{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"400"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"34"}],"units":"Participants"}],"description":"The Maximum tolerated dose (MTD) of BI 836909, which was defined as the highest dose of the dose level tested where ≤1 patient out of 6 developed a Dose-limiting toxicity (DLT). The MTD was defined based on DLTs observed during Cycle 1. However, all Adverse Events corresponding to the definition of a DLT (see below) were to be considered for confirming the MTD. A DLT was defined as any drug-related non-haematological Adverse Event of Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 Grade 3 or higher.","groups":[{"description":"BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles. The first 4 dose levels (0.2, 0.4,0.8, and 1.6 Microgram Per Day (μg/d)) were tested in single patient cohorts. Dose levels ≥3.2 μg/d (3.2, 6.5, 13, 25, 50, 100, 200, 400, and 800 μg/d) were tested in a 3+3 design.","id":"OG000","title":"Intravenous Infusion of BI 836909 (Total Dose Escalation)"}],"paramType":"NUMBER","populationDescription":"MTD evaluation set (MTDS): all patients who were administered trial medication and who were not replaced for the Maximum tolerated dose (MTD) determination.","reportingStatus":"POSTED","timeFrame":"Cycle 1, up to 6 weeks.","title":"The Maximum Tolerated Dose (MTD) of BI 836909","type":"PRIMARY","unitOfMeasure":"Microgram Per Day (μg/d)"}