{"analyses":[{"ciLowerLimit":"4.2","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"17.5","estimateComment":"Difference in the objective response rates between arms is calculated as Pertuzumab arm minus Placebo arm. The 95% CI was calculated using the Hauck-Anderson method.","groupDescription":"Difference in Objective Response (CR + PR) Between Arms","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0011","paramType":"Difference in Objective Response Rates","paramValue":"10.83","statisticalComment":"Stratified by prior treatment status and region.","statisticalMethod":"Mantel Haenszel"},{"ciLowerLimit":"1.26","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.54","groupDescription":"Odds Ratio for Objective Response (CR + PR)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Odds Ratio (OR)","paramValue":"1.79"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"75.6","upperLimit":"84.3","value":"80.2"},{"groupId":"OG001","lowerLimit":"64.1","upperLimit":"74.2","value":"69.3"}]}],"title":"Objective Response (CR + PR)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.4","upperLimit":"8.5","value":"5.5"},{"groupId":"OG001","lowerLimit":"2.3","upperLimit":"6.9","value":"4.2"}]}],"title":"Complete Response (CR)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"69.7","upperLimit":"79.2","value":"74.6"},{"groupId":"OG001","lowerLimit":"59.8","upperLimit":"70.3","value":"65.2"}]}],"title":"Partial Response (PR)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.0","upperLimit":"18.8","value":"14.6"},{"groupId":"OG001","lowerLimit":"16.6","upperLimit":"25.6","value":"20.8"}]}],"title":"Stable Disease (SD)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.0","upperLimit":"6.4","value":"3.8"},{"groupId":"OG001","lowerLimit":"5.6","upperLimit":"11.8","value":"8.3"}]}],"title":"Progressive Disease (PD)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.1","upperLimit":"2.1","value":"0.6"},{"groupId":"OG001","lowerLimit":"0.1","upperLimit":"2.1","value":"0.6"}]}],"title":"Unable to Assess (UA)"},{"categories":[{"measurements":[{"comment":"95% confidence intervals were calculated only for clinical responses.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"0.9"},{"comment":"95% confidence intervals were calculated only for clinical responses.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"0.9"}]}],"title":"Missing (No Assessment)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"343"},{"groupId":"OG001","value":"336"}],"units":"Participants"}],"description":"An objective response was defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR) determined by an independent review facility (IRF) using RECIST v1.0 on two consecutive occasions ≥4 weeks apart. For target lesions, CR: disappearance of all target lesions; PR: ≥30% decrease in the sum of the longest diameter (LD) of target lesions (baseline sum LD as reference); PD: ≥20% increase in the sum of the LD of target lesions (smallest sum of the LD recorded as reference) or appearance of ≥1 new lesion; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase for PD. For non-target lesions, CR: disappearance of all non-target lesions; Incomplete/SD: persistence of ≥1 non-target lesions; PD: unequivocal progression of existing non-target lesions. 95% confidence intervals (CI) were calculated only for clinical responses using the Pearson-Clopper method.","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":"NUMBER","populationDescription":"ITT Population: All randomized participants; only participants with IRF-determined measurable disease at baseline (i.e., ≥1 target lesion) were included in the analysis.","reportingStatus":"POSTED","timeFrame":"Tumor assessments every 9 weeks from Baseline until IRF-determined progressive disease (PD), death, or first administration of next line of anti-cancer therapy (whichever occurred first), up to the primary completion date (up to 3 years, 3 months)","title":"Objective Response Determined by an Independent Review Facility","type":"SECONDARY","unitOfMeasure":"Percentage of patients"}