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NCT00943800 · ADVERSE EVENTS

Adverse events

Combined Haploidentical-Cord Blood Transplantation for Adults and Children · Source last updated 2021-01-27

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
100 days
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment Group

Although the protocol initially had different disease intensities, ultimately, moved to one regimen for all patients. Subjects received 30mg/m\^2 of Fludarabine from Day-7 until Day-3, 140mg/m\^2 of Melphalan on Day-2, and 1.5mg/kg of Rabbit antithymocyte globulin at Day-7,-5,-3 and -1."

24 / 870 / 8718 / 87

Group identifiers: EG000: Treatment Group

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
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      87
    term
    Abdominal infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
    term
    Cytokine release syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      87
    term
    Epstein-barr virus infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
    term
    Esophageal infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
    term
    Febrile neutropenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
    term
    Fever
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
    term
    Gait disturbance
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
    term
    Heart failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
    term
    Hypernatremia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      87
    term
    Hypoxia

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
    event Groups
    1. deaths Num Affected
      18
      deaths Num At Risk
      87
      description
      Although the protocol initially had different disease intensities, ultimately, moved to one regimen for all patients. Subjects received 30mg/m\^2 of Fludarabine from Day-7 until Day-3, 140mg/m\^2 of Melphalan on Day-2, and 1.5mg/kg of Rabbit antithymocyte globulin at Day-7,-5,-3 and -1."
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      87
      serious Num Affected
      24
      serious Num At Risk
      87
      title
      Treatment Group
    frequency Threshold
    5
    serious Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        87
      term
      Abdominal infection
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        87
      term
      Anemia
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        87
      term
      Cytokine release syndrome
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        87
      term
      Diarrhea
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        87
      term
      Epstein-barr virus infection
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        87
      term
      Esophageal infection
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        87
      term
      Febrile neutropenia
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        87
      term
      Fever
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        87
      term
      Gait disturbance
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        87
      term
      Heart failure
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        87
      term
      Hypernatremia
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        87
      term
      Hypoxia
    time Frame
    100 days

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

    Preserved source evidence · Not medical advice