High Percentage of Subjects with Angina Pectoris Attacks


High Percentage of Subjects with Angina Pectoris Attacks
Type of indicator Risk
Risk Category Safety
Golden KRI NO
Therapeutic Area Cardiovascular
IF Risk-Event Too many subjects experience angina pectoris attacks during the study
DUE TO Risk Causes Subject condition, study drug inefficacy, study drug side effects, or ineffective rescue medication
THEN Risk Impact MAY RESULT Compromised subject safety profile, increased withdrawal rates, and the study fail to meet its objectives
Risk Indicator High Percentage of Subjects with Angina Pectoris Attacks
Metric Percent of Subjects Who Have Experienced Angina Pectoris Attacks
Unit %
What level should be measured Study, Country, Site
Purpose Identify potential safety issues related to angina pectoris that may impact subject safety and study outcomes.
Description This KRI monitors the occurrence of a high proportion of angina pectoris attacks among study subjects, which may affect subject safety and well-being, increase withdrawal rates, and jeopardize study success.
Formula (Number of Enrolled Subjects Who Experienced Angina Pectoris During the Study) / (Number of Enrolled Subjects) × 100.
Suggested Thresholds - High 30%
Suggested Thresholds - Medium 20%
Associated Metric 1 Number of Enrolled Subjects
Associated Metric 2 Number of Enrolled Subjects Who Experienced Angina Pectoris During the Study
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