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NCT04549363 · FLOW

Participant flow

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.

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
    FG000
    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
    FG001
    title
    Participants Allocated to Undergo Superficial Keratectomy Procedure
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        3
      comment
      All treated population
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        3
      comment
      IC or SK (ICSK) population is defined as participants from all-treated population who had a tissue sample collected using Impression Cytology (IC) or Superficial Keratectomy (SK) procedure, whether or not the specimen is evaluable.
      type
      ICSK Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      comment
      Evaluable IC or SK (EICSK) population included participants from all-treated population who had an evaluable tissue sample collected using IC or SK procedure. A tissue sample specimen were determined to be evaluable by the pathologist in the pathology report.
      type
      EICSK Population
    4. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        3
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Out of the 16 participants enrolled, 7 were screen failures, 9 participants were allocated to undergo Impression Cytology (IC)/ Superficial Keratectomy (SK) procedure.
recruitment Details
The study has been terminated for reasons pertaining to feasibility.
Complete source fields
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
    FG000
    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
    FG001
    title
    Participants Allocated to Undergo Superficial Keratectomy Procedure
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        3
      comment
      All treated population
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        3
      comment
      IC or SK (ICSK) population is defined as participants from all-treated population who had a tissue sample collected using Impression Cytology (IC) or Superficial Keratectomy (SK) procedure, whether or not the specimen is evaluable.
      type
      ICSK Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      comment
      Evaluable IC or SK (EICSK) population included participants from all-treated population who had an evaluable tissue sample collected using IC or SK procedure. A tissue sample specimen were determined to be evaluable by the pathologist in the pathology report.
      type
      EICSK Population
    4. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        3
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Out of the 16 participants enrolled, 7 were screen failures, 9 participants were allocated to undergo Impression Cytology (IC)/ Superficial Keratectomy (SK) procedure.
recruitment Details
The study has been terminated for reasons pertaining to feasibility.

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Preserved source evidence · Not medical advice