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NCT04162210 · ADVERSE EVENTS

Adverse events

Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) · Source last updated 2026-07-01

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
All-cause mortality, Non-Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected up to approximately 263 weeks. The results presented are based on data cut-off date 22 April 2025.
Other-event reporting threshold
5%

Safety population included all randomized participants who took at least 1 dose of study intervention

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

Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle

101 / 217205 / 217139 / 217
Pomalidomide Plus Dexamethasone

Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants \>75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22)

45 / 10293 / 10271 / 102

Group identifiers: EG000: Belantamab Mafodotin · EG001: Pomalidomide Plus Dexamethasone

Serious 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
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      217
      num Events
      7
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      102
      num Events
      12
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      217
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      102
      num Events
      4
    term
    COVID-19
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      217
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
      num Events
      0
    term
    Urinary tract infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      217
      num Events
      3
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      102
      num Events
      5
    term
    COVID-19 pneumonia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      217
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Septic shock
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      217
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
      num Events
      0
    term
    Lower respiratory tract infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      217
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
      num Events
      0
    term
    Osteomyelitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      217
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      102
      num Events
      3
    term
    Sepsis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      217
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
      num Events
      0
    term
    Acute hepatitis B
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      217
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
      num Events
      0
    term
    Cellulitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      217
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
      num Events
      0
    term
    Meningitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      217
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
      num Events
      0
    term
    Pneumonia influenzal

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
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      217
      num Events
      113
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      102
      num Events
      83
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      217
      num Events
      80
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      102
      num Events
      50
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      217
      num Events
      64
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      102
      num Events
      107
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      217
      num Events
      14
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      102
      num Events
      38
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      217
      num Events
      9
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      102
      num Events
      36
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      105
      num At Risk
      217
      num Events
      370
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      102
      num Events
      7
    term
    Vision blurred
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      217
      num Events
      204
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      102
      num Events
      3
    term
    Dry eye
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      80
      num At Risk
      217
      num Events
      259
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      102
      num Events
      5
    term
    Foreign body sensation in eyes
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      217
      num Events
      159
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      102
      num Events
      5
    term
    Eye irritation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      217
      num Events
      152
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      102
      num Events
      4
    term
    Photophobia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      217
      num Events
      124
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
      num Events
      0
    term
    Eye pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      217
      num Events
      85
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Visual acuity reduced
Complete source fields
description
Safety population included all randomized participants who took at least 1 dose of study intervention
event Groups
  1. deaths Num Affected
    139
    deaths Num At Risk
    217
    description
    Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle
    id
    EG000
    other Num Affected
    205
    other Num At Risk
    217
    serious Num Affected
    101
    serious Num At Risk
    217
    title
    Belantamab Mafodotin
  2. deaths Num Affected
    71
    deaths Num At Risk
    102
    description
    Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants \>75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22)
    id
    EG001
    other Num Affected
    93
    other Num At Risk
    102
    serious Num Affected
    45
    serious Num At Risk
    102
    title
    Pomalidomide Plus Dexamethasone
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      217
      num Events
      113
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      102
      num Events
      83
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      217
      num Events
      80
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      102
      num Events
      50
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      217
      num Events
      64
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      102
      num Events
      107
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      217
      num Events
      14
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      102
      num Events
      38
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      217
      num Events
      9
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      102
      num Events
      36
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      105
      num At Risk
      217
      num Events
      370
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      102
      num Events
      7
    term
    Vision blurred
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      217
      num Events
      204
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      102
      num Events
      3
    term
    Dry eye
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      80
      num At Risk
      217
      num Events
      259
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      102
      num Events
      5
    term
    Foreign body sensation in eyes
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      217
      num Events
      159
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      102
      num Events
      5
    term
    Eye irritation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      217
      num Events
      152
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      102
      num Events
      4
    term
    Photophobia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      217
      num Events
      124
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
      num Events
      0
    term
    Eye pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      217
      num Events
      85
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Visual acuity reduced
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      217
      num Events
      7
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      102
      num Events
      12
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      217
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      102
      num Events
      4
    term
    COVID-19
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      217
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
      num Events
      0
    term
    Urinary tract infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      217
      num Events
      3
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      102
      num Events
      5
    term
    COVID-19 pneumonia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      217
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Septic shock
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      217
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
      num Events
      0
    term
    Lower respiratory tract infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      217
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
      num Events
      0
    term
    Osteomyelitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      217
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      102
      num Events
      3
    term
    Sepsis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      217
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
      num Events
      0
    term
    Acute hepatitis B
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      217
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
      num Events
      0
    term
    Cellulitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      217
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
      num Events
      0
    term
    Meningitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      217
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
      num Events
      0
    term
    Pneumonia influenzal
time Frame
All-cause mortality, Non-Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected up to approximately 263 weeks. The results presented are based on data cut-off date 22 April 2025.

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