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NCT01093586 · ADVERSE EVENTS

Adverse events

Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies · Source last updated 2019-01-23

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
Adverse Events were collected from participant start on study to going off study up to a period of 2 years.
Other-event reporting threshold
5%

Non serious events were not collected. The protocol was assessing efficacy of cord blood in transplants, therefore the research was only gathering SAEs of grade 3 or 4.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I

PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.

9 / 140 / 011 / 14

Group identifiers: EG000: Arm I

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
    Gastrointestinal disorders
    source Vocabulary
    CTCAEv3
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      14
      num Events
      4
    term
    Diarrhea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Supraventricular and nodal arrhythmia - Sinus tachycardia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      14
      num Events
      3
    term
    Death not associated with CTCAE term - Multi-organ failure
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Hemorrhage, pulmonary/upper respiratory - Nose
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Bilirubin (hyperbilirubinemia)
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      14
      num Events
      5
    term
    Hypoxia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Death not associated with CTCAE term - Death NOS
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Hypotension
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Bone marrow cellularity - Primary graft failure
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Catheter related
    organ System
    Product Issues
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Infection with normal ANC or Grade 1 or 2 neutrophils
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Infection with normal ANC or Grade 1 or 2 neutrophils - Brain (encephalitis, infectious)

Other reported adverse events

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

    Complete source fields
    description
    Non serious events were not collected. The protocol was assessing efficacy of cord blood in transplants, therefore the research was only gathering SAEs of grade 3 or 4.
    event Groups
    1. deaths Num Affected
      11
      deaths Num At Risk
      14
      description
      PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      0
      serious Num Affected
      9
      serious Num At Risk
      14
      title
      Arm I
    frequency Threshold
    5
    serious Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAEv3
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        14
        num Events
        4
      term
      Diarrhea
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE v3
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        14
        num Events
        1
      term
      Supraventricular and nodal arrhythmia - Sinus tachycardia
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        14
        num Events
        3
      term
      Death not associated with CTCAE term - Multi-organ failure
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        14
        num Events
        1
      term
      Hemorrhage, pulmonary/upper respiratory - Nose
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Hepatobiliary disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        14
        num Events
        1
      term
      Bilirubin (hyperbilirubinemia)
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        14
        num Events
        5
      term
      Hypoxia
    7. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        14
        num Events
        2
      term
      Death not associated with CTCAE term - Death NOS
    8. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        14
        num Events
        1
      term
      Hypotension
    9. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        14
        num Events
        1
      term
      Bone marrow cellularity - Primary graft failure
    10. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Catheter related
      organ System
      Product Issues
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        14
        num Events
        2
      term
      Infection with normal ANC or Grade 1 or 2 neutrophils
    11. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        14
        num Events
        1
      term
      Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
    12. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        14
        num Events
        1
      term
      Infection with normal ANC or Grade 1 or 2 neutrophils - Brain (encephalitis, infectious)
    time Frame
    Adverse Events were collected from participant start on study to going off study up to a period of 2 years.

    Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

    Preserved source evidence · Not medical advice