{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.12","upperLimit":"0.2","value":"0.16"},{"groupId":"OG001","lowerLimit":"0.15","upperLimit":"0.32","value":"0.23"}]}]}],"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.","dispersionType":"95% Confidence Interval","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":"NUMBER","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":"Incidence Rate of Grade 3-4 Treatment-Related Toxicity","type":"SECONDARY","unitOfMeasure":"proportion of participants"}