{"analyses":[{"ciLowerLimit":"-9.8","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"6.6","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.6987","paramType":"Absolute difference","paramValue":"-1.6","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"38.4","upperLimit":"50.3","value":"44.3"},{"groupId":"OG001","lowerLimit":"36.8","upperLimit":"48.7","value":"42.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"282"},{"groupId":"OG001","value":"281"}],"units":"Participants"}],"description":"MMR is defined as the percentage of participants in MMR (reduction of ≥ 3 logs in BCR-ABL transcripts compared to the standardized baseline established in IRIS, or ≤ 0.1% BCR-ABL/ABL % by international scale and measured by real-time quantitative polymerase chain reaction (RQ-PCR)) at 12 months based on 12-month cut-off interim data.","dispersionType":"95% Confidence Interval","groups":[{"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":"OG000","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":"OG001","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":"12 months","title":"Rate of Major Molecular Response (MMR) at 12 Months Between Two Nilotinib Arms","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}