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NCT03173248 · ADVERSE EVENTS

Adverse events

Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation · Source last updated 2026-06-29

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
3 years
Other-event reporting threshold
5%

SAS included all participants who received at least 1 dose of the study treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
AG-120 + Azacitidine

Participants received AG-120 500 mg orally, QD in combination with azacitidine 75 mg/m\^2/day SC or IV, on Days 1-7, or on Days 1-5 and 8-9, of each 28-day cycle for a minimum of 6 cycles until death, disease relapse, disease progression, development of unacceptable toxicity (adverse event), confirmed pregnancy, withdrawal by participant or protocol violation.

49 / 7168 / 7127 / 71
Placebo + Azacitidine

Participants received AG-120 matching placebo orally, QD in combination with azacitidine 75 mg/m\^2/day SC or IV, on Days 1-7, or on Days 1-5 and 8-9, of each 28-day cycle for a minimum of 6 cycles until death, disease relapse, disease progression, development of unacceptable toxicity (adverse event), confirmed pregnancy, withdrawal by participant or protocol violation.

60 / 7372 / 7345 / 73

Group identifiers: EG000: AG-120 + Azacitidine · EG001: Placebo + Azacitidine

Serious adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      73
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      73
    term
    Bronchopulmonary aspergillosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
    term
    COVID-19
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
    term
    Appendicitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
    term
    Bacterial sepsis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      73
    term
    Clostridium difficile colitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      73
    term
    Enterococcal infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      73
    term
    Escherichia sepsis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
    term
    Infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
    term
    Metapneumovirus infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      73
    term
    Pneumonia fungal
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      73
    term
    Pneumonia pseudomonal

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 (23.1)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      73
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      73
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      73
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      73
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      73
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      73
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      73
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      73
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      73
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      73
    term
    Haemorrhoids
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      73
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      73
    term
    Proctalgia
Complete source fields
description
SAS included all participants who received at least 1 dose of the study treatment.
event Groups
  1. deaths Num Affected
    27
    deaths Num At Risk
    71
    description
    Participants received AG-120 500 mg orally, QD in combination with azacitidine 75 mg/m\^2/day SC or IV, on Days 1-7, or on Days 1-5 and 8-9, of each 28-day cycle for a minimum of 6 cycles until death, disease relapse, disease progression, development of unacceptable toxicity (adverse event), confirmed pregnancy, withdrawal by participant or protocol violation.
    id
    EG000
    other Num Affected
    68
    other Num At Risk
    71
    serious Num Affected
    49
    serious Num At Risk
    71
    title
    AG-120 + Azacitidine
  2. deaths Num Affected
    45
    deaths Num At Risk
    73
    description
    Participants received AG-120 matching placebo orally, QD in combination with azacitidine 75 mg/m\^2/day SC or IV, on Days 1-7, or on Days 1-5 and 8-9, of each 28-day cycle for a minimum of 6 cycles until death, disease relapse, disease progression, development of unacceptable toxicity (adverse event), confirmed pregnancy, withdrawal by participant or protocol violation.
    id
    EG001
    other Num Affected
    72
    other Num At Risk
    73
    serious Num Affected
    60
    serious Num At Risk
    73
    title
    Placebo + Azacitidine
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      73
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      73
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      73
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      73
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      73
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      73
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      73
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      73
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      73
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      73
    term
    Haemorrhoids
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      73
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      73
    term
    Proctalgia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      73
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      73
    term
    Bronchopulmonary aspergillosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
    term
    COVID-19
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
    term
    Appendicitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
    term
    Bacterial sepsis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      73
    term
    Clostridium difficile colitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      73
    term
    Enterococcal infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      73
    term
    Escherichia sepsis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
    term
    Infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
    term
    Metapneumovirus infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      73
    term
    Pneumonia fungal
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      73
    term
    Pneumonia pseudomonal
time Frame
3 years

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