{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"21"}]}],"title":"6 months"},{"categories":[{"measurements":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"22"}]}],"title":"1 year"},{"categories":[{"measurements":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"20"}]}],"title":"18 months"},{"categories":[{"measurements":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"15"}]}],"title":"24 months"},{"categories":[{"measurements":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"11"}]}],"title":"30 months"},{"categories":[{"measurements":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"9"}]}],"title":"36 months"}],"denoms":[{"counts":[{"groupId":"OG000","value":"383"},{"groupId":"OG001","value":"114"}],"units":"Participants"}],"description":"All grade 3 - 4 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade \\>=3 AE of any type during the time of observation.\n\nFor those who were premenopausal pre-chemotherapy, at each follow-up visit (every six months) in order to assess for duration of amenorrhea and also premature ovarian failure.","groups":[{"description":"T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks","id":"OG000","title":"Trastuzumab Emtansine (T-DM1)"},{"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","id":"OG001","title":"Paclitaxel + Trastuzumab (TH)"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"Surveys are took at month 6 and 12 during treatment, and month 18, 24, 30 and 36 during follow up.","title":"Percentage of Patients With Amenorrhea","type":"SECONDARY","unitOfMeasure":"percentage of participants"}