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NCT00072514 · ADVERSE EVENTS

Adverse events

Gemcitabine Hydrochloride, Carboplatin, Dexamethasone, and Rituximab in Treating Patients With Previously Treated Lymphoid Malignancies · Source last updated 2017-06-29

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
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment

Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.

0 / 5145 / 51Not reported / Not reported

Group identifiers: EG000: Treatment

Serious adverse events

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

    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
        38
        num At Risk
        51
      term
      Neutrophils
    2. organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        18
        num At Risk
        51
      term
      Hemoglobin
    3. organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        51
      term
      Hemorrhage
    4. organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        12
        num At Risk
        51
      term
      Infection
    5. organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        45
        num At Risk
        51
      term
      Platelets
    6. organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        51
      term
      Thromboses
    7. organ System
      Vascular disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        51
      term
      Hypotension
    8. organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        51
      term
      Constitutional
    9. organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        51
      term
      GI
    10. organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        11
        num At Risk
        51
      term
      Matabolic/Laboratory
    11. organ System
      Nervous system disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        51
      term
      Neurology
    12. organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        6
        num At Risk
        51
      term
      Pain
    Complete source fields
    event Groups
    1. description
      Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
      id
      EG000
      other Num Affected
      45
      other Num At Risk
      51
      serious Num Affected
      0
      serious Num At Risk
      51
      title
      Treatment
    frequency Threshold
    5
    other Events
    1. organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        38
        num At Risk
        51
      term
      Neutrophils
    2. organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        18
        num At Risk
        51
      term
      Hemoglobin
    3. organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        51
      term
      Hemorrhage
    4. organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        12
        num At Risk
        51
      term
      Infection
    5. organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        45
        num At Risk
        51
      term
      Platelets
    6. organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        51
      term
      Thromboses
    7. organ System
      Vascular disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        51
      term
      Hypotension
    8. organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        51
      term
      Constitutional
    9. organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        51
      term
      GI
    10. organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        11
        num At Risk
        51
      term
      Matabolic/Laboratory
    11. organ System
      Nervous system disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        51
      term
      Neurology
    12. organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        6
        num At Risk
        51
      term
      Pain

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

    Preserved source evidence · Not medical advice