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NCT04177823 · OUTCOME

Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score

A Study of Belantamab Mafodotin to Investigate Safety, Tolerability, Pharmacokinetics, Immunogenicity and Clinical Activity in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) · Source last updated 2025-03-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
Scores on Scale
Interval / dispersion
Standard Deviation
Time frame
Baseline (day 1) Up to 24 months and 21 days

What was measured

The OSDI instrument measures vision-related function. The total OSDI score was calculated as (sum of scores for all questions answered\*100) divided by (total number of questions answered\*4). The 12 items questionnaire assessed ocular symptoms, visual-related functioning and environmental triggers. Scores ranged from 0 to 100, with higher scores indicating a worse status. Baseline was defined as latest pre-dose assessment (day 1) with a non-missing value, including those from unscheduled visits.

Analysis population: All treated population

Groups in this outcome

Belantamab Mafodotin

Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin6

Reported measurements

Source class 1
Values in Scores on Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin12.820.43Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.43
        value
        12.8
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
The OSDI instrument measures vision-related function. The total OSDI score was calculated as (sum of scores for all questions answered\*100) divided by (total number of questions answered\*4). The 12 items questionnaire assessed ocular symptoms, visual-related functioning and environmental triggers. Scores ranged from 0 to 100, with higher scores indicating a worse status. Baseline was defined as latest pre-dose assessment (day 1) with a non-missing value, including those from unscheduled visits.
dispersion Type
Standard Deviation
groups
  1. description
    Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
    id
    OG000
    title
    Belantamab Mafodotin
param Type
MEAN
population Description
All treated population
reporting Status
POSTED
time Frame
Baseline (day 1) Up to 24 months and 21 days
title
Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score
type
SECONDARY
unit Of Measure
Scores on Scale

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

Preserved source evidence · Not medical advice