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 |
|---|---|---|---|---|---|---|---|---|
| Intervention Letter | The CSM-based referral letter alone will be sent to caregivers Intervention letter: Referral letter based on the Common Sense Model of Self-Regulation (CSM). The letter includes the cognitive dimensions of the CSM (identity, cause, timeline, consequences and control). | 0 | None | 0 | 400 | 0 | 400 | View |
| Intervention Letter+DIG | The CSM-based referral letter with the dental information guide will be sent to caregivers. Intervention letter: Referral letter based on the Common Sense Model of Self-Regulation (CSM). The letter includes the cognitive dimensions of the CSM (identity, cause, timeline, consequences and control). DIG: Dental information guide (DIG) to reinforce/change illness perception, knowledge about dental caries, and resources to seek care. DIG is a brochure with illustrations which provides myths and facts about dental caries, hints for getting dental care, making appointments and Medicaid access, transportation and dentist availability resources. | 0 | None | 0 | 398 | 0 | 398 | View |
| Reduced Intervention Letter | The reduced (removing text corresponding to "timeline") CSM-based referral letter alone will be sent to caregivers. Reduced intervention letter: Reduced (removing text corresponding to "timeline") CSM theory-based referral letter. The letter includes the remaining cognitive dimensions of the CSM (identity, cause, consequences and control). | 0 | None | 0 | 43 | 0 | 43 | View |
| Reduced Intervention Letter+Reduced DIG | The reduced CSM-based referral letter with the reduced dental information guide will be sent to caregivers. Reduced intervention letter: Reduced (removing text corresponding to "timeline") CSM theory-based referral letter. The letter includes the remaining cognitive dimensions of the CSM (identity, cause, consequences and control). Reduced DIG: Text and illustrations related to the "timeline" construct of the CSM have been removed in the reduced dental information guide. | 0 | None | 0 | 63 | 0 | 63 | View |
| Standard Letter | Modified standard letter will be sent to caregivers. Standard letter: Standard referral letter according to Ohio Department of Health Bureau guidelines. This letter is consistent with others used across the country. | 0 | None | 0 | 401 | 0 | 401 | View |