High Percentage of Subjects with Hyperglycaemic events
High Percentage of Subjects with Hyperglycaemic Events
Type of indicator
Performance
Risk Category
Safety
Golden KRI
NO
Therapeutic Area
Diabetes
IF Risk-Event
Hyperglycaemic 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 Hyperglycaemic Events
Metric
Percentage of Subjects with Hyperglycaemic Events
Unit
%
What level should be measured
Study, Country, Site
Purpose
Monitor subject safety by identifying unexpectedly high rates of hyperglycaemic events, enabling timely investigation of potential systemic causes (e.g., IMP, instructions, or site practice) and implementation of mitigating actions.
Description
This KRI tracks the proportion of enrolled subjects experiencing hyperglycaemic events. It triggers an alert when the rate exceeds expected levels.
Formula
(Number of Enrolled Subjects with Hyperglycaemic Events) / (Number of Enrolled Subjects) × 100. Use values from the same date.
Suggested Thresholds - High
5%
Suggested Thresholds - Medium
3%
Associated Metric 1
Number of Enrolled Subjects
Associated Metric 2
Number of Enrolled Subjects with Hyperglycaemic Events
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