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 @ 5:08 PM
Ignite Modification Date: 2025-12-25 @ 2:46 PM
NCT ID: NCT03192150
Description: Treatment-emergent adverse events were summarized for the Safety Population, which included all randomized participants who received at least one dose of study treatment (i.e., 152 and 79 participants in the ISV-305 and Vehicle arms, respectively).
Frequency Threshold: 2
Time Frame: Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's final visit (Day 29). Ongoing AEs were followed beyond the final study visit at the discretion of the investigator, observed up to 45 days.
Study: NCT03192150
Study Brief: 2nd Study to Assess ISV-305 Compared to Vehicle for Treatment of Inflammation and Pain Associated With 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
ISV-305 ISV-305 was administered as a topical ophthalmic formulation of 0.1% dexamethasone in DuraSite® 2 vehicle (InSite Vision's drug delivery system) twice daily (one drop in the morning and one drop in the evening) for 16 days. 0 None 1 152 47 152 View
Vehicle Vehicle (DuraSite® 2 vehicle) was administered as a matching topical ophthalmic formulation without dexamethasone twice daily (one drop in the morning and one drop in the evening) for 16 days. 0 None 0 79 30 79 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Small intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 20.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 20.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anterior chamber cell NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 20.1 View
Conjunctival hyperaemia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 20.1 View
Visual acuity reduced NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 20.1 View
Corneal oedema NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 20.1 View
Anterior chamber flare NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 20.1 View
Conjunctival oedema NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 20.1 View
Eye pain NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 20.1 View
Conjunctival haemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 20.1 View
Ciliary hyperaemia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 20.1 View
Foreign body sensation in eyes NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 20.1 View
Punctate keratitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 20.1 View
Intraocular pressure increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 20.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 20.1 View
Photophobia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 20.1 View
Posterior capsule opacification NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 20.1 View
Corneal disorder NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 20.1 View
Corneal pigmentation NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 20.1 View