{"analyses":[{"ciNumSides":"TWO_SIDED","estimateComment":"Pemetrexed + cisplatin + LY2603618 was considered superior to pemetrexed + cisplatin if the posterior probability of superiority exceeded 0.85.","groupDescription":"The analysis for comparing progression-free survival time between the treatment arms used a Bayesian Augmented Control model with a hierarchical random-effects distribution on treatment effects. The final model incorporated historical data from a completed Phase 3 study (NCT00789373) to augment the prospective control arm data.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Bayesian Posterior Probability","paramValue":"0.96"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.2","upperLimit":"7.1","value":"4.7"},{"groupId":"OG001","lowerLimit":"1.3","upperLimit":"2.9","value":"1.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"23"}],"units":"Participants"}],"description":"Progression-free survival (PFS) time is defined as the time from the date of randomization to the first date of documented objective progressive disease (PD) or death from any cause. For participants who were not known to have had objective PD as of the data inclusion cut-off date for a particular analysis, PFS was censored at the date of the last objective progression-free disease assessments. For participants who took any subsequent systemic anticancer therapy prior to progression, PFS was censored at the date of the last objective progression-free disease assessment prior to the start date of any subsequent systemic anticancer therapy. PFS time was summarized using Kaplan-Meier estimates.","dispersionType":"90% Confidence Interval","groups":[{"description":"Cycles 1-4 (21-day cycle):\n\nBefore 25 Oct 2012:\n\nDay 1: pemetrexed 500 mg/m\\^2 + cisplatin 75 mg/m\\^2\n\nDay 2: LY2603618 dose determined from phase 1 (275 mg)\n\nAfter 25 Oct 2012:\n\nDay 1: pemetrexed 500 mg/m\\^2 + cisplatin 75 mg/m\\^2\n\nAfter 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.\n\nMaintenance therapy (every 21 days):\n\nBefore 25 Oct 2012:\n\nDay 1: pemetrexed 500 mg/m\\^2\n\nDay 2: LY2603618 dose determined from phase 1 (275 mg)\n\nAfter 25 Oct 2012:\n\nDay 1: pemetrexed 500 mg/m\\^2\n\nIf, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented.\n\nPemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.","id":"OG000","title":"Phase 2: Pemetrexed + Cisplatin + LY2603618"},{"description":"Cycles 1-4 (21-day cycle):\n\nDay 1: pemetrexed 500 mg/m\\^2 + cisplatin 75 mg/m\\^2\n\nAfter 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met.\n\nMaintenance therapy (every 21 days):\n\nDay 1: pemetrexed 500 mg/m\\^2\n\nPemetrexed was administered IV over 10 minutes, and cisplatin was administered IV over 1 hour.","id":"OG001","title":"Phase 2: Pemetrexed + Cisplatin"}],"paramType":"MEDIAN","populationDescription":"All randomized Phase 2 participants.","reportingStatus":"POSTED","timeFrame":"Randomization up to first date of PD or death from any cause (up to 6 months after the last participant entered treatment)","title":"Phase 2: Progression-Free Survival Time","type":"PRIMARY","unitOfMeasure":"months"}