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.
Study Type
OBSERVATIONAL
Enrollment
3,692
Unnamed facility
Chungju, Chungcheong-do, South Korea
Unnamed facility
Wŏnju, Gangwon-do, South Korea
Unnamed facility
Seongnam, Gyeonggji-do, South Korea
Unnamed facility
Jinju, Gyeongsang-do, South Korea
Number of Participants With Adverse Events
Time frame: From the first Fycompa (Perampanel) administration date up to 24 weeks
Number of Participants With Adverse Drug Reactions
Time frame: From the first Fycompa (Perampanel) administration date up to 24 weeks
Number of Participants With Unexpected Adverse Events
Time frame: From the first Fycompa (Perampanel) administration date up to 24 weeks
Number of Participants With Serious Adverse Events
Time frame: From the first Fycompa (Perampanel) administration date up to 24 weeks
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).
Time frame: Up to 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Gwangju, Jeolla-do, South Korea
Unnamed facility
Busan, South Korea
Unnamed facility
Daegu, South Korea
Unnamed facility
Daejeon, South Korea
Unnamed facility
Seoul, South Korea