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: 2025-12-25 @ 1:43 AM
Ignite Modification Date: 2025-12-26 @ 12:01 AM
NCT ID: NCT03858894
Description: None
Frequency Threshold: 0
Time Frame: All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
Study: NCT03858894
Study Brief: Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma SPECTRUM 6
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Test Arm: DE-117 BID DE-117 Ophthalmic Solution BID Twice daily (20:00 and 8:00) DE-117 Ophthalmic Solution BID: DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye 0 None 0 48 20 48 View
Drug Arm: DE-117 QD DE-117 Ophthalmic Solution QD (20:00) and Vehicle (8:00; no active DE-117 ingredient) QD DE-117 Ophthalmic Solution QD: DE-117 ophthalmic solution QD and Vehicle (no active DE-117 ingredient) QD add one drop in each eye 0 None 1 50 7 50 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctival hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.1 View
Ocular hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.1 View
Accommodation disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.1 View
Corneal pigmentation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.1 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.1 View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.1 View
Glare SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.1 View
Iridocyclitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.1 View
Iritis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.1 View
Ocular discomfort SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.1 View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.1 View
Visual impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.1 View
Punctate keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.1 View
Vital dye staining cornea present SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Device dislocation SYSTEMATIC_ASSESSMENT Product Issues MedDRA 21.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
Myelodysplastic syndrome SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View