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 @ 4:02 PM
Ignite Modification Date: 2025-12-25 @ 2:04 PM
NCT ID: NCT02472366
Description: None
Frequency Threshold: 0
Time Frame: The safety and tolerability of ILUVIEN was monitored over 12 months.
Study: NCT02472366
Study Brief: A Non-Randomized, Open-Label, Single Center Phase 4 Study of the Effect and Safety of ILUVIEN® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies (Laser, Anti-VEGF) With or Without Intravitreal Corticosteroid Therapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Laser laser with or without prior history of intraocular corticosteroid therapy ILUVIEN None None 0 6 2 6 View
Laser and Anti-VEGF laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy ILUVIEN None None 2 10 3 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Cataract Surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 15.1 View
Vitrectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 15.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Intra-ocular pressure (30 mmHg) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Dislocated Shoulder SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Intra-ocular pressure (25mmHG) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Intra-ocular pressure (28mmHg) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View