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NCT04398745 · ADVERSE EVENTS

Adverse events

A Study of Belantamab Mafodotin Monotherapy in Multiple Myeloma Participants With Normal and Varying Degree of Impaired Renal Function · 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 SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Other-event reporting threshold
5%

Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)

Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.

4 / 1010 / 102 / 10
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)

Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.

4 / 99 / 93 / 9
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)

Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.

2 / 43 / 40 / 4
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)

Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.

3 / 55 / 51 / 5
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)

Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.

4 / 88 / 83 / 8

Group identifiers: EG000: Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function) · EG001: Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function) · EG002: Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function) · EG003: Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis) · EG004: Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)

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 V28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    COVID-19 pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      8
      num Events
      2
    term
    Pneumonia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Atypical pneumonia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    COVID-19
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Enterobacter sepsis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Metapneumovirus pneumonia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Septic shock
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      9
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Chronic kidney disease
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Acute kidney injury
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Gastritis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Intestinal ischaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Oesophagitis

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
    Eye disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      10
      num Events
      25
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      9
      num Events
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      5
      num Events
      6
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      8
      num Events
      8
    term
    Vision blurred
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      10
      num Events
      20
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      9
      num Events
      8
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
      num Events
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      8
      num Events
      9
    term
    Dry eye
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      10
      num Events
      19
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      9
      num Events
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      2
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      8
      num Events
      6
    term
    Eye irritation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
      num Events
      14
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      9
      num Events
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      2
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      8
      num Events
      4
    term
    Photophobia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      10
      num Events
      26
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      9
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      8
      num Events
      3
    term
    Foreign body sensation in eyes
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Cataract
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
      num Events
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
      num Events
      2
    term
    Eye pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Blepharitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
      num Events
      2
    term
    Cataract cortical
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      8
      num Events
      4
    term
    Cataract nuclear
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Cataract subcapsular
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Diplopia
Complete source fields
description
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    10
    description
    Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
    id
    EG000
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    4
    serious Num At Risk
    10
    title
    Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
  2. deaths Num Affected
    3
    deaths Num At Risk
    9
    description
    Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
    id
    EG001
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    4
    serious Num At Risk
    9
    title
    Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
  3. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
    id
    EG002
    other Num Affected
    3
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
  4. deaths Num Affected
    1
    deaths Num At Risk
    5
    description
    Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
    id
    EG003
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    3
    serious Num At Risk
    5
    title
    Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
  5. deaths Num Affected
    3
    deaths Num At Risk
    8
    description
    Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
    id
    EG004
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    4
    serious Num At Risk
    8
    title
    Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      10
      num Events
      25
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      9
      num Events
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      5
      num Events
      6
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      8
      num Events
      8
    term
    Vision blurred
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      10
      num Events
      20
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      9
      num Events
      8
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
      num Events
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      8
      num Events
      9
    term
    Dry eye
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      10
      num Events
      19
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      9
      num Events
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      2
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      8
      num Events
      6
    term
    Eye irritation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
      num Events
      14
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      9
      num Events
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      2
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      8
      num Events
      4
    term
    Photophobia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      10
      num Events
      26
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      9
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      8
      num Events
      3
    term
    Foreign body sensation in eyes
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Cataract
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
      num Events
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
      num Events
      2
    term
    Eye pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Blepharitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
      num Events
      2
    term
    Cataract cortical
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      8
      num Events
      4
    term
    Cataract nuclear
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Cataract subcapsular
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Diplopia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    COVID-19 pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      8
      num Events
      2
    term
    Pneumonia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Atypical pneumonia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    COVID-19
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Enterobacter sepsis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Metapneumovirus pneumonia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Septic shock
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      9
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Chronic kidney disease
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Acute kidney injury
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Gastritis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Intestinal ischaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Oesophagitis
time Frame
All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.

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Preserved source evidence · Not medical advice