{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"146"}],"units":"Participants"}],"description":"The proportion of SAE rate among all eligible patients","groups":[{"description":"All enrolled eligible patients.","id":"OG000","title":"Overall"}],"paramType":"NUMBER","populationDescription":"The SAE event was monitored for all eligible patients. It was not compared between subgroups per protocol 9.3.2.","reportingStatus":"POSTED","timeFrame":"4 months","title":"Severe Adverse Events (SAE) Rate.","type":"PRIMARY","unitOfMeasure":"percentage of participants"}