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
Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:57 PM
NCT ID:
NCT04098367
Description:
An AE was defined at any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Frequency Threshold:
5
Time Frame:
Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months.
Study:
NCT04098367
Study Brief:
Clinical Investigation of the AcrySof IQ Vivity Extended Vision Intraocular Lens (IOL)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| VIVITY First Eye | All eyes that had contact with the VIVITY IOL (successful or aborted implant) | 0 | None | 1 | 63 | 7 | 63 | View |
| VIVITY Second Eye | All eyes that had contact with the VIVITY IOL (successful or aborted implant) | 0 | None | 0 | 63 | 7 | 63 | View |
| VIVITY Systemic | All subjects that had contact with the VIVITY IOL (successful or aborted implant) | 0 | None | 0 | 63 | 0 | 63 | View |
| SYMFONY First Eye | All eyes that had contact with the SYMFONY IOL (successful or aborted implant) | 0 | None | 1 | 65 | 12 | 65 | View |
| SYMFONY Second Eye | All eyes that had contact with the SYMFONY IOL (successful or aborted implant) | 0 | None | 3 | 65 | 10 | 65 | View |
| SYMFONY Systemic | All subjects that had contact with the SYMFONY IOL (successful or aborted implant) | 0 | None | 1 | 65 | 0 | 65 | View |
| AT LARA First Eye | All eyes that had contact with the AT LARA IOL (successful or aborted implant) | 0 | None | 3 | 65 | 17 | 65 | View |
| AT LARA Second Eye | All eyes that had contact with the AT LARA IOL (successful or aborted implant) | 0 | None | 2 | 63 | 16 | 63 | View |
| AT LARA Systemic | All subjects that had contact with the AT LARA IOL (successful or aborted implant) | 0 | None | 4 | 65 | 0 | 65 | View |
| Pretreatment | All subjects prior to with attempted implantation with any IOL (successful or aborted implant) | 0 | None | 0 | 193 | 0 | 193 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (22.0) | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (22.0) | View |
| Cystoid macular oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (22.0) | View |
| Halo vision | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (22.0) | View |
| Macular fibrosis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (22.0) | View |
| Visual impairment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (22.0) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (22.0) | View |
| Posterior capsule rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (22.0) | View |
| Intraocular pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| Paracentesis | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| Carotid artery aneurysm | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (22.0) | View |
| Angioplasty | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (22.0) | View |
| Lens extraction | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (22.0) | View |
| Parathyroidectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (22.0) | View |
| Retinal operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (22.0) | View |
| Vitrectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (22.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Posterior capsule opacification | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (22.0) | View |