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NCT00534430 · ADVERSE EVENTS

Adverse events

Busulfan, Etoposide, and Total-Body Irradiation in Treating Patients Undergoing Donor Stem Cell or Bone Marrow Transplant for Advanced Hematologic Cancer · Source last updated 2026-06-03

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
From the start time of the study treatment up to Day 100 post-transplant
Other-event reporting threshold
0%

Systematic Assessment: See the time periods, above.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Busulfan, FTBI and VP16

IV Busulfan + 12 cGy FTBI + VP16 prior to allogeneic Bone Marrow Transplant busulfan cyclosporine etoposide mycophenolate mofetil allogeneic bone marrow transplantation allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation

2 / 3030 / 3018 / 30

Group identifiers: EG000: Busulfan, FTBI and VP16

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
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    term
    Leukocytes (total WBC) for BMT studies, if specified in the protocol.
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and Lymphatic System Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    term
    Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol.
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    term
    Fatigue (asthenia, lethargy, malaise)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    term
    Anorexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, Thoracic and Mediastinal Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    term
    Dyspnea (shortness of breath)

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
    Immune System Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      30
    term
    Allergic reaction/hypersensitivity (including drug fever)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune System Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      30
    term
    Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune System Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    term
    Allergy/Immunology - Other: DRY NOSE
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune System Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    term
    Allergy/Immunology - Other: ENGRAFTMENT SYNDROME
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and Labyrinth Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    term
    Auditory/Ear - Other: DECREASED HEARING DUETO MEDS (AZITHROMYCIN)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and Labyrinth Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    term
    Auditory/Ear - Other: PLUGGED EARS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and Labyrinth Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    term
    Otitis, external ear (non-infectious)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      30
    term
    Graft versus host disease
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      30
    term
    Veno-Occlusive Disease (VOD)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and Lymphatic System Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    term
    Blood/Bone Marrow - Other (Specify, __)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and Lymphatic System Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    term
    Bone marrow cellularity
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and Lymphatic System Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      30
    term
    Hemoglobin
Complete source fields
description
Systematic Assessment: See the time periods, above.
event Groups
  1. deaths Num Affected
    18
    deaths Num At Risk
    30
    description
    IV Busulfan + 12 cGy FTBI + VP16 prior to allogeneic Bone Marrow Transplant busulfan cyclosporine etoposide mycophenolate mofetil allogeneic bone marrow transplantation allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation
    id
    EG000
    other Num Affected
    30
    other Num At Risk
    30
    serious Num Affected
    2
    serious Num At Risk
    30
    title
    Busulfan, FTBI and VP16
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune System Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      30
    term
    Allergic reaction/hypersensitivity (including drug fever)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune System Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      30
    term
    Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune System Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    term
    Allergy/Immunology - Other: DRY NOSE
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune System Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    term
    Allergy/Immunology - Other: ENGRAFTMENT SYNDROME
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and Labyrinth Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    term
    Auditory/Ear - Other: DECREASED HEARING DUETO MEDS (AZITHROMYCIN)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and Labyrinth Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    term
    Auditory/Ear - Other: PLUGGED EARS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and Labyrinth Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    term
    Otitis, external ear (non-infectious)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      30
    term
    Graft versus host disease
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      30
    term
    Veno-Occlusive Disease (VOD)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and Lymphatic System Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    term
    Blood/Bone Marrow - Other (Specify, __)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and Lymphatic System Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    term
    Bone marrow cellularity
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and Lymphatic System Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      30
    term
    Hemoglobin
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and Lymphatic System Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    term
    Leukocytes (total WBC) for BMT studies, if specified in the protocol.
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and Lymphatic System Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    term
    Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol.
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    term
    Fatigue (asthenia, lethargy, malaise)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    term
    Anorexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, Thoracic and Mediastinal Disorders
    source Vocabulary
    CTC v2.0 4/30/1999
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    term
    Dyspnea (shortness of breath)
time Frame
From the start time of the study treatment up to Day 100 post-transplant

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Preserved source evidence · Not medical advice