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 | Inhaler technique education and distribution of spacers to all participants. | 0 | None | 0 | 126 | 0 | 126 | View |
| CAPE | Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge. | 0 | None | 0 | 126 | 0 | 126 | View |
| CAPE + Home | Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. Community-health worker-led home visits. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge. Home: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation. | 0 | None | 0 | 121 | 0 | 121 | View |