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 |
|---|---|---|---|---|---|---|---|---|
| Adult Subjects With Crohn's Disease | These were consecutive subjects prospectively identified and enrolled from an outpatient clinic of Jill Roberts Center for Inflammatory Bowel Disease (IBD) at a tertiary care academic medical center. Subjects between 18 and 65 were enrolled from April 2016 through May 2017. All subjects met clinical, pathological or radiological criteria for CD. Patients with ulcerative colitis, indeterminate colitis, other inflammatory arthritis (eg, rheumatoid arthritis, systemic lupus erythematosus, psoriatic or reactive arthritis), co-existent autoimmune diseases (eg, celiac disease, Behçet's disease) or skin psoriasis were excluded. All subjects were either biologic naïve or had been off systemic biologics \>6 months prior to enrollment and could remain on non-biologic CD therapy (eg, methotrexate, sulfasalazine, azathioprine or 6-mercaptopurine). Patients could also be on vedolizumab, an antagonist of α4β7 integrin in the intestinal epithelium which has no established efficacy in extra-intestinal manifestations of CD. Other exclusions included malignancy less than 5 years in remission (except for non-melanomatous skin cancer) or having a contraindication to MRI. | 0 | None | 0 | 33 | 0 | 33 | View |