Adverse Events Module

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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: 2025-12-24 @ 10:52 PM
Ignite Modification Date: 2025-12-25 @ 8:21 PM
NCT ID: NCT04528069
Description: This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.
Frequency Threshold: 5
Time Frame: Adverse events (AEs) were collected from time of consent to Day 180-210 post-treatment/study exit, up to 8 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Study: NCT04528069
Study Brief: Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Toric IOL in an Asian Population
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pretreatment Events reported in this group occurred prior to attempted implantation with the test article 0 None 0 54 0 54 View
PanOptix Toric Second Eye Events reported in this group occurred after attempted implantation with the test article and include ocular events in the second implanted eye 0 None 1 51 4 51 View
PanOptix Toric Systemic Events reported in this group occurred after attempted implantation with the test article 0 None 1 54 0 54 View
PanOptix Toric First Eye Events reported in this group occurred after attempted implantation with the test article and include ocular events in the first implanted eye 0 None 1 54 5 54 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Coronary arterial stent insertion SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (23.1) View
Intra-ocular injection SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (23.1) View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (23.1) View
Diabetic retinal oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (23.1) View
Iris adhesions SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (23.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Corneal erosion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (23.1) View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (23.1) View