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NCT02041325 · ADVERSE EVENTS

Adverse events

Investigation of the Enhancement of Response to Hepatitis B Vaccine by Lenalidomide in Plasma Cell Dyscrasias · Source last updated 2016-05-17

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
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Lenalidomide

Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.

2 / 220 / 22Not reported / Not reported
Placebo

Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.

2 / 160 / 16Not reported / Not reported

Group identifiers: EG000: Lenalidomide · EG001: Placebo

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Myocardial Infartion
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Musculoskeletal Pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Bleeding
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Ischemic Colitis

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
      Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      22
      serious Num Affected
      2
      serious Num At Risk
      22
      title
      Lenalidomide
    2. description
      Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
      id
      EG001
      other Num Affected
      0
      other Num At Risk
      16
      serious Num Affected
      2
      serious Num At Risk
      16
      title
      Placebo
    frequency Threshold
    0
    serious Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        22
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        16
        num Events
        1
      term
      Myocardial Infartion
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        22
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        16
        num Events
        1
      term
      Musculoskeletal Pain
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Injury, poisoning and procedural complications
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        22
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        16
        num Events
        0
      term
      Bleeding
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        22
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        16
        num Events
        0
      term
      Ischemic Colitis

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

    Preserved source evidence · Not medical advice