This non-interventioal study will be performed by design of post-marketing surveillance (PMS) as an additional pharmacovigilance activity of the Risk Management Plan (RMP) for Vyndamax® Capsules, which is required by the Ministry of Food and Drug Safety (MFDS) according to the local regulation. This post-marketing surveillance will investigate the safety and effectiveness of Vyndamax® Capsules as the treatment of transthyretin amyloid cardiomyopathy during 10 years under the setting of routine practice in Korea.
Study Type
OBSERVATIONAL
Enrollment
110
As prescribed in real world practice
Pfizer
Seoul, South Korea
The incidence of Adverse Events (AEs)
The primary interest of this study is the incidence of AEs investigated during administration period and within 28 days after discontinuation of Vyndamax® Capsules. Incidence of AEs, 95% confidence interval and the number of AEs will be presented. Serious AEs/ADRs, unexpected AEs/ADRs, unexpected serious AEs/ADRs will be summarized separately table.
Time frame: Baseline through 6 months of treatment
Change from baseline in the New York Heart Association (NYHA) class at Month 6
Time frame: Baseline, month 6
Change from baseline in the 6 Minute Walk Distance (6MWD) at Month 6
Time frame: Baseline, month 6
Global assessment by investigator at Month 6
Time frame: Baseline, month 6
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.