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 |
|---|---|---|---|---|---|---|---|---|
| Glaucoma Subjects With IOP 22-32 mmHg | Forty four (44) patients will have testing done using optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF). Testing will be repeated at 1-2 months, 4-6 months and 9-12 months after the initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT's and one (1) VEP). Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL. Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head. Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma. | 0 | None | 0 | 44 | 0 | 44 | View |
| Glaucoma Subjects With IOP >32 mmHg | Six (6) patients will have testing done using optical coherence tomography (OCT), Visual Evoked Potential (VEP) and visual field (VF). This testing will be repeated one (1) hour, one (1) day and three (3) months following the eye pressure lowering intervention. Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL. Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head. Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma. | 0 | None | 0 | 6 | 0 | 6 | View |
| Control Glaucoma Subjects | Eleven (11) patients will have testing done using optical coherence tomography (OCT), Visual Evoked Potential (VEP) and visual field (VF). Testing will be repeated at 1-2 months, 4-6 months and 9-12 months after the initial testing was completed. Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL. Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head. Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma. | 0 | None | 0 | 11 | 0 | 11 | View |