{"analyses":[{"ciLowerLimit":"0.51","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.75","estimateComment":"Hazard ratio is comparing Pertuzumab arm with Placebo arm.","groupDescription":"The null hypothesis (H0) was that the survival distributions of PFS in the two treatments arms (pertuzumab vs. placebo) are the same. The alternative hypothesis (H1) was that the survival distribution of PFS in the experimental arm (pertuzumab) and control arm (placebo) are different.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"Tested at two-sided 5% significance level","paramType":"Cox Proportional Hazard","paramValue":"0.62","statisticalComment":"Stratified by prior treatment status and region","statisticalMethod":"Log Rank (stratified)"},{"ciLowerLimit":"0.52","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.76","estimateComment":"Hazard ratio is comparing Pertuzumab arm with Placebo arm.","groupDescription":"The null hypothesis (H0) was that the survival distributions of PFS in the two treatments arms (pertuzumab vs. placebo) are the same. The alternative hypothesis (H1) was that the survival distribution of PFS in the experimental arm (pertuzumab) and control arm (placebo) are different.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"Tested at two-sided 5% significance level","paramType":"Cox Proportional Hazard","paramValue":"0.63","statisticalComment":"Unstratified","statisticalMethod":"Log Rank (unstratified)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"15","upperLimit":"23","value":"18.5"},{"groupId":"OG001","lowerLimit":"10","upperLimit":"13","value":"12.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"402"},{"groupId":"OG001","value":"406"}],"units":"Participants"}],"description":"PFS was defined as the time from randomization to first documented radiographical progressive disease (PD), as determined by an independent review facility (IRF) using RECIST version 1.0, or death from any cause (within 18 weeks of last tumor assessment), whichever occurred first (Kaplan-Meier method). For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum of the LD recorded since treatment started or the appearance of ≥1 new lesion. For non-target lesions, PD was defined as the appearance of ≥1 new lesion or unequivocal progression of existing lesions. Participants without IRF-determined PD or who had not died within 18 weeks of their last IRF-determined, progression-free tumor assessment were censored at the date of the last IRF-reviewed, evaluable tumor assessment; those with no post-baseline tumor assessment and who had not died within 18 weeks of baseline were censored at 1 day.","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":"Intent-to-Treat (ITT) Population: All randomized participants","reportingStatus":"POSTED","timeFrame":"Tumor assessments every 9 weeks from randomization to IRF-determined PD or death from any cause, whichever occurred first, up to the primary completion date (up to 3 years, 3 months)","title":"Progression-Free Survival (PFS) Determined by an Independent Review Facility","type":"PRIMARY","unitOfMeasure":"Months"}