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NCT03525678 · OUTCOME

Number of Participants With Shift in Corneal Epithelium Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline) for Corneal Epithelium (CE) and Corneal Stroma (CS)

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 and Up to 186 weeks

What was measured

Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Corneal epithelium findings for CE and CS were assessed individually for each eye. Number of participants with shift in corneal epithelium findings from normal (Baseline) to abnormal (worst post-Baseline) for CE and CS are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.

Analysis population: 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

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)92
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)94
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)24

Reported measurements

CE, Right eye, n=53,54,17

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)53
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)54
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)17
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)39Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)40Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)16Not reportedNot reportedNot reportedNot reported
CE, Left eye,n=55,55,15

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)55
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)55
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)15
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)39Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)44Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)14Not reportedNot reportedNot reportedNot reported
CS, Right eye,n=92,94,24

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)92
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)94
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)5Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)7Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)3Not reportedNot reportedNot reportedNot reported
CS, Left eye,n=92,89,23

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)92
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)89
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)23
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)5Not 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
        39
      2. group Id
        OG001
        value
        40
      3. group Id
        OG002
        value
        16
    denoms
    1. counts
      1. group Id
        OG000
        value
        53
      2. group Id
        OG001
        value
        54
      3. group Id
        OG002
        value
        17
      units
      Participants
    title
    CE, Right eye, n=53,54,17
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        39
      2. group Id
        OG001
        value
        44
      3. group Id
        OG002
        value
        14
    denoms
    1. counts
      1. group Id
        OG000
        value
        55
      2. group Id
        OG001
        value
        55
      3. group Id
        OG002
        value
        15
      units
      Participants
    title
    CE, Left eye,n=55,55,15
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        3
    denoms
    1. counts
      1. group Id
        OG000
        value
        92
      2. group Id
        OG001
        value
        94
      3. group Id
        OG002
        value
        24
      units
      Participants
    title
    CS, Right eye,n=92,94,24
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        3
    denoms
    1. counts
      1. group Id
        OG000
        value
        92
      2. group Id
        OG001
        value
        89
      3. group Id
        OG002
        value
        23
      units
      Participants
    title
    CS, Left eye,n=92,89,23
denoms
  1. counts
    1. group Id
      OG000
      value
      92
    2. group Id
      OG001
      value
      94
    3. group Id
      OG002
      value
      24
    units
    Participants
description
Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Corneal epithelium findings for CE and CS were assessed individually for each eye. Number of participants with shift in corneal epithelium findings from normal (Baseline) to abnormal (worst post-Baseline) for CE and CS are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
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. 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 186 weeks
title
Number of Participants With Shift in Corneal Epithelium Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline) for Corneal Epithelium (CE) and Corneal Stroma (CS)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice