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NCT05986682 · ADVERSE EVENTS

Adverse 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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Between baseline and earliest death, lost to contact or end of study timeframe, up to 40 months.
Other-event reporting threshold
0%

Ocular AEs were collected per participant, not per eye. Hematologic toxicity was collected if it was a reason for change to treatment. No other AEs were collected. Ocular toxicity was collected systematically through optometrist visits; measured per the Keratopathy Visual Acuity scale, using belantamab mafodotin REMS guidelines. Ocular symptoms were reported ad hoc by patients at individual clinic visits, as a non-systematic assessment. Serious AEs were not monitored/assessed.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
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.

0 / 029 / 3010 / 30

Group identifiers: EG000: Multiple Myeloma/Blenrep Participants

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Ocular adverse events were collected per participant, not per eye.
      organ System
      Eye disorders
      source Vocabulary
      MedDRA v. 25.1
      stats
      1. group Id
        EG000
        num Affected
        28
        num At Risk
        30
        num Events
        320
      term
      Keratopathy
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Ocular adverse events were collected per participant, not per eye.
      organ System
      Eye disorders
      source Vocabulary
      MedDRA v. 25.1
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        30
        num Events
        3
      term
      Corneal epithelium defect
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Ocular adverse events were collected per participant, not per eye.
      organ System
      Eye disorders
      source Vocabulary
      MedDRA v. 25.1
      stats
      1. group Id
        EG000
        num Affected
        27
        num At Risk
        30
        num Events
        244
      term
      Visual acuity reduced
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Ocular adverse events were collected per participant, not per eye.
      organ System
      Eye disorders
      source Vocabulary
      MedDRA v. 25.1
      stats
      1. group Id
        EG000
        num Affected
        24
        num At Risk
        30
        num Events
        102
      term
      Blurred vision
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Ocular adverse events were collected per participant, not per eye.
      organ System
      Eye disorders
      source Vocabulary
      MedDRA v. 25.1
      stats
      1. group Id
        EG000
        num Affected
        9
        num At Risk
        30
        num Events
        32
      term
      Dry eye
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Ocular adverse events were collected per participant, not per eye.
      organ System
      Eye disorders
      source Vocabulary
      MedDRA v. 25.1
      stats
      1. group Id
        EG000
        num Affected
        9
        num At Risk
        30
        num Events
        26
      term
      Photophobia
    7. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Ocular adverse events were collected per participant, not per eye.
      organ System
      Eye disorders
      source Vocabulary
      MedDRA v. 25.1
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        30
        num Events
        6
      term
      Foreign body sensation in the eye
    8. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Ocular adverse events were collected per participant, not per eye.
      organ System
      Eye disorders
      source Vocabulary
      MedDRA v. 25.1
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        30
        num Events
        10
      term
      Eye pruritus
    9. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Ocular adverse events were collected per participant, not per eye.
      organ System
      Eye disorders
      source Vocabulary
      MedDRA v. 25.1
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        30
        num Events
        5
      term
      Eye pain
    10. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Ocular adverse events were collected per participant, not per eye.
      organ System
      Eye disorders
      source Vocabulary
      MedDRA v. 25.1
      stats
      1. group Id
        EG000
        num Affected
        7
        num At Risk
        30
        num Events
        9
      term
      Eye irritation
    11. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Ocular adverse events were collected per participant, not per eye.
      organ System
      Eye disorders
      source Vocabulary
      MedDRA v. 25.1
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        30
        num Events
        1
      term
      Lacrimation increased
    12. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Ocular adverse events were collected per participant, not per eye.
      organ System
      Eye disorders
      source Vocabulary
      MedDRA v. 25.1
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        30
        num Events
        1
      term
      Ocular discomfort
    Complete source fields
    description
    Ocular AEs were collected per participant, not per eye. Hematologic toxicity was collected if it was a reason for change to treatment. No other AEs were collected. Ocular toxicity was collected systematically through optometrist visits; measured per the Keratopathy Visual Acuity scale, using belantamab mafodotin REMS guidelines. Ocular symptoms were reported ad hoc by patients at individual clinic visits, as a non-systematic assessment. Serious AEs were not monitored/assessed.
    event Groups
    1. deaths Num Affected
      10
      deaths Num At Risk
      30
      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
      EG000
      other Num Affected
      29
      other Num At Risk
      30
      serious Num Affected
      0
      serious Num At Risk
      0
      title
      Multiple Myeloma/Blenrep Participants
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Ocular adverse events were collected per participant, not per eye.
      organ System
      Eye disorders
      source Vocabulary
      MedDRA v. 25.1
      stats
      1. group Id
        EG000
        num Affected
        28
        num At Risk
        30
        num Events
        320
      term
      Keratopathy
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Ocular adverse events were collected per participant, not per eye.
      organ System
      Eye disorders
      source Vocabulary
      MedDRA v. 25.1
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        30
        num Events
        3
      term
      Corneal epithelium defect
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Ocular adverse events were collected per participant, not per eye.
      organ System
      Eye disorders
      source Vocabulary
      MedDRA v. 25.1
      stats
      1. group Id
        EG000
        num Affected
        27
        num At Risk
        30
        num Events
        244
      term
      Visual acuity reduced
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Ocular adverse events were collected per participant, not per eye.
      organ System
      Eye disorders
      source Vocabulary
      MedDRA v. 25.1
      stats
      1. group Id
        EG000
        num Affected
        24
        num At Risk
        30
        num Events
        102
      term
      Blurred vision
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Ocular adverse events were collected per participant, not per eye.
      organ System
      Eye disorders
      source Vocabulary
      MedDRA v. 25.1
      stats
      1. group Id
        EG000
        num Affected
        9
        num At Risk
        30
        num Events
        32
      term
      Dry eye
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Ocular adverse events were collected per participant, not per eye.
      organ System
      Eye disorders
      source Vocabulary
      MedDRA v. 25.1
      stats
      1. group Id
        EG000
        num Affected
        9
        num At Risk
        30
        num Events
        26
      term
      Photophobia
    7. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Ocular adverse events were collected per participant, not per eye.
      organ System
      Eye disorders
      source Vocabulary
      MedDRA v. 25.1
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        30
        num Events
        6
      term
      Foreign body sensation in the eye
    8. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Ocular adverse events were collected per participant, not per eye.
      organ System
      Eye disorders
      source Vocabulary
      MedDRA v. 25.1
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        30
        num Events
        10
      term
      Eye pruritus
    9. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Ocular adverse events were collected per participant, not per eye.
      organ System
      Eye disorders
      source Vocabulary
      MedDRA v. 25.1
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        30
        num Events
        5
      term
      Eye pain
    10. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Ocular adverse events were collected per participant, not per eye.
      organ System
      Eye disorders
      source Vocabulary
      MedDRA v. 25.1
      stats
      1. group Id
        EG000
        num Affected
        7
        num At Risk
        30
        num Events
        9
      term
      Eye irritation
    11. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Ocular adverse events were collected per participant, not per eye.
      organ System
      Eye disorders
      source Vocabulary
      MedDRA v. 25.1
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        30
        num Events
        1
      term
      Lacrimation increased
    12. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Ocular adverse events were collected per participant, not per eye.
      organ System
      Eye disorders
      source Vocabulary
      MedDRA v. 25.1
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        30
        num Events
        1
      term
      Ocular discomfort
    time Frame
    Between baseline and earliest death, lost to contact or end of study timeframe, up to 40 months.

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

    Preserved source evidence · Not medical advice