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NCT01434342 · ADVERSE EVENTS

Adverse events

Feasibility of Delivering a Quitline Based Smoking Cessation Intervention in Cancer Patients · Source last updated 2021-09-28

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
24 weeks
Other-event reporting threshold
5%

Sample size is the number of participants with follow-up toxicity data

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

Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff. The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients. Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period. Participants also learn behavioral tips and coping skills. Nicotine Replacement Patch: Study participants will receive a baseline assessment after they consent to participate and before randomization. The intervention period will last 12 weeks (approximately 1 week for the in-office intervention and 12 weeks for all components of the Quitline intervention- telephone counseling and habitrol patches). Follow-up assessments will be administered at 3, 6, 12, \& 24 we

14 / 7561 / 75Not reported / Not reported
Arm II - Usual Care

Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute's "Clearing the Air" smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy.

5 / 3733 / 37Not reported / Not reported

Group identifiers: EG000: Arm I - Quitline · EG001: Arm II - Usual Care

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      75
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      75
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Bladder Infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      75
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Chest Pain
  4. assessment Type
    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
      75
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Cough
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      75
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      75
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Dry Mouth
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      75
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      37
      num Events
      2
    term
    Dyspnea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      75
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      75
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Febrile Neutropenia
  10. assessment Type
    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
      75
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Generalized Muscle Weakness
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      75
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Headache
  12. assessment Type
    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
      75
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Hypoxia

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
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      75
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      37
      num Events
      3
    term
    Anorexia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      75
      num Events
      74
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      37
      num Events
      27
    term
    Anxiety
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      75
      num Events
      9
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      37
      num Events
      4
    term
    Chest pain cardiac
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      75
      num Events
      41
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      37
      num Events
      16
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      75
      num Events
      15
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      37
      num Events
      9
    term
    Cough
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      75
      num Events
      56
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      37
      num Events
      27
    term
    Depression
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      75
      num Events
      18
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      37
      num Events
      3
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      75
      num Events
      34
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      37
      num Events
      17
    term
    Dry Mouth
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      75
      num Events
      30
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      37
      num Events
      10
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      75
      num Events
      93
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      37
      num Events
      27
    term
    Dyspnea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      75
      num Events
      30
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      37
      num Events
      14
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      75
      num Events
      41
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      37
      num Events
      8
    term
    Headache
Complete source fields
description
Sample size is the number of participants with follow-up toxicity data
event Groups
  1. description
    Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff. The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients. Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period. Participants also learn behavioral tips and coping skills. Nicotine Replacement Patch: Study participants will receive a baseline assessment after they consent to participate and before randomization. The intervention period will last 12 weeks (approximately 1 week for the in-office intervention and 12 weeks for all components of the Quitline intervention- telephone counseling and habitrol patches). Follow-up assessments will be administered at 3, 6, 12, \& 24 we
    id
    EG000
    other Num Affected
    61
    other Num At Risk
    75
    serious Num Affected
    14
    serious Num At Risk
    75
    title
    Arm I - Quitline
  2. description
    Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute's "Clearing the Air" smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy.
    id
    EG001
    other Num Affected
    33
    other Num At Risk
    37
    serious Num Affected
    5
    serious Num At Risk
    37
    title
    Arm II - Usual Care
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      75
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      37
      num Events
      3
    term
    Anorexia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      75
      num Events
      74
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      37
      num Events
      27
    term
    Anxiety
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      75
      num Events
      9
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      37
      num Events
      4
    term
    Chest pain cardiac
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      75
      num Events
      41
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      37
      num Events
      16
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      75
      num Events
      15
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      37
      num Events
      9
    term
    Cough
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      75
      num Events
      56
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      37
      num Events
      27
    term
    Depression
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      75
      num Events
      18
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      37
      num Events
      3
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      75
      num Events
      34
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      37
      num Events
      17
    term
    Dry Mouth
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      75
      num Events
      30
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      37
      num Events
      10
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      75
      num Events
      93
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      37
      num Events
      27
    term
    Dyspnea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      75
      num Events
      30
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      37
      num Events
      14
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      75
      num Events
      41
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      37
      num Events
      8
    term
    Headache
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      75
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      75
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Bladder Infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      75
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Chest Pain
  4. assessment Type
    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
      75
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Cough
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      75
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      75
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Dry Mouth
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      75
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      37
      num Events
      2
    term
    Dyspnea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      75
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      75
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Febrile Neutropenia
  10. assessment Type
    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
      75
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Generalized Muscle Weakness
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      75
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Headache
  12. assessment Type
    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
      75
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Hypoxia
time Frame
24 weeks

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