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 @ 5:01 PM
Ignite Modification Date: 2025-12-25 @ 2:41 PM
NCT ID: NCT00905450
Description: None
Frequency Threshold: 5
Time Frame: 18 days
Study: NCT00905450
Study Brief: Evaluation of BOL-303242-X Versus Vehicle for the Treatment of Inflammation Following Cataract Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
1% Twice a Day BOL-303242-X ophthalmic suspension 1% Twice a Day None None 0 60 43 60 View
2% Once a Day BOL-303242-X ophthalmic suspension 2% Once a Day None None 0 28 20 28 View
2% Twice a Day BOL-303242-X ophthalmic suspension 2% Twice a Day None None 0 28 7 28 View
2% Four Times a Day BOL-303242-X ophthalmic suspension 2% Four times a Day None None 0 60 18 60 View
3% Once a Day BOL-303242-X ophthalmic suspension 3% Once a Day None None 1 59 11 59 View
3% Twice a Day BOL-303242-X ophthalmic suspension 3% Twice a Day None None 1 60 25 60 View
3% Four Times a Day BOL-303242-X ophthalmic suspension 3% Four times a Day None None 0 60 21 60 View
Vehicle Vehicle for BOL-303242-X ophthalmic suspension None None 0 60 37 60 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Subretinal neovascularization NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cystoid macular edema NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Eye pain NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Photophobia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
AC Inflammation NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Ocular hyperaemia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Lacrimation increased NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Corneal edema NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Foreign body sensation in eyes NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Dry eye NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye pruritis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Iritis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Conjunctival hyperemia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
AC Flare NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye inflammation NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Ciliary hyperemia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Intraocular pressure increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View