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NCT03525678 · OUTCOME

Number of Participants With Change From Baseline in Body Temperature

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 body temperature are presented. Data is categorized as: body temperature 'decrease to \<=35 degrees celsius', 'increase to \>=38 degrees celsius' and 'change to normal or no change'. If values were unchanged (example: increase to \>=38 to increase to \>=38 degrees celsius), 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 \<=35' and 'increased to \>=38 degrees celsius' 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. Only those participants with data available at the specified data points were analyzed.

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

GroupSource 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

Reported measurements

Decrease to <=35
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)1Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)3Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)0Not reportedNot reportedNot reportedNot reported
Change to normal or no change
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)86Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)85Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)21Not reportedNot reportedNot reportedNot reported
Increase to >=38
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)8Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)10Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        0
    title
    Decrease to <=35
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        86
      2. group Id
        OG001
        value
        85
      3. group Id
        OG002
        value
        21
    title
    Change to normal or no change
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        3
    title
    Increase to >=38
denoms
  1. counts
    1. group Id
      OG000
      value
      95
    2. group Id
      OG001
      value
      98
    3. group Id
      OG002
      value
      24
    units
    Participants
description
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 body temperature are presented. Data is categorized as: body temperature 'decrease to \<=35 degrees celsius', 'increase to \>=38 degrees celsius' and 'change to normal or no change'. If values were unchanged (example: increase to \>=38 to increase to \>=38 degrees celsius), 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 \<=35' and 'increased to \>=38 degrees celsius' during post Baseline. Data for worst-case post Baseline is presented.
groups
  1. 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)
  2. 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)
  3. 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.
reporting Status
POSTED
time Frame
Baseline (Day 1) and Up to 186 weeks
title
Number of Participants With Change From Baseline in Body Temperature
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice