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 @ 2:52 AM
Ignite Modification Date: 2025-12-26 @ 1:33 AM
NCT ID: NCT03073733
Description: None
Frequency Threshold: 5
Time Frame: one year
Study: NCT03073733
Study Brief: Safety and Efficacy of Intravitreal Injection of Human Retinal Progenitor Cells in Adults With Retinitis Pigmentosa
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sham Treated Control Mock injection: pressing the hub of a syringe with no needle against the study eye 0 None 0 29 13 29 View
Test (jCell Injection) Dose Level 1 Single intravitreal injection of 3.0 x 10e6 retinal progenitor cells into the study eye 0 None 1 27 18 27 View
Test (jCell Injection) Dose Level 2 Single intravitreal injection of 6.0 x 10e6 retinal progenitor cells into the study eye 0 None 0 27 14 27 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ocular hypertension SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anterior chamber flare SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.0 View
Chalazion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.0 View
Conjunctival hemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.0 View
Cystoid macular edema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.0 View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.0 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.0 View
Visual acuity reduced SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Post procedural discomfort SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Intraocular pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Nystagmus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View