{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"18"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"64"}],"units":"Participants"}],"description":"Patients that eligible for amenorrhea assessment and data collecting will be evaluated by standard method defined per protocol 3.9, through menses assessment survey.","groups":[{"description":"80 mg of paclitaxel per square meter of body-surface area weekly for 12 weeks and a loading dose of 4 mg of intravenous trastuzumab per kilogram of body weight on day 1, followed by 2 mg per kilogram weekly, for a total of 12 doses. After the completion of 12 weeks of treatment with Trastuzumab, the dosing of Trastuzumab could be continued on a weekly basis, or the regimen could be changed to 6 mg per kilogram every 3 weeks for 40 weeks to complete a full year of intravenous treatment with trastuzumab.","id":"OG000","title":"Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"64 women are evaluable for the amenorrhea assessment","reportingStatus":"POSTED","timeFrame":"Menses Assessment survey on Q6 months x 1 year, then q6months for year 2 and at progression, and observation years 2-10 or until progression.","title":"Number of Patients With Amenorrhea","type":"SECONDARY","unitOfMeasure":"Participants"}