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: 2025-12-25 @ 1:18 AM
Ignite Modification Date: 2025-12-25 @ 11:26 PM
NCT ID: NCT03739593
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were documented from the time the subject signed the informed consent until Month 6 + 30 days, or up to Month 9 + 30 days in subjects with visible residual implant observed at Month 6 or beyond.
Study: NCT03739593
Study Brief: Study Assessing AR-1105 in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Initial Phase: AR-1105-CF1 Single dose of AR- 1105-clinical formulation 1 (CF1) dexamethasone 340 mcg administered as an intravitreal implant into a single eye 0 None 2 5 5 5 View
Randomization Phase: AR-1105-CF1 Single dose of AR- 1105-clinical formulation 1 (CF1) dexamethasone 340 mcg administered as an intravitreal implant into a single eye 0 None 2 22 9 22 View
Randomization Phase: AR-1105-CF2 Single dose of AR- 1105-clinical formulation 1 (CF2) dexamethasone 340 mcg administered as an intravitreal implant into a single eye 0 None 4 22 11 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Visual Acuity Reduced SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 21.1 View
Iris Neovascularization SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 21.1 View
Angina Pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 21.1 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 21.1 View
Visual Impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 21.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 21.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Visual Acuity Reduced SYSTEMATIC_ASSESSMENT Eye disorders MedDra Version 21.1 View
Macular Edema SYSTEMATIC_ASSESSMENT Eye disorders MedDra Version 21.1 View
Conjunctival Haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDra Version 21.1 View
Ocular Hypertension SYSTEMATIC_ASSESSMENT Eye disorders MedDra Version 21.1 View
Vitreous Haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDra Version 21.1 View
Vitreous Floaters SYSTEMATIC_ASSESSMENT Eye disorders MedDra Version 21.1 View
Intraocular Pressure Increased SYSTEMATIC_ASSESSMENT Investigations MedDra Version 21.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vision Blurred SYSTEMATIC_ASSESSMENT Eye disorders None View
Device Malfunction SYSTEMATIC_ASSESSMENT Product Issues None View
Type 2 Diabetes Mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View