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NCT03848845 · ADVERSE EVENTS

Adverse events

Study Evaluating Safety, Tolerability and Clinical Activity of GSK2857916 in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Multiple Myeloma (RRMM) · Source last updated 2024-04-09

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 from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase.
Other-event reporting threshold
5%

All Treated Population included all participants who received at least one dose of study treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation

Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.

4 / 66 / 62 / 6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation

Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.

5 / 76 / 73 / 7
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion

Participants were administered belantamab mafodotin with recommended phase 2 dose (RP2D) of 2.5 mg/kg in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.

5 / 2827 / 287 / 28
PACT Phase- Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg

Participants who completed approximately 178 weeks of treatment of 2.5 mg/kg belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion had the opportunity to continue receiving belantamab mafodotin in the PACT phase up to approximately 221 weeks.

0 / 20 / 20 / 2

Group identifiers: EG000: Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation · EG001: Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation · EG002: Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion · EG003: PACT Phase- Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg

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
    Blood and lymphatic system disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Atrial flutter
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Cardiac failure congestive
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Cardiopulmonary failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Large intestinal haemorrhage
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Chest pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Anaphylactic reaction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Cytokine release syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Bacteraemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Leishmaniasis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      28
      num Events
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Pneumonia

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 v24.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      6
      num Events
      5
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      7
      num Events
      3
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      28
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
      num Events
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      7
      num Events
      6
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      28
      num Events
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Blepharitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      28
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Dry eye
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Eye pruritus
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      6
      num Events
      7
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      7
      num Events
      7
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      28
      num Events
      27
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Keratopathy
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      28
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Photophobia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
      num Events
      2
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      28
      num Events
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Vision blurred
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      2
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      28
      num Events
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Nausea
Complete source fields
description
All Treated Population included all participants who received at least one dose of study treatment.
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    6
    description
    Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.
    id
    EG000
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    4
    serious Num At Risk
    6
    title
    Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation
  2. deaths Num Affected
    3
    deaths Num At Risk
    7
    description
    Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
    id
    EG001
    other Num Affected
    6
    other Num At Risk
    7
    serious Num Affected
    5
    serious Num At Risk
    7
    title
    Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation
  3. deaths Num Affected
    7
    deaths Num At Risk
    28
    description
    Participants were administered belantamab mafodotin with recommended phase 2 dose (RP2D) of 2.5 mg/kg in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
    id
    EG002
    other Num Affected
    27
    other Num At Risk
    28
    serious Num Affected
    5
    serious Num At Risk
    28
    title
    Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
  4. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    Participants who completed approximately 178 weeks of treatment of 2.5 mg/kg belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion had the opportunity to continue receiving belantamab mafodotin in the PACT phase up to approximately 221 weeks.
    id
    EG003
    other Num Affected
    0
    other Num At Risk
    2
    serious Num Affected
    0
    serious Num At Risk
    2
    title
    PACT Phase- Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      6
      num Events
      5
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      7
      num Events
      3
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      28
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
      num Events
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      7
      num Events
      6
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      28
      num Events
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Blepharitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      28
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Dry eye
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Eye pruritus
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      6
      num Events
      7
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      7
      num Events
      7
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      28
      num Events
      27
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Keratopathy
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      28
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Photophobia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
      num Events
      2
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      28
      num Events
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Vision blurred
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      2
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      28
      num Events
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Nausea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Atrial flutter
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Cardiac failure congestive
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Cardiopulmonary failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Large intestinal haemorrhage
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Chest pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Anaphylactic reaction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Cytokine release syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Bacteraemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Leishmaniasis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    Meddra v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      28
      num Events
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Pneumonia
time Frame
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase.

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Preserved source evidence · Not medical advice