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To evaluate the frequency of bone marrow suppression Adverse Drug Reactions (ADRs) in patients with BRCA mutated HER2 negative high recurrent risk breast cancer treated with LYNPARZA for adjuvant treatment in the actual post-marketing use.
To evaluate the frequency of bone marrow suppression Adverse Drug Reactions (ADRs) in patients with BRCA mutated HER2 negative high recurrent risk breast cancer treated with LYNPARZA for adjuvant treatment in the actual post-marketing use.
This investigation will be conducted for application for re-examination specified in Article 14-4 of the Pharmaceutical Affairs Law.
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of bone marrow suppression | from baseline to 1year |
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Inclusion Criteria:
Exclusion Criteria:
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The patients who started treatment with LYNPARZA for "Adjuvant treatment for patients with BRCA-mutated HER2 negative high recurrent risk breast cancer"
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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 |
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 | 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 | Kanagawa | Japan |
| Research Site | Kochi | Japan |
| Research Site | Kumamoto | Japan |
| Research Site | Kyoto | Japan |
| Research Site | Mie | Japan |
| Research Site | Miyagi | 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 | Tokyo | Japan |
| Research Site | Tottori | Japan |
| Research Site | Toyama | Japan |
| Research Site | Wakayama | Japan |
| Research Site | Yamaguchi | Japan |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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