Table 2.

Population and calculated estimated sample sizes

TrialComparator, nMANIFEST
arm 3
including IPSS int-1 patients, n
MANIFEST
arm 3
excluding IPSS int-1 patients, n
ESS
including IPSS int-1 patients, n
ESS
excluding IPSS int-1 patients, n
COMFORT-I 155 80 69 19.21 14.77 
COMFORT-II 146 80 69 22.10 14.87 
JAKARTA 400 mg 96 80 69 19.69 8.71 
JAKARTA 500 mg 97 80 69 31.37 22.54 
SIMPLIFY-1
ruxolitinib 
217 80 69 34.61 34.61 
SIMPLIFY-1
momelotinib 
215 80 69 33.40 33.40 
TrialComparator, nMANIFEST
arm 3
including IPSS int-1 patients, n
MANIFEST
arm 3
excluding IPSS int-1 patients, n
ESS
including IPSS int-1 patients, n
ESS
excluding IPSS int-1 patients, n
COMFORT-I 155 80 69 19.21 14.77 
COMFORT-II 146 80 69 22.10 14.87 
JAKARTA 400 mg 96 80 69 19.69 8.71 
JAKARTA 500 mg 97 80 69 31.37 22.54 
SIMPLIFY-1
ruxolitinib 
217 80 69 34.61 34.61 
SIMPLIFY-1
momelotinib 
215 80 69 33.40 33.40 

Int-1, intermediate-1 risk.

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