Disposition on treatment
All 28 patients began to study medication at the correct dose (10 mg BID). Within the first 6 months of study treatment, there were a total of seven dose reductions in six patients; two patients interrupted treatment because of AEs (see above). In addition, 11 dose escalations were reported in these patients.None of the analyzed 28 randomized PV patients terminated the study within the first 6 months. There were no recorded protocol violations concerning informed consent, inclusion/exclusion criteria, or randomization.