{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0001","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"383"},{"groupId":"OG001","value":"114"}],"units":"Participants"}],"description":"Reversible Grade 1-4 thrombocytopenia has been observed in ongoing studies with trastuzumab emtansine.","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"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"AE is reported every 3 weeks for the first 12 weeks, then every 9 weeks for the subsequent 39 weeks, then follow-up up to 5 years after completion of study treatment or until death, whichever occurs first. Median follow-up 3.1 years.","title":"Number of Incidence of T-DM1 Induced Grade 2-3 Thrombocytopenia","type":"SECONDARY","unitOfMeasure":"Participants"}