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To capture safety(FN) when IMF is administered to patients with extensive stage small cell lung cancer in clinical practice after launch
To capture the onset (incidence, severity, intervention, outcome, and others) of febrile neutropenia in patients with extensive stage small cell lung cancer who receive durvalumab in combination with platinum agent and etoposide under the actual use.
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of febrile neutropenia (yes/no) and by severity (CTCAE grade) | 16weeks |
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Inclusion Criteria:
-Patients with extensive stage small cell lung cancer who are receiving the product in combination with platinum agent and etoposide.
Exclusion Criteria:
-Patients who have no treatment history with the product (i.e.,durvalumab)
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Patients with extensive stage small cell lung cancer
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| Name | Affiliation | Role |
|---|---|---|
| Toshimitsu Tokimoto | Astrazeneca KK | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Chiba | 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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| ID | Term |
|---|---|
| D018288 | Carcinoma, Small Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Fukuoka |
| Japan |
| Research Site | Gunma | Japan |
| Research Site | Hokkaido | Japan |
| Research Site | Hyōgo | Japan |
| Research Site | Kanagawa | Japan |
| Research Site | Miyagi | Japan |
| Research Site | Nagano | Japan |
| Research Site | Nagasaki | Japan |
| Research Site | Nara | Japan |
| Research Site | Numakunai | Japan |
| Research Site | Okayama | Japan |
| Research Site | Osaka | Japan |
| Research Site | Saitama | Japan |
| Research Site | Shizuoka | Japan |
| Research Site | Tokyo | Japan |
| Research Site | Tottori | Japan |
| Research Site | Wakayama | Japan |