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NCT00136084 · ADVERSE EVENTS

Adverse events

Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia · Source last updated 2012-12-05

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
Adverse events have been collected from study inception (October, 2002) through February, 2009.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm 1: (HDAC)

High-dose Cytarabine (HDAC)

23 / 109107 / 109Not reported / Not reported
Arm 2:(LDAC)

Low-dose Cytarabine (LDAC)

19 / 114112 / 114Not reported / Not reported

Group identifiers: EG000: Arm 1: (HDAC) · EG001: Arm 2:(LDAC)

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
      num Events
      0
    term
    Acidosis (metabolic or respiratory)
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
      num Events
      0
    term
    Acute vascular leak syndrome
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
      num Events
      0
    term
    Adult respiratory distress syndrome (ARDS)
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      109
      num Events
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      114
      num Events
      3
    term
    Anorexia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
      num Events
      0
    term
    Arachnoiditis/meningismus/radiculitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
      num Events
      0
    term
    CNS cerebrovascular ischemia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      109
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      114
      num Events
      4
    term
    CNS hemorrhage/bleeding
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
      num Events
      0
    term
    Cardiac left ventricular function
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
      num Events
      0
    term
    Cardiovascular/Arrhythmia-Other
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      109
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      114
      num Events
      1
    term
    Confusion
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      109
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      114
      num Events
      1
    term
    DIC (disseminated intravascular coagulation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
      num Events
      0
    term
    Depressed level of consciousness

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      109
      num Events
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
      num Events
      0
    term
    Abdominal pain or cramping
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      109
      num Events
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
      num Events
      0
    term
    Acidosis (metabolic or respiratory)
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      109
      num Events
      19
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      114
      num Events
      19
    term
    Allergic reaction/hypersensitivity (including drug fever)
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      109
      num Events
      28
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      114
      num Events
      26
    term
    Anorexia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      109
      num Events
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
      num Events
      0
    term
    Bilirubin
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      109
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
      num Events
      0
    term
    Colitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      109
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
      num Events
      0
    term
    Conjunctivitis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      109
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
      num Events
      0
    term
    DIC (disseminated intravascular coagulation)
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      109
      num Events
      0
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      114
      num Events
      6
    term
    Dehydration
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      109
      num Events
      26
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      114
      num Events
      27
    term
    Diarrhea patients without colostomy
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      109
      num Events
      9
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      114
      num Events
      14
    term
    Epistaxis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      109
      num Events
      138
    2. group Id
      EG001
      num Affected
      92
      num At Risk
      114
      num Events
      181
    term
    Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
Complete source fields
event Groups
  1. description
    High-dose Cytarabine (HDAC)
    id
    EG000
    other Num Affected
    107
    other Num At Risk
    109
    serious Num Affected
    23
    serious Num At Risk
    109
    title
    Arm 1: (HDAC)
  2. description
    Low-dose Cytarabine (LDAC)
    id
    EG001
    other Num Affected
    112
    other Num At Risk
    114
    serious Num Affected
    19
    serious Num At Risk
    114
    title
    Arm 2:(LDAC)
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      109
      num Events
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
      num Events
      0
    term
    Abdominal pain or cramping
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      109
      num Events
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
      num Events
      0
    term
    Acidosis (metabolic or respiratory)
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      109
      num Events
      19
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      114
      num Events
      19
    term
    Allergic reaction/hypersensitivity (including drug fever)
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      109
      num Events
      28
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      114
      num Events
      26
    term
    Anorexia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      109
      num Events
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
      num Events
      0
    term
    Bilirubin
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      109
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
      num Events
      0
    term
    Colitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      109
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
      num Events
      0
    term
    Conjunctivitis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      109
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
      num Events
      0
    term
    DIC (disseminated intravascular coagulation)
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      109
      num Events
      0
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      114
      num Events
      6
    term
    Dehydration
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      109
      num Events
      26
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      114
      num Events
      27
    term
    Diarrhea patients without colostomy
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      109
      num Events
      9
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      114
      num Events
      14
    term
    Epistaxis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      109
      num Events
      138
    2. group Id
      EG001
      num Affected
      92
      num At Risk
      114
      num Events
      181
    term
    Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
      num Events
      0
    term
    Acidosis (metabolic or respiratory)
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
      num Events
      0
    term
    Acute vascular leak syndrome
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
      num Events
      0
    term
    Adult respiratory distress syndrome (ARDS)
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      109
      num Events
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      114
      num Events
      3
    term
    Anorexia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
      num Events
      0
    term
    Arachnoiditis/meningismus/radiculitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
      num Events
      0
    term
    CNS cerebrovascular ischemia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      109
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      114
      num Events
      4
    term
    CNS hemorrhage/bleeding
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
      num Events
      0
    term
    Cardiac left ventricular function
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
      num Events
      0
    term
    Cardiovascular/Arrhythmia-Other
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      109
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      114
      num Events
      1
    term
    Confusion
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      109
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      114
      num Events
      1
    term
    DIC (disseminated intravascular coagulation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
      num Events
      0
    term
    Depressed level of consciousness
time Frame
Adverse events have been collected from study inception (October, 2002) through February, 2009.

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