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NCT02713529 · ADVERSE EVENTS

Adverse events

Safety and Efficacy Study of AMG 820 and Pembrolizumab Combination in Select Advanced Solid Tumor Cancer · Source last updated 2023-01-20

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
The TEAE timeframe was Day 1 up to 207 days for Part 1 and Day 1 up to 572 days for Part 2. The median time frame is 122 days.
Other-event reporting threshold
5%

All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All adverse events (AEs) and disease related events (DREs) are integrated in above summaries.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
AMG 820 1100 MG

Includes participants from all treatment arms that were administered AMG 820 1100 mg.

70 / 9897 / 9812 / 98
AMG 820 1400 MG

Includes participants from all treatment arms that were administered AMG 820 1400 mg.

10 / 1818 / 181 / 18

Group identifiers: EG000: AMG 820 1100 MG · EG001: AMG 820 1400 MG

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Atrial flutter
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Cardiac arrest
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Cardiac failure congestive
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Pericardial effusion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Periorbital oedema
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Uveitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      18
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Autoimmune pancreatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Colitis

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 22.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      18
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Bradycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Hypothyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Parathyroid disorder
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      18
    term
    Periorbital oedema
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Periorbital swelling
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Photophobia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Uveitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      18
    term
    Vision blurred
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Visual impairment
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Abdominal distension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      18
    term
    Abdominal pain
Complete source fields
description
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All adverse events (AEs) and disease related events (DREs) are integrated in above summaries.
event Groups
  1. deaths Num Affected
    12
    deaths Num At Risk
    98
    description
    Includes participants from all treatment arms that were administered AMG 820 1100 mg.
    id
    EG000
    other Num Affected
    97
    other Num At Risk
    98
    serious Num Affected
    70
    serious Num At Risk
    98
    title
    AMG 820 1100 MG
  2. deaths Num Affected
    1
    deaths Num At Risk
    18
    description
    Includes participants from all treatment arms that were administered AMG 820 1400 mg.
    id
    EG001
    other Num Affected
    18
    other Num At Risk
    18
    serious Num Affected
    10
    serious Num At Risk
    18
    title
    AMG 820 1400 MG
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      18
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Bradycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Hypothyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Parathyroid disorder
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      18
    term
    Periorbital oedema
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Periorbital swelling
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Photophobia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Uveitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      18
    term
    Vision blurred
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Visual impairment
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Abdominal distension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      18
    term
    Abdominal pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Atrial flutter
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Cardiac arrest
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Cardiac failure congestive
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Pericardial effusion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Periorbital oedema
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Uveitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      18
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    term
    Autoimmune pancreatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      98
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    term
    Colitis
time Frame
The TEAE timeframe was Day 1 up to 207 days for Part 1 and Day 1 up to 572 days for Part 2. The median time frame is 122 days.

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