High Percentage of Subjects with Angina Pectoris Attacks
High Percentage of Subjects with Angina Pectoris Attacks (kri)
Type of indicator
Risk
Risk Category
safety
Golden KRI
No
Therapeutic Area
Cardiovascular
IF Risk-Event
Too many trial participants have angina pectoris attacks
DUE TO Risk Causes
Subject condition, study drug not working, study drug side effects or the rescue medication not working
THEN Risk Impact MAY RESULT
Trial participants may be adversely affected, the withdrawal rate may be higher than expected and the study might be unsuccessful
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
Comments
Purpose
Detect whether there is a systemic issue with angina pectoris that may impact patient safety and study outcome.
Description
KRI monitors the occurrence of a heightened proportion of angina pectoris attacks in trial participants which impacts participant safety and well-being and may lead to the study being unsuccessful.
Formula
(Number of Enrolled Subjects who have had Angina Pectoris During the Study) / (Number of Enrolled Subjects) x 100.
Suggested Thresholds - High
>30 %
Suggested Thresholds - Medium
>20 %
Associated Metric 1
Number of Enrolled Subjects
Associated Metric 2
Number of Enrolled Subjects who have had Angina Pectoris During the Study
Do you like the KRI description?Thanks for the feedbackThere was a problem submitting your feedback. Please try again later.
