{"analyses":[{"groupDescription":"In the metastatic BCC cohort, a one-sided exact binomial test was conducted for the following hypotheses: Null hypothesis (Ho): objective response rate (ORR) ≤10%; Alternative hypothesis (Ha): ORR \\>10%.","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0011","pValueComment":"The hypothesis was tested at a one-sided α = 0.025 level.","statisticalMethod":"Exact binomial test"},{"groupDescription":"In the locally advanced BCC cohort, a one-sided exact binomial test was conducted for the following hypotheses: Null hypothesis (Ho): objective response rate (ORR) ≤20%; Alternative hypothesis (Ha): ORR \\>20%.","groupIds":["OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"The hypothesis was tested at a one-sided α = 0.025 level.","statisticalMethod":"Exact binomial test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"15.6","upperLimit":"48.2","value":"30.3"},{"groupId":"OG001","lowerLimit":"30.5","upperLimit":"56.0","value":"42.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"63"}],"units":"Participants"}],"description":"OR=complete (CR) or partial response (PR). Metastatic-CR:Disappearance of all targets. PR:≥30% decreased sum of longest diameter (SLD) of targets compared to baseline (B). Locally advanced-Response=No progressive disease (PD) and ≥30% decreased SLD from baseline (radiography \\[R\\]) or ≥30% decreased SLD from B (externally visible dimension \\[EVD\\]) or completely resolved ulceration. CR:Response with no residual BCC on tumor biopsy (otherwise response was PR). PD:Any of ≥20% increased SLD from nadir (R or EVD), new ulceration, new lesions (R or physical exam) or non-target lesion progression by R.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.","id":"OG000","title":"Metastatic Basal-Cell Carcinoma"},{"description":"Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.","id":"OG001","title":"Locally Advanced Basal-Cell Carcinoma"}],"paramType":"NUMBER","populationDescription":"Efficacy-evaluable population: All treated patients for whom the independent pathologist's interpretation of archival tissue or baseline biopsies was consistent with basal cell carcinoma.","reportingStatus":"POSTED","timeFrame":"At Baseline and once every 8 weeks thereafter (responses confirmed within ≥4 weeks) until the end of study (up to the clinical cutoff date of 26 November 2010, up to 90 weeks)","title":"Objective Response (OR) Determined by the Independent Review Facility","type":"PRIMARY","unitOfMeasure":"Percentage of participants"}