Forxiga HF General Drug Use-Results Study

AstraZeneca1,221 enrolled

Overview

To capture safety when Forxiga is administered to patients with HF in clinical practice after launch.

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

Study Type

OBSERVATIONAL

Enrollment

1,221

Conditions

Heart Failure

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

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

Locations (45)

Outcomes

Primary Outcomes

frequency of adverse drug reactions (ADRs)

Development of ADRs by unexpected from "Precautions for Use" of Forxiga JPI, by SOC, by patient demography and by treatment

Time frame: 1 year

Data from ClinicalTrials.gov

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Research Site

Aichi, Japan

Research Site

Akita, Japan

Research Site

Aomori, Japan

Research Site

Chiba, Japan

Research Site

Ehime, Japan

Research Site

Fukui, Japan

Research Site

Fukuoka, Japan

Research Site

Fukushima, Japan

Research Site

Gifu, Japan

Research Site

Gunma, Japan

...and 35 more locations