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NCT00450450 · ADVERSE EVENTS

Adverse events

Donor Bone Marrow Transplant With or Without G-CSF in Treating Young Patients With Hematologic Cancer or Other Diseases · Source last updated 2022-04-28

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
0%

Group 2 enrollment total is 14, patient 774353 enrolled on study, but was not randomized and didn't contribute any data. Group 2 AE total is 13.

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

Conventional bone marrow transplant (BM)

1 / 138 / 13Not reported / Not reported
Experimental G-BM Arm

G-CSF (filgrastim) stimulated bone marrow (G-BM)

0 / 137 / 13Not reported / Not reported

Group identifiers: EG000: Control BM Arm · EG001: Experimental G-BM Arm

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
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Dyspnea
  2. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Pneumonitis
  3. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Pneumothorax

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
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Abdominal pain
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Anemia
  3. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
    term
    Anorexia
  4. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Autoimmune disorder
  5. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Bladder infection
  6. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Blood bilirubin increased
  7. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Death NOS
  8. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Edema face
  9. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Epistaxis
  10. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Hematuria
  11. organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Hepatobiliary disorders - Other, specify
  12. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Hyperglycemia
Complete source fields
description
Group 2 enrollment total is 14, patient 774353 enrolled on study, but was not randomized and didn't contribute any data. Group 2 AE total is 13.
event Groups
  1. description
    Conventional bone marrow transplant (BM)
    id
    EG000
    other Num Affected
    8
    other Num At Risk
    13
    serious Num Affected
    1
    serious Num At Risk
    13
    title
    Control BM Arm
  2. description
    G-CSF (filgrastim) stimulated bone marrow (G-BM)
    id
    EG001
    other Num Affected
    7
    other Num At Risk
    13
    serious Num Affected
    0
    serious Num At Risk
    13
    title
    Experimental G-BM Arm
frequency Threshold
0
other Events
  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Abdominal pain
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Anemia
  3. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
    term
    Anorexia
  4. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Autoimmune disorder
  5. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Bladder infection
  6. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Blood bilirubin increased
  7. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Death NOS
  8. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Edema face
  9. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Epistaxis
  10. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Hematuria
  11. organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Hepatobiliary disorders - Other, specify
  12. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Hyperglycemia
serious Events
  1. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Dyspnea
  2. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Pneumonitis
  3. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Pneumothorax

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Preserved source evidence · Not medical advice