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: 2025-12-26 @ 10:34 AM
Ignite Modification Date: 2025-12-26 @ 10:34 AM
NCT ID: NCT02355028
Description: An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
Frequency Threshold: 5
Time Frame: Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
Study: NCT02355028
Study Brief: LHA510 Proof-of-Concept Study as a Maintenance Therapy for Patients With Wet 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
Pre-treatment All subjects with AE/s reported prior to the initiation of IP administration 0 None 0 136 1 136 View
LHA510 All subjects with AE/s having an onset from IP initiation and up through 7 days after cessation of IP administration 0 None 1 46 28 46 View
Vehicle All subjects with AE/s having an onset from IP initiation and up through 7 days after cessation of IP administration 0 None 0 45 5 45 View
Post-treatment LHA510 All subjects with AE/s having an onset more than 7 days after IP administration cessation through the study exit 0 None 1 46 3 46 View
Post-treatment Vehicle All subjects with AE/s having an onset more than 7 days after IP administration cessation through the study exit 0 None 0 45 0 45 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (17.0) View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (17.0) View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (17.0) View
Bronchial hyperreactivity SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (17.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Corneal oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.0) View
Corneal opacity SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.0) View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.0) View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.0) View
Keratopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.0) View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.0) View
Visual acuity reduced SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.0) View
Vital dye staining cornea present SYSTEMATIC_ASSESSMENT Investigations MedDRA (17.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (17.0) View