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NCT00611351 · ADVERSE EVENTS

Adverse events

Busulfan, Cyclophosphamide, & Antithymocyte Globulin Followed by Stem Cell Transplant in Treating Hematologic Cancer · Source last updated 2023-10-23

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 are collected from the time of consent until day plus 100 from transplant.
Other-event reporting threshold
5%

Grade 4 anemia, thrombocytopenia, and leucopenia, grade 3 dysphagia, and grade 3 infertility are routinely expected for all patients participating in this protocol, so these events were not reported. Multiple grade 1 and grade 2 toxicities are also expected for all patients participating in this protocol; these events will not routinely be reported. All other toxicities \> grade 3 will be reported.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Unrelated Donor Allogeneic

Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.

3 / 55 / 52 / 5

Group identifiers: EG000: Unrelated Donor Allogeneic

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
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Blood bilirubin increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    confusion
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    aspergillus pneumonia
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Lung infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    plasmacytoma
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Investigations - Other
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    positive blood culture
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Infections and infestations - Other
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    hyperglycemia

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
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Hypoalbuminemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      5
      num Events
      3
    term
    Hyperglycemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      2
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Epstein-Barr virus reactivation
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Infections and infestations - Other
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    hemorrhage
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Blood and lymphatic system - Other
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      5
      num Events
      3
    term
    Blood bilirubin increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      5
      num Events
      4
    term
    Febrile Neutropenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      5
      num Events
      3
    term
    Diarrhea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      2
    term
    Serum sickness
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    syncope
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    renal failure
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      2
    term
    Renal and Urinary disorders - Other
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    hypocalcemia
Complete source fields
description
Grade 4 anemia, thrombocytopenia, and leucopenia, grade 3 dysphagia, and grade 3 infertility are routinely expected for all patients participating in this protocol, so these events were not reported. Multiple grade 1 and grade 2 toxicities are also expected for all patients participating in this protocol; these events will not routinely be reported. All other toxicities \> grade 3 will be reported.
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    5
    description
    Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
    id
    EG000
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    3
    serious Num At Risk
    5
    title
    Unrelated Donor Allogeneic
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Hypoalbuminemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      5
      num Events
      3
    term
    Hyperglycemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      2
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Epstein-Barr virus reactivation
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Infections and infestations - Other
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    hemorrhage
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Blood and lymphatic system - Other
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      5
      num Events
      3
    term
    Blood bilirubin increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      5
      num Events
      4
    term
    Febrile Neutropenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      5
      num Events
      3
    term
    Diarrhea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      2
    term
    Serum sickness
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    syncope
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    renal failure
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      2
    term
    Renal and Urinary disorders - Other
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    hypocalcemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Blood bilirubin increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    confusion
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    aspergillus pneumonia
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Lung infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    plasmacytoma
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Investigations - Other
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    positive blood culture
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Infections and infestations - Other
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    hyperglycemia
time Frame
Adverse events are collected from the time of consent until day plus 100 from transplant.

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Preserved source evidence · Not medical advice