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NCT00544466 · ADVERSE EVENTS

Adverse events

Helical Tomotherapy, Fludarabine Phosphate, and Melphalan Followed By Allo-HSCT in Hematological Malignancies · Source last updated 2026-02-19

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 12 years.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Enzyme Inhibitor, Radiation Therapy, Transplant)

PREPARATIVE REGIMEN\*: Patients receive fludarabine phosphate IV on days -7 to -3 and melphalan IV on day -2. Patients also undergo helical tomotherapy twice daily on days -7 to -4. TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0. NOTE: \*Treatment begins 2 days earlier in patients receive tacrolimus and/or sirolimus for GVHD prophylaxis. fludarabine phosphate: 25 mg/m2 day -7 through day -3 prior to transplant melphalan: 140 mg/m2 day -2 prior to transplant allogeneic hematopoietic stem cell transplantation: Cells infused on Day 0 of transplant regimen intensity-modulated radiation therapy: Each fraction is 150 cGy, 2 fractions each day on day -7 through day -4 prior to transplant

13 / 6261 / 6243 / 62

Group identifiers: EG000: Treatment (Enzyme Inhibitor, Radiation Therapy, 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
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      2
    term
    Hemorrhage, CNS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      2
    term
    Hemorrhage, pulmonary/upper respiratory
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      62
      num Events
      2
    term
    Thrombotic microangiopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Cardiac General - Other (Specify, __)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Cardiopulmonary arrest, cause unknown (non-fatal)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      62
      num Events
      4
    term
    Hypotension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Left ventricular diastolic dysfunction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      62
      num Events
      7
    term
    Supraventricular and nodal arrhythmia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Ventricular arrhythmia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Auditory/Ear - Other (Specify, __)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Fistula, GI
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)

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
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      62
      num Events
      4
    term
    Coagulation - Other (Specify, __)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      62
      num Events
      14
    term
    Edema:head and neck
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      62
      num Events
      30
    term
    Edema:limb
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      62
      num Events
      3
    term
    Edema:trunk/genital
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Edema:viscera
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Hematoma
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      62
      num Events
      23
    term
    Hemoglobin
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Hemorrhage, CNS
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      62
      num Events
      14
    term
    Hemorrhage, GI
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      62
      num Events
      17
    term
    Hemorrhage, GU
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      62
      num Events
      17
    term
    Hemorrhage, pulmonary/upper respiratory
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      62
      num Events
      3
    term
    Hemorrhage/Bleeding - Other (Specify, __)
Complete source fields
event Groups
  1. deaths Num Affected
    43
    deaths Num At Risk
    62
    description
    PREPARATIVE REGIMEN\*: Patients receive fludarabine phosphate IV on days -7 to -3 and melphalan IV on day -2. Patients also undergo helical tomotherapy twice daily on days -7 to -4. TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0. NOTE: \*Treatment begins 2 days earlier in patients receive tacrolimus and/or sirolimus for GVHD prophylaxis. fludarabine phosphate: 25 mg/m2 day -7 through day -3 prior to transplant melphalan: 140 mg/m2 day -2 prior to transplant allogeneic hematopoietic stem cell transplantation: Cells infused on Day 0 of transplant regimen intensity-modulated radiation therapy: Each fraction is 150 cGy, 2 fractions each day on day -7 through day -4 prior to transplant
    id
    EG000
    other Num Affected
    61
    other Num At Risk
    62
    serious Num Affected
    13
    serious Num At Risk
    62
    title
    Treatment (Enzyme Inhibitor, Radiation Therapy, Transplant)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      62
      num Events
      4
    term
    Coagulation - Other (Specify, __)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      62
      num Events
      14
    term
    Edema:head and neck
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      62
      num Events
      30
    term
    Edema:limb
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      62
      num Events
      3
    term
    Edema:trunk/genital
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Edema:viscera
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Hematoma
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      62
      num Events
      23
    term
    Hemoglobin
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Hemorrhage, CNS
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      62
      num Events
      14
    term
    Hemorrhage, GI
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      62
      num Events
      17
    term
    Hemorrhage, GU
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      62
      num Events
      17
    term
    Hemorrhage, pulmonary/upper respiratory
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      62
      num Events
      3
    term
    Hemorrhage/Bleeding - Other (Specify, __)
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      2
    term
    Hemorrhage, CNS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      2
    term
    Hemorrhage, pulmonary/upper respiratory
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      62
      num Events
      2
    term
    Thrombotic microangiopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Cardiac General - Other (Specify, __)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Cardiopulmonary arrest, cause unknown (non-fatal)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      62
      num Events
      4
    term
    Hypotension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Left ventricular diastolic dysfunction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      62
      num Events
      7
    term
    Supraventricular and nodal arrhythmia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Ventricular arrhythmia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Auditory/Ear - Other (Specify, __)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Fistula, GI
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
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 12 years.

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