High Percentage of Subjects with Hypoglycaemic events


High Percentage of Subjects with Hypoglycaemic Events
Type of indicator Performance
Risk Category Safety
Golden KRI NO
Therapeutic Area Diabetes
IF Risk-Event Hypoglycaemic events occur more frequently than expected
DUE TO Risk Causes Poor glucose management, unclear instructions, investigational medicinal product (IMP) effects, less healthy subject mix at some sites, or concomitant medications
THEN Risk Impact MAY RESULT Negative health impact on subjects and potential need for protocol or treatment adjustments
Risk Indicator High Percentage of Subjects with Hypoglycaemic Events
Metric Percent of Subjects with Hypoglycaemic Events
Unit %
What level should be measured Study, Country, Site
Purpose Monitor subject safety by identifying unexpectedly high rates of hypoglycaemic events and enabling timely investigation of potential systemic causes.
Description This KRI tracks the proportion of enrolled subjects experiencing hypoglycaemic events. It triggers an alert when the rate exceeds expected levels.
Formula (Number of Enrolled Subjects with Hypoglycaemic Events) / (Number of Enrolled Subjects) × 100.
Suggested Thresholds - High 5%
Suggested Thresholds - Medium 3%
Associated Metric 1 Number of Enrolled Subjects
Associated Metric 2 Number of Enrolled Subjects with Hypoglycaemic Events
Do you like the KRI description? Thanks for the feedback There was a problem submitting your feedback. Please try again later.