{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"343"},{"groupId":"OG001","value":"171"}],"units":"Participants"}],"title":"Anemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"343"},{"groupId":"OG001","value":"171"}],"units":"Participants"}],"title":"Hemoglobin increased"},{"categories":[{"measurements":[{"groupId":"OG000","value":"239"},{"groupId":"OG001","value":"1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"342"},{"groupId":"OG001","value":"171"}],"units":"Participants"}],"title":"Neutrophil count decreased"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"343"},{"groupId":"OG001","value":"171"}],"units":"Participants"}],"title":"Platelet count decreased"},{"categories":[{"measurements":[{"groupId":"OG000","value":"167"},{"groupId":"OG001","value":"0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"343"},{"groupId":"OG001","value":"171"}],"units":"Participants"}],"title":"White blood cell count decreased"}],"denoms":[{"counts":[{"groupId":"OG000","value":"345"},{"groupId":"OG001","value":"172"}],"units":"Participants"}],"description":"Number of participants with shifts from Grade ≤2 at baseline values to post-baseline values (shift to Grade 3 or 4) were reported as per NCI-CTCAE, V4.0 graded from Grade 1 to 5. Grade 1: Mild; asymptomatic/ mild symptoms; clinical/diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local/noninvasive intervention indicated. Grade 3: Severe/medically significant but not immediately life-threatening; hospitalization/prolongation of hospitalization indicated. Grade 4: Life-threatening consequences; urgent intervention indicated. Shifts in lab parameter from Grade ≤2 at baseline to Grade 3 or 4 postbaseline (for parameters Anemia, Hemoglobin increased, Neutrophil count decreased, Platelet count decreased, and White blood cell count decreased) were reported.","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":"COUNT_OF_PARTICIPANTS","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 baseline to end of treatment/withdrawal (up to 4.5 years)","title":"Participants With Shifts From CTCAE Grade ≤2 at Baseline to CTCAE Grade 3 or 4 Postbaseline for Hematology Results","type":"SECONDARY","unitOfMeasure":"Participants"}