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NCT00313586 · ADVERSE EVENTS

Adverse events

Azacitidine With or Without Entinostat in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia · Source last updated 2017-02-02

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
Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A (Azacitidine)

Patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.

92 / 9996 / 99Not reported / Not reported
Arm B (Azacitidine + Entinostat)

Patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.

93 / 9897 / 98Not reported / Not reported

Group identifiers: EG000: Arm A (Azacitidine) · EG001: Arm B (Azacitidine + Entinostat)

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
    Immune system disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Autoimmune reaction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      54
      num At Risk
      98
    term
    Hemoglobin
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Hemolysis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      98
    term
    Leukocytes
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      98
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      78
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      72
      num At Risk
      98
    term
    Neutrophils
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      76
      num At Risk
      98
    term
    Platelets
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Heart block 3rd degree
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      98
    term
    Atrial fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      98
    term
    Hypotension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Left ventricular diastolic dysfunction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Pericardial effusion (non-malignant)

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
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      98
    term
    Allergic rhinitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      80
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      74
      num At Risk
      98
    term
    Hemoglobin
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      98
    term
    Leukocytes
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      98
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      98
    term
    Neutrophils
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      98
    term
    Platelets
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      98
    term
    Hypotension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      71
      num At Risk
      98
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      98
    term
    Fever w/o neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      98
    term
    Insomnia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      98
    term
    Rigors/chills
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      98
    term
    Sweating
Complete source fields
event Groups
  1. description
    Patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
    id
    EG000
    other Num Affected
    96
    other Num At Risk
    99
    serious Num Affected
    92
    serious Num At Risk
    99
    title
    Arm A (Azacitidine)
  2. description
    Patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
    id
    EG001
    other Num Affected
    97
    other Num At Risk
    98
    serious Num Affected
    93
    serious Num At Risk
    98
    title
    Arm B (Azacitidine + Entinostat)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      98
    term
    Allergic rhinitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      80
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      74
      num At Risk
      98
    term
    Hemoglobin
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      98
    term
    Leukocytes
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      98
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      98
    term
    Neutrophils
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      98
    term
    Platelets
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      98
    term
    Hypotension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      71
      num At Risk
      98
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      98
    term
    Fever w/o neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      98
    term
    Insomnia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      98
    term
    Rigors/chills
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      98
    term
    Sweating
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Autoimmune reaction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      54
      num At Risk
      98
    term
    Hemoglobin
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Hemolysis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      98
    term
    Leukocytes
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      98
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      78
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      72
      num At Risk
      98
    term
    Neutrophils
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      76
      num At Risk
      98
    term
    Platelets
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Heart block 3rd degree
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      98
    term
    Atrial fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      98
    term
    Hypotension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Left ventricular diastolic dysfunction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      99
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Pericardial effusion (non-malignant)
time Frame
Assessed every 4 weeks while on treatment and for 30 days after the end of treatment

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