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NCT00119392 · ADVERSE EVENTS

Adverse events

Yttrium Y 90 Ibritumomab Tiuxetan, Fludarabine, Radiation Therapy, and Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma · Source last updated 2018-06-29

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
Not reported
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)

See Detailed Description rituximab: Given IV cyclosporine: Given orally fludarabine phosphate: Given IV mycophenolate mofetil: Given orally yttrium Y 90 ibritumomab tiuxetan: Given IV peripheral blood stem cell transplantation: Undergo transplantation allogeneic hematopoietic stem cell transplantation: Undergo transplantation total-body irradiation: Undergo TBI

8 / 4036 / 40Not reported / Not reported

Group identifiers: EG000: Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Neutropenic fever
  2. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    term
    Bone pain
  3. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Renal insufficiency
  4. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Hypotension
  5. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Stroke
  6. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Tumor lysis syndrome
  7. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Sepsis
  8. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Disease progression
  9. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Atrial fibrillation

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      40
    term
    Anorexia
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    term
    Arrhythmia
  3. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      40
    term
    Infection
  4. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    term
    Pneumonitis
  5. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
    term
    Dehydration
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      40
    term
    Diarrhea
  7. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      40
    term
    Fatigue
  8. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      40
    term
    Neutropenia
  9. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      40
    term
    Thrombocytopenia
  10. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      40
    term
    Febrile Neutropenia
  11. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      40
    term
    Rash
  12. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
    term
    Pain
Complete source fields
event Groups
  1. description
    See Detailed Description rituximab: Given IV cyclosporine: Given orally fludarabine phosphate: Given IV mycophenolate mofetil: Given orally yttrium Y 90 ibritumomab tiuxetan: Given IV peripheral blood stem cell transplantation: Undergo transplantation allogeneic hematopoietic stem cell transplantation: Undergo transplantation total-body irradiation: Undergo TBI
    id
    EG000
    other Num Affected
    36
    other Num At Risk
    40
    serious Num Affected
    8
    serious Num At Risk
    40
    title
    Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)
frequency Threshold
5
other Events
  1. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      40
    term
    Anorexia
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    term
    Arrhythmia
  3. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      40
    term
    Infection
  4. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    term
    Pneumonitis
  5. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
    term
    Dehydration
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      40
    term
    Diarrhea
  7. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      40
    term
    Fatigue
  8. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      40
    term
    Neutropenia
  9. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      40
    term
    Thrombocytopenia
  10. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      40
    term
    Febrile Neutropenia
  11. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      40
    term
    Rash
  12. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
    term
    Pain
serious Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Neutropenic fever
  2. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    term
    Bone pain
  3. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Renal insufficiency
  4. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Hypotension
  5. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Stroke
  6. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Tumor lysis syndrome
  7. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Sepsis
  8. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Disease progression
  9. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    term
    Atrial fibrillation

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Preserved source evidence · Not medical advice