NCT03525678 · OUTCOME

Number of Participants With Change From Baseline in Pulse Rate

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

Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Number of participants with worst case change from Baseline in pulse rate is presented. Data is categorized as: pulse rate 'decrease to \<60 beats per minute \[bpm\]', 'increase to \>100 bpm' and 'change to normal or no change'. If values were unchanged (example: increase to \>100 bpm to increase to \>100 bpm), or whose value became normal, were recorded in the 'change to normal or no change' category. Participants were counted twice if the participant had both 'decreased to \<60 bpm' and 'increased to \>100 bpm' during post Baseline. Data for worst-case post Baseline is 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.

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

Decrease to <60

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)	17	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

Change to normal or no change

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	57	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	55	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	15	Not reported	Not reported	Not reported	Not reported

Increase to >100

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	25	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)	3	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
14
group Id
OG001
value
17
group Id
OG002
value
6
title
Decrease to <60
categories
measurements
group Id
OG000
value
57
group Id
OG001
value
55
group Id
OG002
value
15
title
Change to normal or no change
categories
measurements
group Id
OG000
value
25
group Id
OG001
value
28
group Id
OG002
value
3
title
Increase to >100

denoms

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

description

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.

reporting Status

POSTED

time Frame

Baseline (Day 1) and Up to 186 weeks

title

Number of Participants With Change From Baseline in Pulse Rate

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice