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The purpose of this post-marketing surveillance is to observe the following items regarding the safety profile of Fycompa (Perampanel) film-coated tablets and oral suspension in normal clinical practice setting: serious adverse event/adverse drug reaction profile, unexpected adverse event/adverse drug reaction profile, already known adverse drug reaction profile, non-serious adverse event profile and other information related to the product's safety and effectiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | Participants who are prescribed Fycompa (Perampanel) film-coated tablets and oral suspension per approved prescribing information in a normal clinical practice setting will be enrolled and observed prospectively for up to 24 Weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | From the first Fycompa (Perampanel) administration date up to 24 weeks | |
| Number of Participants With Adverse Drug Reactions | From the first Fycompa (Perampanel) administration date up to 24 weeks | |
| Number of Participants With Unexpected Adverse Events | From the first Fycompa (Perampanel) administration date up to 24 weeks | |
| Number of Participants With Serious Adverse Events | From the first Fycompa (Perampanel) administration date up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Effective Outcome as Measured by Investigator's Clinical Global Impression of Change (CGI-C) Scores | The CGI-C score is a clinician's rating scale for assessing Global Improvement of Change. The CGI-C rates improvement by 7 categories: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), very much worse (7). The CGI-C score ranges from 1 to 7, with lower scores indicating improvement. Effective outcome is defined as CGI-C score of: very much improved (1), much improved (2), or minimally improved (3). |
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Inclusion Criteria:
Participants with approved indication for Fycompa (Perampanel) in Korea as follows:
Monotherapy (film-coated tablets)
o 4 years and older Partial-onset seizures: therapy for treatment of partial-onset seizures with or without secondarily generalized seizures in participants with epilepsy
Adjunctive therapy (film-coated tablets & oral suspension)
Participants who have written consent for use of personal and medical information for the study purpose
Exclusion Criteria:
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Male and female Korean participants who are prescribed with Fycompa (Perampanel) per the approved prescribing information will be enrolled in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungju | Chungcheong-do | South Korea | ||||
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| C562694 | Epilepsy, Idiopathic Generalized |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Up to 24 weeks |
| Wŏnju |
| Gangwon-do |
| South Korea |
| Seongnam | Gyeonggji-do | South Korea |
| Jinju | Gyeongsang-do | South Korea |
| Gwangju | Jeolla-do | South Korea |
| Busan | South Korea |
| Daegu | South Korea |
| Daejeon | South Korea |
| Seoul | South Korea |