{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"30"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"30"}],"units":"Participants"}],"description":"Will assess the presence of all toxicities outlined in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.","groups":[{"description":"Patients received oral cabozantinib 40 mg (as a starting dose) once per day and temozolomide 150 mg/m² on days 1-5 of a 28-day cycle for cycle one. Starting from cycle two, temozolomide was escalated to 200 mg/m² on days 1-5 of each cycle, if the absolute neutrophil count was more than 1·5 × 10⁹/L and platelet count was more than 100·0 × 10⁹/L. Treatment was continued until disease progression or unacceptable drug-related toxicity.","id":"OG000","title":"Cohort 1 - Patients With Unresectable or Metastatic Uterine and Non-uterine Leiomyosarcoma"},{"description":"Patients with gastrointestinal stromal tumour, dermatofibrosarcoma, alveolar soft part sarcoma, kaposi sarcoma, mixed mesodermal tumour or carcinosarcoma, alveolar and embryonal rhabdomyosarcoma, and low grade sarcomas were not included.\n\nPatients received oral cabozantinib 40 mg (as a starting dose) once per day and temozolomide 150 mg/m² on days 1-5 of a 28-day cycle for cycle one. Starting from cycle two, temozolomide was escalated to 200 mg/m² on days 1-5 of each cycle, if the absolute neutrophil count was more than 1·5 × 10⁹/L and platelet count was more than 100·0 × 10⁹/L. Treatment was continued until disease progression or unacceptable drug-related toxicity.","id":"OG001","title":"Cohort 2 - Patients With Other Soft Tissue Sarcomas"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"From time of first treatment up to the end of last treatment, up to 5 years","title":"Number of Participants With Adverse Events","type":"SECONDARY","unitOfMeasure":"Participants"}