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 |
|---|---|---|---|---|---|---|---|---|
| Information Only | INTERVENTION: Information about colon cancer and screening tests. Education information: Typical materials are used to present educational information to participants about colon cancer and screening tests. | 0 | None | 0 | 159 | 0 | 159 | View |
| Screener Narrative | INTERVENTION: Information + Personal Narrative from someone who was screened for colon cancer Health communication intervention: This study will compare the effects of adding personal experiences with colon cancer screening to educational information to explore potential differences in reactions to different role models on individuals' screening intentions and behaviors. Education information: Typical materials are used to present educational information to participants about colon cancer and screening tests. | 0 | None | 0 | 155 | 0 | 155 | View |
| Survivor Narrative | INTERVENTION: Information + Personal Narrative from someone who was screened for, and diagnosed with, colon cancer Health communication intervention: This study will compare the effects of adding personal experiences with colon cancer screening to educational information to explore potential differences in reactions to different role models on individuals' screening intentions and behaviors. Education information: Typical materials are used to present educational information to participants about colon cancer and screening tests. | 0 | None | 0 | 159 | 0 | 159 | View |