Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03525678 · OUTCOME

Time to Response by Independent Review Committee (Efficacy Population)

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
MEDIAN
Unit
Months
Interval / dispersion
Inter-Quartile Range
Time frame
Up to 186 weeks

What was measured

Time to response is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (i.e., confirmed PR or better). Time to response based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of time to response are presented.

Analysis population: Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population. Only responders (confirmed PR or better) by Independent Review Committee were included in this analysis

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.

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)20
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)20

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)1.5Not reported0.82.5Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)1.4Not reported1.11.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.8
        upper Limit
        2.5
        value
        1.5
      2. group Id
        OG001
        lower Limit
        1.1
        upper Limit
        1.9
        value
        1.4
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    2. group Id
      OG001
      value
      20
    units
    Participants
description
Time to response is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (i.e., confirmed PR or better). Time to response based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of time to response are presented.
dispersion Type
Inter-Quartile Range
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)
param Type
MEDIAN
population Description
Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population. Only responders (confirmed PR or better) by Independent Review Committee were included in this analysis
reporting Status
POSTED
time Frame
Up to 186 weeks
title
Time to Response by Independent Review Committee (Efficacy Population)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice