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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic heart failure who use Forxiga for the first time.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Aichi | Japan | ||||
| Research Site |
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| Label | URL |
|---|---|
| CSR Synopsis Redacted D1699C00017 | View source |
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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.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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| 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 |
| Research Site | Hiroshima | Japan |
| Research Site | Hokkaido | Japan |
| Research Site | Hyōgo | Japan |
| Research Site | Ibaraki | Japan |
| Research Site | Ishikawa | Japan |
| Research Site | Kagawa | Japan |
| Research Site | Kagoshima | Japan |
| Research Site | Kanagawa | Japan |
| Research Site | Kochi | Japan |
| Research Site | Kumamoto | Japan |
| Research Site | Kyoto | Japan |
| Research Site | Mie | Japan |
| Research Site | Miyagi | Japan |
| Research Site | Miyazaki | Japan |
| Research Site | Nagano | Japan |
| Research Site | Nagasaki | Japan |
| Research Site | Nara | Japan |
| Research Site | Numakunai | Japan |
| Research Site | Okayama | Japan |
| Research Site | Okinawa | Japan |
| Research Site | Osaka | Japan |
| Research Site | Ōita | Japan |
| Research Site | Saga | Japan |
| Research Site | Saitama | Japan |
| Research Site | Shiga | Japan |
| Research Site | Shimane | Japan |
| Research Site | Shizuoka | Japan |
| Research Site | Tochigi | Japan |
| Research Site | Tokushima | Japan |
| Research Site | Tokyo | Japan |
| Research Site | Toyama | Japan |
| Research Site | Wakayama | Japan |
| Research Site | Yamagata | Japan |
| Research Site | Yamaguchi | Japan |
| Research Site | Yamanashi | Japan |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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