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 |
|---|---|---|---|---|---|---|---|---|
| Speech Recognition (TEAM Intervention) | Speech recognition: The speech recognition intervention was designed to contact families overdue for a refill and encourage greater ICS adherence, personalizing the conversation with information in the EHR while using language designed to activate parents. Families randomized to the Intervention group received one of three speech recognition call types up to eleven times within each year depending on patterns of overdue refills. All routine clinical services, including telephone availability of asthma nurses and pharmacy staff, were available to both Intervention and Usual Care families. | None | None | 0 | 590 | 0 | 590 | View |
| Speech Recognition (Usual Care) | Speech recognition: Automated, speech recognition telephone calls | None | None | 0 | 597 | 0 | 597 | View |