{"analyses":[{"ciLowerLimit":"0.58","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.82","estimateComment":"Hazard ratio is comparing Pertuzumab arm with Placebo arm.","groupDescription":"End-of-Study OS Analysis: This end-of-study OS analysis is considered exploratory only as the confirmatory OS analysis for statistical interpretation had previously occurred at the second interim OS analysis.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Exploratory","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"Exploratory","paramType":"Cox Proportional Hazard","paramValue":"0.69","statisticalComment":"Stratified by prior treatment status and region.","statisticalMethod":"Log Rank (stratified)"},{"ciLowerLimit":"0.56","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.84","estimateComment":"Hazard ratio is comparing Pertuzumab arm with Placebo arm.","groupDescription":"Event-Driven Final OS Analysis: This final OS analysis was event-driven and planned to take place after a total of 385 deaths had occurred. It is considered exploratory only as the confirmatory OS analysis for statistical interpretation had previously occurred at the second interim OS analysis.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Exploratory","nonInferiorityType":"SUPERIORITY","pValue":"0.0002","pValueComment":"Exploratory","paramType":"Cox Proportional Hazard","paramValue":"0.68","statisticalComment":"Stratified by prior treatment status and region.","statisticalMethod":"Log Rank (stratified)"},{"ciLowerLimit":"0.52","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.84","estimateComment":"Hazard ratio (HR) is comparing Pertuzumab arm with Placebo arm.","groupDescription":"Second Interim OS Analysis: For this second interim OS analysis, the pre-defined O'Brien-Fleming stopping boundary for the Lan-DeMets α-spending function was: HR≤0.739, p≤0.0138.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0008","pValueComment":"The threshold for statistical significance was HR≤0.739, p≤0.0138.","paramType":"Cox Proportional Hazard","paramValue":"0.66","statisticalComment":"Stratified by prior treatment status and region.","statisticalMethod":"Log Rank (stratified)"},{"ciLowerLimit":"0.47","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.88","estimateComment":"Hazard ratio (HR) is comparing pertuzumab with placebo arms.","groupDescription":"First Interim OS Analysis: For this first interim OS analysis, the pre-defined O'Brien-Fleming stopping boundary for the Lan-DeMets α-spending function was: HR≤0.603, p≤0.0012.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0050","pValueComment":"The threshold for statistical significance was HR≤0.603, p≤0.0012.","paramType":"Cox Proportional Hazard","paramValue":"0.64","statisticalComment":"Stratified by prior treatment status and region.","statisticalMethod":"Log Rank (stratified)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"50","upperLimit":"72","value":"57.1"},{"groupId":"OG001","lowerLimit":"36","upperLimit":"48","value":"40.8"}]}],"title":"End-of-Study OS Analysis"},{"categories":[{"measurements":[{"comment":"The upper limit of the 95% CI could not be determined because it was larger than the maximum follow-up time at data cutoff for the analysis.","groupId":"OG000","lowerLimit":"49","upperLimit":"NA","value":"56.5"},{"groupId":"OG001","lowerLimit":"36","upperLimit":"48","value":"40.8"}]}],"title":"Event-Driven Final OS Analysis"},{"categories":[{"measurements":[{"comment":"The median and upper limit of the 95% CI could not be determined because they were larger than the maximum follow-up time at data cutoff for the analysis.","groupId":"OG000","lowerLimit":"42","upperLimit":"NA","value":"NA"},{"comment":"The upper limit of the 95% CI could not be determined because it was larger than the maximum follow-up time at data cutoff for the analysis.","groupId":"OG001","lowerLimit":"34","upperLimit":"NA","value":"37.6"}]}],"title":"Second Interim OS Analysis"},{"categories":[{"measurements":[{"comment":"The median and lower and upper limits of the 95% CI could not be determined because they were larger than the maximum follow-up time at data cutoff for the analysis.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"The median and upper limit of the 95% CI could not be determined because they were larger than the maximum follow-up time at data cutoff for the analysis.","groupId":"OG001","lowerLimit":"30","upperLimit":"NA","value":"NA"}]}],"title":"First Interim OS Analysis"}],"denoms":[{"counts":[{"groupId":"OG000","value":"402"},{"groupId":"OG001","value":"406"}],"units":"Participants"}],"description":"Overall survival (OS) was the time from randomization to death from any cause, using Kaplan-Meier methodology. Survival data was collected every 18 weeks during the post-treatment follow-up period until death, loss to follow-up, or withdrawal of consent. Those who were alive, lost to follow up, or withdrew consent were censored at the latest date they participated in the study; those without post-baseline data were censored at 1 day. OS analyses were planned to take place at the primary completion date (First Interim), after 385 deaths (Event-Driven Final), and at the end of study (End-of-Study). A second interim OS analysis was planned due to a formal request from the European Medicines Agency. Median \\[range\\] time in weeks on study at each OS analysis (Pertuzumab vs. Placebo): First: 77.1 \\[0.7-165.3\\] vs. 73.1 \\[0.4-165.3\\]; Second: 117.1 \\[0.7-207.9\\] vs. 105.9 \\[0.4-207.9\\]; Event-Driven Final: 189.9 \\[0.7-304.1\\] vs. 140.5 \\[0.4-301.6\\]; End-of-Study: 201.8 \\[0.7-520.0\\] vs. 138.0 \\[0.4-514.7\\].","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","reportingStatus":"POSTED","timeFrame":"From randomization to death from any cause, up to each respective analysis data cut-off date (see the Description field for the median time on study per treatment arm)","title":"Overall Survival","type":"SECONDARY","unitOfMeasure":"Months"}