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NCT00575965 · ADVERSE EVENTS

Adverse events

Simvastatin in Waldenstrom's Macroglobulinemia · Source last updated 2015-12-16

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
Assessed every 3 months on therapy up to day 30 post-therapy. Median duration on treatment was 6 months (range 1-24 months).
Other-event reporting threshold
1%

The analysis dataset is comprised of all evaluable patients. One patient was lost to follow-up within 3 weeks of enrollment and was unevaluable.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Simvastatin

Simvastatin at 20 mg daily for the first week, then dose escalated weekly by 20 mg a day to a maximum of 80 mg daily by week 4. Patients were maintained on therapy until progression or up to 2 years.

0 / 174 / 17Not reported / Not reported

Group identifiers: EG000: Simvastatin

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
      notes
      1 grade 2
      organ System
      Musculoskeletal and connective tissue disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        17
        num Events
        1
      term
      Elevated CPK
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      3 patients with grade 2
      organ System
      Musculoskeletal and connective tissue disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        17
        num Events
        3
      term
      Musculoskeletal pain
    Complete source fields
    description
    The analysis dataset is comprised of all evaluable patients. One patient was lost to follow-up within 3 weeks of enrollment and was unevaluable.
    event Groups
    1. description
      Simvastatin at 20 mg daily for the first week, then dose escalated weekly by 20 mg a day to a maximum of 80 mg daily by week 4. Patients were maintained on therapy until progression or up to 2 years.
      id
      EG000
      other Num Affected
      4
      other Num At Risk
      17
      serious Num Affected
      0
      serious Num At Risk
      17
      title
      Simvastatin
    frequency Threshold
    1
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      1 grade 2
      organ System
      Musculoskeletal and connective tissue disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        17
        num Events
        1
      term
      Elevated CPK
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      3 patients with grade 2
      organ System
      Musculoskeletal and connective tissue disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        17
        num Events
        3
      term
      Musculoskeletal pain
    time Frame
    Assessed every 3 months on therapy up to day 30 post-therapy. Median duration on treatment was 6 months (range 1-24 months).

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

    Preserved source evidence · Not medical advice