{"analyses":[{"ciLowerLimit":"0.81","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.14","estimateComment":"This two sided p value was stratified by (neo)adjuvant chemotherapy (yes vs no) and age (\\<=50 vs \\>50).","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.65","paramType":"Hazard Ratio (HR)","paramValue":"0.96","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"84.2"},{"groupId":"OG001","value":"84.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2884"},{"groupId":"OG001","value":"2877"}],"units":"Participants"}],"description":"Invasive disease-free survival (iDFS) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed HR+/HER2- invasive early breast cancer (EBC) at 4 years. iDFS is defined as the time from randomization to the date of the first event: local/regional invasive ipsilateral recurrence, contralateral invasive breast cancer, distant recurrence, second primary invasive cancer of non-breast origin or death from any cause. Direct comparison between arms used time to iDFS events and Kaplan-Meier Log-rank analysis. Due to the medians not yet achieved, the percentage of patients considered iDFS at 4 years is reported.","groups":[{"description":"Palbociclib at a dose of 125 mg orally once daily, Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle for a total duration of 2 years, in addition to standard adjuvant endocrine therapy for a duration of at least 5 years.","id":"OG000","title":"Palbociclib Plus Endocrine Therapy (Arm A)"},{"description":"Standard adjuvant endocrine therapy for a duration of at least 5 years.","id":"OG001","title":"Endocrine Therapy Alone (Arm B)"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"4 years","title":"Invasive Disease Free Survival (iDFS)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}