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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Control | A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute (NCI) 5 A's model. Cessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up. | 0 | None | 0 | 52 | 0 | 52 | View |
| COach2Quit | A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute's 5 A's model. Participants in the COach2Quit arm will be provided with an individualized carbon monoxide (iCO) monitor along with instructions on the use of the monitor and the COach2Quit application. Individualized carbon monoxide (iCO) monitor: a personal monitor for a breath test for carbon monoxide (CO) COach2Quit smartphone application: This smartphone application works in conjunction with the iCO monitor Cessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up. | 0 | None | 0 | 50 | 0 | 50 | View |