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NCT01979276 · ADVERSE EVENTS

Adverse events

Study of Pomalidomide, Dexamethasone, and Romidepsin for Rel/Ref Myeloma · Source last updated 2018-06-06

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 events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Other-event reporting threshold
5%

Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pomalidomide, Romidepsin, Dexamethasone

Pomalidomide, 4 mg by mouth daily on days 1-21 of 28 day cycle Dexamethasone, 40 mg by mouth on days 1, 8, 15, and 22 of 28 day cycle Romidepsin, IV on days 1 and 15 of 28 day cycle, dose level to be determined Dexamethasone Romidepsin: Romidepsin intravenously on days 1 and 15 of a 28-day cycle pomalidomide: Pomalidomide 4mg daily by mouth on days 1-21 of a 28-day cycle Dexamethasone: Dexamethasone 40mg by mouth on days 1, 8, 15 and 22 of a 28-day cycle

0 / 22 / 20 / 2

Group identifiers: EG000: Pomalidomide, Romidepsin, Dexamethasone

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
      Psychiatric disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        4
      term
      Insomnia
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Dyspnea with moderate exertion
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Fatigue
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Peripheral Neuropathy
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Eye disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        2
      term
      Blurred Vision
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        2
      term
      Nausea - intermittent
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        3
      term
      Nausea
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Dyspepsia - intermittent
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Dyspepsia
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Generalized weakness
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      constipation
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Paresthesia around mouth
    Complete source fields
    description
    Adverse events were recorded using the CTCAE version 4.0. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      2
      description
      Pomalidomide, 4 mg by mouth daily on days 1-21 of 28 day cycle Dexamethasone, 40 mg by mouth on days 1, 8, 15, and 22 of 28 day cycle Romidepsin, IV on days 1 and 15 of 28 day cycle, dose level to be determined Dexamethasone Romidepsin: Romidepsin intravenously on days 1 and 15 of a 28-day cycle pomalidomide: Pomalidomide 4mg daily by mouth on days 1-21 of a 28-day cycle Dexamethasone: Dexamethasone 40mg by mouth on days 1, 8, 15 and 22 of a 28-day cycle
      id
      EG000
      other Num Affected
      2
      other Num At Risk
      2
      serious Num Affected
      0
      serious Num At Risk
      2
      title
      Pomalidomide, Romidepsin, Dexamethasone
    frequency Threshold
    5
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Psychiatric disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        4
      term
      Insomnia
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Dyspnea with moderate exertion
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Fatigue
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Peripheral Neuropathy
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Eye disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        2
      term
      Blurred Vision
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        2
      term
      Nausea - intermittent
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        3
      term
      Nausea
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Dyspepsia - intermittent
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Dyspepsia
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Generalized weakness
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      constipation
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Paresthesia around mouth
    time Frame
    Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.

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

    Preserved source evidence · Not medical advice