{"groups":[{"description":"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.","id":"FG000","title":"Blinatumomab"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Ongoing in core study"},{"reasons":[{"groupId":"FG000","numSubjects":"46"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"43"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"32"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"23"}],"type":"Disease relapse"},{"reasons":[{"groupId":"FG000","numSubjects":"14"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"7"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"7"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"3"}],"type":"Other"}],"milestones":[{"achievements":[{"comment":"Participants enrolled during the first 3 stages of the study","groupId":"FG000","numSubjects":"189"}],"type":"STARTED"},{"achievements":[{"comment":"Completed 5 cycles of treatment; Data as of the time of the data cut-off date (10 October 2013).","groupId":"FG000","numSubjects":"10"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"179"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Two hundred twenty-five participants enrolled in the study overall. Results below include data for 189 participants enrolled in the first 3 stages of the study (the primary analysis set). An additional 36 participants enrolled in the Additional Evaluation Cohort are not reported here as the study is ongoing and data collection has not completed.","recruitmentDetails":"This study was open to adult patients with relapsed / refractory B-precursor acute lymphoblastic leukemia (ALL).\n\nThe study protocol originally used a Simon 2-stage design and was subsequently expanded to include a third stage. Protocol amendment 4 added an additional cohort of participants for central nervous system evaluations."}