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 |
|---|---|---|---|---|---|---|---|---|
| Sertraline | Fluconazole Standard of Care + Sertraline Sertraline: sertraline 400mg/day Fluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months). | 0 | None | 4 | 11 | 4 | 11 | View |
| Control | Fluconazole Standard of Care + Placebo Oral Tablet Placebo Oral Tablet: matched placebo tablet Fluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months). | 1 | None | 3 | 11 | 1 | 11 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute Gastrointestinal bleeding | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Mania with Psychotic Disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Pulmonary Embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Meningitis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Psychosis with Serotonin Syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Death | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |