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 (Control) | Participants were administered ePROM surveillance alone. Participants who responded to \>=2 ePROMs were included in the analytic cohort. | 2214 | None | 0 | 16180 | 0 | 16180 | View |
| EHR-facilitated Collaborative Care (Intervention) | Participants were administered ePROMs during EHR-facilitated collaborative care (ECC) periods. Automated responses, matched to symptom type and intensity, appeared following a patient's report of an actionable symptom, defined as \>=4/10 on a numeric rating scale (NRS). For any actionable symptom, respondents were asked if they wanted to receive symptom-specific self-management resources. For severe symptoms, \>=7/10, respondents were asked if they wanted to work remotely with a Symptom Care Manager (SCM) to develop an individualized symptom management plan. Participants who responded to \>=2 ePROMs were included in the analytic cohort. | 3192 | None | 0 | 24874 | 0 | 24874 | View |