{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"13"}]}],"title":"Grade 3 or higher non-hematologic toxicity"},{"categories":[{"measurements":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"26"}]}],"title":"Grade 2 or higher neurotoxicity"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"0"}]}],"title":"Grade 4 or higher hematologic toxicity"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"}]}],"title":"Febrile neutropenia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"106"},{"groupId":"OG001","value":"30"}]}],"title":"Any toxicity requiring dose delay"},{"categories":[{"measurements":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"7"}]}],"title":"Any toxicity requiring early discontinuation of protocol therapy"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"6"}]}],"title":"Serious adverse event"}],"denoms":[{"counts":[{"groupId":"OG000","value":"383"},{"groupId":"OG001","value":"114"}],"units":"Participants"}],"description":"Clinically relevant toxicities will include the composite incidence of grade 3 or higher non-hematologic toxicity, grade 2 or higher neurotoxicity, and grade 4 or higher hematologic toxicity. These toxicities will only be assessed at the pre-specified toxicity-assessment visits. In addition, the following events, regardless of timing of their occurrence, will also count towards the composite endpoint: febrile neutropenia, any toxicity requiring dose-delay, discontinuation of any study treatment (Paclitaxel, Trastuzumab, or T-DM1) for toxicity, and any serious adverse event (SAE).","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":"5 years after completion of study treatment or until death, whichever occurs first.","title":"Number of Participants of Clinically Relevant Toxicities (CRT)","type":"PRIMARY","unitOfMeasure":"Participants"}