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NCT01927718 · ADVERSE EVENTS

Adverse events

Thalidomide to Overcome Lenalidomide Resistance After Autologous Hematopoietic Stem Cell Transplantation (HCT) · Source last updated 2019-04-29

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
Adverse event collection with 28 day treatment cycle, and up to 30 days after the last dose of the study drugs.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Thalidomide + Lenalidomide

Thalidomide 100 mg by mouth daily for 28 days and Lenalidomide continued by mouth at the previous dose of 5 mg daily for 21 days on a 28 day cycle, 5 mg daily for 28 days on a 28 day cycle, 10 mg daily for 28 days on a 28 day cycle, or 15 mg daily for 28 day cycle.

0 / 1010 / 10Not reported / Not reported

Group identifiers: EG000: Thalidomide + Lenalidomide

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
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        10
        num Events
        1
      term
      Anemia
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        10
        num Events
        1
      term
      Bone pain
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        10
        num Events
        2
      term
      Constipation
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        10
        num Events
        2
      term
      Diarrhea
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        10
        num Events
        1
      term
      Dizziness
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        10
        num Events
        1
      term
      Elevated alanine transaminase (ALT)
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        10
        num Events
        1
      term
      Elevated Aspartate aminotransferase (AST)
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        10
        num Events
        4
      term
      Elevated creatinine
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        10
        num Events
        1
      term
      Headache
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        10
        num Events
        1
      term
      Hyperglycemia
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        10
        num Events
        1
      term
      Hypoalbuminemia
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        10
        num Events
        1
      term
      Hypocalcemia
    Complete source fields
    event Groups
    1. description
      Thalidomide 100 mg by mouth daily for 28 days and Lenalidomide continued by mouth at the previous dose of 5 mg daily for 21 days on a 28 day cycle, 5 mg daily for 28 days on a 28 day cycle, 10 mg daily for 28 days on a 28 day cycle, or 15 mg daily for 28 day cycle.
      id
      EG000
      other Num Affected
      10
      other Num At Risk
      10
      serious Num Affected
      0
      serious Num At Risk
      10
      title
      Thalidomide + Lenalidomide
    frequency Threshold
    5
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        10
        num Events
        1
      term
      Anemia
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        10
        num Events
        1
      term
      Bone pain
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        10
        num Events
        2
      term
      Constipation
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        10
        num Events
        2
      term
      Diarrhea
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        10
        num Events
        1
      term
      Dizziness
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        10
        num Events
        1
      term
      Elevated alanine transaminase (ALT)
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        10
        num Events
        1
      term
      Elevated Aspartate aminotransferase (AST)
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        10
        num Events
        4
      term
      Elevated creatinine
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        10
        num Events
        1
      term
      Headache
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        10
        num Events
        1
      term
      Hyperglycemia
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        10
        num Events
        1
      term
      Hypoalbuminemia
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        10
        num Events
        1
      term
      Hypocalcemia
    time Frame
    Adverse event collection with 28 day treatment cycle, and up to 30 days after the last dose of the study drugs.

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

    Preserved source evidence · Not medical advice