High Percentage of Treatment Interruption

High Percentage of Treatment Interruption Table

High Percentage of Treatment Interruption

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 (serious) adverse events
THEN Risk Impact MAY RESULT Too few per protocol participants and inability to assess the efficacy of the investigational product
Risk Indicator High Percentage of Treatment Interruption
Metric Percent of enrolled participants with treatment interruptions
Unit %
What level should be measured Study, Country, Site, Subject
Purpose Monitor and mitigate the risk associated with a significant proportion of Subjects experiencing interruptions in their treatment regimen.
Description This KRI monitors the proportion of subjects experiencing interruptions in their treatment regimen to identify and address potential study risks early.
Formula (Number of randomized subjects with treatment interruption)/(Number of randomized subjects)x100
Suggested Thresholds - High >5 %
Suggested Thresholds - Medium >3 %
Associated Metric 1 Number of randomized subjects
Associated Metric 2 Number of randomized subjects with treatment interruption
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