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 |
|---|---|---|---|---|---|---|---|---|
| Cohort 1 | Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision. | 0 | None | 0 | 44 | 10 | 44 | View |
| Cohort 2 | Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision. | 0 | None | 1 | 56 | 13 | 56 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Study Eye - Raised IOP Requiring Treatment | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Study Eye - Posterior Capsule Rupture | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Study Eye -Vitreal Prolapse | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Study Eye - Cystoid Macular Edema | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Study Eye - Increased Inflammation | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Study Eye - Ectropion | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Study Eye - Dry Eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Study Eye - Corneal Edema | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Study Eye - Crocodile Shagreen | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Study Eye - Microcystic Corneal Edema | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Study Eye - IOL Exchange | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |