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NCT04549363 · OUTCOME

Number of Participants With Abnormality in Composition of Corneal Epithelium After Administration of Belantamab Mafodotin

Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin · Source last updated 2023-12-13

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
Up to approximately 23 months

What was measured

Corneal tissue samples were collected to evaluate the composition of microcyst-like epithelium observed in participants treated with belantamab mafodotin.

Analysis population: EICSK population

Groups in this outcome

Participants Allocated to Undergo Impression Cytology Procedure

A superficial corneal epithelial tissue specimen was obtained by performing impression cytology (IC) procedure in participants with relapsed/refractory multiple myeloma (RRMM) treated with belantamab mafodotin. The procedure was only performed in one eye. Participants did not need to be on active treatment.

Participants Allocated to Undergo Superficial Keratectomy Procedure

A superficial corneal epithelial tissue specimen was obtained by performing superficial keratectomy (SK) procedure in participants with relapsed/refractory multiple myeloma (RRMM) treated with belantamab mafodotin. The procedure was only performed in one eye. Participants did not need to be on active treatment.

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

Analysis denominator · Participants

GroupSource count
Participants Allocated to Undergo Impression Cytology Procedure4
Participants Allocated to Undergo Superficial Keratectomy Procedure2

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Participants Allocated to Undergo Impression Cytology Procedure4Not reportedNot reportedNot reportedNot reported
Participants Allocated to Undergo Superficial Keratectomy Procedure2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      2
    units
    Participants
description
Corneal tissue samples were collected to evaluate the composition of microcyst-like epithelium observed in participants treated with belantamab mafodotin.
groups
  1. description
    A superficial corneal epithelial tissue specimen was obtained by performing impression cytology (IC) procedure in participants with relapsed/refractory multiple myeloma (RRMM) treated with belantamab mafodotin. The procedure was only performed in one eye. Participants did not need to be on active treatment.
    id
    OG000
    title
    Participants Allocated to Undergo Impression Cytology Procedure
  2. description
    A superficial corneal epithelial tissue specimen was obtained by performing superficial keratectomy (SK) procedure in participants with relapsed/refractory multiple myeloma (RRMM) treated with belantamab mafodotin. The procedure was only performed in one eye. Participants did not need to be on active treatment.
    id
    OG001
    title
    Participants Allocated to Undergo Superficial Keratectomy Procedure
param Type
COUNT_OF_PARTICIPANTS
population Description
EICSK population
reporting Status
POSTED
time Frame
Up to approximately 23 months
title
Number of Participants With Abnormality in Composition of Corneal Epithelium After Administration of Belantamab Mafodotin
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice