{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"108"},{"groupId":"OG001","value":"55"}]}],"title":"Any non-SAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"26"}]}],"title":"Any SAEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"130"},{"groupId":"OG001","value":"65"}],"units":"Participants"}],"description":"An adverse event (AE) is any untoward medical occurrence in a trial participant administered an investigational product(s), a comparator product, or an approved drug regardless of the causal relationship with treatment. An SAE is an AE that Results in death, life threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, results in a congenital anomaly/birth defect or any important medical events as per medical or scientific judgment. Adverse events which were not Serious were considered as Non-Serious adverse events.","groups":[{"description":"Participants were randomized to receive 200 mg of MMB orally QD and a DAN-placebo orally BID during the randomized 24-week double-blind treatment period.","id":"OG000","title":"MMB 200 mg QD + Placebo- Randomized Double-Blind Treatment Period"},{"description":"Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period.","id":"OG001","title":"DAN 300 mg BID + Placebo- Randomized Double-Blind Treatment Period"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety analysis set included all participants in the ITT Analysis set who received at least one dose of study drug.","reportingStatus":"POSTED","timeFrame":"Up to Week 24","title":"Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)- up to Week 24","type":"SECONDARY","unitOfMeasure":"Participants"}