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NCT00165503 · ADVERSE EVENTS

Adverse events

Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate · Source last updated 2016-09-09

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
The period for reporting adverse events were 30 days from the participant's date of surgery.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Surgery + Heated Cisplatin Lavage + Sodium Thiosulfate

Participants undergo surgery, Pleurectomy/Decortication, followed by heated cisplatin given as a one-hour lavage of the chest and abdominal cavity then sodium thiosulfate given intravenously over 6 hours.

5 / 160 / 16Not reported / Not reported

Group identifiers: EG000: Surgery + Heated Cisplatin Lavage + Sodium Thiosulfate

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
      16
    term
    Pericardial effusion with tamponade
  2. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      16
    term
    Respiratory failure
  3. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    term
    Progression of disease
  4. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    term
    Hypocalcemia
  5. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    term
    Chylothorax
  6. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    term
    Aspiration pneumonia
  7. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    term
    Pneumonia
  8. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    term
    Elevated troponin

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
      Participants undergo surgery, Pleurectomy/Decortication, followed by heated cisplatin given as a one-hour lavage of the chest and abdominal cavity then sodium thiosulfate given intravenously over 6 hours.
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      16
      serious Num Affected
      5
      serious Num At Risk
      16
      title
      Surgery + Heated Cisplatin Lavage + Sodium Thiosulfate
    frequency Threshold
    0
    serious Events
    1. organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
      term
      Pericardial effusion with tamponade
    2. organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        16
      term
      Respiratory failure
    3. organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
      term
      Progression of disease
    4. organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
      term
      Hypocalcemia
    5. organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
      term
      Chylothorax
    6. organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
      term
      Aspiration pneumonia
    7. organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
      term
      Pneumonia
    8. organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
      term
      Elevated troponin
    time Frame
    The period for reporting adverse events were 30 days from the participant's date of surgery.

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

    Preserved source evidence · Not medical advice