{"analyses":[{"ciLowerLimit":"0.57","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.92","estimateComment":"The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\\<= 3 or \\>= 4) and ER/PgR status (positive or negative).","groupDescription":"Invasive disease-free survival (iDFS) in neratinib arm compared to placebo arm.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.008","pValueComment":"The Log-rank test is stratified by prior trastuzumab (concurrent or sequential), nodal status (\\<= 3 or \\>= 4) and ER/PgR status (positive or negative).","paramType":"Hazard Ratio (HR)","paramValue":"0.73","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8.2"},{"groupId":"OG001","value":"11.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1420"},{"groupId":"OG001","value":"1420"}],"units":"Participants"}],"description":"Invasive disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.","groups":[{"description":"Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.","id":"OG000","title":"Neratinib"},{"description":"Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.","id":"OG001","title":"Placebo"}],"paramType":"NUMBER","populationDescription":"Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.","reportingStatus":"POSTED","timeFrame":"From randomization until time of event up to 5 years","title":"Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 5","type":"OTHER_PRE_SPECIFIED","unitOfMeasure":"percentage of participants with events"}