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The purpose of this study is to describe the following in relation to the safety of Equfina Tablet 50 mg in the post marketing setting: 1. Serious adverse events (SAEs) and adverse drug reactions (ADRs) 2. Unexpected adverse events (AEs) and ADRs not reflected in the precautions for use 3. Known ADRs 4. Non-serious ADRs 5. Other safety and efficacy related information.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Equfina 50 mg | Participants who will be prescribed with Equfina 50 mg tablets, orally within the scope of the approved label for Korea under the medical judgment of the investigator will be observed prospectively for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Equfina 50 mg | Drug | Equfina 50 mg tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With SAEs | A SAE is defined as any untoward medical occurrence: resulting in death; life threatening requiring hospitalization or prolongation of hospitalization; resulting in persistent or significant disability or incapacity; resulting in birth defect or congenital anomaly or medically important due to other reasons than above mentioned criteria. | From first dose of study drug up to 24 weeks |
| Number of Participants With ADRs | An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs. | From first dose of study drug up to 24 weeks |
| Number of Participants With Unexpected AEs | An AE is defined as any untoward and unintended signs (example, anomalies in laboratory test results) or symptoms/diseases occurring during administration/use of drugs, which do not necessarily have a causal relationship with the drug in question. An unexpected AE is an AE with a difference in nature, severity, specificity, or outcome, compared to the product licensure/safety notification of the drug. | From first dose of study drug up to 24 weeks |
| Number of Participants With Unexpected ADRs | An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs. An unexpected ADR is an ADR with difference in the nature or severity, specificity, or the outcome, compared to the product licensure/notification of the drug. | From first dose of study drug up to 24 weeks |
| Number of Participants With Known ADRs |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Score of Clinical Global Impression of Change (CGIC) | The CGIC is a 7-point scale that measures a physician's global impression of a participant's clinical condition. Scale ranges from 1 to 7 with lower scores indicating improvement (1=very much improved, 2=much improved, 3=minimally improved), higher scores indicating worsening (5=minimally worse, 6= much worse, 7=very much worse), and a score of 4 indicating no change. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants administered with Equfina Tablet 50 mg tablet will be enrolled in this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site #23 | Wŏnju | Gangwon-do | South Korea | |||
| Site #11 |
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs. Known ADRs are those listed in product licensure/notification of the drug. |
| From first dose of study drug up to 24 weeks |
| Number of Participants With Non-serious ADRs | An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs. | From first dose of study drug up to 24 weeks |
| Baseline up to 24 weeks |
| Ilsan |
| Gyeonggi-do |
| South Korea |
| Site #22 | Yongin-si | Gyeonggi-do | South Korea |
| Site #06 | Cheonan | Gyeongsangnam-do | South Korea |
| Site #09 | Jinju | Gyeongsangnam-do | South Korea |
| Site #07 | Yangsan | Gyeongsangnam-do | South Korea |
| Site #08 | Iksan | Jeollabuk-do | South Korea |
| Site #17 | Jeonju | Jeollabuk-do | South Korea |
| Site #18 | Jeonju | Jeollabuk-do | South Korea |
| Site #26 | Jeonju | Jeollabuk-do | South Korea |
| Site #03 | Cheongju-si | North Chungcheong | South Korea |
| Site #05 | Busan | South Korea |
| Site #16 | Daegu | South Korea |
| Site #25 | Daegu | South Korea |
| Site #20 | Daejeon | South Korea |
| Site #19 | Gwanju | South Korea |
| Site #24 | Incheon | South Korea |
| Site #02 | Jeju City | South Korea |
| Site #21 | Sejong | South Korea |
| Site #01 | Seoul | South Korea |
| Site #04 | Seoul | South Korea |
| Site #10 | Seoul | South Korea |
| Site #12 | Seoul | South Korea |
| Site #13 | Seoul | South Korea |
| Site #14 | Seoul | South Korea |
| Site #15 | Seoul | South Korea |
| Site #27 | Ulsan | South Korea |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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