{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.1","upperLimit":"4.4","value":"3"}]}],"title":"TTP"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.1","upperLimit":"3.9","value":"3"}]}],"title":"PFS"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"13.2","upperLimit":"42.4","value":"26.7"}]}],"title":"OS"}],"denoms":[{"counts":[{"groupId":"OG000","value":"34"}],"units":"Participants"}],"description":"Progressive disease\n\nRequires any one or more of the following:\n\nIncrease of ≥ 25% from baseline in\n\n* Serum M-component and/or (the absolute increase must be ≥ 0.5 g/dL) (increases of ≥ 1 g/dL are sufficient to define relapse if starting M-component is ≥ 5 g/dL).\n* Urine M-component and/or (the absolute increase must be ≥ 200mg/24h).\n\nOnly in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels. The absolute increase must be \\> 10 mg/dL.\n\nBone marrow plasma cell percentage: the absolute % must be ≥ 10% (relapse form CR as a 5% cutoff instead of 10%).\n\nDefinite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas.\n\nDevelopment of hypercalcemia (corrected serum calcium \\> 11.5 mg/dL or 2.65 mmol/l) that can be attributed solely to the plasma cell proliferative disorder.","dispersionType":"95% Confidence Interval","groups":[{"description":"BT062: intravenous administration","id":"OG000","title":"BT062"}],"paramType":"MEDIAN","populationDescription":"The Intention-to-treat (ITT) population included all subjects who were enrolled in the study and received at least 1 dose of BT062 and who had any post-Baseline evaluations or data (n = 34).","reportingStatus":"POSTED","timeFrame":"Starting with first study drug administration until death or 3 years from first study treatment.","title":"Time to Progression (TTP), Progression Free Survival (PFS) and Overall Survival (OS)","type":"SECONDARY","unitOfMeasure":"months"}