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NCT03525678 · OUTCOME

Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range

A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Participants With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody · Source last updated 2025-09-03

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 (Day 1) and Up to 186 weeks

What was measured

Blood samples were collected for analysis of clinical chemistry parameters: bicarbonate, direct bilirubin(D.Bil), calcium, chloride, lactate dehydrogenase(LDH), total protein,Urea enzymatic colorimetry.Baseline is latest pre-dose assessment(Day 1) with a non-missing value, including unscheduled visits. Number of participants with worst case clinical chemistry change from Baseline with respect to normal range are presented. Data was categorized as decrease to low (value below the lower LNR), increase to high (value above the upper LNR) and change to normal or NC. If values were unchanged (example: high to high), or whose value became normal, were recorded in the change to normal or NC category. Participants were counted twice if the participant had both decreased to low and increased to high during post Baseline. 3 out of 221participants did not receive any study treatment, were excluded from FSP.

Analysis population: Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but 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

Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)

Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.

Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)

Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.

Main Study: GSK2857916 3.4 mg/kg (Lyophilized)

Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.

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
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	99
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Reported measurements

Bicarbonate, decrease to low, n=90,93,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	90
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	93
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	12	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	22	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	4	Not reported	Not reported	Not reported	Not reported

Bicarbonate, change to normal or NC, n=90,93,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	90
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	93
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	67	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	59	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	16	Not reported	Not reported	Not reported	Not reported

Bicarbonate, increase to high, n=90,93,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	90
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	93
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	12	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	16	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	4	Not reported	Not reported	Not reported	Not reported

Direct Bilirubin, decrease to low, n=70,72,21

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	70
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	72
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	21

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	2	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

Direct Bilirubin, change to normal or NC, n=70,72,21

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	70
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	72
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	21

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	60	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	60	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	20	Not reported	Not reported	Not reported	Not reported

Direct Bilirubin, increase to high, n=70,72,21

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	70
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	72
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	21

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	10	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	10	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	1	Not reported	Not reported	Not reported	Not reported

Calcium, decrease to low, n=95,98,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	98
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	26	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	28	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	8	Not reported	Not reported	Not reported	Not reported

Calcium, change to normal or NC, n=95,98,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	98
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	49	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	48	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	9	Not reported	Not reported	Not reported	Not reported

Calcium, increase to high, n=95,98,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	98
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	29	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	27	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	9	Not reported	Not reported	Not reported	Not reported

Chloride, decrease to low, n=94,97,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	94
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	17	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	14	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	2	Not reported	Not reported	Not reported	Not reported

Chloride, change to normal or NC, n=94,97,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	94
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	63	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	63	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	20	Not reported	Not reported	Not reported	Not reported

Chloride, increase to high, n=94,97,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	94
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	14	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	24	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	2	Not reported	Not reported	Not reported	Not reported

LDH, decrease to low, n=92,98,23

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	92
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	98
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	23

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	1	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	1	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

LDH, change to normal or NC, n=92,98,23

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	92
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	98
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	23

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	46	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	51	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	12	Not reported	Not reported	Not reported	Not reported

LDH, increase to high, n=92,98,23

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	92
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	98
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	23

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	45	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	47	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	11	Not reported	Not reported	Not reported	Not reported

Protein, decrease to low, n=94,98,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	94
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	98
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	32	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	32	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	8	Not reported	Not reported	Not reported	Not reported

Protein, change to normal or NC, n=94,98,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	94
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	98
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	49	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	58	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	14	Not reported	Not reported	Not reported	Not reported

Protein, increase to high, n=94,98,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	94
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	98
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	17	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	11	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	2	Not reported	Not reported	Not reported	Not reported

Urea enzymatic colorimetry , decrease to low, n=90,93,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	90
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	93
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	10	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	13	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

Urea enzymatic colorimetry, change to normal or NC, n=90,93,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	90
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	93
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	66	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	56	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	16	Not reported	Not reported	Not reported	Not reported

Urea enzymatic colorimetry, increase to high, n=90,93,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	90
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	93
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	15	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	26	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	8	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
12
group Id
OG001
value
22
group Id
OG002
value
4
denoms
counts
group Id
OG000
value
90
group Id
OG001
value
93
group Id
OG002
value
24
units
Participants
title
Bicarbonate, decrease to low, n=90,93,24
categories
measurements
group Id
OG000
value
67
group Id
OG001
value
59
group Id
OG002
value
16
denoms
counts
group Id
OG000
value
90
group Id
OG001
value
93
group Id
OG002
value
24
units
Participants
title
Bicarbonate, change to normal or NC, n=90,93,24
categories
measurements
group Id
OG000
value
12
group Id
OG001
value
16
group Id
OG002
value
4
denoms
counts
group Id
OG000
value
90
group Id
OG001
value
93
group Id
OG002
value
24
units
Participants
title
Bicarbonate, increase to high, n=90,93,24
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
70
group Id
OG001
value
72
group Id
OG002
value
21
units
Participants
title
Direct Bilirubin, decrease to low, n=70,72,21
categories
measurements
group Id
OG000
value
60
group Id
OG001
value
60
group Id
OG002
value
20
denoms
counts
group Id
OG000
value
70
group Id
OG001
value
72
group Id
OG002
value
21
units
Participants
title
Direct Bilirubin, change to normal or NC, n=70,72,21
categories
measurements
group Id
OG000
value
10
group Id
OG001
value
10
group Id
OG002
value
1
denoms
counts
group Id
OG000
value
70
group Id
OG001
value
72
group Id
OG002
value
21
units
Participants
title
Direct Bilirubin, increase to high, n=70,72,21
categories
measurements
group Id
OG000
value
26
group Id
OG001
value
28
group Id
OG002
value
8
denoms
counts
group Id
OG000
value
95
group Id
OG001
value
98
group Id
OG002
value
24
units
Participants
title
Calcium, decrease to low, n=95,98,24
categories
measurements
group Id
OG000
value
49
group Id
OG001
value
48
group Id
OG002
value
9
denoms
counts
group Id
OG000
value
95
group Id
OG001
value
98
group Id
OG002
value
24
units
Participants
title
Calcium, change to normal or NC, n=95,98,24
categories
measurements
group Id
OG000
value
29
group Id
OG001
value
27
group Id
OG002
value
9
denoms
counts
group Id
OG000
value
95
group Id
OG001
value
98
group Id
OG002
value
24
units
Participants
title
Calcium, increase to high, n=95,98,24
categories
measurements
group Id
OG000
value
17
group Id
OG001
value
14
group Id
OG002
value
2
denoms
counts
group Id
OG000
value
94
group Id
OG001
value
97
group Id
OG002
value
24
units
Participants
title
Chloride, decrease to low, n=94,97,24
categories
measurements
group Id
OG000
value
63
group Id
OG001
value
63
group Id
OG002
value
20
denoms
counts
group Id
OG000
value
94
group Id
OG001
value
97
group Id
OG002
value
24
units
Participants
title
Chloride, change to normal or NC, n=94,97,24
categories
measurements
group Id
OG000
value
14
group Id
OG001
value
24
group Id
OG002
value
2
denoms
counts
group Id
OG000
value
94
group Id
OG001
value
97
group Id
OG002
value
24
units
Participants
title
Chloride, increase to high, n=94,97,24

denoms

counts
group Id
OG000
value
95
group Id
OG001
value
99
group Id
OG002
value
24
units
Participants

description

Blood samples were collected for analysis of clinical chemistry parameters: bicarbonate, direct bilirubin(D.Bil), calcium, chloride, lactate dehydrogenase(LDH), total protein,Urea enzymatic colorimetry.Baseline is latest pre-dose assessment(Day 1) with a non-missing value, including unscheduled visits. Number of participants with worst case clinical chemistry change from Baseline with respect to normal range are presented. Data was categorized as decrease to low (value below the lower LNR), increase to high (value above the upper LNR) and change to normal or NC. If values were unchanged (example: high to high), or whose value became normal, were recorded in the change to normal or NC category. Participants were counted twice if the participant had both decreased to low and increased to high during post Baseline. 3 out of 221participants did not receive any study treatment, were excluded from FSP.

groups

description
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
id
OG000
title
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)
description
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
id
OG001
title
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)
description
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
id
OG002
title
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)

param Type

COUNT_OF_PARTICIPANTS

population Description

Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but 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 (Day 1) and Up to 186 weeks

title

Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice