High Percentage of Subjects with NYHA stage deterioration


High Percentage of Subjects with NYHA stage deterioration (kri)
Type of indicator Risk
Risk Category safety
Golden KRI NO
Therapeutic Area Cardiovascular
IF Risk-Event the Subject NYHA stage deteriorates (worsening of fatigue, palpitation, dyspnea (shortness of breath))
DUE TO Risk Causes a lack of efficacy of the study drug
THEN Risk Impact MAY RESULT a negative impact on Subject safety
Risk Indicator High Percentage of Subjects with NYHA stage deterioration
Metric Percent of subjects with NYHA stage deteriorations
Unit %
What level should be measured Study, Country, Site
Comments NYHA - New York Heart Association
Purpose Improve Subject outcomes, optimize heart failure management, and enhance the quality of life for individuals with cardiovascular disease.
Description KRI monitors the occurrence of a significant proportion of study participants experiencing a deterioration in their New York Heart Association (NYHA) functional classification stage in cardiovascular clinical trials or healthcare settings, indicating worsening heart failure symptoms and the need for optimized management strategies.
Formula Devide a number of enrolled Subjects with NYHA scoring worsenings by a number of enrolled Subjects, multiplied by 100%.
Suggested Thresholds - High >10 %
Suggested Thresholds - Medium >5 %
Associated Metric 1 Number of enrolled Subjects
Associated Metric 2 Number of enrolled Subjects with NYHA scoring worsenings
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