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 |
|---|---|---|---|---|---|---|---|---|
| Reciprocal Peer Support Intervention | participants in the intervention arm are paired with a peer Peer-support telephone calls: peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study. group outpatient counseling visits: participants are given the option to attend 3 optional group visits with other participants and case managers. this gives them the opportunity to ask any diabetes related questions of nurses or other participants who have diabetes. | None | None | 2 | 125 | 0 | 125 | View |
| Nurse Case Management Intervention | participants were randomized to receive usual care with an initial educational session to review lab results and discuss any questions related to educational handouts | None | None | 1 | 119 | 0 | 119 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Death | SYSTEMATIC_ASSESSMENT | General disorders | death | View |