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NCT03848845 · OUTCOME

Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings

Study Evaluating Safety, Tolerability and Clinical Activity of GSK2857916 in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Multiple Myeloma (RRMM) · Source last updated 2024-04-09

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 approximately 178 weeks

What was measured

Participants with worse case punctate keratopathy findings post baseline at any ocular exam by right eye, left eye and worse eye are presented as none, mild, moderate and severe. Worse eye indicates the eye with the worst visual acuity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

Analysis population: All Treated Population. Only those participants with data available at specified time points have been analyzed.

Groups in this outcome

Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion

Participants were administered belantamab mafodotin with recommended phase 2 dose (RP2D) of 2.5 mg/kg in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.

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 Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion26

Reported measurements

Right eye, Worst findings

None

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion2Not reportedNot reportedNot reportedNot reported

Mild

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion11Not reportedNot reportedNot reportedNot reported

Moderate

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion7Not reportedNot reportedNot reportedNot reported

Severe

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion6Not reportedNot reportedNot reportedNot reported
Left eye, Worst findings

None

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion2Not reportedNot reportedNot reportedNot reported

Mild

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion9Not reportedNot reportedNot reportedNot reported

Moderate

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion9Not reportedNot reportedNot reportedNot reported

Severe

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion6Not reportedNot reportedNot reportedNot reported
Worst eye, Worst findings

None

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion2Not reportedNot reportedNot reportedNot reported

Mild

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion8Not reportedNot reportedNot reportedNot reported

Moderate

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion10Not reportedNot reportedNot reportedNot reported

Severe

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion6Not reportedNot reportedNot reportedNot reported
Right eye, Most frequent findings

None

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion10Not reportedNot reportedNot reportedNot reported

Mild

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion14Not reportedNot reportedNot reportedNot reported

Moderate

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion2Not reportedNot reportedNot reportedNot reported

Severe

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
Left eye, Most frequent findings

None

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion8Not reportedNot reportedNot reportedNot reported

Mild

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion13Not reportedNot reportedNot reportedNot reported

Moderate

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion5Not reportedNot reportedNot reportedNot reported

Severe

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
Worst eye, Most frequent findings

None

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion7Not reportedNot reportedNot reportedNot reported

Mild

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion14Not reportedNot reportedNot reportedNot reported

Moderate

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion5Not reportedNot reportedNot reportedNot reported

Severe

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      title
      None
    2. measurements
      1. group Id
        OG000
        value
        11
      title
      Mild
    3. measurements
      1. group Id
        OG000
        value
        7
      title
      Moderate
    4. measurements
      1. group Id
        OG000
        value
        6
      title
      Severe
    title
    Right eye, Worst findings
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      title
      None
    2. measurements
      1. group Id
        OG000
        value
        9
      title
      Mild
    3. measurements
      1. group Id
        OG000
        value
        9
      title
      Moderate
    4. measurements
      1. group Id
        OG000
        value
        6
      title
      Severe
    title
    Left eye, Worst findings
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      title
      None
    2. measurements
      1. group Id
        OG000
        value
        8
      title
      Mild
    3. measurements
      1. group Id
        OG000
        value
        10
      title
      Moderate
    4. measurements
      1. group Id
        OG000
        value
        6
      title
      Severe
    title
    Worst eye, Worst findings
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      title
      None
    2. measurements
      1. group Id
        OG000
        value
        14
      title
      Mild
    3. measurements
      1. group Id
        OG000
        value
        2
      title
      Moderate
    4. measurements
      1. group Id
        OG000
        value
        0
      title
      Severe
    title
    Right eye, Most frequent findings
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      title
      None
    2. measurements
      1. group Id
        OG000
        value
        13
      title
      Mild
    3. measurements
      1. group Id
        OG000
        value
        5
      title
      Moderate
    4. measurements
      1. group Id
        OG000
        value
        0
      title
      Severe
    title
    Left eye, Most frequent findings
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      title
      None
    2. measurements
      1. group Id
        OG000
        value
        14
      title
      Mild
    3. measurements
      1. group Id
        OG000
        value
        5
      title
      Moderate
    4. measurements
      1. group Id
        OG000
        value
        0
      title
      Severe
    title
    Worst eye, Most frequent findings
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    units
    Participants
description
Participants with worse case punctate keratopathy findings post baseline at any ocular exam by right eye, left eye and worse eye are presented as none, mild, moderate and severe. Worse eye indicates the eye with the worst visual acuity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.
groups
  1. description
    Participants were administered belantamab mafodotin with recommended phase 2 dose (RP2D) of 2.5 mg/kg in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
    id
    OG000
    title
    Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
param Type
COUNT_OF_PARTICIPANTS
population Description
All Treated Population. Only those participants with data available at specified time points have been analyzed.
reporting Status
POSTED
time Frame
Baseline (Day 1) and up to approximately 178 weeks
title
Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice