{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"}],"units":"Participants"}],"description":"DLT was defined as at least possibly related to tinostamustine based on common terminology criteria for adverse events 4.03 (CTCAE 4.03): (1) delayed engraftment (greater than \\[\\>\\] 30 days after ASCT) where subject has not met criteria for both neutrophil (first of 3 consecutive days with ANC \\> 0.5×10\\^9/liter \\[L\\]) and platelet (plt) engraftment (first of 3 consecutive days of plt count \\> 20×10\\^9/L without plt transfusion in prior 7 days) (2) QTcF \\> 500 millisecond (msec) or \\> 60 msec increase from baseline with duration of \\> 30 minutes or greater than or equal to (\\>=) Grade 3 QTcF interval prolongation with ventricular arrhythmia (3) Grade 4 non-hematologic toxicity (4) Grade 3 non-hematologic toxicity related to treatment, except: nausea, emesis, diarrhea, fatigue, dehydration, glucose intolerance, skin rash with treatment, fever (\\> 40C for \\>= 24 hours), infection, dyspnea, hypoxia, pneumonitis, pain, dysphagia, oral mucositis, anorexia, flu-like or engraftment syndrome, weight.","groups":[{"description":"Participants received single dose of tinostamustine 180 mg/m\\^2 IV injection on Day -1 followed by ASCT on Day 1.","id":"OG000","title":"Tinostamustine 180 mg/m^2"},{"description":"Participants received single dose of tinostamustine 220 mg/m\\^2 IV injection on Day -1 followed by ASCT on Day 1.","id":"OG001","title":"Tinostamustine 220 mg/m^2"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety population included all participants who received tinostamustine. The study was early terminated on 17 April 2019, due to safety signals during Phase 1, participants were not enrolled in Phase 2.","reportingStatus":"POSTED","timeFrame":"Phase 1: From Day -1 up to 30 Days post-ASCT","title":"Phase 1: Number of Participants With Dose Limiting Toxicities (DLT)","type":"PRIMARY","unitOfMeasure":"Participants"}