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 |
|---|---|---|---|---|---|---|---|---|
| Monofocal IOL | Monofocal IOL, bilateral implantation | None | None | 9 | 100 | 0 | 100 | View |
| Multifocal IOL | AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation | None | None | 13 | 106 | 0 | 106 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Endophthalmitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Chronic pulmonary obstructive disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Cardiac disorder | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.0) | View |
| Astigmatism | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.0) | View |
| Corneal oedema | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.0) | View |
| Cystoid macular oedema | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.0) | View |
| Iridocele | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.0) | View |
| Lens dislocation | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.0) | View |
| Photophobia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.0) | View |
| Posterior capsular opacification | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.0) | View |
| Retinal detachment | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.0) | View |
| Retinal tear | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.0) | View |
| Vitreous detachment | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.0) | View |
| Vitreous loss | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.0) | View |
| Vitritis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.0) | View |
| Intestinal functional disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Device material issue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Eye operation complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Intraocular pressure increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.0) | View |
| Leukaemia | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | View |
| Lung neoplasm malignant | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | View |
| Neuroma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | View |
| Nephrolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (14.0) | View |