Forxiga HF General Drug Use-Results Study

Forxiga Tablets General Drug Use-Results Study in Patients With HF

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04865406

Enrollment

1221

Registered

2021-04-29

Start date

2021-05-10

Completion date

2024-08-22

Last updated

2025-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Japan

Outcome results