{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"17"}]}],"title":"Any adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"17"}]}],"title":"Adverse drug reaction"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"SAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Discontinuation due to adverse events"}],"denoms":[{"counts":[{"groupId":"OG000","value":"17"}],"units":"Participants"}],"description":"All adverse events occurring during the administration of the investigational product are to be examined for safety by cross tabulation lists and tables of incidence from the viewpoint of relationship with the drug, disease severity and medicine treated group.","groups":[{"description":"SyB L-0501: The administration of SyB L-0501 at 90 mg/m\\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.","id":"OG000","title":"SyB L-0501"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"up to around 44 weeks","title":"Adverse Events","type":"SECONDARY","unitOfMeasure":"participants"}