NCT02064387 · OUTCOME
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of GSK2857916 · Source last updated 2020-08-11
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure COUNT_OF_PARTICIPANTS
Unit Participants
Interval / dispersion Not reported
Time frame Baseline and Up to 21.6 months (maximum duration of follow-up from first dose to last contact or death) What was measured Blood samples were collected for the analysis of following clinical chemistry parameters: albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (T.Bil.), calcium (Ca), creatinine (Creat), creatinine kinase (CK), gamma glutamyl transferase (GGT), glucose (Gl), potassium (Pot), magnesium (Mg), sodium (Sod), phosphate (Ph) and urate. Values(Hyper and hypo)for Gl, Pot, Mg, Sod and Ca is presented. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. All increases are an increase in grade from Baseline. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Data for worst-case post Baseline is presented.
Analysis population: Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Groups in this outcome Part 1: GSK2857916 0.03 mg/kg Participants were administered a dose of 0.03 milligrams per kilogram (mg/kg) GSK2857916 as intravenous (IV) infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
Part 1: GSK2857916 0.06 mg/kg Participants were administered a dose of 0.06 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
Part 1: GSK2857916 0.12 mg/kg Participants were administered a dose of 0.12 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
Part 1: GSK2857916 0.24 mg/kg Participants were administered a dose of 0.24 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
Part 1: GSK2857916 0.48 mg/kg Participants were administered a dose of 0.48 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
Part 1: GSK2857916 0.96 mg/kg Participants were administered a dose of 0.96 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
Part 1: GSK2857916 1.92 mg/kg Participants were administered a dose of 1.92 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
Part 1: GSK2857916 2.50 mg/kg Participants were administered a dose of 2.50 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
Part 1: GSK2857916 3.40 mg/kg Participants were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
Part 1: GSK2857916 4.60 mg/kg Participants were administered a dose of 4.60 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Reported measurements Gl, Hyper,any grade increase,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 4 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 4 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 6 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 4 Not reported Not reported Not reported Not reported
Gl, Hyper,increase toGrade 3,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 2 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Gl, Hyper,increase toGrade 4,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Gl, Hypo,any grade increase,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 2 Not reported Not reported Not reported Not reported
Gl, Hypo,increase toGrade 3,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Gl, Hypo,increase toGrade 4,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Albumin,any grade increase,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 2 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 3 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 2 Not reported Not reported Not reported Not reported
Albumin,increase to Grade 3,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Albumin,increase to Grade 4,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
ALP,any grade increase,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 2 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 2 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 5 Not reported Not reported Not reported Not reported
ALP,increase to Grade 3,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
ALP,increase to Grade 4,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
ALT,any grade increase,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 2 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 5 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 5 Not reported Not reported Not reported Not reported
ALT,increase to Grade 3,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
ALT,increase to Grade 4,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
AST,any grade increase,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 2 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 2 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 3 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 6 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 3 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 5 Not reported Not reported Not reported Not reported
AST,increase to Grade 3,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
AST,increase to Grade 4,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
T.Bil.,any grade increase,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 2 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
T.Bil.,increase to Grade 3,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
T.Bil.,increase to Grade 4,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
CK,any grade increase,n=1,1,4,4,3,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 3 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 3 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 3 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 3 Not reported Not reported Not reported Not reported
CK,increase to Grade 3,n=1,1,4,4,3,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 3 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
CK,increase to Grade 4,n=1,1,4,4,3,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 3 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Creat,any grade increase,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 2 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Creat,increase to Grade 3,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Creat,increase to Grade 4,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
GGT,any grade increase,1,1,4,4,3,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 3 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 3 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 3 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 3 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 4 Not reported Not reported Not reported Not reported
GGT,increase to Grade 3,n=1,1,4,4,3,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 3 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
GGT,increase to Grade 4,n=1,1,4,4,3,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 3 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Pot,Hyper,any grade increase,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Pot,Hyper,increase to Grade3,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Pot,Hyper,increase to Grade4,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Pot,Hypo,any grade increase,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 2 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 2 Not reported Not reported Not reported Not reported
Pot,Hypo,increase to Grade3,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Pot,Hypo,increase to Grade4,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Mg,Hyper,any grade increase,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Mg,Hyper,increase to Grade3,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Mg,Hyper,increase to Grade4,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Mg,Hypo,any grade increase,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 3 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 3 Not reported Not reported Not reported Not reported
Mg,Hypo,increase to Grade3,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Mg,Hypo,increase to Grade 4,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Ph,any grade increase,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 2 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Ph,increase to Grade 3,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Ph,increase to Grade 4,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Sod,Hyper,any grade increase,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Sod,Hyper,increase to Grade3,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Sod,Hyper,increase to Grade4,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Sod,Hypo,any grade increase,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 2 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 2 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 3 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 2 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 3 Not reported Not reported Not reported Not reported
Sod,Hypo,increase to Grade3,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 2 Not reported Not reported Not reported Not reported
Sod,Hypo,increase to Grade4,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Urate,any grade increase,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Urate,increase to Grade 3,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Urate,increase to Grade4,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Ca,Hyper,any grade increase,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 3 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 2 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 1 Not reported Not reported Not reported Not reported
Ca,Hyper,increase to Grade3,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 1 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Ca,Hyper,increase to Grade4,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Ca,Hypo,any grade increase,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 2 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 1 Not reported Not reported Not reported Not reported
Ca,Hypo,increase to Grade3,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Ca,Hypo,increase to Grade4,n=1,1,4,4,4,3,4,8,3,6 Analysis denominator · Participants
Group Source count Part 1: GSK2857916 0.03 mg/kg 1 Part 1: GSK2857916 0.06 mg/kg 1 Part 1: GSK2857916 0.12 mg/kg 4 Part 1: GSK2857916 0.24 mg/kg 4 Part 1: GSK2857916 0.48 mg/kg 4 Part 1: GSK2857916 0.96 mg/kg 3 Part 1: GSK2857916 1.92 mg/kg 4 Part 1: GSK2857916 2.50 mg/kg 8 Part 1: GSK2857916 3.40 mg/kg 3 Part 1: GSK2857916 4.60 mg/kg 6
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1: GSK2857916 0.03 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.06 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.12 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.24 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.48 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 0.96 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 1.92 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 2.50 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 3.40 mg/kg 0 Not reported Not reported Not reported Not reported Part 1: GSK2857916 4.60 mg/kg 0 Not reported Not reported Not reported Not reported
Complete source fields classes categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 1
group Id OG003
value 1
group Id OG004
value 4
group Id OG005
value 0
group Id OG006
value 4
group Id OG007
value 6
group Id OG008
value 0
group Id OG009
value 4 denoms counts
group Id OG000
value 1
group Id OG001
value 1
group Id OG002
value 4
group Id OG003
value 4
group Id OG004
value 4
group Id OG005
value 3
group Id OG006
value 4
group Id OG007
value 8
group Id OG008
value 3
group Id OG009
value 6
units Participants
title Gl, Hyper,any grade increase,n=1,1,4,4,4,3,4,8,3,6 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 2
group Id OG007
value 0
group Id OG008
value 0
group Id OG009
value 0 denoms counts
group Id OG000
value 1
group Id OG001
value 1
group Id OG002
value 4
group Id OG003
value 4
group Id OG004
value 4
group Id OG005
value 3
group Id OG006
value 4
group Id OG007
value 8
group Id OG008
value 3
group Id OG009
value 6
units Participants
title Gl, Hyper,increase toGrade 3,n=1,1,4,4,4,3,4,8,3,6 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 0
group Id OG007
value 0
group Id OG008
value 0
group Id OG009
value 0 denoms counts
group Id OG000
value 1
group Id OG001
value 1
group Id OG002
value 4
group Id OG003
value 4
group Id OG004
value 4
group Id OG005
value 3
group Id OG006
value 4
group Id OG007
value 8
group Id OG008
value 3
group Id OG009
value 6
units Participants
title Gl, Hyper,increase toGrade 4,n=1,1,4,4,4,3,4,8,3,6 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 1
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 0
group Id OG007
value 1
group Id OG008
value 0
group Id OG009
value 2 denoms counts
group Id OG000
value 1
group Id OG001
value 1
group Id OG002
value 4
group Id OG003
value 4
group Id OG004
value 4
group Id OG005
value 3
group Id OG006
value 4
group Id OG007
value 8
group Id OG008
value 3
group Id OG009
value 6
units Participants
title Gl, Hypo,any grade increase,n=1,1,4,4,4,3,4,8,3,6 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 0
group Id OG007
value 0
group Id OG008
value 0
group Id OG009
value 0 denoms counts
group Id OG000
value 1
group Id OG001
value 1
group Id OG002
value 4
group Id OG003
value 4
group Id OG004
value 4
group Id OG005
value 3
group Id OG006
value 4
group Id OG007
value 8
group Id OG008
value 3
group Id OG009
value 6
units Participants
title Gl, Hypo,increase toGrade 3,n=1,1,4,4,4,3,4,8,3,6 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 0
group Id OG007
value 0
group Id OG008
value 0
group Id OG009
value 0 denoms counts
group Id OG000
value 1
group Id OG001
value 1
group Id OG002
value 4
group Id OG003
value 4
group Id OG004
value 4
group Id OG005
value 3
group Id OG006
value 4
group Id OG007
value 8
group Id OG008
value 3
group Id OG009
value 6
units Participants
title Gl, Hypo,increase toGrade 4,n=1,1,4,4,4,3,4,8,3,6 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 1
group Id OG003
value 2
group Id OG004
value 3
group Id OG005
value 1
group Id OG006
value 1
group Id OG007
value 1
group Id OG008
value 1
group Id OG009
value 2 denoms counts
group Id OG000
value 1
group Id OG001
value 1
group Id OG002
value 4
group Id OG003
value 4
group Id OG004
value 4
group Id OG005
value 3
group Id OG006
value 4
group Id OG007
value 8
group Id OG008
value 3
group Id OG009
value 6
units Participants
title Albumin,any grade increase,n=1,1,4,4,4,3,4,8,3,6 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 0
group Id OG007
value 0
group Id OG008
value 0
group Id OG009
value 0 denoms counts
group Id OG000
value 1
group Id OG001
value 1
group Id OG002
value 4
group Id OG003
value 4
group Id OG004
value 4
group Id OG005
value 3
group Id OG006
value 4
group Id OG007
value 8
group Id OG008
value 3
group Id OG009
value 6
units Participants
title Albumin,increase to Grade 3,n=1,1,4,4,4,3,4,8,3,6 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 0
group Id OG007
value 0
group Id OG008
value 0
group Id OG009
value 0 denoms counts
group Id OG000
value 1
group Id OG001
value 1
group Id OG002
value 4
group Id OG003
value 4
group Id OG004
value 4
group Id OG005
value 3
group Id OG006
value 4
group Id OG007
value 8
group Id OG008
value 3
group Id OG009
value 6
units Participants
title Albumin,increase to Grade 4,n=1,1,4,4,4,3,4,8,3,6 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 1
group Id OG004
value 1
group Id OG005
value 0
group Id OG006
value 1
group Id OG007
value 2
group Id OG008
value 2
group Id OG009
value 5 denoms counts
group Id OG000
value 1
group Id OG001
value 1
group Id OG002
value 4
group Id OG003
value 4
group Id OG004
value 4
group Id OG005
value 3
group Id OG006
value 4
group Id OG007
value 8
group Id OG008
value 3
group Id OG009
value 6
units Participants
title ALP,any grade increase,n=1,1,4,4,4,3,4,8,3,6 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 0
group Id OG007
value 0
group Id OG008
value 0
group Id OG009
value 0 denoms counts
group Id OG000
value 1
group Id OG001
value 1
group Id OG002
value 4
group Id OG003
value 4
group Id OG004
value 4
group Id OG005
value 3
group Id OG006
value 4
group Id OG007
value 8
group Id OG008
value 3
group Id OG009
value 6
units Participants
title ALP,increase to Grade 3,n=1,1,4,4,4,3,4,8,3,6 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 0
group Id OG007
value 0
group Id OG008
value 0
group Id OG009
value 0 denoms counts
group Id OG000
value 1
group Id OG001
value 1
group Id OG002
value 4
group Id OG003
value 4
group Id OG004
value 4
group Id OG005
value 3
group Id OG006
value 4
group Id OG007
value 8
group Id OG008
value 3
group Id OG009
value 6
units Participants
title ALP,increase to Grade 4,n=1,1,4,4,4,3,4,8,3,6 Show more (12 of 60) denoms counts
group Id OG000
value 1
group Id OG001
value 1
group Id OG002
value 4
group Id OG003
value 4
group Id OG004
value 4
group Id OG005
value 3
group Id OG006
value 4
group Id OG007
value 8
group Id OG008
value 3
group Id OG009
value 6
units Participants
description Blood samples were collected for the analysis of following clinical chemistry parameters: albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (T.Bil.), calcium (Ca), creatinine (Creat), creatinine kinase (CK), gamma glutamyl transferase (GGT), glucose (Gl), potassium (Pot), magnesium (Mg), sodium (Sod), phosphate (Ph) and urate. Values(Hyper and hypo)for Gl, Pot, Mg, Sod and Ca is presented. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. All increases are an increase in grade from Baseline. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Data for worst-case post Baseline is presented. groups
description Participants were administered a dose of 0.03 milligrams per kilogram (mg/kg) GSK2857916 as intravenous (IV) infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id OG000
title Part 1: GSK2857916 0.03 mg/kg
description Participants were administered a dose of 0.06 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id OG001
title Part 1: GSK2857916 0.06 mg/kg
description Participants were administered a dose of 0.12 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id OG002
title Part 1: GSK2857916 0.12 mg/kg
description Participants were administered a dose of 0.24 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id OG003
title Part 1: GSK2857916 0.24 mg/kg
description Participants were administered a dose of 0.48 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id OG004
title Part 1: GSK2857916 0.48 mg/kg
description Participants were administered a dose of 0.96 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id OG005
title Part 1: GSK2857916 0.96 mg/kg
description Participants were administered a dose of 1.92 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id OG006
title Part 1: GSK2857916 1.92 mg/kg
description Participants were administered a dose of 2.50 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id OG007
title Part 1: GSK2857916 2.50 mg/kg
description Participants were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id OG008
title Part 1: GSK2857916 3.40 mg/kg
description Participants were administered a dose of 4.60 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id OG009
title Part 1: GSK2857916 4.60 mg/kg
param Type COUNT_OF_PARTICIPANTS
population Description Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
reporting Status POSTED
time Frame Baseline and Up to 21.6 months (maximum duration of follow-up from first dose to last contact or death)
title Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1
type PRIMARY
unit Of Measure Participants Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle