{"analyses":[{"ciLowerLimit":"0.62","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.00","estimateComment":"The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio \\< 1.0 indicates a lower average death rate and a longer overall survival for talimogene laherparepvec relative to GM-CSF.","groupDescription":"The primary method for analysis of overall survival was an unadjusted log-rank test. Testing of overall survival was conditional on a statistically significance difference in the primary endpoint of durable response. Success was defined as a p-value ≤ 0.05.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0511","paramType":"Hazard Ratio (HR)","paramValue":"0.79","statisticalMethod":"Log Rank","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"16.0","upperLimit":"23.7","value":"18.9"},{"groupId":"OG001","lowerLimit":"19.5","upperLimit":"29.6","value":"23.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"295"}],"units":"Participants"}],"description":"Overall survival was defined as the time from the date of randomization to the date of death from any cause. Overall survival time was censored at the last date the patient was known to be alive when the confirmation of death was absent or unknown. Participants were censored at the date of randomization if no additional follow-up data were obtained.","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":"Intent-to-treat population","reportingStatus":"POSTED","timeFrame":"From randomization until the first 290 survival events had occurred (data cut-off date of 31 March 2014); median time on follow-up was 44 months.","title":"Overall Survival","type":"SECONDARY","unitOfMeasure":"months"}