{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"99.1"},{"groupId":"OG001","value":"96.4"}]}],"title":"Participants with AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"28.2"},{"groupId":"OG001","value":"17.1"}]}],"title":"Participants with SAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"83.1"},{"groupId":"OG001","value":"30.2"}]}],"title":"Participants with Grade 3 or 4 AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3.6"},{"groupId":"OG001","value":"2.3"}]}],"title":"Participants with Grade 5 AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4.1"},{"groupId":"OG001","value":"2.3"}]}],"title":"Permanently discontinued study due to AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"14.4"},{"groupId":"OG001","value":"6.3"}]}],"title":"Permanently disc. palbociclib/placebo due to AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9.2"},{"groupId":"OG001","value":"5.9"}]}],"title":"Permanently discontinued letrozole due to AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"79.7"},{"groupId":"OG001","value":"17.1"}]}],"title":"Temporarily disc. palbociclib/placebo due to AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"23.0"},{"groupId":"OG001","value":"11.3"}]}],"title":"Temporarily discontinued letrozole due to AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"41.9"},{"groupId":"OG001","value":"2.3"}]}],"title":"With palbociclib/placebo dose reduction due to AEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"444"},{"groupId":"OG001","value":"222"}],"units":"Participants"}],"description":"An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization; resulted in persistent or significant disability or in congenital anomaly/birth defect. TEAE were events that occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Severity was graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0 as Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening and Grade 5 = death related to AE. Discontinuation included permanent, temporary discontinuation and dose reduction due to AEs.","groups":[{"description":"Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.","id":"OG000","title":"Palbociclib Plus Letrozole"},{"description":"Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.","id":"OG001","title":"Placebo Plus Letrozole"}],"paramType":"NUMBER","populationDescription":"AT population included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.","reportingStatus":"POSTED","timeFrame":"From date of randomization up to 28 days after last dose of study drug (final analysis till study completion, approximately up to 10.51 years)","title":"Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs): All Causalities","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}