{"analyses":[{"ciLowerLimit":"0.32","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.54","estimateComment":"The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio \\< 1.0 indicates a longer average time to treatment failure for talimogene laherparepvec relative to GM-CSF.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"Descriptive","paramType":"Hazard Ratio (HR)","paramValue":"0.42","statisticalMethod":"Log Rank","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.8","upperLimit":"4.0","value":"2.9"},{"groupId":"OG001","lowerLimit":"6.5","upperLimit":"9.9","value":"8.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"295"}],"units":"Participants"}],"description":"Time to treatment failure was assessed by the investigator, and calculated from randomization until the first clinically relevant disease progression where there is no response achieved after the progression, or until death if no such progression occurs. Participants who did not have clinically relevant progression or did not die were censored at the time of the their last tumor assessment. Participants who withdrew from treatment due to a clinically unacceptable toxicity were not considered as an event in the analysis.\n\nProgressive disease (PD) is defined as a ≥ 25% increase in the sum of the products of the perpendicular diameters of all measurable tumors since baseline, or the unequivocal appearance of a new tumor since the last response assessment time point.\n\nClinically relevant progressive disease is PD that is associated with a decline in performance status and/or in the opinion of the investigator the patient requires alternative therapy.","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 plaque forming units (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 data cut-off date of 21 December 2012; median follow-up time was 20 months.","title":"Time to Treatment Failure","type":"SECONDARY","unitOfMeasure":"months"}