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 @ 11:05 PM
Ignite Modification Date: 2025-12-25 @ 8:36 PM
NCT ID: NCT03231969
Description: None
Frequency Threshold: 0
Time Frame: Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
Study: NCT03231969
Study Brief: A Single-Center, Phase 2 Study Evaluating Bilastine Ophthalmic Solution in the CAC® Model
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Bilastine 0.2% Bilastine 0.2%: 1 drop in each eye at 3 separate times during a 25 day period. 0 None 0 30 8 30 View
Bilastine 0.4% Bilastine 0.4%: 1 drop in each eye at 3 separate times during a 25 day period. 0 None 0 30 3 30 View
Bilastine 0.6% Bilastine 0.6%: 1 drop in each eye at 3 separate times during a 25 day period. 0 None 0 31 1 31 View
Bilastine 0% Bilastine 0%: 1 drop in each eye at 3 separate times during a 25 day period. 0 None 0 30 7 30 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Visual Acuity Reduced NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 20.0 View
Blepharitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 20.0 View
Corneal Deposits NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 20.0 View
Eye Discharge NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 20.0 View
Keratitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 20.0 View
Macular Fibrosis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 20.0 View
Hordeolum NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 20.0 View
Viral Upper Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 20.0 View
Gastroenteritis Viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 20.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 20.0 View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 20.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 20.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 20.0 View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 20.0 View