{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"3"}],"units":"Participants"}],"description":"A dose limiting toxicity is defined as any events occurring within the first cycle of treatment (21 days) such as any death not clearly due to the underlying disease or extraneous causes, transaminitis that meets criteria for Hy's Law: grade ≥2 elevation of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) with simultaneous elevation of total bilirubin to ≥ 2x ULN while alkaline phosphatase remains \\< 2x upper limit of normal (ULN). Some hematological toxicities, and Grade ≥3 non-hematological toxicities; and any other drug related toxicity considered significant enough to be qualifies as a DLT in the opinion of the principal investigator. Inability to start cycle 2 within 2 weeks after completing cycle 1 due to drug-related adverse events.","groups":[{"description":"LMB-100 100 mcg/kg\n\nLMB-100: Arms 1: Administered intravenous (IV) as an approximate 30-minute infusion of each 21-day cycle on days 4, 6 and 8 until disease progression, intolerance or withdrawal from study.\n\nTofacitinib: Arms 1: Administered orally twice daily on days 1-10 of each cycle until disease progression, intolerance or withdrawal from study.","id":"OG000","title":"Dose Escalation Dose Level 1 LMB-100 100 mcg/kg"},{"description":"LMB-100 140 mcg/kg\n\nLMB-100: Arms 2: Administered intravenous (IV) as an approximate 30-minute infusion of each 21-day cycle on days 4, 6 and 8 until disease progression, intolerance or withdrawal from study.\n\nTofacitinib: Arms 2: Administered orally twice daily on days 1-10 of each cycle until disease progression, intolerance or withdrawal from study.","id":"OG001","title":"Dose Escalation Dose Level 2 LMB-100 140 mcg/kg"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"1 of 7 participants in Dose Escalation-Dose Level 1 is not evaluable due to withdrawal from the study with loss of follow-up before the conclusion of the DLT period.","reportingStatus":"POSTED","timeFrame":"First cycle (21 days)","title":"Number of Participants With a Dose-Limiting Toxicity (DLT)","type":"OTHER_PRE_SPECIFIED","unitOfMeasure":"Participants"}