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 |
|---|---|---|---|---|---|---|---|---|
| 2.0 mg Intravitreal Aflibercept | open label, Subjects seen monthly \& given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT) aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg | None | None | 9 | 45 | 6 | 45 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Urinary Tract Infection | None | Infections and infestations | None | View |
| Death | None | Cardiac disorders | None | View |
| Atrial fibrillation | None | Cardiac disorders | None | View |
| Squamous cell carcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Upper respiratory tract infection | None | Respiratory, thoracic and mediastinal disorders | None | View |