Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2 (NHL)
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 7.2 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, ALP, ALT, AST, Bilirubin, Ca, Creat, CK, GGT, Glucose, Pot, Mg, Sod, and Ph. Values(Hyper and hypo)for Glucose, 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 2 NHL Population. Only those participants with data available at the specified data points were analyzed.
Groups in this outcome
Part 2: GSK2857916 3.40 mg/kg (NHL)
Participants with non-hodgkin's lymphoma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 36 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 2: GSK2857916 3.40 mg/kg (NHL)
5
Reported measurements
Gl, Hyperglycemia,any grade increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
2
Not reported
Not reported
Not reported
Not reported
Gl, Hyperglycemia,increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
Gl, Hyperglycemia,increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
Gl, Hypoglycemia,any grade increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
Gl, Hypoglycemia,increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
Gl, Hypoglycemia,increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
Albumin,any grade increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
2
Not reported
Not reported
Not reported
Not reported
Albumin,increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
Albumin,increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
ALP,any grade increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
1
Not reported
Not reported
Not reported
Not reported
ALP,increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
ALP,increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
ALT,any grade increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
1
Not reported
Not reported
Not reported
Not reported
ALT,increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
ALT,increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
AST,any grade increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
2
Not reported
Not reported
Not reported
Not reported
AST,increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
AST,increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
Total bilirubin,any grade increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
2
Not reported
Not reported
Not reported
Not reported
Total bilirubin,increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
Total bilirubin,increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
CK,any grade increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
1
Not reported
Not reported
Not reported
Not reported
CK,increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
CK,increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
Creatinine,any grade increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
1
Not reported
Not reported
Not reported
Not reported
Creatinine,increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
Creatinine,increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
GGT,any grade increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
2
Not reported
Not reported
Not reported
Not reported
GGT,increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
GGT,increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
Pot,Hyperkalemia,any grade increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
Pot,Hyperkalemia,increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
Pot,Hyperkalemia,increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
Pot,Hypokalemia,any grade increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
1
Not reported
Not reported
Not reported
Not reported
Pot,Hypokalemia,increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
Pot,Hypokalemia,increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
Mg,Hypermagnesemia,any grade increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
Mg,Hypermagnesemia,increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
Mg,Hypermagnesemia,increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
Mg,Hypomagnesemia,any grade increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
1
Not reported
Not reported
Not reported
Not reported
Mg,Hypomagnesemia,increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
Mg,Hypomagnesemia,increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
Phosphate,any grade increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
2
Not reported
Not reported
Not reported
Not reported
Phosphate,increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
1
Not reported
Not reported
Not reported
Not reported
Phosphate,increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
Sod,Hypernatremia,any grade increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
Sod,Hypernatremia,increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
Sod,Hypernatremia,increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
Sod,Hyponatremia,any grade increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
3
Not reported
Not reported
Not reported
Not reported
Sod,Hyponatremia,increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
Sod,Hyponatremia,increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
Ca,Hypercalcemia,any grade increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
4
Not reported
Not reported
Not reported
Not reported
Ca,Hypercalcemia,increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
1
Not reported
Not reported
Not reported
Not reported
Ca,Hypercalcemia,increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
Ca,Hypocalcemia,any grade increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
1
Not reported
Not reported
Not reported
Not reported
Ca,Hypocalcemia,increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
Ca,Hypocalcemia,increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
2
title
Gl, Hyperglycemia,any grade increase
categories
measurements
group Id
OG000
value
0
title
Gl, Hyperglycemia,increase to Grade 3
categories
measurements
group Id
OG000
value
0
title
Gl, Hyperglycemia,increase to Grade 4
categories
measurements
group Id
OG000
value
0
title
Gl, Hypoglycemia,any grade increase
categories
measurements
group Id
OG000
value
0
title
Gl, Hypoglycemia,increase to Grade 3
categories
measurements
group Id
OG000
value
0
title
Gl, Hypoglycemia,increase to Grade 4
categories
measurements
group Id
OG000
value
2
title
Albumin,any grade increase
categories
measurements
group Id
OG000
value
0
title
Albumin,increase to Grade 3
categories
measurements
group Id
OG000
value
0
title
Albumin,increase to Grade 4
categories
measurements
group Id
OG000
value
1
title
ALP,any grade increase
categories
measurements
group Id
OG000
value
0
title
ALP,increase to Grade 3
categories
measurements
group Id
OG000
value
0
title
ALP,increase to Grade 4
denoms
counts
group Id
OG000
value
5
units
Participants
description
Blood samples were collected for the analysis of following clinical chemistry parameters: albumin, ALP, ALT, AST, Bilirubin, Ca, Creat, CK, GGT, Glucose, Pot, Mg, Sod, and Ph. Values(Hyper and hypo)for Glucose, 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 with non-hodgkin's lymphoma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 36 cycles (1 cycle=21 days).
id
OG000
title
Part 2: GSK2857916 3.40 mg/kg (NHL)
param Type
COUNT_OF_PARTICIPANTS
population Description
Part 2 NHL Population. Only those participants with data available at the specified data points were analyzed.
reporting Status
POSTED
time Frame
Baseline and Up to 7.2 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 2 (NHL)
Triangle