Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01522976 · ADVERSE EVENTS

Adverse events

Azacitidine With or Without Lenalidomide or Vorinostat in Treating Patients With Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia · Source last updated 2026-09-09

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
Up to 5 years
Other-event reporting threshold
5%

Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm 1: Azacitidine/Lenalidomide

Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Lenalidomide: Given PO

37 / 8988 / 89Not reported / Not reported
Arm 2: Azacitidine

Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV

8 / 9189 / 91Not reported / Not reported
Arm 3: Azacitidine/Vorinostat

Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Vorinostat: Given PO

47 / 9191 / 91Not reported / Not reported

Group identifiers: EG000: Arm 1: Azacitidine/Lenalidomide · EG001: Arm 2: Azacitidine · EG002: Arm 3: Azacitidine/Vorinostat

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
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      91
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      91
    term
    Blood and lymphatic system disorders - Other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      91
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      91
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      91
    term
    Atrioventricular block first degree
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      91
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      91
    term
    Chest pain - cardiac
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      91
    term
    Heart failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      91
    term
    Myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      91
    term
    Pericardial effusion
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      91
    term
    Sinus bradycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      91
    term
    Sinus tachycardia

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
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      71
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      72
      num At Risk
      91
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      91
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      91
    term
    Chest pain - cardiac
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      91
    term
    Sinus tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      91
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      54
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      44
      num At Risk
      91
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      53
      num At Risk
      91
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      91
    term
    Dry mouth
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      91
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      91
    term
    Gastroesophageal reflux disease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      91
    term
    Hemorrhoids
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      91
    term
    Mucositis oral
Complete source fields
description
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
event Groups
  1. description
    Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Lenalidomide: Given PO
    id
    EG000
    other Num Affected
    88
    other Num At Risk
    89
    serious Num Affected
    37
    serious Num At Risk
    89
    title
    Arm 1: Azacitidine/Lenalidomide
  2. description
    Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
    id
    EG001
    other Num Affected
    89
    other Num At Risk
    91
    serious Num Affected
    8
    serious Num At Risk
    91
    title
    Arm 2: Azacitidine
  3. description
    Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Vorinostat: Given PO
    id
    EG002
    other Num Affected
    91
    other Num At Risk
    91
    serious Num Affected
    47
    serious Num At Risk
    91
    title
    Arm 3: Azacitidine/Vorinostat
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      71
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      72
      num At Risk
      91
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      91
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      91
    term
    Chest pain - cardiac
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      91
    term
    Sinus tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      91
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      54
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      44
      num At Risk
      91
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      53
      num At Risk
      91
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      91
    term
    Dry mouth
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      91
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      91
    term
    Gastroesophageal reflux disease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      91
    term
    Hemorrhoids
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      91
    term
    Mucositis oral
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      91
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      91
    term
    Blood and lymphatic system disorders - Other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      91
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      91
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      91
    term
    Atrioventricular block first degree
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      91
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      91
    term
    Chest pain - cardiac
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      91
    term
    Heart failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      91
    term
    Myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      91
    term
    Pericardial effusion
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      91
    term
    Sinus bradycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      91
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      91
    term
    Sinus tachycardia
time Frame
Up to 5 years

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice