Figure 2.

(a) Detectable event rate as a function of active cohort size and power. There is little to gain by increasing the cohort size from 10 to 12 subjects; but an increase from four to six subjects results in an appreciable increase in sensitivity. Reprinted with permission from Buöen et al.30 (b) The relationship between background rate and the probability of the event spontaneously occurring in at least one subject depicted for an active cohort size of three, six, and 10 subjects. Reprinted with permission from Buöen et al.30 DDI, drug‐drug interaction; MAD, multiple ascending dose; MTD, maximum tolerated dose.