{"denoms":[{"counts":[{"groupId":"BG000","value":"2400"},{"groupId":"BG001","value":"2404"},{"groupId":"BG002","value":"4804"}],"units":"Participants"}],"groups":[{"description":"Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\\^2 + epirubicin 90-120 mg/m\\^2 or doxorubicin 50 mg/m\\^2 + cyclophosphamide 500-600 mg/m\\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\\^2 for 3 cycles, 75 mg/m\\^2 in first cycle and 100 mg/m\\^2 in subsequent cycles, or 75 mg/m\\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\\^2 or epirubicin 90-120 mg/m\\^2 + cyclophosphamide 500-600 mg/m\\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).","id":"BG000","title":"Pertuzumab + Trastuzumab + Chemotherapy"},{"description":"Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\\^2 + epirubicin 90-120 mg/m\\^2 or doxorubicin 50 mg/m\\^2 + cyclophosphamide 500-600 mg/m\\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\\^2 for 3 cycles, 75 mg/m\\^2 in first cycle and 100 mg/m\\^2 in subsequent cycles, or 75 mg/m\\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\\^2 or epirubicin 90-120 mg/m\\^2 + cyclophosphamide 500-600 mg/m\\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\\^2 + carboplatin AUC 6 (up to 900 mg).","id":"BG001","title":"Placebo + Trastuzumab + Chemotherapy"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"10.9","value":"51.7"},{"groupId":"BG001","spread":"10.7","value":"51.4"},{"groupId":"BG002","spread":"10.8","value":"51.5"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2397"},{"groupId":"BG001","value":"2396"},{"groupId":"BG002","value":"4793"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"11"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"ITT population","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"45"},{"groupId":"BG001","value":"42"},{"groupId":"BG002","value":"87"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"432"},{"groupId":"BG001","value":"386"},{"groupId":"BG002","value":"818"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"1923"},{"groupId":"BG001","value":"1976"},{"groupId":"BG002","value":"3899"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1705"},{"groupId":"BG001","value":"1694"},{"groupId":"BG002","value":"3399"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"32"},{"groupId":"BG001","value":"41"},{"groupId":"BG002","value":"73"}],"title":"Black"},{"measurements":[{"groupId":"BG000","value":"590"},{"groupId":"BG001","value":"598"},{"groupId":"BG002","value":"1188"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"66"},{"groupId":"BG001","value":"69"},{"groupId":"BG002","value":"135"}],"title":"Other"},{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"9"}],"title":"Not reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race/Ethnicity, Customized","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"90"},{"groupId":"BG001","value":"84"},{"groupId":"BG002","value":"174"}],"title":"0 Positive Nodes and Tumor ≤1 cm"},{"measurements":[{"groupId":"BG000","value":"807"},{"groupId":"BG001","value":"818"},{"groupId":"BG002","value":"1625"}],"title":"0 Positive Nodes and Tumor >1 cm"},{"measurements":[{"groupId":"BG000","value":"907"},{"groupId":"BG001","value":"900"},{"groupId":"BG002","value":"1807"}],"title":"1 to 3 Positive Nodes"},{"measurements":[{"groupId":"BG000","value":"596"},{"groupId":"BG001","value":"602"},{"groupId":"BG002","value":"1198"}],"title":"≥4 Positive Nodes"}]}],"description":"The disease status of a participant's lymph nodes (positive or negative and number affected) was one of the study's randomization stratification factors. Nodal status may have taken any of the four categories for participants who enrolled under protocol version A, but only the two categories with positive nodes after protocol version B had been implemented.","paramType":"COUNT_OF_PARTICIPANTS","title":"Nodal Status","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1865"},{"groupId":"BG001","value":"1877"},{"groupId":"BG002","value":"3742"}],"title":"Anthracycline containing regimen"},{"measurements":[{"groupId":"BG000","value":"535"},{"groupId":"BG001","value":"527"},{"groupId":"BG002","value":"1062"}],"title":"Non-anthracycline containing regimen"}]}],"description":"The type of adjuvant chemotherapy regimen that the investigator chose for each participant's treatment (anthracycline or non-anthracycline containing regimen) was one of the study's randomization stratification factors.","paramType":"COUNT_OF_PARTICIPANTS","title":"Adjuvant Chemotherapy Regimen","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"864"},{"groupId":"BG001","value":"858"},{"groupId":"BG002","value":"1722"}],"title":"Negative (ER and PgR negative)"},{"measurements":[{"groupId":"BG000","value":"1536"},{"groupId":"BG001","value":"1546"},{"groupId":"BG002","value":"3082"}],"title":"Positive (ER and/or PgR positive)"}]}],"description":"Central laboratory assessment of the hormone receptor status (estrogen receptor \\[ER\\] and progesterone receptor \\[PgR\\] positive or negative) of each participant's tumor tissue sample was conducted at screening. The hormone receptor status was one of the study's randomization stratification factors.","paramType":"COUNT_OF_PARTICIPANTS","title":"Hormone Receptor Status","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1828"},{"groupId":"BG001","value":"1827"},{"groupId":"BG002","value":"3655"}],"title":"Protocol Version A"},{"measurements":[{"groupId":"BG000","value":"572"},{"groupId":"BG001","value":"577"},{"groupId":"BG002","value":"1149"}],"title":"Protocol Version B"}]}],"description":"The protocol version at enrollment (Version A or B) was one of the study's randomization stratification factors. The amendment from protocol version A (28-June-2011) to version B (20-Nov-2012) was made mainly to adjust for a higher than expected rate of recruitment of node-negative patients. Therefore, the trial sample size was increased from N=3806 to N=4800 and node-negative patients were no longer permitted to enroll.","paramType":"COUNT_OF_PARTICIPANTS","title":"Protocol Version at Enrollment","unitOfMeasure":"Participants"}],"populationDescription":"Intent-to-treat (ITT) population included all randomized participants regardless of treatment received."}