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 |
|---|---|---|---|---|---|---|---|---|
| Usual Care | Usual care | 2 | None | 0 | 1863 | 0 | 1863 | View |
| Electronic Health Record "Gaps" | Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient | 2 | None | 0 | 1863 | 0 | 1863 | View |
| Bulk Outreach | Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient Bulk outreach: A bulk letter or email will be sent | 3 | None | 0 | 1862 | 0 | 1862 | View |
| Personalized Outreach | Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent and patients will receive a personalized call by a registered dietitian EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient Bulk outreach: A bulk letter or email will be sent Dietician call: Patients will receive a personalized call by a registered dietitian | 1 | None | 0 | 1000 | 0 | 1000 | View |