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 |
|---|---|---|---|---|---|---|---|---|
| Semi-structured Interview | This is a qualitative study using semi-structured interviews with young people aged 12-18 who are receiving consultation summaries. Patients attending a single diabetes service will be invited to enrol. This service serves a population from a wide geographic area and socio-economic backgrounds. Interviews will be conducted by a qualitative researcher with relevant experience. They will be held on the day of a participant's clinic appointment within the same hospital or on the day agreed with the participant. No intervention: Interviews contain no intervention, purely observational. | 0 | None | 0 | 9 | 0 | 9 | View |