Table 2 Study-drug exposure and... | American Society of Hematology

Table 2

Study-drug exposure and disposition

	All Patients (N = 35)
Drug exposure
Median treatment duration, days (range)	272 (2-589)
Actual dose intensity (mg/day)	394 (87.5-400)
Relative dose intensity (%)	98.5 (22-100)
Reason for study-drug discontinuation
AE/SAE	9 (26%)
Sponsor’s decision to terminate the study*	8 (23%)
Disease progression	7 (20%)
Lack of response	6 (17%)
Subject withdrew consent	4 (11%)
Protocol deviation	1 (3%)†

	All Patients (N = 35)
Drug exposure
Median treatment duration, days (range)	272 (2-589)
Actual dose intensity (mg/day)	394 (87.5-400)
Relative dose intensity (%)	98.5 (22-100)
Reason for study-drug discontinuation
AE/SAE	9 (26%)
Sponsor’s decision to terminate the study*	8 (23%)
Disease progression	7 (20%)
Lack of response	6 (17%)
Subject withdrew consent	4 (11%)
Protocol deviation	1 (3%)†

Source: supplemental Table 1.

The sponsor terminated the study in October 2011 for commercial reasons.

The study drug was discontinued after a protocol deviation was recognized, consisting of a patient enrolled due to a diagnostic error (not MF).