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NCT03481556 · ADVERSE EVENTS

Adverse events

Study of Melphalan Flufenamide (Melflufen) + Dex With Bortezomib or Daratumumab in Patients With RRMM · Source last updated 2022-12-19

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
Cycle 1 Day 1 up to a maximum of 198.9 weeks
Other-event reporting threshold
0%

All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
A (Melflufen+Bortezomib+Dex) 30 mg

Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.

9 / 1515 / 154 / 15
A (Melflufen+Bortezomib+Dex) 40 mg

Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.

5 / 88 / 82 / 8
B (Melflufen+Daratumumab+Dex) 30 mg

Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone PO at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).

4 / 66 / 63 / 6
B (Melflufen+Daratumumab+Dex) 40 mg

Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone PO at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).

11 / 2727 / 2716 / 27

Group identifiers: EG000: A (Melflufen+Bortezomib+Dex) 30 mg · EG001: A (Melflufen+Bortezomib+Dex) 40 mg · EG002: B (Melflufen+Daratumumab+Dex) 30 mg · EG003: B (Melflufen+Daratumumab+Dex) 40 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
    Infections and infestations
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      27
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    term
    COVID-19 pneumonia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      27
    term
    Influenza
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      27
    term
    Urinary tract infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      27
    term
    Infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      27
    term
    Parainfluenzae virus infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      27
    term
    Sepsis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    term
    Atypical pneumonia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    term
    Bronchitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    term
    Diverticulitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      27
    term
    Erysipelas
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    term
    Pneumonia pneumococcal

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
    General disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      27
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      27
    term
    Asthenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      27
    term
    Pyrexia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      27
    term
    Oedema peripheral
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      27
    term
    Non-cardiac chest pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      27
    term
    Chills
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      27
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      27
    term
    Neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      27
    term
    Anaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      27
    term
    Leukopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      27
    term
    Lymphopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      27
    term
    Diarrhoea
Complete source fields
description
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
event Groups
  1. deaths Num Affected
    4
    deaths Num At Risk
    15
    description
    Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
    id
    EG000
    other Num Affected
    15
    other Num At Risk
    15
    serious Num Affected
    9
    serious Num At Risk
    15
    title
    A (Melflufen+Bortezomib+Dex) 30 mg
  2. deaths Num Affected
    2
    deaths Num At Risk
    8
    description
    Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
    id
    EG001
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    5
    serious Num At Risk
    8
    title
    A (Melflufen+Bortezomib+Dex) 40 mg
  3. deaths Num Affected
    3
    deaths Num At Risk
    6
    description
    Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone PO at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
    id
    EG002
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    4
    serious Num At Risk
    6
    title
    B (Melflufen+Daratumumab+Dex) 30 mg
  4. deaths Num Affected
    16
    deaths Num At Risk
    27
    description
    Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone PO at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
    id
    EG003
    other Num Affected
    27
    other Num At Risk
    27
    serious Num Affected
    11
    serious Num At Risk
    27
    title
    B (Melflufen+Daratumumab+Dex) 40 mg
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      27
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      27
    term
    Asthenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      27
    term
    Pyrexia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      27
    term
    Oedema peripheral
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      27
    term
    Non-cardiac chest pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      27
    term
    Chills
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      27
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      27
    term
    Neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      27
    term
    Anaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      27
    term
    Leukopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      27
    term
    Lymphopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      27
    term
    Diarrhoea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      27
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    term
    COVID-19 pneumonia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      27
    term
    Influenza
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      27
    term
    Urinary tract infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      27
    term
    Infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      27
    term
    Parainfluenzae virus infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      27
    term
    Sepsis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    term
    Atypical pneumonia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    term
    Bronchitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    term
    Diverticulitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      27
    term
    Erysipelas
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    term
    Pneumonia pneumococcal
time Frame
Cycle 1 Day 1 up to a maximum of 198.9 weeks

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Preserved source evidence · Not medical advice