{"groups":[{"description":"Patients randomized to this arm were to receive 400 mg imatinib once a day (QD). If the patient required a dose escalation from 400 mg/day, the patient was to receive 400 mg imatinib twice daily orally. Imatinib was taken with food and a large glass of water. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits during the study. In cases of vomiting doses were not to be repeated","id":"FG000","title":"Imatinib 400 mg QD"},{"description":"Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.","id":"FG001","title":"Nilotinb 300 mg BID"},{"description":"Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.","id":"FG002","title":"Nilotinib 400 mg BID"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"9"}],"type":"Abnormal Laboratory Values"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Abnormal Test Procedures"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Condition no longer requires study drug"},{"reasons":[{"groupId":"FG000","numSubjects":"31"},{"groupId":"FG001","numSubjects":"29"},{"groupId":"FG002","numSubjects":"34"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"3"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"3"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"4"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"15"},{"groupId":"FG002","numSubjects":"11"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"11"},{"groupId":"FG002","numSubjects":"13"}],"type":"Sub optimal response or treat. failure"},{"reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"12"}],"type":"Administrative problems"},{"reasons":[{"groupId":"FG000","numSubjects":"43"},{"groupId":"FG001","numSubjects":"53"},{"groupId":"FG002","numSubjects":"89"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Disc. Core/Entered Ext. - DP progression"},{"reasons":[{"groupId":"FG000","numSubjects":"46"},{"groupId":"FG001","numSubjects":"26"},{"groupId":"FG002","numSubjects":"3"}],"type":"Disc. Core/Entered Ext.- SOR/TF"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"283"},{"groupId":"FG001","numSubjects":"282"},{"groupId":"FG002","numSubjects":"281"}],"type":"STARTED"},{"achievements":[{"comment":"Safety set contained patients who received at least one dose of study medication.","groupId":"FG000","numSubjects":"280"},{"comment":"Safety set contained patients who received at least one dose of study medication.","groupId":"FG001","numSubjects":"279"},{"comment":"Safety set contained patients who received at least one dose of study medication.","groupId":"FG002","numSubjects":"277"}],"type":"Safety Analysis Set"},{"achievements":[{"groupId":"FG000","numSubjects":"235"},{"groupId":"FG001","numSubjects":"256"},{"groupId":"FG002","numSubjects":"278"}],"type":"Discon. Core/Did Not Enter Ext."},{"achievements":[{"groupId":"FG000","numSubjects":"48"},{"groupId":"FG001","numSubjects":"26"},{"groupId":"FG002","numSubjects":"3"}],"type":"Discontinued Core/Entered Ext."},{"achievements":[{"groupId":"FG000","numSubjects":"99"},{"groupId":"FG001","numSubjects":"107"},{"groupId":"FG002","numSubjects":"99"}],"comment":"Completed = Completed Core phase as per protocol","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"184"},{"groupId":"FG001","numSubjects":"175"},{"groupId":"FG002","numSubjects":"182"}],"type":"NOT COMPLETED"}],"title":"Core Treatment Phase"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"1"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"0"}],"type":"Unsatisfactory therapeutic effect"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}],"type":"Protocol Violation"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"48"},{"groupId":"FG001","numSubjects":"26"},{"groupId":"FG002","numSubjects":"3"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"12"},{"groupId":"FG002","numSubjects":"2"}],"comment":"Completed = Completed Ext. phase as per protocol","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"27"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"1"}],"type":"NOT COMPLETED"}],"title":"Extension Phase"}],"preAssignmentDetails":"Randomization was planned for a total of 771 patients.","recruitmentDetails":"The study over-enrolled, and 846 patients (283 in the imatinib 400 mg arm, 282 in the nilotinib 300 mg arm and 281 in the nilotinib 400 mg arm) were randomized. DP = disease progression, SOR/TF = Suboptimal response or treatment failure"}