{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.827","upperLimit":"1.435","value":"1.090"},{"groupId":"OG001","lowerLimit":"0.291","upperLimit":"1.345","value":"0.625"},{"groupId":"OG002","lowerLimit":"1.173","upperLimit":"1.415","value":"1.288"},{"groupId":"OG003","lowerLimit":"1.081","upperLimit":"1.386","value":"1.224"},{"groupId":"OG004","lowerLimit":"0.819","upperLimit":"3.959","value":"1.801"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"11"},{"groupId":"OG004","value":"4"}],"units":"Participants"}],"description":"Accumulation ratio was determined from the ratio of AUC (0-tau) on Cycle 1 Day 15/AUC (0-tau) on Cycle 1 Day 1 by dose cohort. Only those participants with data available at the specified data points were analyzed. To assess accumulation ratio for a dose level based on ANOVA method, it was required that at least 2 participants had derived PK parameter AUC(0- tau) on both Cycle 1 Day 1 and Cycle 1 Day 15. For dose 100mg, 200mg and 400mg, only 1 participant received treatment. For dose 50mg, 2 participants received treatment but there was one participant whose AUC(0- tau) on Cycle 1 Day 15 could not be derived due to discontinuation of treatment before Day 15. Hence, accumulation ratio could not be calculated for these 4 arms. Accumulation ratio of GSK2816126 was estimated by calculating the ratio of geometric least squares (GLS) means of the AUC between Day 15 and Day 1 for all dose levels and corresponding 90 percent (%) confidence interval (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 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).","id":"OG001","title":"Part 1:GSK2816126 1200 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":"OG002","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":"OG003","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":"OG004","title":"Part 1:GSK2816126 3000 mg Twice-weekly"}],"paramType":"NUMBER","populationDescription":"Pharmacokinetic Population. To assess accumulation ratio by ANOVA, it requires at least 2 participants to derive PK parameter AUC(0- tau) on both Cycle 1 Day 1 and Cycle 1 Day 15 which was not observed for dose 50mg, 100mg, 200mg and 400mg. Hence data could not be calculated for these 4 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: Accumulation Ratio Following Administration of GSK2816126","type":"SECONDARY","unitOfMeasure":"Ratio of AUC"}