{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"140"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"35"}],"units":"Participants"}],"description":"The Phase I part of the study was to include the dose escalation cohort; a conventional dose escalation design, following 3 + 3 rules was chosen to define the MTD.\n\nOnly DLTs occurring in cycle 1 for each subject were counted in the dose escalation decisions.\n\nThree subjects were treated at the first or newest dose level as available. If none of the 3 subjects experienced a DLT during Cycle 1, three subjects could be treated at the next dose level as available.\n\nIn case of a DLT the cohort was expanded to up to 6 subjects. If not more than 1 of these 6 subjects experienced a DLT during Cycle 1, a first subject could be treated at the next dose level.\n\nIf 2 or more of the 6 subjects experienced a DLT during Cycle 1 the dose escalation was stopped.\n\nThe highest dose level at which \\< 2 of 6 subjects experienced a DLT is defined as the MTD.","groups":[{"description":"BT062: intravenous administration","id":"OG000","title":"BT062"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"First 28-day cycle","title":"Maximum Tolerated Dose (MTD)","type":"PRIMARY","unitOfMeasure":"mg/m²"}