{"denoms":[{"counts":[{"groupId":"OG000","value":"0"}],"units":"Participants"}],"description":"An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.\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 Adverse Events Leading to Discontinuation - Part B","type":"SECONDARY","unitOfMeasure":"Participants"}