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NCT00309907 · ADVERSE EVENTS

Adverse events

Etanercept in Treating Young Patients With Idiopathic Pneumonia Syndrome After Undergoing a Donor Stem Cell Transplant · Source last updated 2017-09-29

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%

Eleven ineligible patients are not reported in the adverse events.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Etanercept and Corticosteroid Therapy

Patients receive etanercept IV (dose 0.4 mg/kg- max 25 mg) over 30 minutes on day 0 and subcutaneously (dose 0.4 mg/kg- max 25 mg) on days 3, 7, 10, 14, 17, 21, and 24. Treatment continues in the absence of an infectious pathogen, disease progression, or unacceptable toxicity. Patients also receive methylprednisolone (or corticosteroid equivalent) IV (dose 2.0 mg/kg/day) on days 0-2 and then orally with a taper beginning day 7. Dose on days 7-20 (1.0 mg/kg/day), days 21-34 (0.5 mg/kg/day), days 35-48 (0.25 mg/kg/day) and days 49-56 (0.25 mg/kg/every other day) discontinuing on day 56. etanercept: Given IV and subcutaneously methylprednisolone: Given IV and orally

5 / 286 / 28Not reported / Not reported

Group identifiers: EG000: Etanercept and Corticosteroid Therapy

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
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Acute kidney injury
  2. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Adult respiratory distress syndrome
  3. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Alkalosis
  4. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Blood bilirubin increased
  5. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Death NOS
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Esophageal hemorrhage
  7. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Hyperglycemia
  8. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
    term
    Hypoxia
  9. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Infections and infestations - Other, specify
  10. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Multi-organ failure
  11. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Nervous system disorders - Other, specify
  12. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Peripheral motor neuropathy

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
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Acute kidney injury
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Ascites
  3. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Creatinine increased
  4. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Enterocolitis infectious
  5. organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Hepatic failure
  6. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Hyperglycemia
  7. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Hypokalemia
  8. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Infections and infestations - Other, specify
  9. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Neutrophil count decreased
  10. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Platelet count decreased
  11. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Pneumothorax
  12. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
    term
    White blood cell decreased
Complete source fields
description
Eleven ineligible patients are not reported in the adverse events.
event Groups
  1. description
    Patients receive etanercept IV (dose 0.4 mg/kg- max 25 mg) over 30 minutes on day 0 and subcutaneously (dose 0.4 mg/kg- max 25 mg) on days 3, 7, 10, 14, 17, 21, and 24. Treatment continues in the absence of an infectious pathogen, disease progression, or unacceptable toxicity. Patients also receive methylprednisolone (or corticosteroid equivalent) IV (dose 2.0 mg/kg/day) on days 0-2 and then orally with a taper beginning day 7. Dose on days 7-20 (1.0 mg/kg/day), days 21-34 (0.5 mg/kg/day), days 35-48 (0.25 mg/kg/day) and days 49-56 (0.25 mg/kg/every other day) discontinuing on day 56. etanercept: Given IV and subcutaneously methylprednisolone: Given IV and orally
    id
    EG000
    other Num Affected
    6
    other Num At Risk
    28
    serious Num Affected
    5
    serious Num At Risk
    28
    title
    Etanercept and Corticosteroid Therapy
frequency Threshold
0
other Events
  1. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Acute kidney injury
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Ascites
  3. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Creatinine increased
  4. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Enterocolitis infectious
  5. organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Hepatic failure
  6. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Hyperglycemia
  7. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Hypokalemia
  8. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Infections and infestations - Other, specify
  9. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Neutrophil count decreased
  10. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Platelet count decreased
  11. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Pneumothorax
  12. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
    term
    White blood cell decreased
serious Events
  1. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Acute kidney injury
  2. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Adult respiratory distress syndrome
  3. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Alkalosis
  4. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Blood bilirubin increased
  5. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Death NOS
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Esophageal hemorrhage
  7. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Hyperglycemia
  8. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
    term
    Hypoxia
  9. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Infections and infestations - Other, specify
  10. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Multi-organ failure
  11. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Nervous system disorders - Other, specify
  12. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Peripheral motor neuropathy

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Preserved source evidence · Not medical advice