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NCT01793051 · ADVERSE EVENTS

Adverse events

Intervention for Symptom Burden During Maintenance Therapy for Multiple Myeloma · Source last updated 2021-11-24

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
From the start of the study medication, up to 30 days after last dose administered, up to a total of 4 months
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Minocycline

Minocycline 100 mg (capsule) two times a day to begin with start of maintenance therapy (3 months +/- 2 days)

0 / 333 / 330 / 33
Placebo

Placebo 100 mg (capsule) two times a day to begin with start of maintenance therapy (3 months +/- 2 days)

0 / 364 / 360 / 36

Group identifiers: EG000: Minocycline · EG001: 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
        1
        num At Risk
        33
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        36
      term
      Anxiety
    2. 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
        33
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        36
      term
      Back pain
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Eye disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        33
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        36
      term
      Blurred Vision
    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
        33
      2. group Id
        EG001
        num Affected
        4
        num At Risk
        36
      term
      Constipation
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        33
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        36
      term
      Cough
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        33
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        36
      term
      Cytopenia
    7. 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
        33
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        36
      term
      Diarrhea
    8. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        33
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        36
      term
      Dizziness
    Complete source fields
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      33
      description
      Minocycline 100 mg (capsule) two times a day to begin with start of maintenance therapy (3 months +/- 2 days)
      id
      EG000
      other Num Affected
      3
      other Num At Risk
      33
      serious Num Affected
      0
      serious Num At Risk
      33
      title
      Minocycline
    2. deaths Num Affected
      0
      deaths Num At Risk
      36
      description
      Placebo 100 mg (capsule) two times a day to begin with start of maintenance therapy (3 months +/- 2 days)
      id
      EG001
      other Num Affected
      4
      other Num At Risk
      36
      serious Num Affected
      0
      serious Num At Risk
      36
      title
      Placebo
    frequency Threshold
    0
    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
        1
        num At Risk
        33
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        36
      term
      Anxiety
    2. 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
        33
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        36
      term
      Back pain
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Eye disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        33
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        36
      term
      Blurred Vision
    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
        33
      2. group Id
        EG001
        num Affected
        4
        num At Risk
        36
      term
      Constipation
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        33
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        36
      term
      Cough
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        33
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        36
      term
      Cytopenia
    7. 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
        33
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        36
      term
      Diarrhea
    8. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        33
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        36
      term
      Dizziness
    time Frame
    From the start of the study medication, up to 30 days after last dose administered, up to a total of 4 months

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

    Preserved source evidence · Not medical advice