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NCT00099047 · ADVERSE EVENTS

Adverse events

Celecoxib in Preventing Multiple Myeloma in Patients With Monoclonal Gammopathy or Smoldering Myeloma · Source last updated 2016-12-30

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
Not reported
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (Celecoxib)

Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.

0 / 116 / 11Not reported / Not reported
Arm II (Placebo)

Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.

0 / 128 / 12Not reported / Not reported

Group identifiers: EG000: Arm I (Celecoxib) · EG001: Arm II (Placebo)

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
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        11
        num Events
        2
      2. group Id
        EG001
        num Affected
        4
        num At Risk
        12
        num Events
        4
      term
      headache
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        11
        num Events
        1
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        12
        num Events
        2
      term
      Fatigue
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        11
        num Events
        2
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        12
        num Events
        1
      term
      Pruritus/Itching
    4. assessment Type
      NON_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
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        12
        num Events
        1
      term
      Diarrhea
    5. assessment Type
      NON_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
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        12
        num Events
        0
      term
      Constipation
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        11
        num Events
        1
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        12
        num Events
        1
      term
      Dizziness
    7. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        11
        num Events
        2
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        12
        num Events
        0
      term
      Neuorpathy
    8. assessment Type
      NON_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
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        12
        num Events
        1
      term
      Back Pain
    9. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        11
        num Events
        0
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        12
        num Events
        5
      term
      Exremity Limb Pain
    10. assessment Type
      NON_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
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        12
        num Events
        1
      term
      Neck Pain
    11. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        11
        num Events
        0
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        12
        num Events
        2
      term
      Pain NOS
    12. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        11
        num Events
        1
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        12
        num Events
        1
      term
      Upper Respiratory
    Complete source fields
    event Groups
    1. description
      Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
      id
      EG000
      other Num Affected
      6
      other Num At Risk
      11
      serious Num Affected
      0
      serious Num At Risk
      11
      title
      Arm I (Celecoxib)
    2. description
      Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
      id
      EG001
      other Num Affected
      8
      other Num At Risk
      12
      serious Num Affected
      0
      serious Num At Risk
      12
      title
      Arm II (Placebo)
    frequency Threshold
    5
    other Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        11
        num Events
        2
      2. group Id
        EG001
        num Affected
        4
        num At Risk
        12
        num Events
        4
      term
      headache
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        11
        num Events
        1
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        12
        num Events
        2
      term
      Fatigue
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        11
        num Events
        2
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        12
        num Events
        1
      term
      Pruritus/Itching
    4. assessment Type
      NON_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
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        12
        num Events
        1
      term
      Diarrhea
    5. assessment Type
      NON_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
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        12
        num Events
        0
      term
      Constipation
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        11
        num Events
        1
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        12
        num Events
        1
      term
      Dizziness
    7. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        11
        num Events
        2
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        12
        num Events
        0
      term
      Neuorpathy
    8. assessment Type
      NON_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
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        12
        num Events
        1
      term
      Back Pain
    9. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        11
        num Events
        0
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        12
        num Events
        5
      term
      Exremity Limb Pain
    10. assessment Type
      NON_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
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        12
        num Events
        1
      term
      Neck Pain
    11. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        11
        num Events
        0
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        12
        num Events
        2
      term
      Pain NOS
    12. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        11
        num Events
        1
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        12
        num Events
        1
      term
      Upper Respiratory

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    Preserved source evidence · Not medical advice