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: 2025-12-24 @ 9:15 PM
Ignite Modification Date: 2025-12-25 @ 7:03 PM
NCT ID: NCT03758404
Description: None
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT03758404
Study Brief: Gene Therapy for Achromatopsia (CNGA3)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Low Dose AAV - CNGA3 Subretinal administration of a single low dose AAV - CNGA3 AAV- CNGA3: AAV gene therapy for defects in CNGA3 gene 0 None 0 3 3 3 View
Intermediate Dose AAV - CNGA3 Subretinal administration of a single intermediate dose AAV - CNGA3 AAV- CNGA3: AAV gene therapy for defects in CNGA3 gene 0 None 0 3 3 3 View
High Dose AAV - CNGA3 Subretinal administration of a single high dose AAV - CNGA3 AAV- CNGA3: AAV gene therapy for defects in CNGA3 gene 0 None 0 5 5 5 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Visual acuity reduced SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctival hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders None View
Lenticular opacities SYSTEMATIC_ASSESSMENT Eye disorders None View
Ocular discomfort SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye inflammation SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders None View
Subconjunctival cyst SYSTEMATIC_ASSESSMENT Eye disorders None View
Chorioretinal folds SYSTEMATIC_ASSESSMENT Eye disorders None View
Foreign body sensation in eyes SYSTEMATIC_ASSESSMENT Eye disorders None View
Iridocyclitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders None View
Punctate keratitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinal disorder SYSTEMATIC_ASSESSMENT Eye disorders None View
Uveitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Vitreous floaters SYSTEMATIC_ASSESSMENT Eye disorders None View
Intraocular pressure increased SYSTEMATIC_ASSESSMENT Investigations None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations None View
Intraocular pressure decreased SYSTEMATIC_ASSESSMENT Investigations None View
Slit-lamp tests abnormal SYSTEMATIC_ASSESSMENT Investigations None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperlipidaemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders None View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tenon's cyst SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View