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NCT00400686 · ADVERSE EVENTS

Adverse events

Epoetin Alfa in Treating Anemia in Patients Undergoing Chemotherapy for Multiple Myeloma · Source last updated 2018-02-22

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
AE data highlights development of VTEs in patients receiving one of the following: 1. lenalidomide, high dose dexamethasone & Aspirin 325mg daily 2. thalidomide & doxil based therapy with aspirin 81mg daily 3. cyclophosphamide & prednisone without VTE
Other-event reporting threshold
5%

Only immediately reportable Serious Adverse Events (SAE) \& Venous thrombolytic event (VTE) were captured for the purpose of this study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Epoetin Alfa - 80,000 U sc

Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1.

0 / 313 / 31Not reported / Not reported

Group identifiers: EG000: Epoetin Alfa - 80,000 U sc

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. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        31
        num Events
        3
      term
      Venous Thromboembolic Event (VTE)
    Complete source fields
    description
    Only immediately reportable Serious Adverse Events (SAE) \& Venous thrombolytic event (VTE) were captured for the purpose of this study.
    event Groups
    1. description
      Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1.
      id
      EG000
      other Num Affected
      3
      other Num At Risk
      31
      serious Num Affected
      0
      serious Num At Risk
      31
      title
      Epoetin Alfa - 80,000 U sc
    frequency Threshold
    5
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        31
        num Events
        3
      term
      Venous Thromboembolic Event (VTE)
    time Frame
    AE data highlights development of VTEs in patients receiving one of the following: 1. lenalidomide, high dose dexamethasone & Aspirin 325mg daily 2. thalidomide & doxil based therapy with aspirin 81mg daily 3. cyclophosphamide & prednisone without VTE

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

    Preserved source evidence · Not medical advice