High Percentage of Subjects with Hypoglycaemic events

High Percentage of Subjects with Hypoglycaemic Events (kri)

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, IMP, less healthy trial participants at some sites, concomitant medication
THEN Risk Impact MAY RESULT	Negative health impact on trial participants
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	Monitoring safety is critical in a clinical trial. In a diabetes trial, optimal glucose management is very important for the health of study participants. By monitoring the occurrence of hypoglycaemic events, an unexpectedly high number can be detected and investigated for possible systemic cause.
Description	This KRI monitors the occurrence of a higher than expected proportion of trial participants with hypoglycaemic events. The KRI alarms if the rate is higher than expected.
Formula	Divide a number of enrolled Subjects with Hypoglycaemic events by number of enrolled Subjects, multiply 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 Hypoglycaemic events