{"analyses":[{"groupIds":["OG000","OG001","OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0012","statisticalMethod":"Mantel Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"267"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"36"},{"groupId":"OG003","value":"11"}],"title":"No, mild, or moderate neuropathy"},{"measurements":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"17"},{"groupId":"OG002","value":"22"},{"groupId":"OG003","value":"12"}],"title":"Moderate to severe and severe neuropathy"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"291"},{"groupId":"OG001","value":"81"},{"groupId":"OG002","value":"58"},{"groupId":"OG003","value":"23"}],"units":"Participants"}],"description":"Neuropathy evaluated by Patient Neurotoxicity Questionnaire (PNQ) defined per protocol.","groups":[{"description":"T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks. No neuropathy at baseline","id":"OG000","title":"T-DM1 With no Baseline Neuropathy"},{"description":"paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments.\n\nNo neuropathy at baseline","id":"OG001","title":"TH With no Baseline Neuropathy"},{"description":"T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks. Neuropathy at baseline","id":"OG002","title":"T-DM1 With Any Baseline Neuropathy"},{"description":"paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments.\n\nNeuropathy at baseline","id":"OG003","title":"TH With Any Baseline Neuropathy"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The PNQ analysis was done on patients that completed at least baseline questionnaires and at least one follow-up questionnaire. Some patients did not complete this questionnaire at either baseline or follow-up. This is the reason for the reduced number of patients when reporting PNQ results.","reportingStatus":"POSTED","timeFrame":"Surveys are took at week 3, 12 and month 6 and 12 during treatment, and month 18. The data cutoff date is 18 month.","title":"Number of Patients Has Neuropathy","type":"SECONDARY","unitOfMeasure":"Participants"}