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NCT00448357 · ADVERSE EVENTS

Adverse events

Allogeneic Hematopoietic Cell Transplantation for Patients With Busulfex-based Regimen · Source last updated 2017-07-17

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
Mortality was assessed at one year
Other-event reporting threshold
5%

Additional toxicities were not captured as this was a high-dose transplant study and grades 1, 2 and 3 AEs were generally expected and no unexpected toxicities were seen beyond those reported as SAEs

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Experimental: GVHD Prophylaxis

Experimental: GVHD prophylaxis Subjects with matched-related donors (MRDs) were treated with tacrolimus and methotrexate with or without alemtuzumab for graft vs host disease prophylaxis Subjects also receive busulfan and fludarabine . Matched unrelated donor (MUD) or mismatched related donor (MMRD) subjects receive GVHD prophylaxis with rabbit anti-thymocyte globulin (ATG) + Methotrexate Subjects also receive busulfan, fludarabine, and tacrolimus.

26 / 5454 / 5415 / 54

Group identifiers: EG000: Experimental: GVHD Prophylaxis

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    term
    BK cystitis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    term
    Liver Failiure
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      54
    term
    Sepsis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    term
    Gr 4 GVHD
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      54
    term
    Gr 4 mucositis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      54
    term
    Veno-occlusive disease
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      54
    term
    Aspergillus pneumonia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    term
    CMV pneumonitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    term
    Graft Failure
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    term
    Diffuse alveolar hemorrhage
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    term
    anemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      54
    term
    thrombocytopenia

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
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Additional toxicities were not captured as this was a high-dose transplant study and grades 1, 2 and 3 adverse events (AEs) were generally expected and no unexpected toxicities were seen beyond those reported as Serious Adverse Events (SAEs)
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      54
    term
    grade 3 or 4 hematologic toxicities (expected)
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      54
    term
    Alopecia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    nausea or diarrhea
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      54
    term
    grade 3 GI toxicity
Complete source fields
description
Additional toxicities were not captured as this was a high-dose transplant study and grades 1, 2 and 3 AEs were generally expected and no unexpected toxicities were seen beyond those reported as SAEs
event Groups
  1. deaths Num Affected
    15
    deaths Num At Risk
    54
    description
    Experimental: GVHD prophylaxis Subjects with matched-related donors (MRDs) were treated with tacrolimus and methotrexate with or without alemtuzumab for graft vs host disease prophylaxis Subjects also receive busulfan and fludarabine . Matched unrelated donor (MUD) or mismatched related donor (MMRD) subjects receive GVHD prophylaxis with rabbit anti-thymocyte globulin (ATG) + Methotrexate Subjects also receive busulfan, fludarabine, and tacrolimus.
    id
    EG000
    other Num Affected
    54
    other Num At Risk
    54
    serious Num Affected
    26
    serious Num At Risk
    54
    title
    Experimental: GVHD Prophylaxis
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Additional toxicities were not captured as this was a high-dose transplant study and grades 1, 2 and 3 adverse events (AEs) were generally expected and no unexpected toxicities were seen beyond those reported as Serious Adverse Events (SAEs)
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      54
    term
    grade 3 or 4 hematologic toxicities (expected)
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      54
    term
    Alopecia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    nausea or diarrhea
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      54
    term
    grade 3 GI toxicity
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    term
    BK cystitis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    term
    Liver Failiure
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      54
    term
    Sepsis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    term
    Gr 4 GVHD
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      54
    term
    Gr 4 mucositis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      54
    term
    Veno-occlusive disease
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      54
    term
    Aspergillus pneumonia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    term
    CMV pneumonitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    term
    Graft Failure
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    term
    Diffuse alveolar hemorrhage
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    term
    anemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      54
    term
    thrombocytopenia
time Frame
Mortality was assessed at one year

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Preserved source evidence · Not medical advice