Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 4:03 AM
Ignite Modification Date: 2025-12-26 @ 2:57 AM
NCT ID: NCT03216902
Description: None
Frequency Threshold: 5
Time Frame: Reporting time frame is from Inform Consent to end of the study at Month3.
Study: NCT03216902
Study Brief: A Phase IIb Safety and Efficacy Study of DE-126 Ophthalmic Solution in Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ultra-low Dose DE-126 Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks 0 None 0 43 13 43 View
Medium Dose DE-126 Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks 0 None 0 44 10 44 View
Placebo P1 Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks. 0 None 1 22 2 22 View
Placebo P2 Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution treatment arm dosed by high dose of DE-126 dosed once daily from w6 to month3. 0 None 0 20 10 20 View
0.005% Latanoprost 0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks 0 None 0 44 18 44 View
Low Dose DE-126 Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks 0 None 0 43 12 43 View
High Dose of DE-126 Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks 0 None 0 45 12 45 View
High Dose of DE-126 Total Summarizes columns High dose of DE-126 and Placebo P2 0 None 0 65 22 65 View
DE-126 Total Total summarizes columns Ultra Low Dose, Low Dose, Medium Dose, High Dose and Placebo P2. 0 None 0 195 57 195 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctival Hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye Irritation SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye Pruritus SYSTEMATIC_ASSESSMENT Eye disorders None View
Growth Of Eyelashes SYSTEMATIC_ASSESSMENT Eye disorders None View
Lacrimation Increased SYSTEMATIC_ASSESSMENT Eye disorders None View
Instillation Site Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Alveolar Osteitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hepatic Enzyme Increased SYSTEMATIC_ASSESSMENT Investigations None View
Hypertonic Bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Skin Lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders None View