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 @ 1:13 PM
Ignite Modification Date: 2025-12-25 @ 12:24 PM
NCT ID: NCT01001195
Description: The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).
Frequency Threshold: 5
Time Frame: None
Study: NCT01001195
Study Brief: Safety and Efficacy of Three Formulations of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AGN-210669 Ophthalmic Solution, 0.1% One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. None None 1 39 28 39 View
AGN-210669 Ophthalmic Solution, 0.075% One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. None None 0 41 35 41 View
AGN-210669 Ophthalmic Solution, 0.05% One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. None None 0 44 23 44 View
Bimatoprost Ophthalmic Solution 0.03% One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. None None 0 41 29 41 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctival Hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 13.0 View
Punctate Keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 13.0 View
Photophobia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 13.0 View
Eye Pain NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 13.0 View
Vision Blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 13.0 View
Foreign Body Sensation in Eyes NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 13.0 View
Anterior Chamber Cell SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 13.0 View
Eye Irritation NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 13.0 View
Instillation Site Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 13.0 View
Eye Pruritus NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 13.0 View