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 |
|---|---|---|---|---|---|---|---|---|
| Condition 7 | Location triggered messaging - ON, Benefits of change - OFF, Coach monitoring - ON, Household support - ON. | 0 | None | 1 | 5 | 0 | 5 | View |
| Condition 8 | Location triggered messaging - ON, Benefits of change - OFF, Coach monitoring - OFF, Household support - ON. | 0 | None | 0 | 2 | 0 | 2 | View |
| Condition 9 | Location triggered messaging - ON, Benefits of change - OFF, Coach monitoring - ON, Household support - OFF. | 0 | None | 0 | 3 | 0 | 3 | View |
| Condition 10 | Location triggered messaging - OFF, Benefits of change - ON, Coach monitoring - OFF, Household support - OFF. | 0 | None | 0 | 5 | 0 | 5 | View |
| Condition 11 | Location triggered messaging - OFF, Benefits of change - ON, Coach monitoring - ON, Household support - OFF. | 0 | None | 0 | 6 | 0 | 6 | View |
| Condition 12 | Location triggered messaging - OFF, Benefits of change - ON, Coach monitoring - ON, Household support - ON. | 0 | None | 0 | 2 | 0 | 2 | View |
| Condition 13 | Location triggered messaging - OFF, Benefits of change - ON, Coach monitoring - OFF, Household support - ON. | 0 | None | 0 | 5 | 0 | 5 | View |
| Condition 14 | Location triggered messaging - OFF, Benefits of change - OFF, Coach monitoring - ON, Household support - OFF. | 0 | None | 0 | 2 | 0 | 2 | View |
| Condition 15 | Location triggered messaging - OFF, Benefits of change - OFF, Coach monitoring - OFF, Household support - ON. | 0 | None | 0 | 4 | 0 | 4 | View |
| Condition 16 | Location triggered messaging - OFF, Benefits of change - OFF, Coach monitoring - ON, Household support - ON. | 0 | None | 0 | 4 | 0 | 4 | View |
| Condition 1 | Location triggered messaging - OFF, Benefits of change - OFF, Coach monitoring - OFF, Household support - OFF. | 0 | None | 0 | 4 | 0 | 4 | View |
| Condition 2 | Location triggered messaging - ON, Benefits of change - OFF, Coach monitoring - OFF, Household support - OFF. | 0 | None | 0 | 7 | 0 | 7 | View |
| Condition 3 | Location triggered messaging - ON, Benefits of change - ON, Coach monitoring - OFF, Household support - OFF. | 0 | None | 0 | 2 | 0 | 2 | View |
| Condition 4 | Location triggered messaging - ON, Benefits of change - ON, Coach monitoring - ON, Household support - OFF. | 0 | None | 0 | 2 | 0 | 2 | View |
| Condition 5 | Location triggered messaging - ON, Benefits of change - ON, Coach monitoring - ON, Household support - ON. | 0 | None | 0 | 7 | 0 | 7 | View |
| Condition 6 | Location triggered messaging - ON, Benefits of change - ON, Coach monitoring - OFF, Household support - ON. | 0 | None | 0 | 2 | 0 | 2 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |