{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Blood and lymphatic system disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Cardiac disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Eye disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"}]}],"title":"Gastrointestinal disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"General disorders and administration site conditions"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}],"title":"Infections and infestations"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Injury, poisoning and procedural complications"},{"categories":[{"measurements":[{"groupId":"OG000","value":"25"}]}],"title":"Investigations"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}],"title":"Metabolism and nutrition disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"Musculoskeletal and connective tissue disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Nervous system disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Psychiatric disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"Renal and urinary disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"Respiratory, thoracic and mediastinal disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Skin and subcutaneous tissue disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}],"title":"Vascular disorders"}],"denoms":[{"counts":[{"groupId":"OG000","value":"49"}],"units":"Participants"}],"description":"Number of participants who experienced at least one adverse event of grade 3 or higher. Adverse events were graded and categorized using CTCAE v5.0.","groups":[{"description":"Ribociclib 600 mg administered orally daily for 21 days followed by 7 days off in 28-day treatment cycle plus Letrozole 2.5 mg administered orally daily for 28 days.","id":"OG000","title":"Ribociclib and Letrozole"}],"paramType":"NUMBER","populationDescription":"Eligible participants who received any amount of protocol therapy.","reportingStatus":"POSTED","timeFrame":"During treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months.","title":"Incidence of Adverse Events (Grade 3 or Higher)","type":"SECONDARY","unitOfMeasure":"participants"}