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NCT01885689 · ADVERSE EVENTS

Adverse events

Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia · Source last updated 2026-08-27

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 were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 6 years.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Clofarabine, Melphalan, Transplant)

CONDITIONING REGIMEN: Patients receive clofarabine IV over 2 hours on days -9 to -5 and melphalan IV over 30 minutes on day -4. TRANSPLANT: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS: Beginning on day -3, patients receive tacrolimus IV or PO and sirolimus PO once daily with taper per City of Hope standard operating procedure. clofarabine: Given IV melphalan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant tacrolimus: Given IV or PO sirolimus: Given PO Pharmacological Study: Correlative studies

16 / 5252 / 5223 / 52

Group identifiers: EG000: Treatment (Clofarabine, Melphalan, Transplant)

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 (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Blood and lymphatic system disorders - Other, specify
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
      num Events
      2
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Cardiac disorders - Other, specify
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Myocarditis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
      num Events
      2
    term
    Fever
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      2
    term
    Multi-organ failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Catheter related infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Encephalitis infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
      num Events
      3
    term
    Infections and infestations - Other, specify
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
      num Events
      3
    term
    Lung infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
      num Events
      5
    term
    Sepsis

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 (4.03)
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      52
      num Events
      118
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      52
      num Events
      8
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      52
      num Events
      34
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Spleen disorder
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Acute coronary syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      52
      num Events
      5
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
      num Events
      2
    term
    Atrial flutter
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      52
      num Events
      17
    term
    Cardiac disorders - Other, specify
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      52
      num Events
      6
    term
    Chest pain - cardiac
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
      num Events
      3
    term
    Heart failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
      num Events
      3
    term
    Palpitations
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
      num Events
      2
    term
    Pericardial effusion
Complete source fields
event Groups
  1. deaths Num Affected
    23
    deaths Num At Risk
    52
    description
    CONDITIONING REGIMEN: Patients receive clofarabine IV over 2 hours on days -9 to -5 and melphalan IV over 30 minutes on day -4. TRANSPLANT: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS: Beginning on day -3, patients receive tacrolimus IV or PO and sirolimus PO once daily with taper per City of Hope standard operating procedure. clofarabine: Given IV melphalan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant tacrolimus: Given IV or PO sirolimus: Given PO Pharmacological Study: Correlative studies
    id
    EG000
    other Num Affected
    52
    other Num At Risk
    52
    serious Num Affected
    16
    serious Num At Risk
    52
    title
    Treatment (Clofarabine, Melphalan, Transplant)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      52
      num Events
      118
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      52
      num Events
      8
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      52
      num Events
      34
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Spleen disorder
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Acute coronary syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      52
      num Events
      5
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
      num Events
      2
    term
    Atrial flutter
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      52
      num Events
      17
    term
    Cardiac disorders - Other, specify
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      52
      num Events
      6
    term
    Chest pain - cardiac
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
      num Events
      3
    term
    Heart failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
      num Events
      3
    term
    Palpitations
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
      num Events
      2
    term
    Pericardial effusion
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Blood and lymphatic system disorders - Other, specify
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
      num Events
      2
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Cardiac disorders - Other, specify
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Myocarditis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
      num Events
      2
    term
    Fever
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      2
    term
    Multi-organ failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Catheter related infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Encephalitis infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
      num Events
      3
    term
    Infections and infestations - Other, specify
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
      num Events
      3
    term
    Lung infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
      num Events
      5
    term
    Sepsis
time Frame
Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 6 years.

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