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 @ 3:26 AM
Ignite Modification Date: 2025-12-26 @ 2:06 AM
NCT ID: NCT05275205
Description: None
Frequency Threshold: 5
Time Frame: Treatment Emergent Adverse Events by System Organ Class, Preferred Term - Week 0-48 Analysis
Study: NCT05275205
Study Brief: Safety, Tolerability, and Efficacy Study of UBX1325 in Patients With Neovascular Age-Related Macular Degeneration (ENVISION)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
UBX1325 UBX1325 injection 50 μL: Patients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28 1 None 2 25 20 25 View
Aflibercept (EYLEA ®) EYLEA® (aflibercept) Injection 2 mg (0.05mL): Patients randomized to the active-control aflibercept arm will receive aflibercept per label every 8 weeks starting from day 1 until Week 40. In addition, these patients will receive UBX1325 on Week 24 and Week 32; and a sham procedure at Week 4 and Week 28. 0 None 3 25 20 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Retroperitoneal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wrist fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal haematoma SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders None View
Crush injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Rectal cancer stage III SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Neovascular age-related macular degeneration SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinal haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Macular oedema SYSTEMATIC_ASSESSMENT Eye disorders None View
Punctate keratitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Subretinal fluid SYSTEMATIC_ASSESSMENT Eye disorders None View
Macular degeneration SYSTEMATIC_ASSESSMENT Eye disorders None View
Optic nerve sheath haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders None View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Macular thickening SYSTEMATIC_ASSESSMENT Eye disorders None View
Visual acuity reduced SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinal oedema SYSTEMATIC_ASSESSMENT Eye disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View