Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-25 @ 1:44 PM
NCT ID:
NCT01393392
Description:
AEs assessed at each counseling and research visit.
Frequency Threshold:
0
Time Frame:
2.5 years
Study:
NCT01393392
Study Brief:
Developing a Smoking Cessation Intervention for Methadone Maintained Smokers
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Intensive, Tailored Intervention | Participants in the intensive intervention condition will receive eight individual counseling sessions, with a smoking cessation counselor, over three months. Each session will last approximately 45 minutes and occur in the methadone clinic. Participant treatment needs will be assessed during the first session and the intervention will be tailored to the participants' needs. Prior to quitting participants will receive nicotine replacement patches and lozenges and instructions on how to use them. Intensive, tailored intervention: Eight, 45 minute counseling sessions, tailored to the individual and based on the Information-Motivation-Behavioral Skills model of behavior change. Incorporates motivational interviewing, education, cognitive-behavioral skills training. 12 week course of nicotine replacement patches provided. Nicotine lozenges also provided. | 0 | None | 0 | 44 | 20 | 44 | View |
| Control Intervention | Participants randomized to the control intervention will receive a referral to the NJ Quitline (a telephone smoking cessation counseling service). Participants will receive a brochure and information about the referral. Study staff will contact the NJ Quitline for control participants, and a counselor from the Quitline will call control participants. NJ Quitline Referral: Participants will receive a facilitated referral to the NJ Quitline (i.e. fax to quit). | 1 | None | 1 | 43 | 1 | 43 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Death | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| cough up blood | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| leg pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| nausea | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| insomnia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| increased alcohol use | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| itching/irritation at patch site | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| jittery/agitated/irritable | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| headache | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| vivid dreams | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| chest discomfort/pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| increased appetite | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Extremely high expired carbon monoxide level | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| shortness of breath | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| sores on tongue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| pneumonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| insomnia/restless sleep | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| cough | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| hemorrhoids | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| vertigo | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| appendicitis | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |