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 |
|---|---|---|---|---|---|---|---|---|
| Attention Guidance + Exposure | Participants will complete teleconferencing-based exposure trials with an attention guidance component. Experimental: Attention Guidance + Exposure: 1) Participants will receive a brief standardized psychoeducation module, presented via a video recording. 2\) Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes. 3\) Between speeches participants will have a 1-minute break. 4) Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial. The experimental attention guidance condition: (1) the intervention rationale will include information about the importance of visually attending to the faces of the audience; (2) participants will be given target audience members to focus their gaze on during the their impromptu response. They will be told that they should look at and focus on the target audience member for the whole response. | 0 | None | 0 | 13 | 0 | 13 | View |
| Exposure Alone | Participants will complete teleconferencing-based exposure trials. Active Comparator: Exposure Alone: 1) Participants will receive a brief standardized psychoeducation module, presented via a video recording. 2\) Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes. 3\) Between speeches participants will have a 1-minute break. 4) Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial. | 0 | None | 0 | 18 | 0 | 18 | View |
| Attention Control + Exposure | Participants will complete teleconferencing-based exposure trials with an attention control component. Experimental: Attention Control + Exposure: 1) Participants will receive a brief standardized psychoeducation module, presented via a video recording. F 2) Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes. During each call participants will be prompted by one of the audience members. 3\) Between speeches participants will have a 1-minute break. 4) Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial. The experimental attention control condition: (1) the intervention rationale will include information about the importance of attention control; (2) participants will be given target at the center of the screen to focus their gaze on during the their impromptu response. They will be told that they should look at and focus on the target for the whole response. | 0 | None | 0 | 22 | 0 | 22 | View |