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 @ 4:35 PM
Ignite Modification Date: 2025-12-25 @ 2:26 PM
NCT ID: NCT01657266
Description: During the pharmacological intervention period, in each visit, the principal investigator asked information about adverse events: 1. Serious or No serious 2. Severity: mild, moderate, severe 3. relation with study drug or not
Frequency Threshold: 1
Time Frame: Interval of 30 days of intervention in which adverse events could occur, included in the treatment period (January 2014-2015)
Study: NCT01657266
Study Brief: Efficacy and Safety of PRO-155 Versus Nevanac in Post Phacoemulsification
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PRO-155 Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye Maintenance therapy: 1 drop 3 times a day for 30 days PRO-155: Pre-medication (before surgery) and maintenance treatment. None None 0 73 5 73 View
Nevanac Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye Maintenance therapy: 1 drop 3 times a day for 30 days Nevanac: Pre-medication (before surgery) and maintenance treatment. None None 2 75 2 75 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
central retinal artery occlusion SYSTEMATIC_ASSESSMENT Eye disorders None View
Rhegmatogenous retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
fall from their own height SYSTEMATIC_ASSESSMENT Vascular disorders None View
Cystoid macular edema SYSTEMATIC_ASSESSMENT Eye disorders None View
Traumatic corneal desepithelization SYSTEMATIC_ASSESSMENT Eye disorders None View
Posterior Capsular Rupture SYSTEMATIC_ASSESSMENT Eye disorders None View
viral conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Inflammatory cells in the corneal endothelium SYSTEMATIC_ASSESSMENT Eye disorders None View
intraocular lens exchange SYSTEMATIC_ASSESSMENT Eye disorders None View