{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"28"},{"groupId":"OG002","value":"34"}]}],"title":"Adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"20"}]}],"title":"Mild intensity adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"14"}]}],"title":"Moderate intensity adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"}]}],"title":"Severe intensity adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"11"}]}],"title":"Drug-related adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Serious adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"}]}],"title":"AEs leading to study drug discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Deaths"}],"denoms":[{"counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"70"},{"groupId":"OG002","value":"65"}],"units":"Participants"}],"description":"Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild, moderate or severe and for causal relationship to study drug.","groups":[{"description":"Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.","id":"OG000","title":"Placebo"},{"description":"Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.","id":"OG001","title":"Mirabegron 50 mg"},{"description":"Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.","id":"OG002","title":"Mirabegron 100 mg"}],"paramType":"NUMBER","populationDescription":"The Safety Analysis set included all participants who received at least one dose of study drug.","reportingStatus":"POSTED","timeFrame":"From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).","title":"Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests","type":"SECONDARY","unitOfMeasure":"participants"}