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 |
|---|---|---|---|---|---|---|---|---|
| BHW Plus Movies | Brain Health Workshop consists of 2-hour, 10 weekly sessions using Power Point presentations and national geographic movies (2-hour, 10 weekly sessions). Brain Health Workshop: . BHW was developed specifically for consistency with GMT session length and contact with the facilitator49. BHW is an education presentation on brain function and cognitive principles of learning with homework and quizzes on information covered. To match time and contact of attention training, control participants will meet with the therapist for a separate two-hour session from BHW National geographic movies: participants will select movies to watch and answer a few questions about to equate the time and therapist interaction to attention training in arm 1. | 0 | None | 0 | 2 | 0 | 2 | View |
| GMT Plus Attention | GMT consists of 2-hour, 10 weekly sessions using an interactive Power Point presentations. Attention training consists of 2-hour computerized attention training using Attention Process Training III and Brain HQ. Goal Management Training: GMT: is a 10-session intervention to improve planning and problem solving. Interactive Power Point modules are administered by a cognitive therapist. Each session builds on the steps of a five-stage planning and problem-solving strategy. Veterans will be taught to generate and verbalize the following five-steps: "stop-what am I doing?", "define the goal", "list the steps", "learn the steps"; then, "check-am I doing what I planned?" The five-stage strategy is then incorporated into a variety of activities in the laboratory and in-home assignments. Attention Training: Attention Process Training (APT-III) will be administered for a second weekly session in addition to the GMT session. Each session will be 2 hours/ week for 10 weeks. Veterans will also engage in BrainHQTM attention training at home for one-hour, five days/ week comprised of selected components of BrainHQ from Posit Science Corporation. This web-based computerized CRT modality of cognitive training is a restorative or "bottom-up" approach that targets basic cognitive skills such as arousal and vigilance processes, attention and information processing, and directly engages fundamental attention-control skills through repetitive graded exercises. | 0 | None | 0 | 18 | 0 | 18 | View |