NCT01434342 · ADVERSE EVENTS
Adverse events
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
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Arm I - Quitline | 14 / 75 | 61 / 75 | Not reported / Not reported |
| Arm II - Usual Care | 5 / 37 | 33 / 37 | Not reported / Not reported |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 75
- num Events
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 75
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- term
- Bladder Infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 75
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 37
- num Events
- 1
- term
- Chest Pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 75
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- term
- Cough
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 75
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 75
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- term
- Dry Mouth
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 75
- num Events
- 3
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 37
- num Events
- 2
- term
- Dyspnea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 75
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 75
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 37
- num Events
- 1
- term
- Febrile Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 75
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- term
- Generalized Muscle Weakness
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 75
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- term
- Headache
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 75
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- term
- Hypoxia
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 75
- num Events
- 5
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 37
- num Events
- 3
- term
- Anorexia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 35
- num At Risk
- 75
- num Events
- 74
- group Id
- EG001
- num Affected
- 15
- num At Risk
- 37
- num Events
- 27
- term
- Anxiety
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 75
- num Events
- 9
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 37
- num Events
- 4
- term
- Chest pain cardiac
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 21
- num At Risk
- 75
- num Events
- 41
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 37
- num Events
- 16
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 75
- num Events
- 15
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 37
- num Events
- 9
- term
- Cough
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 26
- num At Risk
- 75
- num Events
- 56
- group Id
- EG001
- num Affected
- 14
- num At Risk
- 37
- num Events
- 27
- term
- Depression
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 9
- num At Risk
- 75
- num Events
- 18
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 37
- num Events
- 3
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 21
- num At Risk
- 75
- num Events
- 34
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 37
- num Events
- 17
- term
- Dry Mouth
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 15
- num At Risk
- 75
- num Events
- 30
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 37
- num Events
- 10
- term
- Dyspepsia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 39
- num At Risk
- 75
- num Events
- 93
- group Id
- EG001
- num Affected
- 15
- num At Risk
- 37
- num Events
- 27
- term
- Dyspnea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 18
- num At Risk
- 75
- num Events
- 30
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 37
- num Events
- 14
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 25
- num At Risk
- 75
- num Events
- 41
- 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
- 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
- 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
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 75
- num Events
- 5
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 37
- num Events
- 3
- term
- Anorexia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 35
- num At Risk
- 75
- num Events
- 74
- group Id
- EG001
- num Affected
- 15
- num At Risk
- 37
- num Events
- 27
- term
- Anxiety
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 75
- num Events
- 9
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 37
- num Events
- 4
- term
- Chest pain cardiac
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 21
- num At Risk
- 75
- num Events
- 41
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 37
- num Events
- 16
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 75
- num Events
- 15
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 37
- num Events
- 9
- term
- Cough
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 26
- num At Risk
- 75
- num Events
- 56
- group Id
- EG001
- num Affected
- 14
- num At Risk
- 37
- num Events
- 27
- term
- Depression
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 9
- num At Risk
- 75
- num Events
- 18
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 37
- num Events
- 3
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 21
- num At Risk
- 75
- num Events
- 34
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 37
- num Events
- 17
- term
- Dry Mouth
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 15
- num At Risk
- 75
- num Events
- 30
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 37
- num Events
- 10
- term
- Dyspepsia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 39
- num At Risk
- 75
- num Events
- 93
- group Id
- EG001
- num Affected
- 15
- num At Risk
- 37
- num Events
- 27
- term
- Dyspnea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 18
- num At Risk
- 75
- num Events
- 30
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 37
- num Events
- 14
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 25
- num At Risk
- 75
- num Events
- 41
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 37
- num Events
- 8
- term
- Headache
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 75
- num Events
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 75
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- term
- Bladder Infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 75
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 37
- num Events
- 1
- term
- Chest Pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 75
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- term
- Cough
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 75
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 75
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- term
- Dry Mouth
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 75
- num Events
- 3
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 37
- num Events
- 2
- term
- Dyspnea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 75
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 75
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 37
- num Events
- 1
- term
- Febrile Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 75
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- term
- Generalized Muscle Weakness
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 75
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- term
- Headache
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 75
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- term
- Hypoxia
- time Frame
- 24 weeks
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Preserved source evidence · Not medical advice
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