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NCT01675141 · ADVERSE EVENTS

Adverse events

Lenalidomide Maintenance Therapy for Multiple Myeloma · Source last updated 2018-02-05

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
37 months and 12 days
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Lenalidomide Maintenance Therapy for Multiple Myeloma

10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity. Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.

0 / 1111 / 110 / 11

Group identifiers: EG000: Lenalidomide Maintenance Therapy for Multiple Myeloma

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
      Investigations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        11
        num Events
        2
      term
      Activated partial thromboplastin time prolonged
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        11
        num Events
        6
      term
      Alanine aminotransferase increased
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        11
        num Events
        6
      term
      Alkaline phosphatase increased
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        11
        num Events
        11
      term
      Anemia
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        11
        num Events
        9
      term
      Aspartate aminotransferase increased
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        11
        num Events
        2
      term
      Back pain
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        11
        num Events
        3
      term
      Blood bilirubin increased
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        11
        num Events
        6
      term
      CPK increased
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        11
        num Events
        1
      term
      Chest wall pain
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        11
        num Events
        2
      term
      Constipation
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        11
        num Events
        11
      term
      Creatinine increased
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        11
        num Events
        2
      term
      Diarrhea
    Complete source fields
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      11
      description
      10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity. Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.
      id
      EG000
      other Num Affected
      11
      other Num At Risk
      11
      serious Num Affected
      0
      serious Num At Risk
      11
      title
      Lenalidomide Maintenance Therapy for Multiple Myeloma
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        11
        num Events
        2
      term
      Activated partial thromboplastin time prolonged
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        11
        num Events
        6
      term
      Alanine aminotransferase increased
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        11
        num Events
        6
      term
      Alkaline phosphatase increased
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        11
        num Events
        11
      term
      Anemia
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        11
        num Events
        9
      term
      Aspartate aminotransferase increased
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        11
        num Events
        2
      term
      Back pain
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        11
        num Events
        3
      term
      Blood bilirubin increased
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        11
        num Events
        6
      term
      CPK increased
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        11
        num Events
        1
      term
      Chest wall pain
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        11
        num Events
        2
      term
      Constipation
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        11
        num Events
        11
      term
      Creatinine increased
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        11
        num Events
        2
      term
      Diarrhea
    time Frame
    37 months and 12 days

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

    Preserved source evidence · Not medical advice