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NCT02561962 · ADVERSE EVENTS

Adverse events

A Phase 1 Study in Subjects With Relapsed or Refractory Multiple Myeloma · Source last updated 2024-02-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
All-cause mortality was collected from enrollment to the end of study visit, up to approximately 6 years. Treatment-emergent adverse events were collected from the first administration of AMG 224 up to 37 days after the last dose of investigational product (median treatment duration was 9 weeks).
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.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Dose Exploration: AMG 224 Dose A

Participants were administered AMG 224 Dose A as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.

0 / 33 / 30 / 3
Dose Exploration: AMG 224 Dose B

Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.

1 / 33 / 30 / 3
Dose Exploration: AMG 224 Dose C

Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.

0 / 33 / 30 / 3
Dose Exploration: AMG 224 Dose D

Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks

2 / 33 / 30 / 3
Dose Exploration: AMG 224 Dose E

Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.

2 / 65 / 60 / 6
Dose Exploration: AMG 224 Dose F

Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.

2 / 66 / 60 / 6
Dose Exploration: AMG 224 Dose G

Participants were administered AMG 224 Dose G as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks

2 / 55 / 50 / 5
Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment

Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose \[MTD\] identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.

6 / 97 / 90 / 11
Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment

Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.

0 / 22 / 20 / 2

Group identifiers: EG000: Dose Exploration: AMG 224 Dose A · EG001: Dose Exploration: AMG 224 Dose B · EG002: Dose Exploration: AMG 224 Dose C · EG003: Dose Exploration: AMG 224 Dose D · EG004: Dose Exploration: AMG 224 Dose E · EG005: Dose Exploration: AMG 224 Dose F · EG006: Dose Exploration: AMG 224 Dose G · EG007: Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment · EG008: Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment

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 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Febrile neutropenia
  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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Neutropenia
  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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Plasma cell disorder
  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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Atrial flutter
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Pyrexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Cholecystitis acute
  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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Acute sinusitis
  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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Influenza
  12. 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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Lower respiratory tract infection

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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Leukopenia
  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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      2
    term
    Neutropenia
  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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Splenic lesion
  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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Splenomegaly
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      6
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      2
    term
    Thrombocytopenia
  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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Thrombocytosis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Palpitations
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Tinnitus
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Vertigo positional
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Conjunctival haemorrhage
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.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Participants were administered AMG 224 Dose A as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Dose Exploration: AMG 224 Dose A
  2. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Dose Exploration: AMG 224 Dose B
  3. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    EG002
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Dose Exploration: AMG 224 Dose C
  4. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks
    id
    EG003
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Dose Exploration: AMG 224 Dose D
  5. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    EG004
    other Num Affected
    5
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    Dose Exploration: AMG 224 Dose E
  6. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    EG005
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    Dose Exploration: AMG 224 Dose F
  7. deaths Num Affected
    0
    deaths Num At Risk
    5
    description
    Participants were administered AMG 224 Dose G as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks
    id
    EG006
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    2
    serious Num At Risk
    5
    title
    Dose Exploration: AMG 224 Dose G
  8. deaths Num Affected
    0
    deaths Num At Risk
    11
    description
    Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose \[MTD\] identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    EG007
    other Num Affected
    7
    other Num At Risk
    9
    serious Num Affected
    6
    serious Num At Risk
    9
    title
    Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment
  9. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    EG008
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    0
    serious Num At Risk
    2
    title
    Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment
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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Leukopenia
  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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      2
    term
    Neutropenia
  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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Splenic lesion
  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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Splenomegaly
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      6
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      2
    term
    Thrombocytopenia
  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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Thrombocytosis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Palpitations
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Tinnitus
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Vertigo positional
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Conjunctival haemorrhage
serious 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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Febrile neutropenia
  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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Neutropenia
  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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Plasma cell disorder
  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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Atrial flutter
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Pyrexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Cholecystitis acute
  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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Acute sinusitis
  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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Influenza
  12. 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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      9
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
    term
    Lower respiratory tract infection
time Frame
All-cause mortality was collected from enrollment to the end of study visit, up to approximately 6 years. Treatment-emergent adverse events were collected from the first administration of AMG 224 up to 37 days after the last dose of investigational product (median treatment duration was 9 weeks).

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Preserved source evidence · Not medical advice