Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01350258 · ADVERSE EVENTS

Adverse events

Bone Marrow Transplant Using a Reduced Intensity Regimen That is Given in Two Steps · Source last updated 2025-05-31

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
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Transplant Treatment Group

REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2. TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28.

8 / 88 / 8Not reported / Not reported

Group identifiers: EG000: Transplant Treatment Group

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
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      2
    term
    CMV reactivation
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Colitis/enteritis
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      8
      num Events
      5
    term
    Diarrhea
  4. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      2
    term
    Fever
  5. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Gram negative sepsis
  6. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    HHV-6 viremia
  7. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      2
    term
    Hyperbilirubinemia
  8. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Hypoxia
  9. organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Increased LFTs
  10. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Lacunar infarct in pons
  11. organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Liver failure
  12. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Orthostatic hypotension

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
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Abdominal cramping
  2. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      8
      num Events
      7
    term
    Abdominal pain
  3. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      2
    term
    Acute kidney injury
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Acute pancreatitis
  5. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      2
    term
    Anorexia
  6. organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      8
      num Events
      7
    term
    Anxiety
  7. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Arrhythmia
  8. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      3
    term
    Atrial fibrillation
  9. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      2
    term
    Back pain
  10. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Balance problems
  11. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Blister at PICC site
  12. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      2
    term
    Bloating
Complete source fields
event Groups
  1. description
    REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2. TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28.
    id
    EG000
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    8
    serious Num At Risk
    8
    title
    Transplant Treatment Group
frequency Threshold
0
other Events
  1. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Abdominal cramping
  2. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      8
      num Events
      7
    term
    Abdominal pain
  3. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      2
    term
    Acute kidney injury
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Acute pancreatitis
  5. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      2
    term
    Anorexia
  6. organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      8
      num Events
      7
    term
    Anxiety
  7. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Arrhythmia
  8. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      3
    term
    Atrial fibrillation
  9. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      2
    term
    Back pain
  10. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Balance problems
  11. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Blister at PICC site
  12. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      2
    term
    Bloating
serious Events
  1. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      2
    term
    CMV reactivation
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Colitis/enteritis
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      8
      num Events
      5
    term
    Diarrhea
  4. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      2
    term
    Fever
  5. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Gram negative sepsis
  6. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    HHV-6 viremia
  7. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      2
    term
    Hyperbilirubinemia
  8. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Hypoxia
  9. organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Increased LFTs
  10. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Lacunar infarct in pons
  11. organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Liver failure
  12. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Orthostatic hypotension

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice