EU Clinical Trial Information System (CTIS)

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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

Forxiga HF General Drug Use-Results Study

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

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Forxiga Tablets General Drug Use-Results Study in patients with HF

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

Forxiga HF General Drug Use-Results Study

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Documents available

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