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 |
|---|---|---|---|---|---|---|---|---|
| Test Product | Ciclopirox Olamine Topical Suspension | None | None | 0 | 220 | 0 | 220 | View |
| Reference Product | Loprox® Topical Suspension 0.77% | None | None | 2 | 224 | 0 | 224 | View |
| Vehicle Product | placebo of test product | None | None | 4 | 109 | 0 | 109 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 7.1 | View |
| Perforated sigmoid colon | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 7.1 | View |
| Subarachnoid hemorrhage; MCA aneurysm; PCOM | None | Nervous system disorders | MedDRA (7.1) | View |
| Blood clots spleen | None | Gastrointestinal disorders | MedDRA (7.1) | View |
| Seizures (transient ischaemic attack) | None | Nervous system disorders | MedDRA (7.1) | View |
| Right hip fracture | None | Musculoskeletal and connective tissue disorders | MedDRA (7.1) | View |