The study objective is to confirm appropriate use and safety profile of Prazaxa® Capsules in real-world setting after the availability of idarucizumab
The study is Post-Marketing Surveillance on the Long-Term Use of Prazaxa® Capsules in Japanese patients with nonvalvular atrial fibrillation after the availability of idarucizumab. Even after the availability of idarucizumab in real clinical practice, appropriate use of Prazaxa® Capsules will continue. The patient population who receive Prazaxa® Capsules and the safety profile of Prazaxa® Capsules is not expected to change. This study investigates appropriate use with prospective investigation in the routine medical practice
Study Type
OBSERVATIONAL
Enrollment
5,660
Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg \[as 2 capsules of 75 mg\] twice a day (b.i.d)) or 220 mg (110 mg \[as 1 capsule of 110 mg\] b.i.d) for a treatment duration of 52 weeks.
Nippon Boehringer Ingelheim Co., Ltd
Tokyo, Japan
Percentage of Patients With Suspected Adverse Drug Reactions (ADRs)
Percentage of patients with suspected adverse drug reactions (ADRs). An adverse drug reaction is defined as a response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility. Percentages were pre-specified to be rounded to two decimal places.
Time frame: From baseline till the last administration + 6 days. Up to 364 days.
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