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 |
|---|---|---|---|---|---|---|---|---|
| People Diagnosed With Inflammatory Bowel Disease and Presence of a Mental Health Condition | Children, adolescents and young adults (aged 5- 25 years) diagnosed with Inflammatory Bowel Disease (IBD); comprising of Ulcerative Colitis, Crohn's Disease and Unclassified IBD and presence of a diagnosis of a mental health condition. Mental health condition comprises any of depression (recurrent depressive disorder or depressive episode), non-phobia-related anxiety disorder (AD), eating disorders, body image disorder, attention-deficit disorder, behavioural disorders, adjustment disorder, acute stress disorder, schizophrenia, bipolar disorder or post-traumatic stress disorder. | 0 | None | 0 | 0 | 0 | 0 | View |
| People Diagnosed With Inflammatory Bowel Disease and Absence of a Mental Health Condition | Children, adolescents and young adults (aged 5- 25 years) diagnosed with Inflammatory Bowel Disease (IBD); comprising of Ulcerative Colitis, Crohn's Disease and Unclassified IBD and absence of a diagnosis of a mental health condition. Mental health condition comprises any of depression (recurrent depressive disorder or depressive episode), non-phobia-related anxiety disorder (AD), eating disorders, body image disorder, attention-deficit disorder, behavioural disorders, adjustment disorder, acute stress disorder, schizophrenia, bipolar disorder or post-traumatic stress disorder. | 0 | None | 0 | 0 | 0 | 0 | View |