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/SAE9 (26%)
 Sponsor’s decision to terminate the study*8 (23%)
 Disease progression7 (20%)
 Lack of response6 (17%)
 Subject withdrew consent4 (11%)
 Protocol deviation1 (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).