{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.814","upperLimit":"1.269","value":"1.016"},{"groupId":"OG001","lowerLimit":"1.074","upperLimit":"1.247","value":"1.157"},{"groupId":"OG002","lowerLimit":"0.937","upperLimit":"1.269","value":"1.091"},{"groupId":"OG003","lowerLimit":"0.806","upperLimit":"3.198","value":"1.606"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"4"}],"units":"Participants"}],"description":"Ratio of AUC(0-tau) on Day15/Day1 AUC(0-inf) was calculated to assess time invariance. Only those participants with data available at specified data points were analyzed. To assess time invariance based on ANOVA method, it is required that at least 2 participants in a dose level had AUC(0-inf) on Cycle1 Day1 and AUC(0-tau) on Cycle1 Day15. For dose 100mg, 200mg and 400mg, only 1 participant received treatment. For 50mg, 2 participants received treatment but there was one participant whose AUC(0-tau) on Cycle1 Day15 could not be derived due to discontinuation of treatment before Day15, so time invariance could not be calculated. For 1200mg, 4 participants received treatment, however, AUC(0-inf) derivation on Cycle1 Day1 for 3 out of 4 participants did not strictly conform to the prescribed acceptance criteria. Time invariance ratio of GSK2816126 was estimated by calculating ratio of GLS means of AUC between Day15 and Day1 for all dose levels and corresponding 90% CI for each ratio.","dispersionType":"90% Confidence Interval","groups":[{"description":"Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).","id":"OG000","title":"Part 1:GSK2816126 800 mg Twice-weekly"},{"description":"Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).","id":"OG001","title":"Part 1:GSK2816126 1800 mg Twice-weekly"},{"description":"Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).","id":"OG002","title":"Part 1:GSK2816126 2400 mg Twice-weekly"},{"description":"Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).","id":"OG003","title":"Part 1:GSK2816126 3000 mg Twice-weekly"}],"paramType":"NUMBER","populationDescription":"Pharmacokinetic Population. To assess time invariance by ANOVA, it requires at least 2 participants to have AUC(0-inf) and AUC(0-tau) on Cycle1 Day15 which was not observed for dose 50mg, 100mg, 200mg, 400mg. For 1200mg, AUC(0-inf) on Cycle1 Day1 for 3 participants did not meet acceptance criteria. Data could not be calculated for these 5 arms.","reportingStatus":"POSTED","timeFrame":"Pre-dose, 0.5, 1, 2, (12, 18 on Day 1 only), 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 and Day 15 (Each cycle was of 28 days)","title":"Part 1: Time Invariance Ratio Following Administration of GSK2816126","type":"SECONDARY","unitOfMeasure":"Ratio of AUC"}