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NCT00578942 · ADVERSE EVENTS

Adverse events

Allo Non-myeloablative SCT Utilizing Matched Family Member Stem Cells Purged Using Campath · Source last updated 2016-06-24

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
Toxicities were formally recorded for all patients twice weekly for the first 100 days, at each follow up visit, and as needed intercurrently, up to 10 years
Other-event reporting threshold
0%

NCI Common Terminology Criteria for Adverse Events version 3 was used to grade toxicities. The drug manufacturer, Berlex, required the reporting of all Serious Adverse Events associated with the study to Berlex Global Medical Safety Surveillance Group.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Campath Purged Non-myeloablative ASCT

Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors 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. Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45.

36 / 4848 / 48Not 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 (2.0)
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      48
      num Events
      36
    term
    Death
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    e.g. thrombotic thrombocytopenic purpura \[TTP\] or hemolytic uremic syndrome \[HUS\]
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 2.0 and 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    term
    Thrombotic microangiopathy
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 2.0 and 3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      48
      num Events
      6
    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
    Immune system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      48
      num Events
      2
    term
    Allergic reaction / hypersensitivity
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 2.0 and 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      48
      num Events
      4
    term
    Hypotension
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 2.0 and 3.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      48
      num Events
      9
    term
    Diarrhea
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 2.0 and 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      48
      num Events
      4
    term
    Vomiting
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    fever of unknown origin without clinically or microbiologically documented infection)(ANC \<1.0 x 10e9/L, fever \>=38.5 degrees C
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 2.0 and 3.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      48
      num Events
      21
    term
    Febrile neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 2.0 and 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      48
      num Events
      4
    term
    Creatinine
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE 2.0 and 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      2
    term
    Neuropathy: motor
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE 2.0 and 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    term
    Neuropathy: sensory
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE 2.0 and 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    term
    Seizure
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    shortness of breath
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 2.0 and 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      48
      num Events
      2
    term
    Dyspnea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    lack of oxygen
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 2.0 and 3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      48
      num Events
      6
    term
    Hypoxia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 2.0 and 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      48
      num Events
      4
    term
    Pneumonitis
Complete source fields
description
NCI Common Terminology Criteria for Adverse Events version 3 was used to grade toxicities. The drug manufacturer, Berlex, required the reporting of all Serious Adverse Events associated with the study to Berlex Global Medical Safety Surveillance Group.
event Groups
  1. description
    Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors 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. Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45.
    id
    EG000
    other Num Affected
    48
    other Num At Risk
    48
    serious Num Affected
    36
    serious Num At Risk
    48
    title
    Campath Purged Non-myeloablative ASCT
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      48
      num Events
      2
    term
    Allergic reaction / hypersensitivity
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 2.0 and 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      48
      num Events
      4
    term
    Hypotension
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 2.0 and 3.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      48
      num Events
      9
    term
    Diarrhea
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 2.0 and 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      48
      num Events
      4
    term
    Vomiting
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    fever of unknown origin without clinically or microbiologically documented infection)(ANC \<1.0 x 10e9/L, fever \>=38.5 degrees C
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 2.0 and 3.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      48
      num Events
      21
    term
    Febrile neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 2.0 and 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      48
      num Events
      4
    term
    Creatinine
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE 2.0 and 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      2
    term
    Neuropathy: motor
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE 2.0 and 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    term
    Neuropathy: sensory
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE 2.0 and 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    term
    Seizure
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    shortness of breath
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 2.0 and 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      48
      num Events
      2
    term
    Dyspnea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    lack of oxygen
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 2.0 and 3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      48
      num Events
      6
    term
    Hypoxia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 2.0 and 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      48
      num Events
      4
    term
    Pneumonitis
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      48
      num Events
      36
    term
    Death
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    e.g. thrombotic thrombocytopenic purpura \[TTP\] or hemolytic uremic syndrome \[HUS\]
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 2.0 and 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    term
    Thrombotic microangiopathy
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 2.0 and 3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      48
      num Events
      6
    term
    Hemorrhage
time Frame
Toxicities were formally recorded for all patients twice weekly for the first 100 days, at each follow up visit, and as needed intercurrently, up to 10 years

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