{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":".167","upperLimit":".580","value":".35"},{"groupId":"OG001","lowerLimit":".09","upperLimit":".404","value":".22"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"23"}],"units":"Participants"}],"description":"Response is defined as achieving complete or partial response.Complete response (CR) for both cohorts was defined as resolution of all identified tumor masses on the vulva or disappearance of all target and non-target lesions with no evidence of new lesions documented by two disease assessments at least 4 weeks apart. For cohort 1 pts, a partial response (PR) was defined as a 30% reduction in the product of all diameters of the vulva tumor/tumors compared to baseline measurements. For cohort 2 pts, PR defined according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was at least a 30% decrease in the sum of the longest diameter (LD) of all target measurable lesions (baseline sum LD reference).","dispersionType":"90% Confidence Interval","groups":[{"description":"Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Two potential dose reductions were prescribed to 100 and 50 mg/day.","id":"OG000","title":"Erlotinib-Cohort 1"},{"description":"Patients rcvd oral erlotinib 150 mg/day. Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.","id":"OG001","title":"Erlotinib-Cohort 2"}],"paramType":"NUMBER","populationDescription":"The analysis dataset is comprised of response evaluable patients.","reportingStatus":"POSTED","timeFrame":"Assessed prior to definitive surgery or chemoradiation therapy (cohort 1 pts) or after 2 cycles of therapy (cohort 2 pts).","title":"Response Rate","type":"PRIMARY","unitOfMeasure":"proportion of participants"}