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NCT00365508 · ADVERSE EVENTS

Adverse events

Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking · Source last updated 2016-03-29

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
6 months
Other-event reporting threshold
1%

Administered a checklist of side effects from NRT and collected any additional information on adverse events.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I

Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.

4 / 3210 / 321Not reported / Not reported
Arm II

Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).

7 / 3210 / 321Not reported / Not reported

Group identifiers: EG000: Arm I · EG001: Arm II

Serious 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
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      321
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      321
      num Events
      0
    term
    Stroke
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      321
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      321
      num Events
      1
    term
    Seizure
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      321
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      321
      num Events
      0
    term
    killed in car accident
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      321
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      321
      num Events
      1
    term
    Heart disease
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      321
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      321
      num Events
      1
    term
    ulcer
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      321
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      321
      num Events
      1
    term
    appendicitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      321
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      321
      num Events
      1
    term
    heart attack
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      321
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      321
      num Events
      1
    term
    cough
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Surgical and medical procedures
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      321
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      321
      num Events
      1
    term
    Abcessed tooth

Other reported adverse events

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

    Complete source fields
    description
    Administered a checklist of side effects from NRT and collected any additional information on adverse events.
    event Groups
    1. description
      Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      321
      serious Num Affected
      4
      serious Num At Risk
      321
      title
      Arm I
    2. description
      Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
      id
      EG001
      other Num Affected
      0
      other Num At Risk
      321
      serious Num Affected
      7
      serious Num At Risk
      321
      title
      Arm II
    frequency Threshold
    1
    serious Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        321
        num Events
        2
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        321
        num Events
        0
      term
      Stroke
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        321
        num Events
        1
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        321
        num Events
        1
      term
      Seizure
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Injury, poisoning and procedural complications
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        321
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        321
        num Events
        0
      term
      killed in car accident
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        321
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        321
        num Events
        1
      term
      Heart disease
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        321
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        321
        num Events
        1
      term
      ulcer
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        321
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        321
        num Events
        1
      term
      appendicitis
    7. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        321
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        321
        num Events
        1
      term
      heart attack
    8. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        321
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        321
        num Events
        1
      term
      cough
    9. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Surgical and medical procedures
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        321
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        321
        num Events
        1
      term
      Abcessed tooth
    time Frame
    6 months

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

    Preserved source evidence · Not medical advice