{"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"}],"units":"Participants"}],"description":"The pharmacokinetic/pharmacodynamic relationship between GSK2816126 exposure markers (dose, concentration, Cmax or AUC) was characterized by linear and/or non-linear mixed effect models. This analysis was planned but not performed as the pharmacodynamic response was not observed and therefore a relationship between pharmacokinetic and pharmacodynamic parameters could not be determined.","groups":[{"description":"Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).","id":"OG000","title":"Part 1:GSK2816126 50 mg Twice-weekly"},{"description":"Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).","id":"OG001","title":"Part 1:GSK2816126 100 mg Twice-weekly"},{"description":"Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).","id":"OG002","title":"Part 1:GSK2816126 200 mg Twice-weekly"},{"description":"Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).","id":"OG003","title":"Part 1:GSK2816126 400 mg Twice-weekly"},{"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":"OG004","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":"OG005","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":"OG006","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":"OG007","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":"OG008","title":"Part 1:GSK2816126 3000 mg Twice-weekly"}],"populationDescription":"Pharmacodynamic Population. Analysis was not performed as pharmacodynamic response was not observed.","reportingStatus":"POSTED","timeFrame":"Up to 3.2 years","title":"Part 1: Maximum Effect (Emax) of GSK2816126 With Respect to Exposure Markers","type":"SECONDARY"}