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 @ 1:37 PM
Ignite Modification Date: 2025-12-25 @ 12:35 PM
NCT ID: NCT01482195
Description: The adverse events were collected : 1. systematically ( blood samples withdrawn to test for rise in antiViral titers). One temporary rise occurred in the post-operative period in one patient = non serious adverse events) 2. Non systematic collection: ( one patient reported filamentary keratitis, another patient eported oscillopsiain the injected eye- = Other non serious adverse events
Frequency Threshold: 0
Time Frame: through study completion, an average of 2 years
Study: NCT01482195
Study Brief: Trial of Subretinal Injection of (rAAV2-VMD2-hMERTK)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Recombinant Adeno-Associated Virus Recombinant Adeno-Associated Virus: Ocular Subretinal Injection of a Recombinant Adeno-Associated Virus 0 None 0 6 3 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Filamentary keratitis SYSTEMATIC_ASSESSMENT Eye disorders None View
delayed resolution of subretinal fluid postoperatively, cataract, oscillopsia SYSTEMATIC_ASSESSMENT Eye disorders None View
systemic SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View