{"analyses":[{"ciLowerLimit":"0.30","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.30","estimateComment":"The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio \\> 1.0 indicates a a higher average response onset rate for talimogene laherparepvec relative to GM-CSF.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.2020","pValueComment":"Descriptive","paramType":"Hazard Ratio (HR)","paramValue":"0.62","statisticalMethod":"Log Rank","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.9","upperLimit":"5.6","value":"3.7"},{"groupId":"OG001","lowerLimit":"3.8","upperLimit":"5.4","value":"4.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"78"}],"units":"Participants"}],"description":"Response onset is defined as the time from the date of randomization to the date of the first documented evidence of response (CR or PR) per EAC assessment.","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":"MEDIAN","populationDescription":"Participants with an objective response (CR or PR) per EAC assessment.","reportingStatus":"POSTED","timeFrame":"From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.","title":"Response Onset","type":"SECONDARY","unitOfMeasure":"months"}