{"analyses":[{"ciLowerLimit":"14.4","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"27.1","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"Descriptive","paramType":"Treatment Difference","paramValue":"20.8","statisticalMethod":"Fisher Exact","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.9","upperLimit":"9.5","value":"5.7"},{"groupId":"OG001","lowerLimit":"21.4","upperLimit":"31.5","value":"26.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"295"}],"units":"Participants"}],"description":"Objective response rate was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) assessed by the Endpoint Assessment Committee (EAC). Best overall response for a patient is the best overall response observed across all time points.\n\nDisease assessments were performed at the beginning of each treatment cycle and assessed in accordance with modified World Health Organization criteria.\n\nCR: Disappearance of all clinical evidence of tumor (both measurable and non-measurable but evaluable disease); PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment as compared to baseline.","dispersionType":"95% Confidence Interval","groups":[{"description":"GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.","id":"OG000","title":"GM-CSF"},{"description":"Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.","id":"OG001","title":"Talimogene Laherparepvec"}],"paramType":"NUMBER","populationDescription":"Intent-to-treat population","reportingStatus":"POSTED","timeFrame":"From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.","title":"Objective Response Rate","type":"SECONDARY","unitOfMeasure":"percentage of participants"}