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To identify the following items through the post marketing surveillance under routine clinical practice after marketing authorization of Brilinta Tablet: the occurrence of unrevealed Serious Adverse Events (SAEs), current status of occurrence of Adverse Events (AEs), the factors that may influence safety and efficacy of the drug.
A Post Marketing Surveillance to evaluate the safety and efficacy of Brilinta
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Unstable angina, Non ST-segment Elevation Myocardial Infarction or ST-segment elevation myocardial infarction including patients managed medically, and those who are managed with percutaneous coronary intervention or coronary artery by-pass grafting |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Hemorrhage events | up to 54 months | |
| Number of other AEs | up to 54 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Stroke events | for efficacy | up to 54 months |
| Number of Cardiovascular (CV) related deaths events | for efficacy | up to 54 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who take Brilinta according to the local approval condition
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| Name | Affiliation | Role |
|---|---|---|
| JooWon Lee | AstraZeneca Korea | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Cheonan-si | Chungcheongnam-do | South Korea | |||
| Research Site |
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| Label | URL |
|---|---|
| CSR Synopsis | View source |
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| Number of Myocardial Infarction events | for efficacy | up to 54 months |
| Chuncheon |
| Gangwon-do |
| South Korea |
| Research Site | Wŏnju | Gangwon-do | South Korea |
| Research Site | Ansan-si | Gyeonggi-do | South Korea |
| Research Site | Anyang-si | Gyeonggi-do | South Korea |
| Research Site | Bucheon-si | Gyeonggi-do | South Korea |
| Research Site | Goyang-si | Gyeonggi-do | South Korea |
| Research Site | Koyang-shi | Gyeonggi-do | South Korea |
| Research Site | Seongnam-si | Gyeonggi-do | South Korea |
| Research Site | Suwon | Gyeonggi-do | South Korea |
| Research Site | Andong | Gyeongsangbuk-do | South Korea |
| Research Site | Gumi | Gyeongsangbuk-do | South Korea |
| Research Site | Gimhae | Gyeongsangnam-do | South Korea |
| Research Site | Iksan-si | Jeollabuk-do | South Korea |
| Research Site | Jeonju | Jeollabuk-do | South Korea |
| Research Site | Suncheon-si | Jeollanam-do | South Korea |
| Research Site | Busan | South Korea |
| Research Site | Daegu | South Korea |
| Research Site | Daejeon | South Korea |
| Research Site | Gwangju | South Korea |
| Research Site | Incheon | South Korea |
| Research Site | Seoul | South Korea |
| Research Site | Ulsan | South Korea |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D000789 | Angina, Unstable |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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