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NCT05986682 · OUTCOME

Ophthalmology: Grade of Ocular Toxicities (Corneal Events)

Real-World Analysis of Belantamab Mafodotin Care Patterns in Patients With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2025-02-03

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

Measure
COUNT_OF_UNITS
Unit
Corneal Events
Interval / dispersion
Not reported
Time frame
Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.

What was measured

Ocular toxicity as measured by corneal events per the Keratopathy Visual Acuity scale, and graded using belantamab mafodotin REMS \[Risk Evaluation and Mitigation Strategies\] guidelines. Corneal examination changes from baseline are categorized as normal or grade 1, 2, 3, or 4 and are based on the worst overall finding. Normal: Cornea clear/No change from baseline. Grade 1: Mild superficial keratopathy with or without symptoms. Grade 2: Moderate superficial keratopathy. Grade 3: Severe superficial keratopathy. Moderate/Severe keratopathy could be with or without patchy microcyst-like deposits, sub-epithelial haze (peripheral), or a new peripheral stromal opacity. Grade 4: Corneal epithelial defect (such as corneal ulcer). The Data table reports the total number of corneal events experienced, along with counts and percentage by grade of event.

Analysis population: The 30 patients in the study experienced ocular toxicity (corneal events) a total of 323 times as reported during clinic visits. The analysis population is the 323 events reported.

Groups in this outcome

Multiple Myeloma/Blenrep Participants

Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023

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

Analysis denominator · Participants

GroupSource count
Multiple Myeloma/Blenrep Participants30

Analysis denominator · Corneal Events

GroupSource count
Multiple Myeloma/Blenrep Participants323

Reported measurements

Total Number of Corneal Events
Values in Corneal Events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Multiple Myeloma/Blenrep Participants323Not reportedNot reportedNot reportedNot reported
Grade 1
Values in Corneal Events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Multiple Myeloma/Blenrep Participants158Not reportedNot reportedNot reportedNot reported
Grade 2
Values in Corneal Events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Multiple Myeloma/Blenrep Participants158Not reportedNot reportedNot reportedNot reported
Grade 3
Values in Corneal Events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Multiple Myeloma/Blenrep Participants4Not reportedNot reportedNot reportedNot reported
Grade 4
Values in Corneal Events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Multiple Myeloma/Blenrep Participants3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        323
    title
    Total Number of Corneal Events
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        158
    title
    Grade 1
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        158
    title
    Grade 2
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Grade 3
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Grade 4
denom Units Selected
Corneal Events
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      323
    units
    Corneal Events
description
Ocular toxicity as measured by corneal events per the Keratopathy Visual Acuity scale, and graded using belantamab mafodotin REMS \[Risk Evaluation and Mitigation Strategies\] guidelines. Corneal examination changes from baseline are categorized as normal or grade 1, 2, 3, or 4 and are based on the worst overall finding. Normal: Cornea clear/No change from baseline. Grade 1: Mild superficial keratopathy with or without symptoms. Grade 2: Moderate superficial keratopathy. Grade 3: Severe superficial keratopathy. Moderate/Severe keratopathy could be with or without patchy microcyst-like deposits, sub-epithelial haze (peripheral), or a new peripheral stromal opacity. Grade 4: Corneal epithelial defect (such as corneal ulcer). The Data table reports the total number of corneal events experienced, along with counts and percentage by grade of event.
groups
  1. description
    Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023
    id
    OG000
    title
    Multiple Myeloma/Blenrep Participants
param Type
COUNT_OF_UNITS
population Description
The 30 patients in the study experienced ocular toxicity (corneal events) a total of 323 times as reported during clinic visits. The analysis population is the 323 events reported.
reporting Status
POSTED
time Frame
Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
title
Ophthalmology: Grade of Ocular Toxicities (Corneal Events)
type
POST_HOC
type Units Analyzed
Corneal Events
unit Of Measure
Corneal Events

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

Preserved source evidence · Not medical advice