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This Phase 4, prospective, multicenter, non-interventional, regulatory post-marketing surveillance study will collect information on the the safety and effectiveness of atezolizumab under the clinical practice, and update the drug label approved by the MFDS in Korea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants who Receive Atezolizumab | Participants who are administered with atezolizumab as per the local label and standard of care at physician's discretion will be observed for approximately 6 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Participants will receive atezolizumab as per the local label and standard of care at physician's discretion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Approximately 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Response (CR) Assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Approximately 6 years | |
| Percentage of Participants With Partial Response (PR) Assessed per RECIST 1.1 | Approximately 6 years |
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Inclusion Criteria:
Exclusion Criteria:
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Participants who are administered with atezolizumab at physician's discretion will be enrolled for the study.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongnam Inst.of Radiological & Medical Sciences | Busan | 46033 | South Korea | |||
| Inje University Busan Paik Hospital |
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|
| Percentage of Participants With Stable Disease (SD) Assessed per RECIST 1.1 | Approximately 6 years |
| Percentage of Participants With Progressive Disease (PD) Assessed per RECIST 1.1 | Approximately 6 years |
| Busan |
| 47392 |
| South Korea |
| Inje university Haeundae Paik Hospital | Busan | 48108 | South Korea |
| Dong-A University Hospital | Busan | 49201 | South Korea |
| Pusan National University Hospital | Busan | 49241 | South Korea |
| Kosin University Gospel Hospital | Busan | 49267 | South Korea |
| Donga Uni Medical Center; Pulmonary | Busan | 602-715 | South Korea |
| Pusan University Hospital | Busan | 602-739 | South Korea |
| Pusan University Hospital; Hemato-oncology | Busan | South Korea |
| Kyungpook National University Medical Center | Daegu | 41404 | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | 41931 | South Korea |
| Daegu Catholic University Medical Center | Daegu | 42472 | South Korea |
| Keimyung University Dongsan Hospital; Pulmonology | Daegu | 42601 | South Korea |
| Konyang University Hospital | Daejeon | 35365 | South Korea |
| Hallym University Medical Center Chuncheon Sacred Heart Hospital | Gangwon-do | 24253 | South Korea |
| Yonsei University Wonju Severance Christian Hospital | Gangwon-do | 26426 | South Korea |
| Gangneung Asan Hospital | Gangwon-do | South Korea |
| Uijeongbu St. Mary's Hospital | Gyeonggi-do | 11765 | South Korea |
| CHA Bundang Medical Center | Gyeonggi-do | 13496 | South Korea |
| Hallym University Sacred Heart Hospital | Gyeonggi-do | 14068 | South Korea |
| Soonchunhyang University Bucheon Hospital | Gyeonggi-do | 14584 | South Korea |
| Bucheon St Mary's hospital | Gyeonggi-do | 14647 | South Korea |
| Korea University Ansan Hospital | Gyeonggi-do | 15355 | South Korea |
| St. Vincent's Hospital | Gyeonggi-do | 16247 | South Korea |
| Pusan National University Yangsan Hospital | Gyeongsangnam-do | 50612 | South Korea |
| Hallym University Dongtan Sacred Heart Hospital | Hwaseong-si | South Korea |
| Chonbuk National University Hospital | Jeollabuk-do | 54907 | South Korea |
| Chonnam National University Hwasun Hospital | Jeollanam-do | 58128 | South Korea |
| Wonkwang University School of Medicine & Hospital | Jeonlabuk-do | 54538 | South Korea |
| Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences | Seoul | 01812 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Kangbuk Samsung Hospital | Seoul | 03181 | South Korea |
| Eunpyeong St. Mary's Hoapital | Seoul | 03312 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Severance Hospital, Yonsei University | Seoul | 03722 | South Korea |
| Soonchunhyang University Hospital | Seoul | 04401 | South Korea |
| Hanyang University Medical Center | Seoul | 04763 | South Korea |
| Gangdong Kyung Hee University Hospital | Seoul | 05278 | South Korea |
| VHS Medical Center | Seoul | 05368 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Gangnam Severance Hospital | Seoul | 06273 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Seoul St Mary's Hospital | Seoul | 06591 | South Korea |
| ChungAng University Hospital | Seoul | 06973 | South Korea |
| Borame Medical Center | Seoul | 07061 | South Korea |
| Yeouido St. Mary's Hospital | Seoul | 07345 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| Severance Hospital, Yonsei University Health System; Oncology | Seoul | 120-752 | South Korea |
| Samsung Medical Centre; Division of Hematology/Oncology | Seoul | 135-710 | South Korea |
| Ewha Womans University Mokdong Hospital; Urology | Seoul | South Korea |
| Korea Uni Anam Hospital; Internal Medicine | Seoul | South Korea |
| SoonChunHyang University Hospital Seoul | Seoul | South Korea |
| Ulsan University Hosiptal | Ulsan | 44033 | South Korea |
| Ulsan University Hospital | Ulsan | 44033 | South Korea |
| Yonsei University Wonju Severance Christian Hospital | Wŏnju | 220-701 | South Korea |
| Pusan National University Yangsan Hospital; hemato-oncology | Yangsan | South Korea |
| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| D064726 | Triple Negative Breast Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
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