidence rate of Stroke and SEE (number of patients per 100 patient year) with 95% confidence interval (CI) is reported. Stroke and SEE were recorded as adverse events (AEs) of special interest. Exact Poisson confidence intervals are presented for incidence rate.

Time frame: Up to 104 weeks from first administration of study drug

Data from ClinicalTrials.gov

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Boehringer Ingelheim Investigational Site 1

Abashiri, Hokkaido, Japan

Boehringer Ingelheim Investigational Site 287

Adachi,Tokyo, Japan

Boehringer Ingelheim Investigational Site 288

Adachi,Tokyo, Japan

Boehringer Ingelheim Investigational Site 289

Adachi,Tokyo, Japan

Boehringer Ingelheim Investigational Site 290

Adachi,Tokyo, Japan

Boehringer Ingelheim Investigational Site 291

Adachi,Tokyo, Japan

Boehringer Ingelheim Investigational Site 292

Adachi,Tokyo, Japan

Boehringer Ingelheim Investigational Site 1141

Aira,Kagoshima, Japan

Boehringer Ingelheim Investigational Site 622

Aisai,Aichi, Japan

Boehringer Ingelheim Investigational Site 111

Aizuwakamatsu,Fukushima, Japan

...and 1154 more locations