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: 2025-12-26 @ 2:40 PM
Ignite Modification Date: 2025-12-26 @ 2:40 PM
NCT ID: NCT02197806
Description: The Safety Population included all patients who received at least 1 dose of study treatment and was used to assess adverse events (AEs) and serious adverse events (SAEs).
Frequency Threshold: 5
Time Frame: None
Study: NCT02197806
Study Brief: Safety and Efficacy of AGN-199201 and AGN-190584 in Patients With Presbyopia
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-199201 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each. None None 0 15 5 15 View
AGN-190584 1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each. None None 0 17 4 17 View
AGN-199201 + AGN-190584 in One Eye 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each. None None 0 16 8 16 View
AGN-199201 + AGN-190584 in Both Eyes 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each. None None 0 17 5 17 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vision Blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 17.1 View
Conjunctival Hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 17.1 View
Lacrimation Increased NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 17.1 View
Metamorphopsia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 17.1 View
Ocular Discomfort NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 17.1 View
Eyelid Retraction NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 17.1 View
Photophobia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 17.1 View
Eye Irritation NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 17.1 View
Punctate Keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 17.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 17.1 View
Product Taste Abnormal NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 17.1 View
Discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 17.1 View
Upper Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 17.1 View
Blood Pressure Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 17.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 17.1 View