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 @ 12:22 AM
Ignite Modification Date: 2025-12-25 @ 10:27 PM
NCT ID: NCT00412958
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 Day 180 post-injection.
Study: NCT00412958
Study Brief: A Study of the Safety and Efficacy of Microplasmin to Induce a Posterior Vitreous Detachment (MIVI III)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Intravitreal injection of placebo. None None 2 31 30 31 View
Ocriplasmin 25µg 25µg of ocriplasmin intravitreal injection. None None 2 29 29 29 View
Ocriplasmin 75µg 75µg of ocriplasmin intravitreal injection. None None 3 33 32 33 View
Ocriplasmin 125µg 125µg of ocriplasmin intravitreal injection. None None 0 32 31 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 10.1. View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 10.1. View
Sinutis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 10.1. View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 10.1. View
Anterior chamber inflammation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Radius fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 10.1. View
Bening pancreatic neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 10.1. View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 10.1. View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ocular hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Retinal disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Cataract subcapsular SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Macular degeneration SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Vitreous haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Anterior chamber inflammation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Conjunctival oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Visual disturbance SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Foreign body sensation in eyes SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Conjunctival hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Corneal disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Vitreous disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Corneal bleeding SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Photopsia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Cataract cortical SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Corneal oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Retinal cyst SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Macular hole SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Corneal striae SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Eye inflammation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Retinal degeneration SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Intraocular pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 10.1. View
Intraocular pressure decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 10.1. View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 10.1. View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 10.1. View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 10.1. View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 10.1. View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA version 10.1. View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA version 10.1. View
Retinal oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Conjunctival haemorrahge SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Anterior chamber cell SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Anterior chamber flare SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Cataract nuclear SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Macular oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Eyelid oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Retinal haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Retinal tear SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Retinal depigmentation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Ocular discomfort SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Maculopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View
Vitreous floaters SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 10.1. View