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NCT00666211 · ADVERSE EVENTS

Adverse events

Opioid Titration Order Sheet or Standard Care in Treating Patients With Cancer Pain · Source last updated 2012-09-06

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
Not reported
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Standard of Care

Standard pain control drugs.

1 / 4213 / 42Not reported / Not reported
Opioid Titration

Pain will be Monitored and Medication Titrated

8 / 5627 / 56Not reported / Not reported

Group identifiers: EG000: Standard of Care · EG001: Opioid Titration

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Somnolence/depressed level of consciousness
  2. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Pain - Throat/pharynx/larynx - odynophagia
  3. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Pleural effusion
  4. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Death not associated with CTCAE term
  5. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    nausea
  6. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    infection with normal ANC
  7. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Dyspnea (shortness of breath)
  8. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Pain - Back
  9. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    extremity-lower gait
  10. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      56
      num Events
      2
    term
    Mucositis/stomatisis
  11. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    aspiration
  12. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    neutrapenia

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      42
      num Events
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      56
      num Events
      9
    term
    drowsiness, somnolence
  2. organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
      num Events
      12
    term
    confusion
  3. organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
      num Events
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    anorexia
  4. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    bruising
  5. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
      num Events
      3
    term
    cardiac arrhythmia
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      8
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      56
      num Events
      41
    term
    constipation
  7. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      56
      num Events
      13
    term
    cough
  8. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      56
      num Events
      33
    term
    dysphagia
  9. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      56
      num Events
      14
    term
    edema
  10. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      56
      num Events
      46
    term
    fatigue
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      56
      num Events
      50
    term
    nausea
  12. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      56
      num Events
      11
    term
    neuropathy
Complete source fields
event Groups
  1. description
    Standard pain control drugs.
    id
    EG000
    other Num Affected
    13
    other Num At Risk
    42
    serious Num Affected
    1
    serious Num At Risk
    42
    title
    Standard of Care
  2. description
    Pain will be Monitored and Medication Titrated
    id
    EG001
    other Num Affected
    27
    other Num At Risk
    56
    serious Num Affected
    8
    serious Num At Risk
    56
    title
    Opioid Titration
frequency Threshold
5
other Events
  1. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      42
      num Events
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      56
      num Events
      9
    term
    drowsiness, somnolence
  2. organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
      num Events
      12
    term
    confusion
  3. organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
      num Events
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    anorexia
  4. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    bruising
  5. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
      num Events
      3
    term
    cardiac arrhythmia
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      8
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      56
      num Events
      41
    term
    constipation
  7. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      56
      num Events
      13
    term
    cough
  8. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      56
      num Events
      33
    term
    dysphagia
  9. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      56
      num Events
      14
    term
    edema
  10. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      56
      num Events
      46
    term
    fatigue
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      56
      num Events
      50
    term
    nausea
  12. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      56
      num Events
      11
    term
    neuropathy
serious Events
  1. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Somnolence/depressed level of consciousness
  2. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Pain - Throat/pharynx/larynx - odynophagia
  3. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Pleural effusion
  4. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Death not associated with CTCAE term
  5. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    nausea
  6. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    infection with normal ANC
  7. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Dyspnea (shortness of breath)
  8. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Pain - Back
  9. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    extremity-lower gait
  10. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      56
      num Events
      2
    term
    Mucositis/stomatisis
  11. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    aspiration
  12. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    neutrapenia

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