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NCT00113841 · ADVERSE EVENTS

Adverse events

Curcumin (Diferuloylmethane Derivative) With or Without Bioperine in Patients With Multiple Myeloma · Source last updated 2011-11-23

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
4 years and 2 months
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Curcumin

Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.)

0 / 169 / 16Not reported / Not reported
Curcumin + Bioperine

Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily

0 / 179 / 17Not reported / Not reported

Group identifiers: EG000: Curcumin · EG001: Curcumin + Bioperine

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
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        16
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        17
      term
      Appetite decreased
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Eye disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        16
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        17
      term
      Burning in the eyes
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        17
      term
      Chest discomfort
    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
        16
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        17
      term
      Constipation
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        17
      term
      Diarrhea
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Eye disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        16
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        17
      term
      Redness of eyes
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Eye disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        17
      term
      Watering eyes
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        16
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        17
      term
      Feeling of fullness with capsules
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        17
      term
      Dyspnea
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        17
      term
      Flatulence
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        16
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        17
      term
      Flushing
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        16
      2. group Id
        EG001
        num Affected
        4
        num At Risk
        17
      term
      Headache
    Complete source fields
    event Groups
    1. description
      Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.)
      id
      EG000
      other Num Affected
      9
      other Num At Risk
      16
      serious Num Affected
      0
      serious Num At Risk
      16
      title
      Curcumin
    2. description
      Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily
      id
      EG001
      other Num Affected
      9
      other Num At Risk
      17
      serious Num Affected
      0
      serious Num At Risk
      17
      title
      Curcumin + Bioperine
    frequency Threshold
    5
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        16
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        17
      term
      Appetite decreased
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Eye disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        16
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        17
      term
      Burning in the eyes
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        17
      term
      Chest discomfort
    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
        16
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        17
      term
      Constipation
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        17
      term
      Diarrhea
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Eye disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        16
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        17
      term
      Redness of eyes
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Eye disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        17
      term
      Watering eyes
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        16
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        17
      term
      Feeling of fullness with capsules
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        17
      term
      Dyspnea
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        17
      term
      Flatulence
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        16
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        17
      term
      Flushing
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        16
      2. group Id
        EG001
        num Affected
        4
        num At Risk
        17
      term
      Headache
    time Frame
    4 years and 2 months

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

    Preserved source evidence · Not medical advice