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NCT01008462 · ADVERSE EVENTS

Adverse events

Autologous Peripheral Blood Stem Cell Transplant Followed by Donor Bone Marrow Transplant in Treating Patients With High-Risk Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia · Source last updated 2019-06-11

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
AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Autologous HCT, Donor HCT)

Allogeneic Bone Marrow Transplantation: Undergo donor HCT Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT Carmustine: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Etoposide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative study Melphalan: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo donor HCT Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI

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Group identifiers: EG000: Treatment (Autologous HCT, Donor HCT)

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
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Respiratory failure

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
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Acute kidney injury
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Anal hemorrhage
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Blood bilirubin increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Creatinine increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      3
    term
    Febrile neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Fever
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Hemolysis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Hypotension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Pneumonitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      2
    term
    Syncope
Complete source fields
event Groups
  1. deaths Num Affected
    6
    deaths Num At Risk
    16
    description
    Allogeneic Bone Marrow Transplantation: Undergo donor HCT Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT Carmustine: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Etoposide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative study Melphalan: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo donor HCT Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
    id
    EG000
    other Num Affected
    5
    other Num At Risk
    16
    serious Num Affected
    1
    serious Num At Risk
    16
    title
    Treatment (Autologous HCT, Donor HCT)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Acute kidney injury
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Anal hemorrhage
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Blood bilirubin increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Creatinine increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      3
    term
    Febrile neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Fever
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Hemolysis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Hypotension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Pneumonitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      2
    term
    Syncope
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Respiratory failure
time Frame
AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.

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Preserved source evidence · Not medical advice