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NCT02610777 · ADVERSE EVENTS

Adverse events

An Efficacy and Safety Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML) and Low-Blast Acute Myelogenous Leukemia (AML) · Source last updated 2022-09-19

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 up to 30 days after administration of the last dose of any study drug (up to approximately 5 years)
Other-event reporting threshold
5%

At each visit the investigator had to document any occurrence of adverse events, abnormal laboratory findings, and vital signs. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

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

Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).

40 / 6258 / 6250 / 62
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2

Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 and pevonedistat 20 mg/m\^2, infusion, intravenously, on Days 1, 3, and 5 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).

40 / 5851 / 5847 / 58

Group identifiers: EG000: Azacitidine 75 mg/m^2 · EG001: Azacitidine 75 mg/m^2 + Pevonedistat 20 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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      58
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      58
    term
    Abscess limb
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      58
    term
    Acute febrile neutrophilic dermatosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      58
    term
    Acute kidney injury
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      58
    term
    Acute myeloid leukaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      58
    term
    Anaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      58
    term
    Angina unstable
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      58
    term
    Ankle fracture
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      58
    term
    Anuria
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      58
    term
    Arthritis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      58
    term
    Arthritis bacterial
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      58
    term
    Arthritis infective

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 23
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      58
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      58
    term
    Acute kidney injury
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      58
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      58
    term
    Anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      58
    term
    Arthralgia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      58
    term
    Aspartate aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      58
    term
    Asthenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      58
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      58
    term
    Back pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      58
    term
    Blood alkaline phosphatase increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      58
    term
    Blood bilirubin increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      58
    term
    Blood creatinine increased
Complete source fields
description
At each visit the investigator had to document any occurrence of adverse events, abnormal laboratory findings, and vital signs. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
event Groups
  1. deaths Num Affected
    50
    deaths Num At Risk
    62
    description
    Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
    id
    EG000
    other Num Affected
    58
    other Num At Risk
    62
    serious Num Affected
    40
    serious Num At Risk
    62
    title
    Azacitidine 75 mg/m^2
  2. deaths Num Affected
    47
    deaths Num At Risk
    58
    description
    Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 and pevonedistat 20 mg/m\^2, infusion, intravenously, on Days 1, 3, and 5 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
    id
    EG001
    other Num Affected
    51
    other Num At Risk
    58
    serious Num Affected
    40
    serious Num At Risk
    58
    title
    Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      58
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      58
    term
    Acute kidney injury
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      58
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      58
    term
    Anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      58
    term
    Arthralgia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      58
    term
    Aspartate aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      58
    term
    Asthenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      58
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      58
    term
    Back pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      58
    term
    Blood alkaline phosphatase increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      58
    term
    Blood bilirubin increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      58
    term
    Blood creatinine increased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      58
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      58
    term
    Abscess limb
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      58
    term
    Acute febrile neutrophilic dermatosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      58
    term
    Acute kidney injury
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      58
    term
    Acute myeloid leukaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      58
    term
    Anaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      58
    term
    Angina unstable
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      58
    term
    Ankle fracture
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      58
    term
    Anuria
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      58
    term
    Arthritis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      58
    term
    Arthritis bacterial
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      62
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      58
    term
    Arthritis infective
time Frame
From first dose up to 30 days after administration of the last dose of any study drug (up to approximately 5 years)

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