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: 2025-12-25 @ 2:51 AM
Ignite Modification Date: 2025-12-26 @ 1:33 AM
NCT ID: NCT03579433
Description: Adverse events were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. "At Risk" population for ocular adverse events is included with unit of "eyes."
Frequency Threshold: 5
Time Frame: Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days.
Study: NCT03579433
Study Brief: Postmarket Study of an Intraocular Lens Power Selection System
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 All subjects prior to with attempted implantation with any IOL (successful or aborted after contact with the eye) 0 None 0 104 0 104 View
ORA With VerifEye+ Study Eye All eyes with attempted implantation (successful or aborted after contact with the eye) of Acrysof® IQ Toric IOL and ORA with VerifEye+ 0 None 2 96 10 96 View
Barrett Toric Calculator Study Eye All eyes with attempted implantation (successful or aborted after contact with the eye) of Acrysof® IQ Toric IOL and Barrett Toric Calculator 0 None 2 102 7 102 View
Overall Systemic All subjects with attempted implantation with any IOL (successful or aborted after contact with the eye) 0 None 1 104 0 104 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Metamorphopsia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (21.0) View
Retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (21.0) View
Retinal tear SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (21.0) View
Vaginal prolapse SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (21.0) View
Eye laser surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (21.0) View
Intraocular lens implant SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (21.0) View
Intraocular lens repositioning SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (21.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Posterior capsule opacification SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (21.0) View
Intraocular pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View