{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"}]}],"title":"Participants with TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}],"title":"Participants with TESAEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"}],"units":"Participants"}],"description":"An Adverse Event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Serious adverse event (SAE) was defined as AE resulting in any of the following outcomes deemed significant for any other reason: death, was life-threatening (participant was at immediate risk of death from event as it occurred), requires in-patient hospitalization (formal admission to a hospital for medical reasons) or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect. TEAE was defined as an adverse event that started on or after the first dose of tinostamustine through Day 107, or after the end of the study if thought to be related to study drug.","groups":[{"description":"Participants received single dose of tinostamustine 180 mg/m\\^2 IV injection followed by autologous stem cell transplantation (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 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":"From first dose of tinostamustine up to end of study (up to 6 months)","title":"Phase 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)","type":"SECONDARY","unitOfMeasure":"Participants"}