{"analyses":[{"ciLowerLimit":"0.20","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.61","estimateComment":"HRs were estimated using a Pike estimator. HR was adjusted for disease stage at screening.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Hazard Ratio (HR)","paramValue":"0.35"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.0","upperLimit":"6.9","value":"6.7"},{"groupId":"OG001","lowerLimit":"1.7","upperLimit":"4.9","value":"2.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"187"},{"groupId":"OG001","value":"63"}],"units":"Participants"}],"description":"PFS is defined as the interval of time between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause. Disease progression was based on radiographic or photographic evidence, and assessments were made by an independent radiologist according to RECIST version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. For participants who did not progress or die, PFS was censored at the date of last contact.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.","id":"OG000","title":"GSK2118436 150 mg BID"},{"description":"In the RP, participants received IV DTIC 1000 mg/m\\^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.","id":"OG001","title":"DTIC 1000 mg/m^2 in RP"}],"paramType":"MEDIAN","populationDescription":"ITT Population","reportingStatus":"POSTED","timeFrame":"Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months)","title":"Progression-free Survival (PFS) as Assessed by an Independent Radiologist: Randomized Phase","type":"PRIMARY","unitOfMeasure":"Months"}