{"denoms":[{"counts":[{"groupId":"BG000","value":"39"}],"units":"Participants"}],"groups":[{"description":"All subjects received at least one dose of study treatment, from any of the arms (low risk, medium risk, and high risk). This study protocol requires the same neoadjuvant therapy and surgery for all subjects. Adjuvant treatment is assigned based on the risk group. Adjuvant treatment arms were not randomized. Therefore, baseline characteristics were reported based on the whole group.","id":"BG000","title":"All Subjects"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"27"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"12"}],"title":">=65 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"11"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"28"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"37"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"4"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"32"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"3"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"39"}]}],"title":"United States"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"}],"populationDescription":"This study protocol requires the same neoadjuvant therapy and surgery for all subjects. Adjuvant treatment is assigned based on the risk group. The primary outcome measure is the complete pathologic response that is defined by the surgical pathology report. Complete pathologic response is not related to adjuvant therapy."}