{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"155"},{"groupId":"OG001","value":"52"}]}],"title":"Serious Adverse Events (SAEs)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"375"},{"groupId":"OG001","value":"166"}]}],"title":"Adverse Events (AEs)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"378"},{"groupId":"OG001","value":"172"}],"units":"Participants"}],"description":"An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.","groups":[{"description":"Trabectedin at a dose of 1.5 milligram per meter square (mg/m\\^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.","id":"OG000","title":"Trabectedin"},{"description":"Dacarbazine at a dose of 1 gram per meter square (mg/m\\^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.","id":"OG001","title":"Dacarbazine"}],"paramType":"NUMBER","populationDescription":"Safety population included all the treated participants.","reportingStatus":"POSTED","timeFrame":"approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015])","title":"Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)","type":"SECONDARY","unitOfMeasure":"Participants"}