Forxiga HF General Drug Use-Results Study
Completed
- Conditions
- Heart Failure
- Registration Number
- NCT04865406
- Lead Sponsor
- AstraZeneca
- Brief Summary
To capture safety when Forxiga is administered to patients with HF in clinical practice after launch.
- Detailed Description
The purpose of the study is to review the following points during use of Forxiga Tablets (hereinafter referred to as Forxiga) in the real world setting after launch.
1. ADRs which are unexpected from the precautions for use
2. Understanding of incidence of ADRs during use of Forxiga in the real world setting
3. Factors possibly having an impact on the safety
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1221
Inclusion Criteria
- Patients aged more than 15 years
- Patients who have been prescribed Forxiga for the first time
Exclusion Criteria
- Patients with a history of hypersensitivity to any ingredients of this drug.
- Patients with severe ketosis, diabetic coma or precoma
- Patients with severe infections, before or after a surgery, or with serious trauma
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method frequency of adverse drug reactions (ADRs) 1 year Development of ADRs by unexpected from "Precautions for Use" of Forxiga JPI, by SOC, by patient demography and by treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇯🇵Yamanashi, Japan