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 |
|---|---|---|---|---|---|---|---|---|
| Normals | Nidek Mirante: The Nidek Mirante Optical Coherence Tomography (OCT) including scanning laser ophthalmoscope (SLO) function is an non-contact system for imaging the fundus and for axial cross sectional imaging of anterior and posterior ocular structures. Optovue RTVue XR Avanti: The Avanti is an optical coherence tomography system indicated for the in vivo imaging,axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures. Optos P200DTx: The P200DTx scanning laser ophthalmoscope (SLO) is indicated for use as a widefield and retinal fluorescence and autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases and disorders that manifest in the retina. | 0 | None | 0 | 45 | 0 | 45 | View |
| Retina | Nidek Mirante: The Nidek Mirante Optical Coherence Tomography (OCT) including scanning laser ophthalmoscope (SLO) function is an non-contact system for imaging the fundus and for axial cross sectional imaging of anterior and posterior ocular structures. Optovue RTVue XR Avanti: The Avanti is an optical coherence tomography system indicated for the in vivo imaging,axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures. Optos P200DTx: The P200DTx scanning laser ophthalmoscope (SLO) is indicated for use as a widefield and retinal fluorescence and autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases and disorders that manifest in the retina. | 0 | None | 0 | 47 | 0 | 47 | View |
| Glaucoma | Nidek Mirante: The Nidek Mirante Optical Coherence Tomography (OCT) including scanning laser ophthalmoscope (SLO) function is an non-contact system for imaging the fundus and for axial cross sectional imaging of anterior and posterior ocular structures. Optovue RTVue XR Avanti: The Avanti is an optical coherence tomography system indicated for the in vivo imaging,axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures. Optos P200DTx: The P200DTx scanning laser ophthalmoscope (SLO) is indicated for use as a widefield and retinal fluorescence and autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases and disorders that manifest in the retina. | 0 | None | 0 | 46 | 0 | 46 | View |
| Corneal Disease | Nidek Mirante: The Nidek Mirante Optical Coherence Tomography (OCT) including scanning laser ophthalmoscope (SLO) function is an non-contact system for imaging the fundus and for axial cross sectional imaging of anterior and posterior ocular structures. Optovue RTVue XR Avanti: The Avanti is an optical coherence tomography system indicated for the in vivo imaging,axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures. | 0 | None | 0 | 32 | 0 | 32 | View |