{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.0","upperLimit":"12.4","value":"7.9"},{"groupId":"OG001","lowerLimit":"1.7","upperLimit":"13.9","value":"3.4"},{"groupId":"OG002","lowerLimit":"2.3","upperLimit":"12.1","value":"4.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"27"}],"units":"Participants"}],"description":"Relapse-free survival (RFS) was assessed for participants who achieved a complete remission during the core study and was measured from the time the participant first achieved remission until first documented relapse or death due to any cause. Participants without a documented relapse (hematological or extramedullary) or who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission.\n\nRelapse free survival was estimated using Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan-Meier method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate ranging from 5 to 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.","id":"OG000","title":"Phase 1: Blinatumomab"},{"description":"Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.","id":"OG001","title":"Phase 2: Blinatumomab 5/15 µg/m²/Day"},{"description":"Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/ day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.","id":"OG002","title":"Phase 1+2: Blinatumomab 5/15 µg/m²/Day"}],"paramType":"MEDIAN","populationDescription":"Full analysis set with complete remission","reportingStatus":"POSTED","timeFrame":"Up to the data cut-off date of 12 January 2015; median observation time was 23.5 months for phase 1 and 11.5 months for phase 2.","title":"Relapse-free Survival","type":"SECONDARY","unitOfMeasure":"months"}