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The objectives of this study are to assess safety and efficacy of Imfinzi (durvalumab) in a real world setting in patients treated with Imfinzi under the approved indication in Korea.
Primary objective : To assess safety of Imfinzi for patients treated with Imfinzi under the approved indication in Korea
Outcome Measure:
Outcome Measure:
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| Measure | Description | Time Frame |
|---|---|---|
| Safety (AE, SAE, ADR, SADR, AESI, DAE, fatal AE) | safety outcome | for up to 1 year after the first dose of Imfinzi |
| Dose interruptions | Safety outcome | for up to 1 year after the first dose of Imfinzi |
| Duration of treatment | Safety outcome | for up to 1 year after the first dose of Imfinzi |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | efficacy outcome | for up to 1 year after the first dose of Imfinzi |
| Objective response rate (ORR) | efficacy outcome |
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Inclusion Criteria:
Exclusion Criteria:
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Imfinzi treatment according to the approved label
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Anyang-si | South Korea | South Korea | |||
| Research Site |
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| Label | URL |
|---|---|
| CSR Synopsis\_Redacted | 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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| for up to 1 year after the first dose of Imfinzi |
| Duration of response (DoR) | efficacy outcome | for up to 1 year after the first dose of Imfinzi |
| Bucheon-si |
| South Korea |
| South Korea |
| Research Site | Busan | South Korea | South Korea |
| Research Site | Changwon | South Korea | South Korea |
| Research Site | Changwon-si | South Korea | South Korea |
| Research Site | Cheonan | South Korea | South Korea |
| Research Site | Chuncheon | South Korea | South Korea |
| Research Site | Daegu | South Korea | South Korea |
| Research Site | Daejeon | South Korea | South Korea |
| Research Site | Goyang-si | South Korea | South Korea |
| Research Site | Gwangju | South Korea | South Korea |
| Research Site | Hwasun-gun | South Korea | South Korea |
| Research Site | Iksan-si | South Korea | South Korea |
| Research Site | Incheon | South Korea | South Korea |
| Research Site | Jeju-do | South Korea | South Korea |
| Research Site | Jeonju | South Korea | South Korea |
| Research Site | Pohang-si | South Korea | South Korea |
| Research Site | Seongnam-si | South Korea | South Korea |
| Research Site | Seoul | South Korea | South Korea |
| Research Site | Suwon | South Korea | South Korea |
| Research Site | Uijeongbu-si | South Korea | South Korea |
| Research Site | Wŏnju | South Korea | South Korea |
| Research Site | Yangsan | South Korea | South Korea |
| Research Site | Yongin-si | South Korea | South Korea |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D001661 | Biliary Tract Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004067 | Digestive System Neoplasms |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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