Table 4.

Comparison of gilteritinib Ctrough values at steady state across studies

ParameterLACEWING trialADMIRAL trial∗
Population ND FLT3mut+ AML ineligible for IIC R/R FLT3mut+ AML 
Treatment GIL + AZA and gilteritinib alone Gilteritinib monotherapy 
ParameterLACEWING trialADMIRAL trial∗
Population ND FLT3mut+ AML ineligible for IIC R/R FLT3mut+ AML 
Treatment GIL + AZA and gilteritinib alone Gilteritinib monotherapy 
Cycle/dayCycle 1, day 15Cycle 2, day 1Cycle 1, day 15Cycle 2, day 1
No. of values 82 57 231 219 
Median 584.5 583 279 311 
-fold diff pop PK 2.1 2.1 1.0 1.1 
Mean 698 721 330 372 
-fold diff pop PK 2.1 2.2 1.0 1.1 
%CV 62% 71% 68% 80% 
Cycle/dayCycle 1, day 15Cycle 2, day 1Cycle 1, day 15Cycle 2, day 1
No. of values 82 57 231 219 
Median 584.5 583 279 311 
-fold diff pop PK 2.1 2.1 1.0 1.1 
Mean 698 721 330 372 
-fold diff pop PK 2.1 2.2 1.0 1.1 
%CV 62% 71% 68% 80% 

CV, coefficient of variation; diff, difference; pop, population.

Data not previously presented for ADMIRAL trial.

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