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Safety analyses were performed on data from all subjects in the Safety Population.\n\nAdverse events are reported on a patient basis. The percentages are calculated using the number of patients in the Safety Analysis Set as the denominator.","groups":[{"description":"Patients with Relapsed/refractory small cell lung cancer (SCLC)","id":"OG000","title":"Tinostamustine (EDO-S101) - Phase 2 SCLC Cohort"},{"description":"Patients with Relapsed/refractory soft tissue sarcoma (STS)","id":"OG001","title":"Tinostamustine (EDO-S101) - Phase 2 STS Cohort"},{"description":"Patients with Relapsed/refractory triple-negative breast cancer (TNBC)","id":"OG002","title":"Tinostamustine (EDO-S101) - Phase 2 TNBC Cohort"},{"description":"Patients with Relapsed/refractory Ovarian Cancer (OC)","id":"OG003","title":"Tinostamustine (EDO-S101) - Phase 2 OC Cohort"},{"description":"Patients with Relapsed/refractory Endometrial Cancer (EC)","id":"OG004","title":"Tinostamustine (EDO-S101) - Phase 2 EC Cohort"},{"description":"Subgroup treated with a dose of 60 mg/m2 over 60 minutes infusion time of EDO-S101","id":"OG005","title":"Tinostamustine (EDO-S101) - Sub Study 1 (SS1)"},{"description":"Subgroup treated with a dose of 80 mg/m2 over 80 minutes infusion time of EDO-S101","id":"OG006","title":"Tinostamustine (EDO-S101) - Sub Study 2 (SS2)"}],"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 informed consent to discontinuation of study drug (at any time or D28 of the last treatment cycle), up to 8 months","title":"Treatment-related Adverse Events on Phase 2 and Sub Studies","type":"SECONDARY","unitOfMeasure":"Participants"}