High Percentage of Subjects with Hypoglycaemic events


High Percentage of Subjects with Hypoglycemic events (kri)
Type of indicator Performance
Risk Category safety
Golden KRI NO
Therapeutic Area Diabetes
IF Risk-Event hypoglycemic events occur more frequently than expected
DUE TO Risk Causes poor monitoring and unclear instructions
THEN Risk Impact MAY RESULT jeopardy of a successful outcome of the study
Risk Indicator High Percentage of Subjects with Hypoglycemic events
Metric Percent of Subjects with hypoglycemic events
Unit %
What level should be measured Study, Country, Site
Purpose Ensure optimal glucose management, minimize the occurrence of hypoglycemic events, and mitigate the associated risks to Subject health and well-being.
Description KRI monitors the occurrence of a significant proportion of hypoglycemic events in individuals, highlighting the need for improved glucose management and prevention of complications in clinical trials or healthcare settings.
Formula Devide a number of enrolled Subjects with Hypoglycemic events by number of enrolled Subjects, multipy by 100%.
Suggested Thresholds - High >5 %
Suggested Thresholds - Medium >3 %
Associated Metric 1 Number of enrolled Subjects
Associated Metric 2 Number of enrolled Subjects with Hypoglycemic events
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