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NCT02064387 · OUTCOME

Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2 (MM)

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 24.2 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,T.Bil.,Ca, Creat,CK, GGT,Gl, Pot,Mg, Sod, 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 2 MM 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 2: GSK2857916 3.40 mg/kg (MM)

Participants with multiple myeloma 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).

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 (MM)	35

Reported measurements

Gl, Hyperglycemia,any grade increase,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	19	Not reported	Not reported	Not reported	Not reported

Gl, Hyperglycemia,increase to Grade 3,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Gl, Hyperglycemia,increase to Grade 4,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Gl, Hypoglycemia,any grade increase,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	1	Not reported	Not reported	Not reported	Not reported

Gl, Hypoglycemia,increase to Grade 3,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Gl, Hypoglycemia,increase to Grade 4,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Albumin,any grade increase,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	15	Not reported	Not reported	Not reported	Not reported

Albumin,increase to Grade 3,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	2	Not reported	Not reported	Not reported	Not reported

Albumin,increase to Grade 4,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

ALP,any grade increase,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	19	Not reported	Not reported	Not reported	Not reported

ALP,increase to Grade 3,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

ALP,increase to Grade 4,,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

ALT,any grade increase,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	19	Not reported	Not reported	Not reported	Not reported

ALT,increase to Grade 3,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

ALT,increase to Grade 4,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

AST,any grade increase,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	29	Not reported	Not reported	Not reported	Not reported

AST,increase to Grade 3,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	3	Not reported	Not reported	Not reported	Not reported

AST,increase to Grade 4,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Total bilirubin,any grade increase,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	3	Not reported	Not reported	Not reported	Not reported

Total bilirubin,increase to Grade 3,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Total bilirubin,increase to Grade 4,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

CK,any grade increase,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	15	Not reported	Not reported	Not reported	Not reported

CK,increase to Grade 3,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	1	Not reported	Not reported	Not reported	Not reported

CK,increase to Grade 4 ,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Creatinine,any grade increase,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	7	Not reported	Not reported	Not reported	Not reported

Creatinine,increase to Grade 3,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Creatinine,increase to Grade 4,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

GGT,any grade increase,n=34

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	34

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	21	Not reported	Not reported	Not reported	Not reported

GGT,increase to Grade 3,n=34

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	34

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	6	Not reported	Not reported	Not reported	Not reported

GGT,increase to Grade 4,n=34

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	34

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Pot,Hyperkalemia,any grade increase,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	1	Not reported	Not reported	Not reported	Not reported

Pot,Hyperkalemia,increase to Grade 3,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Pot,Hyperkalemia,increase to Grade 4,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	1	Not reported	Not reported	Not reported	Not reported

Pot,Hypokalemia,any grade increase,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	12	Not reported	Not reported	Not reported	Not reported

Pot,Hypokalemia,increase to Grade 3,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	3	Not reported	Not reported	Not reported	Not reported

Pot,Hypokalemia,increase to Grade 4,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	1	Not reported	Not reported	Not reported	Not reported

Mg,Hypermagnesemia,any grade increase,n=34

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	34

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	1	Not reported	Not reported	Not reported	Not reported

Mg,Hypermagnesemia,increase to Grade 3,n=34

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	34

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Mg,Hypermagnesemia,increase to Grade 4,n=34

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	34

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Mg,Hypomagnesemia,any grade increase,n=34

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	34

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	9	Not reported	Not reported	Not reported	Not reported

Mg,Hypomagnesemia,increase to Grade 3,n=34

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	34

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Mg,Hypomagnesemia,increase to Grade 4,n=34

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	34

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	1	Not reported	Not reported	Not reported	Not reported

Phosphate,any grade increase,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	8	Not reported	Not reported	Not reported	Not reported

Phosphate,increase to Grade 3,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Phosphate,increase to Grade 4,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Sod,Hypernatremia,any grade increase,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Sod,Hypernatremia,increase to Grade 3,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Sod,Hypernatremia,increase to Grade 4,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Sod,Hyponatremia,any grade increase,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	4	Not reported	Not reported	Not reported	Not reported

Sod,Hyponatremia,increase to Grade 3,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Sod,Hyponatremia,increase to Grade 4,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	1	Not reported	Not reported	Not reported	Not reported

Urate,any grade increase,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	1	Not reported	Not reported	Not reported	Not reported

Urate,increase to Grade 3,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Urate,increase to Grade 4,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	1	Not reported	Not reported	Not reported	Not reported

Ca,Hypercalcemia,any grade increase,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	8	Not reported	Not reported	Not reported	Not reported

Ca,Hypercalcemia,increase to Grade 3,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	2	Not reported	Not reported	Not reported	Not reported

Ca,Hypercalcemia,increase to Grade 4,,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	1	Not reported	Not reported	Not reported	Not reported

Ca,Hypocalcemia,any grade increase,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	4	Not reported	Not reported	Not reported	Not reported

Ca,Hypocalcemia,increase to Grade 3,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Ca,Hypocalcemia,increase to Grade 4,n=35

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
19
denoms
counts
group Id
OG000
value
35
units
Participants
title
Gl, Hyperglycemia,any grade increase,n=35
categories
measurements
group Id
OG000
value
0
denoms
counts
group Id
OG000
value
35
units
Participants
title
Gl, Hyperglycemia,increase to Grade 3,n=35
categories
measurements
group Id
OG000
value
0
denoms
counts
group Id
OG000
value
35
units
Participants
title
Gl, Hyperglycemia,increase to Grade 4,n=35
categories
measurements
group Id
OG000
value
1
denoms
counts
group Id
OG000
value
35
units
Participants
title
Gl, Hypoglycemia,any grade increase,n=35
categories
measurements
group Id
OG000
value
0
denoms
counts
group Id
OG000
value
35
units
Participants
title
Gl, Hypoglycemia,increase to Grade 3,n=35
categories
measurements
group Id
OG000
value
0
denoms
counts
group Id
OG000
value
35
units
Participants
title
Gl, Hypoglycemia,increase to Grade 4,n=35
categories
measurements
group Id
OG000
value
15
denoms
counts
group Id
OG000
value
35
units
Participants
title
Albumin,any grade increase,n=35
categories
measurements
group Id
OG000
value
2
denoms
counts
group Id
OG000
value
35
units
Participants
title
Albumin,increase to Grade 3,n=35
categories
measurements
group Id
OG000
value
0
denoms
counts
group Id
OG000
value
35
units
Participants
title
Albumin,increase to Grade 4,n=35
categories
measurements
group Id
OG000
value
19
denoms
counts
group Id
OG000
value
35
units
Participants
title
ALP,any grade increase,n=35
categories
measurements
group Id
OG000
value
0
denoms
counts
group Id
OG000
value
35
units
Participants
title
ALP,increase to Grade 3,n=35
categories
measurements
group Id
OG000
value
0
denoms
counts
group Id
OG000
value
35
units
Participants
title
ALP,increase to Grade 4,,n=35

denoms

counts
group Id
OG000
value
35
units
Participants

description

Blood samples were collected for the analysis of following clinical chemistry parameters: albumin,ALP,ALT,AST,T.Bil.,Ca, Creat,CK, GGT,Gl, Pot,Mg, Sod, 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 with multiple myeloma 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
OG000
title
Part 2: GSK2857916 3.40 mg/kg (MM)

param Type

COUNT_OF_PARTICIPANTS

population Description

Part 2 MM 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 24.2 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 (MM)

type

PRIMARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice