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The objectives of this study are to assess safety and effectiveness of Lynparza tablet (olaparib, hereinafter "the study drug") in a real world setting in patients who are prescribed with the study drug according to the approved indications in South Korea
Primary Objective: To assess the safety of the study drug for patients prescribed with the study drug under the approved indications in South Korea Secondary Objective: To assess effectiveness of the study drug for patients prescribed with the study drug under the approved indication in South Korea Exploratory Objective: To assess effectiveness of the study drug for ovarian cancer patients diagnosed as Homologous Recombination Deficiency (HRD) positive via locally available validated HRD test and prescribed with the study drug under the approved indication in South Korea
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| Measure | Description | Time Frame |
|---|---|---|
| Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions(ADRs), serious ADRs (SADRs), unexpected AEs/ADRs) | For about 1 year since the first dose of the study drug |
| Measure | Description | Time Frame |
|---|---|---|
| 6-month real-world Progression free survival (rwPFS) | In this PMS, the secondary/pre-specified endpoint is not just PFS, but real-world PFS (rwPFS). That means the sponsor cannot claim investigator/patients to visit hospital for study assessment purposes. We, study sponsor, can only assess and record patient's disease progression status when patients visit hospital for their original follow-up. That's why we need further +50% duration for assessing rwPFS. |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year real-world Progression free survival (rwPFS) | for the exploratory objective, "In this PMS, the secondary/pre-specified endpoint is not just PFS, but real-world PFS (rwPFS). That means the sponsor cannot claim investigator/patients to visit hospital for study assessment purposes. We, study sponsor, can only assess and record patient's disease progression status when patients visit hospital for their original follow-up. That's why we need further +50% duration for assessing rwPFS. |
Inclusion Criteria:
Exclusion Criteria:
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On active study drug treatment according to the approved local label.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Ansan | South Korea | ||||
| Research Site |
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| For about 1 year since the first dose of the study drug |
| For about 18 months since the first dose of the study drug |
| Bucheon-si |
| South Korea |
| Research Site | Busan | South Korea |
| Research Site | Changwon | South Korea |
| Research Site | Daegu | South Korea |
| Research Site | Daejeon | South Korea |
| Research Site | Goyang | South Korea |
| Research Site | Gunpo | South Korea |
| Research Site | Hwaseong | South Korea |
| Research Site | Ilsan | South Korea |
| Research Site | Incheon | South Korea |
| Research Site | Jeonju | South Korea |
| Research Site | Seongnam | South Korea |
| Research Site | Seoul | South Korea |
| Research Site | Suwon | South Korea |
| Research Site | Uijeongbu-si | South Korea |
| Research Site | Yangsan | South Korea |
| Research Site | Yongin | South Korea |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D001943 | Breast Neoplasms |
| D011471 | Prostatic Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
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