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NCT00580034 · ADVERSE EVENTS

Adverse events

Allo Non-Myeloablative SCT Utilizing Mis-Matched Family Member Stem Cells Purged Using Campath · Source last updated 2014-06-03

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 beginning of Campath regimen until 6 years after transplant.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Campath Purged Non-myeloablative ASCT

Campath Purged Non-myeloablative ASCT in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte macrophage colony stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneously or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized. Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours. Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45.

75 / 8871 / 88Not reported / Not reported

Group identifiers: EG000: Campath Purged Non-myeloablative ASCT

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
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      88
      num Events
      71
    term
    Death
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      88
      num Events
      13
    term
    Hemorrhage

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
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      88
      num Events
      17
    term
    Failure to Engraft
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      88
      num Events
      7
    term
    Cardiac Left Ventricular Function
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      88
      num Events
      6
    term
    Rash / desquamation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      88
      num Events
      10
    term
    Diarrhea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      88
      num Events
      5
    term
    Vomiting
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      88
      num Events
      36
    term
    Febrile Neutropenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      88
      num Events
      10
    term
    Infection - other
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      88
      num Events
      65
    term
    Infection - with grade 3 or 4 neutrophils
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Infection with Grade1 or 2 neutrophils (normal ANC)
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      88
      num Events
      25
    term
    Infection - grade 1 or 2 neutrophils
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      88
      num Events
      64
    term
    Infection - without febrile neutropenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      88
      num Events
      7
    term
    Metabolic - Creatinine
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      88
      num Events
      6
    term
    Seizure
Complete source fields
event Groups
  1. description
    Campath Purged Non-myeloablative ASCT in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte macrophage colony stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneously or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized. Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours. Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45.
    id
    EG000
    other Num Affected
    71
    other Num At Risk
    88
    serious Num Affected
    75
    serious Num At Risk
    88
    title
    Campath Purged Non-myeloablative ASCT
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      88
      num Events
      17
    term
    Failure to Engraft
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      88
      num Events
      7
    term
    Cardiac Left Ventricular Function
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      88
      num Events
      6
    term
    Rash / desquamation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      88
      num Events
      10
    term
    Diarrhea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      88
      num Events
      5
    term
    Vomiting
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      88
      num Events
      36
    term
    Febrile Neutropenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      88
      num Events
      10
    term
    Infection - other
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      88
      num Events
      65
    term
    Infection - with grade 3 or 4 neutrophils
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Infection with Grade1 or 2 neutrophils (normal ANC)
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      88
      num Events
      25
    term
    Infection - grade 1 or 2 neutrophils
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      88
      num Events
      64
    term
    Infection - without febrile neutropenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      88
      num Events
      7
    term
    Metabolic - Creatinine
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      88
      num Events
      6
    term
    Seizure
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      88
      num Events
      71
    term
    Death
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      88
      num Events
      13
    term
    Hemorrhage
time Frame
From the beginning of Campath regimen until 6 years after transplant.

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Preserved source evidence · Not medical advice