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NCT03268954 · ADVERSE EVENTS

Adverse events

Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML) · Source last updated 2025-10-29

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
From first dose of study drug up to end of study (up to approximately 6.9 years)
Other-event reporting threshold
5%

The Safety Population included all participants who received at least 1 dose of study drug (i.e., pevonedistat + azacitidine or single-agent azacitidine).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Azacitidine 75 mg/m^2

Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9, in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.

145 / 220207 / 220153 / 220
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2

Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9 and pevonedistat 20 mg/m\^2 IV infusion, on Days 1, 3, and 5 in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.

156 / 223210 / 223150 / 223

Group identifiers: EG000: Azacitidine 75 mg/m^2 · EG001: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2

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 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      223
    term
    Abdominal infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
    term
    Abdominal sepsis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      223
    term
    Abscess limb
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      223
    term
    Acute febrile neutrophilic dermatosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      223
    term
    Acute myeloid leukaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      223
    term
    Acute pulmonary oedema
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
    term
    Acute respiratory distress syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      223
    term
    Acute respiratory failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      223
    term
    Adenocarcinoma of colon
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      223
    term
    Altered state of consciousness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      223
    term
    Anaemia

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      223
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      223
    term
    Abdominal pain upper
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      223
    term
    Abnormal loss of weight
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      223
    term
    Alanine aminotransferase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      78
      num At Risk
      223
    term
    Anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      223
    term
    Arthralgia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      223
    term
    Aspartate aminotransferase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      223
    term
    Asthenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      223
    term
    Back pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      223
    term
    Blood bilirubin increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      223
    term
    Blood creatinine increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      90
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      82
      num At Risk
      223
    term
    Constipation
Complete source fields
description
The Safety Population included all participants who received at least 1 dose of study drug (i.e., pevonedistat + azacitidine or single-agent azacitidine).
event Groups
  1. deaths Num Affected
    153
    deaths Num At Risk
    220
    description
    Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9, in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.
    id
    EG000
    other Num Affected
    207
    other Num At Risk
    220
    serious Num Affected
    145
    serious Num At Risk
    220
    title
    Azacitidine 75 mg/m^2
  2. deaths Num Affected
    150
    deaths Num At Risk
    223
    description
    Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9 and pevonedistat 20 mg/m\^2 IV infusion, on Days 1, 3, and 5 in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.
    id
    EG001
    other Num Affected
    210
    other Num At Risk
    223
    serious Num Affected
    156
    serious Num At Risk
    223
    title
    Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      223
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      223
    term
    Abdominal pain upper
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      223
    term
    Abnormal loss of weight
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      223
    term
    Alanine aminotransferase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      78
      num At Risk
      223
    term
    Anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      223
    term
    Arthralgia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      223
    term
    Aspartate aminotransferase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      223
    term
    Asthenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      223
    term
    Back pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      223
    term
    Blood bilirubin increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      223
    term
    Blood creatinine increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      90
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      82
      num At Risk
      223
    term
    Constipation
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      223
    term
    Abdominal infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
    term
    Abdominal sepsis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      223
    term
    Abscess limb
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      223
    term
    Acute febrile neutrophilic dermatosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      223
    term
    Acute myeloid leukaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      223
    term
    Acute pulmonary oedema
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
    term
    Acute respiratory distress syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      223
    term
    Acute respiratory failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      223
    term
    Adenocarcinoma of colon
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      223
    term
    Altered state of consciousness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      220
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      223
    term
    Anaemia
time Frame
From first dose of study drug up to end of study (up to approximately 6.9 years)

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