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 @ 9:14 PM
Ignite Modification Date: 2025-12-25 @ 7:03 PM
NCT ID: NCT06071104
Description: AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.
Frequency Threshold: 5
Time Frame: Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 3 months.
Study: NCT06071104
Study Brief: Next Generation Cataract Surgery Study
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 AEs in this group occurred prior to treatment with UNITY VCS 0 None 0 108 0 108 View
UNITYVCSstudyeye AEs in this group occurred after attempted treatment with with UNITY VCS and include ocular events in the study eye. "At Risk" population is reported in units of eyes. 0 None 2 108 0 108 View
UNITYVCSSystemic AEs in this group occurred after attempted treatment with UNITY VCS and include overall systemic events as well as ocular events in the non-study eye. "At Risk" population is reported in units of subjects. 0 None 3 108 0 108 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (26.1) View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (26.1) View
Pneumonia streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (26.1) View
Cataract operation complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (26.1) View
Intraocular pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (26.1) View
Lens extraction SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (26.1) View
Other Events(If Any):