High Percentage of Treatment Interruption

High Percentage of Treatment Interruption (kri)
Type of indicator Risk
Risk Category IMP
Golden KRI NO
Therapeutic Area General
IF Risk-Event the treatment with the investigational product is interrupted
DUE TO Risk Causes the occurrence of adverse events or serious adverse events
THEN Risk Impact MAY RESULT not enough Subjects or poor statistical significance
Risk Indicator High Percentage of Treatment Interruption
Metric Percent of Treatment Interruption
Unit %
What level should be measured Study, Country, Site, Subject
Comments only enrolled Subjects should be considered for the KRI
Purpose Monitor and mitigate the risk associated with a significant proportion of Subjects experiencing interruptions in their treatment regimen.
Description KRI monitors the percentage of Subjects experiencing interruptions in their treatment regimen to identify and address potential risks.
Formula Devide a number of enrolled Subjects with treatment status “incomplete” (or any interraptions) by a number of enrolled Subjects.
Suggested Thresholds - High >5 %
Suggested Thresholds - Medium >3 %
Associated Metric 1 Number of enrolled Subjects
Associated Metric 2 Number of enrolled Subjects with treatment status “incomplete” (or any interraptions)
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