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 @ 7:58 PM
Ignite Modification Date: 2025-12-25 @ 5:32 PM
NCT ID: NCT05022004
Description: None
Frequency Threshold: 0
Time Frame: 7 Weeks
Study: NCT05022004
Study Brief: A Therapeutic Equivalence Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Azopt® Azopt®: dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks 0 None 1 300 38 300 View
BRIN-20-01 Brinzolamide ophthalmic suspension: dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks 0 None 0 297 49 297 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypertensive Crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 24.0 View
Abnormal Sensation in Eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 24.0 View
Blepharitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 24.0 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 24.0 View
Conjunctival Hyperemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 24.0 View
Conjunctival Oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 24.0 View
Conjunctivitis Allergic SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 24.0 View
Dry Eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 24.0 View
Eye Irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 24.0 View
Eye Pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 24.0 View
Eye Pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 24.0 View
Foreign Body Sensation in Eyes SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 24.0 View
Keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 24.0 View
Lacrimation Increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 24.0 View
Ocular Hyperemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 24.0 View
Swelling of Eyelid SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 24.0 View
Vision Blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 24.0 View
Visual Acuity Reduced SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 24.0 View
Visual Impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 24.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 24.0 View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 24.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 24.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 24.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA version 24.0 View
Instillation Site Dryness SYSTEMATIC_ASSESSMENT General disorders MedDRA version 24.0 View
Instillation Site Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA version 24.0 View
Instillation Site Pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA version 24.0 View
Instillation Site Reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA version 24.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA version 24.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA version 24.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 24.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 24.0 View
Respiratory Tract Infection Viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 24.0 View
Ligament Sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 24.0 View
Blood Pressure Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 24.0 View
Intraocular Pressure Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 24.0 View
Hypercholesterolemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 24.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 24.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 24.0 View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 24.0 View
Osteochondrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 24.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 24.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 24.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 24.0 View
Breast Cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA version 24.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 24.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 24.0 View
Respiratory Disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 24.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 24.0 View
Hypertensive Crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 24.0 View