{"analyses":[{"ciLowerLimit":"0.81","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.16","estimateComment":"Hazard ratio is comparing Pertuzumab arm with Placebo arm.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.7161","pValueComment":"Stratified by prior treatment status and region.","paramType":"Cox Proportional Hazard","paramValue":"0.97","statisticalMethod":"Log Rank (stratified)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"18","upperLimit":"27","value":"18.4"},{"groupId":"OG001","lowerLimit":"18","upperLimit":"27","value":"18.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"402"},{"groupId":"OG001","value":"404"}],"units":"Participants"}],"description":"Time to symptom progression was defined as the time from randomization to the first symptom progression as measured by the Functional Assessment of Cancer Therapy-for patients with Breast Cancer (FACT-B) questionnaire with the Trial Outcomes Index-Physical/Functional/Breast (TOI-PFB) subscale. The FACT-B TOI-PFB subscale contains 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer patients (breast cancer subscale \\[BCS\\]). All items in the questionnaire were rated by the patient on a 5-point scale ranging from 0 (\"not at all\") to 4 (\"very much\"). The total score ranged from 0 to 96. A higher score indicates better perceived quality of life. A positive change score from baseline indicates improvement. Symptom progression was defined as a decrease from baseline of 5 points or more.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants randomized to this arm received pertuzumab 420 milligrams (mg) intravenously (IV) once every 3 weeks (q3w) and trastuzumab 6 milligrams per kilogram (mg/kg) IV q3w, plus docetaxel 75 milligrams per square metre of body surface (mg/m\\^2) IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.","id":"OG000","title":"Pertuzumab + Trastuzumab + Docetaxel"},{"description":"Participants randomized to this arm received placebo IV q3w and trastuzumab 6 mg/kg IV q3w, plus docetaxel 75 mg/m\\^2 IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.","id":"OG001","title":"Placebo + Trastuzumab + Docetaxel"}],"paramType":"MEDIAN","populationDescription":"ITT population: All randomized participants; only female participants were included in the analysis.","reportingStatus":"POSTED","timeFrame":"Every 9 weeks from Baseline until investigator-determined progressive disease, up to the primary completion date (up to 3 years, 3 months)","title":"Time to Symptom Progression","type":"SECONDARY","unitOfMeasure":"Weeks"}