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NCT03836053 · ADVERSE EVENTS

Adverse events

Assessment of AMG 420 in Subjects With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2025-09-11

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
Up to approximately 3 years
Other-event reporting threshold
5%

Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
AMG 420 200 µg/Day

28 day continuous intravenous infusion of AMG 420 200 µg/day followed by a 2 week treatment-free interval, until progressive disease (PD) or relapse as defined by International Myeloma Working Group (IMWG) response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation

1 / 11 / 11 / 1
AMG 420 400 µg/Day

28 day continuous intravenous infusion of AMG 420 400 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation

10 / 1212 / 126 / 12
AMG 420 600 µg/Day

28 day continuous intravenous infusion of AMG 420 600 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation

8 / 1010 / 104 / 10
Total

AMG 420 Total

19 / 2323 / 2311 / 23

Group identifiers: EG000: AMG 420 200 µg/Day · EG001: AMG 420 400 µg/Day · EG002: AMG 420 600 µg/Day · EG003: Total

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
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
    term
    Asthenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      23
    term
    Disease progression
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      23
    term
    Pyrexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      23
    term
    Cytokine release syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      23
    term
    Bacteraemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
    term
    Device related infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
    term
    Influenza
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
    term
    Infusion site infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
    term
    Sepsis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
    term
    Staphylococcal bacteraemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      23
    term
    Staphylococcal sepsis

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 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      23
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
    term
    Hyperfibrinogenaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      23
    term
    Leukocyte vacuolisation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      23
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
    term
    Lymphopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      23
    term
    Neutropenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      23
    term
    Neutrophilia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      23
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
    term
    Atrial fibrillation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      23
    term
    Sinus tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
    term
    Tachycardia
Complete source fields
description
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    28 day continuous intravenous infusion of AMG 420 200 µg/day followed by a 2 week treatment-free interval, until progressive disease (PD) or relapse as defined by International Myeloma Working Group (IMWG) response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation
    id
    EG000
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    AMG 420 200 µg/Day
  2. deaths Num Affected
    6
    deaths Num At Risk
    12
    description
    28 day continuous intravenous infusion of AMG 420 400 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation
    id
    EG001
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    10
    serious Num At Risk
    12
    title
    AMG 420 400 µg/Day
  3. deaths Num Affected
    4
    deaths Num At Risk
    10
    description
    28 day continuous intravenous infusion of AMG 420 600 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation
    id
    EG002
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    8
    serious Num At Risk
    10
    title
    AMG 420 600 µg/Day
  4. deaths Num Affected
    11
    deaths Num At Risk
    23
    description
    AMG 420 Total
    id
    EG003
    other Num Affected
    23
    other Num At Risk
    23
    serious Num Affected
    19
    serious Num At Risk
    23
    title
    Total
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      23
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
    term
    Hyperfibrinogenaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      23
    term
    Leukocyte vacuolisation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      23
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
    term
    Lymphopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      23
    term
    Neutropenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      23
    term
    Neutrophilia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      23
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
    term
    Atrial fibrillation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      23
    term
    Sinus tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
    term
    Tachycardia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
    term
    Asthenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      23
    term
    Disease progression
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      23
    term
    Pyrexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      23
    term
    Cytokine release syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      23
    term
    Bacteraemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
    term
    Device related infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
    term
    Influenza
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
    term
    Infusion site infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
    term
    Sepsis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
    term
    Staphylococcal bacteraemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      23
    term
    Staphylococcal sepsis
time Frame
Up to approximately 3 years

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Preserved source evidence · Not medical advice