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NCT01760655 · ADVERSE EVENTS

Adverse events

Reduced-Intensity Conditioning Before Donor Stem Cell Transplant in With High-Risk Hematologic Malignancies · Source last updated 2025-10-30

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
All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (RIC and allogeneic PBSCT)

REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV on days -15 to -12, busulfan IV on days -14 to -13, DLI on day -6, and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI on day -10. TRANSPLANT: Patients undergo allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV on days -1 to 42 followed by taper and mycophenolate mofetil IV BID on days -1 to 28 Fludarabine phosphate: Given IV Busulfan: Given IV Total-Body Irradiation: Undergo TBI Therapeutic Allogeneic Lymphocytes: Undergo DLI Cyclophosphamide: Given IV Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Tacrolimus: Given IV Mycophenolate Mofetil: Given IV Laboratory Biomarker Analysis: Correlative studies

30 / 6243 / 6227 / 62

Group identifiers: EG000: Treatment (RIC and allogeneic PBSCT)

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
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Acute Kidney Injury - Grade 2
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      62
      num Events
      2
    term
    Acute Kidney Injury - Grade 4
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Blood bilirubin increased - Grade 4
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Blood bilirubin increased - Grade 3
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    cholelithiasis - grade 3
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Dyspnea - Grade 3
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Fibrinogen - grade 4
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      62
      num Events
      2
    term
    Heart failure - grade 3
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      62
      num Events
      2
    term
    Hypertension - Grade 4
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Hypotension - Grade 4
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      62
      num Events
      3
    term
    Hypoxia - grade 3
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      62
      num Events
      2
    term
    Ileus - grade 3

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
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Abdominal Discomfort - Grade 1
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      62
      num Events
      5
    term
    Abdominal Distention - Grade 1
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Acid Reflux - Grade 1
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      62
      num Events
      7
    term
    Acute Kidney Injury - Grade 1
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Acute Kidney Injury - Grade 2
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      62
      num Events
      6
    term
    Acute Kidney Injury - Grade 3
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      62
      num Events
      3
    term
    Acute Kidney Injury - Grade 4
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Acute Pericatheter Thrombus - Grade 1
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Adenopathy - Grade 1
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      62
      num Events
      4
    term
    Atrial Fibrillation - Grade 2
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Agitation - Grade 1
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      62
      num Events
      3
    term
    Agitation - Grade 2
Complete source fields
event Groups
  1. deaths Num Affected
    27
    deaths Num At Risk
    62
    description
    REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV on days -15 to -12, busulfan IV on days -14 to -13, DLI on day -6, and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI on day -10. TRANSPLANT: Patients undergo allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV on days -1 to 42 followed by taper and mycophenolate mofetil IV BID on days -1 to 28 Fludarabine phosphate: Given IV Busulfan: Given IV Total-Body Irradiation: Undergo TBI Therapeutic Allogeneic Lymphocytes: Undergo DLI Cyclophosphamide: Given IV Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Tacrolimus: Given IV Mycophenolate Mofetil: Given IV Laboratory Biomarker Analysis: Correlative studies
    id
    EG000
    other Num Affected
    43
    other Num At Risk
    62
    serious Num Affected
    30
    serious Num At Risk
    62
    title
    Treatment (RIC and allogeneic PBSCT)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Abdominal Discomfort - Grade 1
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      62
      num Events
      5
    term
    Abdominal Distention - Grade 1
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Acid Reflux - Grade 1
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      62
      num Events
      7
    term
    Acute Kidney Injury - Grade 1
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Acute Kidney Injury - Grade 2
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      62
      num Events
      6
    term
    Acute Kidney Injury - Grade 3
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      62
      num Events
      3
    term
    Acute Kidney Injury - Grade 4
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Acute Pericatheter Thrombus - Grade 1
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Adenopathy - Grade 1
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      62
      num Events
      4
    term
    Atrial Fibrillation - Grade 2
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Agitation - Grade 1
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      62
      num Events
      3
    term
    Agitation - Grade 2
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Acute Kidney Injury - Grade 2
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      62
      num Events
      2
    term
    Acute Kidney Injury - Grade 4
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Blood bilirubin increased - Grade 4
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Blood bilirubin increased - Grade 3
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    cholelithiasis - grade 3
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Dyspnea - Grade 3
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Fibrinogen - grade 4
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      62
      num Events
      2
    term
    Heart failure - grade 3
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      62
      num Events
      2
    term
    Hypertension - Grade 4
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Hypotension - Grade 4
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      62
      num Events
      3
    term
    Hypoxia - grade 3
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      62
      num Events
      2
    term
    Ileus - grade 3
time Frame
All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant

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