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 |
|---|---|---|---|---|---|---|---|---|
| SMS Turkey | 6-week smoking cessation program delivered via daily text messages SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory. Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day. Depending on the participant's content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages). | None | None | 0 | 76 | 0 | 76 | View |
| Brochure Control | A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages. The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter. | None | None | 0 | 75 | 0 | 75 | View |