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 @ 2:46 PM
Ignite Modification Date: 2025-12-25 @ 1:15 PM
NCT ID: NCT04324359
Description: Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.
Frequency Threshold: 5
Time Frame: Overall study period
Study: NCT04324359
Study Brief: Study to See How Well an Eye Drop, SURF-201, Works and What Side Effects There Are in Cataract Surgery Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SURF-201 0.2% topical preservative-free corticosteroid solution (0.2% betamethasone sodium phosphate) SURF-201: One drop twice daily (BID) in the study eye for 16 days. 0 None 3 40 26 40 View
Vehicle Topical preservative-free vehicle (Placebo) Placebo: One drop twice daily (BID) in the study eye for 16 days. 0 None 0 43 23 43 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Intraocular pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 23.0 View
Cystoid macular edema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 23.0 View
Posterior caple rupture SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 23.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Visual acuity reduced SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 23.0 View
Eye inflammation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 23.0 View
Posterior capsule opacification SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 23.0 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 23.0 View
Corneal edema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 23.0 View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 23.0 View
Conjunctival hyperemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 23.0 View
Iritis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 23.0 View
Vitreous detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 23.0 View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 23.0 View
Vitreous floaters SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 23.0 View
Intraocular pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 23.0 View