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 |
|---|---|---|---|---|---|---|---|---|
| Verbally Repeat Body-related Thoughts | A cognitive defusion strategy in which participants repeat a target unwanted thought out loud and as quickly as possible for 60 seconds. Cognitive Defusion: Cognitive defusion aims to change one's relationship to their thoughts - as opposed to changing the content, form, or frequency - by reframing internal experiences as less threatening (Hayes, Luoma, Bond, Masuda, \& Lillis, 2006). It is the process of detaching the link between one's thoughts and perceptions of reality and acknowledging the role one's thoughts play in their internal events. A number of techniques have been developed to remove the literal quality of such thoughts, including repeating the thought, and, more recently, singing the thought. | 0 | None | 0 | 27 | 0 | 27 | View |
| Sing Negative Body-related Thoughts | A cognitive defusion strategy in which participants sing a target unwanted thought to the tune of 'twinkle, twinkle' for 60 seconds Cognitive Defusion: Cognitive defusion aims to change one's relationship to their thoughts - as opposed to changing the content, form, or frequency - by reframing internal experiences as less threatening (Hayes, Luoma, Bond, Masuda, \& Lillis, 2006). It is the process of detaching the link between one's thoughts and perceptions of reality and acknowledging the role one's thoughts play in their internal events. A number of techniques have been developed to remove the literal quality of such thoughts, including repeating the thought, and, more recently, singing the thought. | 0 | None | 0 | 33 | 0 | 33 | View |
| Verbally Repeat Body-unrelated Thoughts | A control condition in which participants repeat the phrase "I am talking" out loud and as quickly as possible for 60 seconds. | 0 | None | 0 | 31 | 0 | 31 | View |
| Sing Body-unrelated Thoughts | A control condition in which participants sing the phrase "I am singing" to the tune of 'twinkle, twinkle' for 60 seconds | 0 | None | 0 | 31 | 0 | 31 | View |