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NCT03525678 · OUTCOME

Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

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: Up to 186 weeks

What was measured

The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. It included symptomatic toxicities drawn from the CTCAE like blurred vision, chills, constipation, decreased appetite, fatigue, general pain, heart palpitations, mouth/throat sores, nausea, nosebleed, shortness of breath, vomiting and watery eyes. Items were scored individually on a 0 to 4 scale for severity, frequency and interference. Number of participants with symptomatic AEs (those who had a maximum post-Baseline rating greater than 0, example; 1, 2, 3, or 4) measured by PRO-CTCAE are presented.

Analysis population: Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety 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

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)	84
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	92
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	22

Reported measurements

Blurred Vision, n= 84,92,22

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	84
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	92
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	22

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	59	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	67	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	19	Not reported	Not reported	Not reported	Not reported

Chills, n=43,42,13

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	43
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	42
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	13

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	39	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	36	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

Constipation, n=84,92, 22

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	84
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	92
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	22

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	42	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)	17	Not reported	Not reported	Not reported	Not reported

Decreased Appetite, n=84,92, 22

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	84
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	92
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	22

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)	65	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

Fatigue, n=84,92, 22

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	84
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	92
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	22

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	81	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	87	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	21	Not reported	Not reported	Not reported	Not reported

General Pain, n= 79, 80, 20

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	79
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	80
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	20

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	78	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	80	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	19	Not reported	Not reported	Not reported	Not reported

Heart Palpitations, n=37, 37, 14

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	37
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	37
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	14

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	35	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	33	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

Mouth/Throat Sores, n=84,92, 22

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	84
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	92
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	22

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	28	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	25	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

Nausea, n=48, 52, 11

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	48
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	52
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	47	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	50	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

Nosebleed, n=23, 33, 6

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	23
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	33
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	22	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	33	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	6	Not reported	Not reported	Not reported	Not reported

Shortness Of Breath, n=84,92, 22

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	84
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	92
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	22

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)	58	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	17	Not reported	Not reported	Not reported	Not reported

Vomiting, n=21, 28, 6

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	21
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	28
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	20	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)	5	Not reported	Not reported	Not reported	Not reported

Watery Eyes, n=84,92, 22

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	84
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	92
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	22

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	50	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)	19	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
59
group Id
OG001
value
67
group Id
OG002
value
19
denoms
counts
group Id
OG000
value
84
group Id
OG001
value
92
group Id
OG002
value
22
units
Participants
title
Blurred Vision, n= 84,92,22
categories
measurements
group Id
OG000
value
39
group Id
OG001
value
36
group Id
OG002
value
12
denoms
counts
group Id
OG000
value
43
group Id
OG001
value
42
group Id
OG002
value
13
units
Participants
title
Chills, n=43,42,13
categories
measurements
group Id
OG000
value
42
group Id
OG001
value
47
group Id
OG002
value
17
denoms
counts
group Id
OG000
value
84
group Id
OG001
value
92
group Id
OG002
value
22
units
Participants
title
Constipation, n=84,92, 22
categories
measurements
group Id
OG000
value
60
group Id
OG001
value
65
group Id
OG002
value
16
denoms
counts
group Id
OG000
value
84
group Id
OG001
value
92
group Id
OG002
value
22
units
Participants
title
Decreased Appetite, n=84,92, 22
categories
measurements
group Id
OG000
value
81
group Id
OG001
value
87
group Id
OG002
value
21
denoms
counts
group Id
OG000
value
84
group Id
OG001
value
92
group Id
OG002
value
22
units
Participants
title
Fatigue, n=84,92, 22
categories
measurements
group Id
OG000
value
78
group Id
OG001
value
80
group Id
OG002
value
19
denoms
counts
group Id
OG000
value
79
group Id
OG001
value
80
group Id
OG002
value
20
units
Participants
title
General Pain, n= 79, 80, 20
categories
measurements
group Id
OG000
value
35
group Id
OG001
value
33
group Id
OG002
value
14
denoms
counts
group Id
OG000
value
37
group Id
OG001
value
37
group Id
OG002
value
14
units
Participants
title
Heart Palpitations, n=37, 37, 14
categories
measurements
group Id
OG000
value
28
group Id
OG001
value
25
group Id
OG002
value
8
denoms
counts
group Id
OG000
value
84
group Id
OG001
value
92
group Id
OG002
value
22
units
Participants
title
Mouth/Throat Sores, n=84,92, 22
categories
measurements
group Id
OG000
value
47
group Id
OG001
value
50
group Id
OG002
value
11
denoms
counts
group Id
OG000
value
48
group Id
OG001
value
52
group Id
OG002
value
11
units
Participants
title
Nausea, n=48, 52, 11
categories
measurements
group Id
OG000
value
22
group Id
OG001
value
33
group Id
OG002
value
6
denoms
counts
group Id
OG000
value
23
group Id
OG001
value
33
group Id
OG002
value
6
units
Participants
title
Nosebleed, n=23, 33, 6
categories
measurements
group Id
OG000
value
60
group Id
OG001
value
58
group Id
OG002
value
17
denoms
counts
group Id
OG000
value
84
group Id
OG001
value
92
group Id
OG002
value
22
units
Participants
title
Shortness Of Breath, n=84,92, 22
categories
measurements
group Id
OG000
value
20
group Id
OG001
value
28
group Id
OG002
value
5
denoms
counts
group Id
OG000
value
21
group Id
OG001
value
28
group Id
OG002
value
6
units
Participants
title
Vomiting, n=21, 28, 6

denoms

counts
group Id
OG000
value
84
group Id
OG001
value
92
group Id
OG002
value
22
units
Participants

description

The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. It included symptomatic toxicities drawn from the CTCAE like blurred vision, chills, constipation, decreased appetite, fatigue, general pain, heart palpitations, mouth/throat sores, nausea, nosebleed, shortness of breath, vomiting and watery eyes. Items were scored individually on a 0 to 4 scale for severity, frequency and interference. Number of participants with symptomatic AEs (those who had a maximum post-Baseline rating greater than 0, example; 1, 2, 3, or 4) measured by PRO-CTCAE are presented.

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. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety 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

Up to 186 weeks

title

Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice