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To capture safety when Forxige is administrated to CKD patients in the real world setting
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 for treatment of CKD.
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of ADRs during use of Forxiga in the real world setting | To be calculated incidence of ADRs related to Forxiga during the observation period | from baseline of 1year |
| Incidence of ADRs which are unexpected from the precautions for use in our JPI | To be calculated incidence of ADRs related to Forxiga during the observation period not expected from the precautions for use of Forxiga JPI | from baseline to 1 year |
| Factors (ie demography, treatment) possibly having an impact on the safety | Factors which may impact incidence of ADRs analysed by patient demographic characteristic (past medical history and concomitant disease etc) | from baseline to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who initiate Forxiga treatment for chronic kidney disease aligned with the approved Japanese label for the first time
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| Name | Affiliation | Role |
|---|---|---|
| Toshimitsu Tokimoto | Astrazeneca KK | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Aichi | Japan | ||||
| Research Site |
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| Label | URL |
|---|---|
| Redacted CSR Synopsis | 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 a 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 | Niigata | 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 |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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