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 @ 12:09 PM
Ignite Modification Date: 2025-12-25 @ 11:59 AM
NCT ID: NCT01086761
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01086761
Study Brief: Study of MP0112 Intravitreal Injection in Patients With Wet Age Related Macular Degeneration
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MP0112 (0.04 mg) Single 0.04 mg intravitreal injection of MP0112 in the study eye. None None 0 9 8 9 View
MP0112 (0.15 mg) Single 0.15 mg intravitreal injection of MP0112 in the study eye. None None 0 7 7 7 View
MP0112 (0.4 mg) Single 0.4 mg intravitreal injection of MP0112 in the study eye. None None 0 6 6 6 View
MP0112 (1.0 mg) Single 1.0 mg intravitreal injection of MP0112 in the study eye. None None 0 6 4 6 View
MP0112 (2.0 mg) Single 2.0 mg intravitreal injection of MP0112 in the study eye. None None 1 4 4 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Endophthalmitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ventricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Macular degeneration SYSTEMATIC_ASSESSMENT Eye disorders None View
Anterior chamber inflammation SYSTEMATIC_ASSESSMENT Eye disorders None View
Anterior chamber cell SYSTEMATIC_ASSESSMENT Eye disorders None View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Corneal epithelium defect SYSTEMATIC_ASSESSMENT Eye disorders None View
Detachment of retinal pigment epithelium SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye pain NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Iridocyclitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Macular cyst SYSTEMATIC_ASSESSMENT Eye disorders None View
Macular oedema SYSTEMATIC_ASSESSMENT Eye disorders None View
Ocular toxicity SYSTEMATIC_ASSESSMENT Eye disorders None View
Pseudoendophthalmitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinal haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinal neovascularisation SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinal oedema SYSTEMATIC_ASSESSMENT Eye disorders None View
Subretinal fibrosis SYSTEMATIC_ASSESSMENT Eye disorders None View
Uveitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Vitreal cells SYSTEMATIC_ASSESSMENT Eye disorders None View
Vitreous detachment SYSTEMATIC_ASSESSMENT Eye disorders None View
Vitreous opacities SYSTEMATIC_ASSESSMENT Eye disorders None View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations None View
Intraocular pressure decreased SYSTEMATIC_ASSESSMENT Investigations None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vitritis SYSTEMATIC_ASSESSMENT Eye disorders None View
Endophthalmitis SYSTEMATIC_ASSESSMENT Infections and infestations None View