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NCT00255684 · ADVERSE EVENTS

Adverse events

Fludarabine, Cyclophosphamide, and Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients Who Are Undergoing a Donor Umbilical Cord Blood Transplant for Hematologic Cancer · Source last updated 2016-11-03

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
Not reported
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Conditioning Therapy Followed by TBI

Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil graft-versus-tumor prophylaxis therapy cyclophosphamide cyclosporine fludarabine phosphate mycophenolate mofetil umbilical cord blood transplantation radiation therapy

11 / 160 / 16Not reported / Not reported

Group identifiers: EG000: Conditioning Therapy Followed by TBI

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
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      16
    term
    graft versus host disease
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
    term
    multi-organ failure
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    term
    Post-transplant lymphoproliferative disorder
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    term
    Syndrome of Inappropriate Antidiuretic Hormone Secretion
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      16
    term
    sepsis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      16
    term
    relapsed transplant resulting in death

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. description
      Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil graft-versus-tumor prophylaxis therapy cyclophosphamide cyclosporine fludarabine phosphate mycophenolate mofetil umbilical cord blood transplantation radiation therapy
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      16
      serious Num Affected
      11
      serious Num At Risk
      16
      title
      Conditioning Therapy Followed by TBI
    frequency Threshold
    5
    serious Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        16
      term
      graft versus host disease
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        16
      term
      multi-organ failure
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
      term
      Post-transplant lymphoproliferative disorder
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
      term
      Syndrome of Inappropriate Antidiuretic Hormone Secretion
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        16
      term
      sepsis
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        16
      term
      relapsed transplant resulting in death

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

    Preserved source evidence · Not medical advice