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 @ 2:49 PM
Ignite Modification Date: 2025-12-25 @ 1:16 PM
NCT ID: NCT00781859
Description: AEs/SAEs were assessed by the investigator at all study visits.
Frequency Threshold: 5
Time Frame: Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection.
Study: NCT00781859
Study Brief: Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-006) Trial.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ocriplasmin 125µg 125µg ocriplasmin intravitreal injection None None 32 220 127 220 View
Placebo Intravitreal injection of placebo None None 13 106 35 106 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Macular hole SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Maculopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Visual acuity reduced SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Upper gastrointestinal hemorrahge SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
Pancreatic carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Spondylolisthesis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Cerebral hemorrahge SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vitreous floaters SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Conjunctival Hemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Photopsia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Visual impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Visual acuity reduced SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Retinal edema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Intraocular pressure incresed SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View