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NCT01380106 · ADVERSE EVENTS

Adverse events

Study to Evaluate Two Lenalidomide Dose Regimens With Low Dose Dexamethasone for the Treatment Relapsed Multiple Myeloma · Source last updated 2021-01-25

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
Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Lenalidomide 25mg

Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle Lenalidomide 25mg: Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle

12 / 160 / 161 / 16
Lenalidomide 15mg

Subjects will receive oral lenalidomide 15mg once daily for days 1-21 out of a 28 cycle Lenalidomide 15mg: Subjects will receive oral lenalidomide 15 mg once daily for 1-21 of a 28 day cycle.

10 / 170 / 170 / 17

Group identifiers: EG000: Lenalidomide 25mg · EG001: Lenalidomide 15mg

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
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      17
      num Events
      2
    term
    DVT
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Loss of consciousness
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Hematochezia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      17
      num Events
      2
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      16
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      17
      num Events
      3
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    COPD
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      17
      num Events
      2
    term
    Hypercalcemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Hyperglycemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Basal cell carcinoma
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pneumonia
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Death
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Rectal adenocarcinoma
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Back pain

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. deaths Num Affected
      1
      deaths Num At Risk
      16
      description
      Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle Lenalidomide 25mg: Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      16
      serious Num Affected
      12
      serious Num At Risk
      16
      title
      Lenalidomide 25mg
    2. deaths Num Affected
      0
      deaths Num At Risk
      17
      description
      Subjects will receive oral lenalidomide 15mg once daily for days 1-21 out of a 28 cycle Lenalidomide 15mg: Subjects will receive oral lenalidomide 15 mg once daily for 1-21 of a 28 day cycle.
      id
      EG001
      other Num Affected
      0
      other Num At Risk
      17
      serious Num Affected
      10
      serious Num At Risk
      17
      title
      Lenalidomide 15mg
    frequency Threshold
    5
    serious Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        16
        num Events
        2
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        17
        num Events
        2
      term
      DVT
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        17
        num Events
        0
      term
      Loss of consciousness
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        17
        num Events
        0
      term
      Hematochezia
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        16
        num Events
        2
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        17
        num Events
        2
      term
      Anemia
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        16
        num Events
        4
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        17
        num Events
        3
      term
      Pneumonia
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        17
        num Events
        1
      term
      COPD
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        16
        num Events
        0
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        17
        num Events
        2
      term
      Hypercalcemia
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        16
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        17
        num Events
        1
      term
      Hyperglycemia
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Neoplasms benign, malignant and unspecified (incl cysts and polyps)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        17
        num Events
        0
      term
      Basal cell carcinoma
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Pneumonia
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        17
        num Events
        0
      term
      Death
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        17
        num Events
        0
      term
      Rectal adenocarcinoma
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        17
        num Events
        1
      term
      Back pain
    time Frame
    Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.

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

    Preserved source evidence · Not medical advice