{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"98.8"},{"groupId":"OG001","value":"93.6"}]}],"title":"With AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"22.6"},{"groupId":"OG001","value":"19.2"}]}],"title":"With SAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"80.6"},{"groupId":"OG001","value":"26.7"}]}],"title":"With Grade 3 or 4 AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2.3"},{"groupId":"OG001","value":"1.7"}]}],"title":"With Grade 5 AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7.5"},{"groupId":"OG001","value":"4.7"}]}],"title":"Discontinued palbociclib/placebo due to AEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"345"},{"groupId":"OG001","value":"172"}],"units":"Participants"}],"description":"An AE is any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening; requires hospitalization; results in persistent or significant disability or in congenital anomaly/birth defect. Severity will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0.","groups":[{"description":"Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 105 cycles.","id":"OG000","title":"Palbociclib + Fulvestrant"},{"description":"Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 93 cycles.","id":"OG001","title":"Placebo + Fulvestrant"}],"paramType":"NUMBER","populationDescription":"The as-treated (AT) population or safety analysis set included all participants who received at least 1 dose of study intervention, with treatment assignments designated according to actual study intervention received.","reportingStatus":"POSTED","timeFrame":"From the date of randomization up to 28 calendar days (±7 days) after last dose of study intervention (up to 8.4 years).","title":"Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}