{"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"description":"Transplant-related non-hematologic grade 3 toxicity was defined by CTCAE 4.03 stratified by hematopoietic cell transplantation comorbidity index (HCT-CI). HCT-CI is a validated comorbidity index that comprises 17 different categories of organ dysfunction. Positive findings are summated into a total score. The HCT-CI provides information with regard to the overall as well as non-relapse mortality risk a patient is likely to experience after stem cell transplantation (SCT).","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"}],"populationDescription":"The study was early terminated on 17 April 2019, due to safety signals during Phase 1. Hence, data for this outcome measure was not collected as planned, analyzed and reported at specific time point.","reportingStatus":"POSTED","timeFrame":"Up to 6 months","title":"Phase 1 and 2: Number of Participants With Transplant-related Non-hematologic Grade 3 Toxicity","type":"SECONDARY"}