{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.2","upperLimit":"3.1","value":"1.1"},{"groupId":"OG001","lowerLimit":"5.8","upperLimit":"12.8","value":"8.9"},{"groupId":"OG002","lowerLimit":"3.3","upperLimit":"9.1","value":"5.7"}]}],"title":"Molecular response of <=0.01% at 6 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.0","upperLimit":"6.8","value":"3.9"},{"groupId":"OG001","lowerLimit":"8.5","upperLimit":"16.4","value":"12.1"},{"groupId":"OG002","lowerLimit":"5.8","upperLimit":"12.9","value":"8.9"}]}],"title":"Molecular response of <=0.01% at 12 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.0","upperLimit":"14.4","value":"10.2"},{"groupId":"OG001","lowerLimit":"19.6","upperLimit":"29.9","value":"24.5"},{"groupId":"OG002","lowerLimit":"17.4","upperLimit":"27.4","value":"22.1"}]}],"title":"Molecular response of <=0.01% at 24 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"10.3","upperLimit":"18.7","value":"14.1"},{"groupId":"OG001","lowerLimit":"24.2","upperLimit":"35.1","value":"29.4"},{"groupId":"OG002","lowerLimit":"19.0","upperLimit":"29.3","value":"23.8"}]}],"title":"Molecular response of <=0.01% at 36 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"15.3","upperLimit":"24.9","value":"19.8"},{"groupId":"OG001","lowerLimit":"27.5","upperLimit":"38.8","value":"33.0"},{"groupId":"OG002","lowerLimit":"24.6","upperLimit":"35.6","value":"29.9"}]}],"title":"Molecular response of <=0.01% at 48 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"25.7","upperLimit":"36.8","value":"31.1"},{"groupId":"OG001","lowerLimit":"41.9","upperLimit":"53.9","value":"47.9"},{"groupId":"OG002","lowerLimit":"37.5","upperLimit":"49.4","value":"43.4"}]}],"title":"Molecular response of <=0.01% at 60 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"22.1","upperLimit":"32.8","value":"27.2"},{"groupId":"OG001","lowerLimit":"38.4","upperLimit":"50.3","value":"44.3"},{"groupId":"OG002","lowerLimit":"39.3","upperLimit":"51.2","value":"45.2"}]}],"title":"Molecular response of <=0.01% at 72 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"23.8","upperLimit":"34.6","value":"29.0"},{"groupId":"OG001","lowerLimit":"37.1","upperLimit":"48.9","value":"42.9"},{"groupId":"OG002","lowerLimit":"34.8","upperLimit":"46.6","value":"40.6"}]}],"title":"Molecular response of <=0.01% at 84 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"23.1","upperLimit":"33.9","value":"28.3"},{"groupId":"OG001","lowerLimit":"34.0","upperLimit":"45.7","value":"39.7"},{"groupId":"OG002","lowerLimit":"32.4","upperLimit":"44.0","value":"38.1"}]}],"title":"Molecular response of <=0.01% at 96 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"26.7","upperLimit":"37.9","value":"32.2"},{"groupId":"OG001","lowerLimit":"34.6","upperLimit":"46.4","value":"40.4"},{"groupId":"OG002","lowerLimit":"29.3","upperLimit":"40.8","value":"34.9"}]}],"title":"Molecular response of <=0.01% at 108 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"23.1","upperLimit":"33.9","value":"28.3"},{"groupId":"OG001","lowerLimit":"29.9","upperLimit":"41.4","value":"35.5"},{"groupId":"OG002","lowerLimit":"28.3","upperLimit":"39.7","value":"33.8"}]}],"title":"Molecular response of <=0.01% at 120 months"}],"denoms":[{"counts":[{"groupId":"OG000","value":"283"},{"groupId":"OG001","value":"282"},{"groupId":"OG002","value":"281"}],"units":"Participants"}],"description":"Molecular response of \\<=0.01% is defined as BCR-ABL ratio (%) on IS \\<= 0.01% (corresponds to \\>=4 log reduction of BCR-ABL transcripts from standardized baseline value)","dispersionType":"95% Confidence Interval","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":"OG000","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":"OG001","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":"OG002","title":"Nilotinib 400 mg BID"}],"paramType":"NUMBER","populationDescription":"Full analysis Set (FAS): Contained 846 randomized patients. Patients were analyzed according to the treatment they were randomized to, regardless of actual treatment received.","reportingStatus":"POSTED","timeFrame":"at 6, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120 months","title":"Rate of a ≥ 4 Log Reduction in BCR-ABL Transcripts in Nilotinib Treatment Arms With Imatinib","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}