{"analyses":[{"ciLowerLimit":"0.26","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.60","estimateComment":"HRs were estimated using a Pike estimator. HR from a stratified log-rank test was adjusted for disease stage at screening.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"The p value from a stratified log-rank test was adjusted for disease stage at screening.","paramType":"Hazard Ratio (HR)","paramValue":"0.40","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.5","upperLimit":"9.0","value":"6.9"},{"groupId":"OG001","lowerLimit":"1.4","upperLimit":"3.2","value":"2.7"}]}]}],"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 the investigator according to Response Evaluation Criteria in Solid Tumors (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 millimeters (mm). For participants who did not progress or die, PFS was censored at the date of last contact. Data are presented as median and 96% confidence interval.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants were randomly assigned to receive oral GSK2118436 150 milligrams (mg) twice a day (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 disease progression (DP), death, the occurrence of an unacceptable adverse event (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 intravenous (IV) Dacarbazine (DTIC) 1000 milligrams per meters squared (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":"Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered","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 the Investigator","type":"PRIMARY","unitOfMeasure":"Months"}