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NCT00763490 · ADVERSE EVENTS

Adverse events

Trial Of Double Umbilical Cord Blood Transplantation · Source last updated 2016-12-23

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
Not reported
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Double Cord Blood Tranplant

Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.

14 / 208 / 20Not reported / Not reported

Group identifiers: EG000: Double Cord Blood Tranplant

Serious adverse events

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

  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    Blood/Bone Marrow - Other
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Hypotension
  3. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Fever
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    Anorexia
  5. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      2
    term
    Hemorrhage, GI
  6. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Infection with normal ANC
  7. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Confusion
  8. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Syncope (fainting)
  9. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Dyspnea
  10. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Hypoxia
  11. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Pulmonary/Upper Respiratory - Other
  12. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Bladder spasms

Other reported adverse events

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

  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    Blood/Bone Marrow - Other
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Hypertension
  3. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      20
      num Events
      6
    term
    Hypotension
  4. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      3
    term
    Weight gain
  5. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Pruritus/itching
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    Anorexia
  7. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Heartburn/dyspepsia
  8. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Hemorrhage, pulmonary/upper respiratory
  9. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    Infection with normal ANC
  10. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      20
      num Events
      4
    term
    Confusion
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    Abdominal Pain
  12. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      20
      num Events
      4
    term
    Head Pain
Complete source fields
event Groups
  1. description
    Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
    id
    EG000
    other Num Affected
    8
    other Num At Risk
    20
    serious Num Affected
    14
    serious Num At Risk
    20
    title
    Double Cord Blood Tranplant
frequency Threshold
5
other Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    Blood/Bone Marrow - Other
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Hypertension
  3. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      20
      num Events
      6
    term
    Hypotension
  4. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      3
    term
    Weight gain
  5. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Pruritus/itching
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    Anorexia
  7. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Heartburn/dyspepsia
  8. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Hemorrhage, pulmonary/upper respiratory
  9. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    Infection with normal ANC
  10. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      20
      num Events
      4
    term
    Confusion
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    Abdominal Pain
  12. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      20
      num Events
      4
    term
    Head Pain
serious Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    Blood/Bone Marrow - Other
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Hypotension
  3. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Fever
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    Anorexia
  5. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      2
    term
    Hemorrhage, GI
  6. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Infection with normal ANC
  7. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Confusion
  8. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Syncope (fainting)
  9. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Dyspnea
  10. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Hypoxia
  11. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Pulmonary/Upper Respiratory - Other
  12. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Bladder spasms

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Preserved source evidence · Not medical advice