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NCT01083706 · ADVERSE EVENTS

Adverse events

Azacitidine in Treating Patients With Relapsed Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia Who Have Undergone Stem Cell Transplant · Source last updated 2017-05-24

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
Not reported
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Chemotherapy)

Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. azacitidine: Given SC or IV laboratory biomarker analysis: Correlative studies

3 / 398 / 39Not reported / Not reported

Group identifiers: EG000: Treatment (Chemotherapy)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Hospital Admission for Hypoxia
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Hospital Admission for Cardioplumonary Arrest
  3. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Hospital Admission for Cardioplumonary Arrest

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      39
      num Events
      11
    term
    Thrombocytopenia
  2. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      39
      num Events
      3
    term
    Hypoxia
  3. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
      num Events
      2
    term
    Infection- Rhizopus Pneumonia
  4. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
      num Events
      3
    term
    Neutropenia
  5. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
      num Events
      4
    term
    Anemia
  6. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
      num Events
      3
    term
    Hypomagnesium
  7. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
      num Events
      2
    term
    Elevated Billirubin
Complete source fields
event Groups
  1. description
    Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. azacitidine: Given SC or IV laboratory biomarker analysis: Correlative studies
    id
    EG000
    other Num Affected
    8
    other Num At Risk
    39
    serious Num Affected
    3
    serious Num At Risk
    39
    title
    Treatment (Chemotherapy)
frequency Threshold
5
other Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      39
      num Events
      11
    term
    Thrombocytopenia
  2. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      39
      num Events
      3
    term
    Hypoxia
  3. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
      num Events
      2
    term
    Infection- Rhizopus Pneumonia
  4. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
      num Events
      3
    term
    Neutropenia
  5. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
      num Events
      4
    term
    Anemia
  6. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
      num Events
      3
    term
    Hypomagnesium
  7. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
      num Events
      2
    term
    Elevated Billirubin
serious Events
  1. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Hospital Admission for Hypoxia
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Hospital Admission for Cardioplumonary Arrest
  3. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Hospital Admission for Cardioplumonary Arrest

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Preserved source evidence · Not medical advice