Rumke offered a simple rule of thumb for identifying the upper confidence limit for a treatment causing adverse events if none are seen in a clinical trial.
n = size of a study group for which no adverse events were noted
Upper Confidence Limit for the Occurrence of an Adverse Event
Expression in Terms of the Study Group Size
95%
3 / n
99%
4.61 / n
99.5%
5.30 / n
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