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To characterise the development of ADRs of bone marrow depression in patients under actual post-marketing use
To characterise the development of adverse drug reactions (ADRs) of bone marrow depression in patients with unresectable or recurrent BRCA mutated HER2 negative breast cancer who have previously received anticancer chemotherapy under actual post-marketing use.
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse drug reactions of bone marrow depression | Bone marrow depression will be investigated as safety specification topics | One year period |
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Inclusion Criteria:
Exclusion Criteria:
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Investigation sites mainly consisted of department of surgical related department (surgery, mammary gland surgery, and endocrine surgery, etc.) and department of internal medicine.
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| Name | Affiliation | Role |
|---|---|---|
| Toshimitsu Tokimoto | AstraZeneca KK | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Aichi | D0819C00005 | Japan | |||
| Research Site |
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| Label | URL |
|---|---|
| Related Info | 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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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Aomori |
| D0819C00005 |
| Japan |
| Research Site | Chiba | D0819C00005 | Japan |
| Research Site | Ehime | D0819C00005 | Japan |
| Research Site | Fukui | D0819C00005 | Japan |
| Research Site | Fukuoka | D0819C00005 | Japan |
| Research Site | Gunma | D0819C00005 | Japan |
| Research Site | Hiroshima | D0819C00005 | Japan |
| Research Site | Hokkaido | D0819C00005 | Japan |
| Research Site | Hyōgo | D0819C00005 | Japan |
| Research Site | Ibaraki | D0819C00005 | Japan |
| Research Site | Ishikawa | D0819C00005 | Japan |
| Research Site | Kagawa | D0819C00005 | Japan |
| Research Site | Kagoshima | D0819C00005 | Japan |
| Research Site | Kanagawa | D0819C00005 | Japan |
| Research Site | Kochi | D0819C00005 | Japan |
| Research Site | Kyoto | D0819C00005 | Japan |
| Research Site | Miyagi | D0819C00005 | Japan |
| Research Site | Nagano | D0819C00005 | Japan |
| Research Site | Nara | D0819C00005 | Japan |
| Research Site | Okayama | D0819C00005 | Japan |
| Research Site | Okinawa | D0819C00005 | Japan |
| Research Site | Osaka | D0819C00005 | Japan |
| Research Site | Saitama | D0819C00005 | Japan |
| Research Site | Shiga | D0819C00005 | Japan |
| Research Site | Shimane | D0819C00005 | Japan |
| Research Site | Shizuoka | D0819C00005 | Japan |
| Research Site | Tokyo | D0819C00005 | Japan |
| Research Site | Toyama | D0819C00005 | Japan |
| Research Site | Yamagata | D0819C00005 | Japan |
| Research Site | Yamaguchi | D0819C00005 | Japan |
| D017437 |
| Skin and Connective Tissue Diseases |