{"denoms":[{"counts":[{"groupId":"OG000","value":"0"}],"units":"Participants"}],"description":"Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.\n\nNo participants enrolled in part B.","groups":[{"description":"No participants enrolled in part B","id":"OG000","title":"Part B"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All treated participants in part B","reportingStatus":"POSTED","timeFrame":"From first dose to 135 days post last dose","title":"Number of Participants With Serious Adverse Events (SAEs) - Part B","type":"SECONDARY","unitOfMeasure":"Participants"}