{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"6"}],"units":"Participants"}],"description":"The maximum tolerated dose (MTD) was defined as one or fewer out of 6 participants experiencing a dose limiting toxicity (DLT) or the maximum administered dose (MAD).\n\nA dose limiting toxicity is any Grade ≥ 3 adverse event related to study drug, Grade 3 fatigue, headache, insomnia, fever, hypotension or infection were not considered dose limiting toxicities. Laboratory parameters of Grade ≥ 3 but not considered as clinically relevant and/or responding to routine medical management, thrombocytopenia, leukopenia (including neutropenia and lymphopenia), and anemia were not considered dose limiting toxicities.","groups":[{"description":"Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 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 5 µg/m²/Day"},{"description":"Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.","id":"OG001","title":"Phase 1: Blinatumomab 15 µg/m²/Day"},{"description":"Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.","id":"OG002","title":"Phase 1: Blinatumomab 30 µg/m²/Day"},{"description":"Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.","id":"OG003","title":"Phase 1: Blinatumomab 15/30 µg/m²/Day"}],"paramType":"NUMBER","populationDescription":"Participants in the Phase 1 dose evaluation/escalation part of the study","reportingStatus":"POSTED","timeFrame":"Cycle 1, 28 days","title":"Phase I: Number of Participants With Dose-limiting Toxicities (DLTs)","type":"PRIMARY","unitOfMeasure":"participants"}