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To collect and characterise the incidence of adverse events related to the safety specifications of the maintenance treatment after platinum-based chemotherapy in patients with BRCA mutated pancreatic cancer under the actual post-marketing use of LYNPAZA.
To collect and characterise the incidence of adverse events related to the safety specifications*1 of the maintenance treatment after platinum-based chemotherapy in patients with BRCA mutated pancreatic cancer under the actual post-marketing use of LYNPAZA.
This investigation will be conducted for application for re-examination specified in Article 14-4 of the Pharmaceutical Affairs Law.
*1: Bone marrow depression, interstitial lung disease, new primary malignancies, and embryofoetal toxicity
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events related to the safety specifications | Safety specifications:Bone marrow depression, interstitial lung disease, new primary malignancies, and embryofoetal toxicity | from baseline to 1year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients on maintenance treatment after platinum-based chemotherapy for BRCA mutated curatively unresectable pancreas cancer
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| Name | Affiliation | Role |
|---|---|---|
| Toshimitsu Tokimoto | Astrazeneca KK | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Osaka | Lyn010001 | D081FC00004 | 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 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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| Kanagawa |
| Lyn010003 |
| D081FC00004 |
| Japan |
| Research Site | Okayama | Lyn010004 | D081FC00004 | Japan |
| Research Site | Akita | Lyn010005 | D081FC00004 | Japan |
| Research Site | Niigata | Lyn010006 | D081FC00004 | Japan |
| Research Site | Shizuoka | Lyn010007 | D081FC00004 | Japan |
| Research Site | Niigata | Lyn010008 | D081FC00004 | Japan |
| Research Site | Tokyo | Lyn010009 | D081FC00004 | Japan |
| Research Site | Saitama | Lyn010010 | D081FC00004 | Japan |
| Research Site | Aichi | Lyn010011 | D081FC00004 | Japan |
| Research Site | Osaka | Lyn010012 | D081FC00004 | Japan |
| Research Site | Tokyo | Lyn010013 | D081FC00004 | Japan |
| Research Site | Nara | Lyn010014 | D081FC00004 | Japan |
| Research Site | Wakayama | Lyn010015 | D081FC00004 | Japan |
| Research Site | Miyagi | Lyn010016 | D081FC00004 | Japan |
| Research Site | Tokyo | Lyn010017 | D081FC00004 | Japan |
| Research Site | Osaka | Lyn010018 | D081FC00004 | Japan |
| Research Site | Gunma | Lyn010019 | D081FC00004 | Japan |
| Research Site | Hiroshima | Lyn010020 | Japan |
| Research Site | Tochigi | Lyn010021 | D081FC00004 | Japan |
| Research Site | Numakunai | Lyn010022 | D081FC00004 | Japan |
| Research Site | Osaka | Lyn010025 | D081FC00004 | Japan |
| Research Site | Shizuoka | Lyn010026 | D081FC00004 | Japan |
| Research Site | Nagasaki | Lyn010027 | D081FC00004 | Japan |
| Research Site | Kumamoto | Lyn010028 | D081FC00004 | Japan |
| Research Site | Saitama | Lyn010029 | D081FC00004 | Japan |
| Research Site | Nagano | Lyn010031 | D081FC00004 | Japan |
| Research Site | Hyōgo | Lyn010032 | D081FC00004 | Japan |
| Research Site | Shimane | Lyn010033 | D081FC00004 | Japan |
| Research Site | Hyōgo | Lyn010034 | D081FC00004 | Japan |
| Research Site | Shizuoka | Lyn010035 | D081FC00004 | Japan |
| Research Site | Hyōgo | Lyn010036 | D081FC00004 | Japan |
| Research Site | Okayama | Lyn010038 | D081FC00004 | Japan |
| Research Site | Fukuoka | Lyn010041 | Japan |
| Research Site | Hokkaido | Lyn010042 | Japan |
| Research Site | Ehime | Lyn010044 | Japan |
| Research Site | Osaka | Lyn010045 | Japan |
| Research Site | Shizuoka | Lyn010047 | Japan |
| Research Site | Tokyo | Lyn010050 | Japan |
| Research Site | Aichi | Japan |
| Research Site | Chiba | Japan |
| Research Site | Fukuoka | Japan |
| Research Site | Gunma | Japan |
| Research Site | Hiroshima | Japan |
| Research Site | Hokkaido | Japan |
| Research Site | Hyōgo | Japan |
| Research Site | Ibaraki | Japan |
| Research Site | Kagawa | Japan |
| Research Site | Kanagawa | Japan |
| Research Site | Kyoto | Japan |
| Research Site | Nagano | Japan |
| Research Site | Nagasaki | Japan |
| Research Site | Nara | Japan |
| Research Site | Okayama | Japan |
| Research Site | Osaka | Japan |
| Research Site | Shizuoka | Japan |
| Research Site | Tokyo | Japan |
| Research Site | Tottori | Japan |
| Research Site | Toyama | Japan |
| Research Site | Yamagata | Japan |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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