{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"2"}]}],"title":"Investigations"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"8"},{"groupId":"OG005","value":"2"}]}],"title":"Gastrointestinal disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"1"}]}],"title":"Blood and lymphatic system disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"5"},{"groupId":"OG005","value":"1"}]}],"title":"General disorders and administration site conditions"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"2"}]}],"title":"Nervous system disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"0"}]}],"title":"Skin and subcutaneous tissue disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"1"}]}],"title":"Metabolism and nutrition disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"}]}],"title":"Injury, poisoning and procedural complications"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"}]}],"title":"Respiratory, thoracic and mediastinal disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"}]}],"title":"Cardiac disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"}]}],"title":"Musculoskeletal and connective tissue disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}],"title":"Vascular disorders"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"8"},{"groupId":"OG005","value":"2"}],"units":"Participants"}],"description":"All TEAEs was reported from the first dose of study drug through the time of study drug discontinuation (at any time or Day 28 of the last treatment Cycle). All treatment-related TEAEs was followed until resolution or stabilization. For the purpose of regulatory reporting requirements, causal relationships of definite, probable, and possible was considered treatment-related.\n\nNumber of patients experiencing treatment-related adverse events (TEAE) as assessed by CTCAE v4.03. (June 2010).","groups":[{"description":"Patients who received Tinostamustine at 60mg/m2 (30min) on D1 and D15 of a 4-week cycle","id":"OG000","title":"Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (30 Min) Cohort 1"},{"description":"Patients who received Tinostamustine at 80mg/m2 (30min) on D1 and D15 of a 4-week cycle","id":"OG001","title":"Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (30 Min) Cohort 2"},{"description":"Patients who received Tinostamustine at 100mg/m2 (30min) on D1 and D15 of a 4-week cycle","id":"OG002","title":"Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (30 Min) Cohort 3"},{"description":"Patients who received Tinostamustine at 60mg/m2 (60min) on D1 and D15 of a 4-week cycle","id":"OG003","title":"Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (60 Min) Cohort 4"},{"description":"Patients who received Tinostamustine at 80mg/m2 (60min) on D1 and D15 of a 4-week cycle","id":"OG004","title":"Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (60 Min) Cohort 5"},{"description":"Patients who received Tinostamustine at 100mg/m2 (60min) on D1 and D15 of a 4-week cycle","id":"OG005","title":"Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (60 Min) Cohort 6"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The safety analysis summarised TEAEs for all treated subjects using discrete summaries at the subject and event level by system organ class (SOC) and preferred term (PT). Treatment-related TEAEs were summarised similarly. TEAEs were also summarised by the grade of National Cancer Institute Common Terminology Criteria for Adverse Events. All AEs were coded using the MedDRA® version 24.0","reportingStatus":"POSTED","timeFrame":"From each patient's time of first dose administration to discontinuation of study drug (at any time or D28 of the last treatment cycle), up to 6 months.","title":"Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE V4.03 on Phase 1","type":"PRIMARY","unitOfMeasure":"Participants"}