Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00073918 · ADVERSE EVENTS

Adverse events

Iodine I 131 Tositumomab, Etoposide and Cyclophosphamide Followed by Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma · Source last updated 2017-08-18

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
Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)

RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4. CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2. AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0. cyclophosphamide: Given IV etoposide: Given IV iodine I 131 tositumomab: Given IV quality-of-life assessment: Ancillary study peripheral blood stem cell transplantation: Undergo ASCT given via central catheter

9 / 1070 / 107Not reported / Not reported

Group identifiers: EG000: Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      107
      num Events
      2
    term
    Mucositis/stomatitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    term
    Renal Failure
  3. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    term
    Respiratory distress
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    term
    Idiopathic pneumonia syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    term
    Pulmonary edema
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    term
    cardiac left ventricular function
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Acute respiratory distress syndrome
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    term
    ARDS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    term
    radiation pneumonitis

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
      RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4. CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2. AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0. cyclophosphamide: Given IV etoposide: Given IV iodine I 131 tositumomab: Given IV quality-of-life assessment: Ancillary study peripheral blood stem cell transplantation: Undergo ASCT given via central catheter
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      107
      serious Num Affected
      9
      serious Num At Risk
      107
      title
      Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)
    frequency Threshold
    5
    serious Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        107
        num Events
        2
      term
      Mucositis/stomatitis
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Renal and urinary disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        107
        num Events
        1
      term
      Renal Failure
    3. organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        107
        num Events
        1
      term
      Respiratory distress
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        107
        num Events
        1
      term
      Idiopathic pneumonia syndrome
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        107
        num Events
        1
      term
      Pulmonary edema
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        107
        num Events
        1
      term
      cardiac left ventricular function
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Acute respiratory distress syndrome
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        107
        num Events
        1
      term
      ARDS
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        107
        num Events
        1
      term
      radiation pneumonitis

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

    Preserved source evidence · Not medical advice