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: 2025-12-24 @ 9:16 PM
Ignite Modification Date: 2025-12-25 @ 7:04 PM
NCT ID: NCT02181504
Description: The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
Frequency Threshold: 5
Time Frame: None
Study: NCT02181504
Study Brief: A Study of Abicipar Pegol in Japanese Patients With Neovascular Age-related Macular Degeneration
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Abicipar Pegol 2 mg Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16. None None 0 10 4 10 View
Abicipar Pegol 1 mg Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16. None None 0 10 8 10 View
Ranibizumab 0.5 mg Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16. None None 2 5 5 5 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chronic respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Embolic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Angle closure glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Iritis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Vitreous floaters SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Vitreous opacities SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Foreign body sensation in eyes NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Anterior chamber inflammation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Asthenopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Device breakage SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Dry eye NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Eosinophil count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Epicondylitis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Injection site haemorrhage NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Lymphadenitis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Periodontitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Vision blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Vitritis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Intraocular pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Retinal exudates SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View