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 |
|---|---|---|---|---|---|---|---|---|
| Online Speech Perception Training | Participants will be randomly assigned to transition from the baseline to the treatment condition at one of 7 possible points, ranging from 4 to 10 baseline sessions. All participants will receive 12 sessions of perceptual training over 4 weeks. Finally, participants will complete a 3-session maintenance phase in which perception and production are probed but not treated. Perception will be measured using the identification and category goodness judgment. Following completion of perception training all participants will complete two weeks of production training. The production training will consists of 4, 60-minute sessions. Each session will provide instruction and practice trials. | 0 | None | 0 | 10 | 0 | 10 | View |