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 @ 4:41 PM
Ignite Modification Date: 2025-12-25 @ 2:29 PM
NCT ID: NCT01358266
Description: Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Frequency Threshold: 5
Time Frame: Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months.
Study: NCT01358266
Study Brief: Study Assessing Double-masked Uveitis Treatment
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DE-109 44 µg - Double Masked Double Masked Phase Low Dose 44 µg 1 None 41 207 165 207 View
DE-109 440 µg - Double Masked Double Masked Phase Medium Dose 440 µg 0 None 45 205 166 205 View
DE-109 880 µg - Double Masked Double Masked Phase High Dose 880 µg 0 None 38 178 148 178 View
DE-109 880 µg - Open-Label Open-label Phase High Dose 880 µg 0 None 59 321 210 321 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Central nervous system lymphoma SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Breast cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16.0 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 16.0 View
Metrorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 16.0 View
Cataract subcapsular SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Optic Neuritis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Tibia Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Cystoid macular oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Eye inflammation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Intermediate uveitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Macular oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Optic atrophy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Optic neuropathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Vitreous haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Anterior chamber inflammation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Choroidal neovascularisation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Corneal deposits SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Corneal epithelium defect SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Corneal oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Eye haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Iritis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Ocular hypertension SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Ocular vasculitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Open angle glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Retinal haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Retinal infiltrates SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Retinal oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Retinal tear SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Endophthalmitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Eye infection toxoplasmal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Anal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Keratitis herpetic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Intraocular pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Lower limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Multiple sclerosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Uveitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Choroiditis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Non-infectious endophthalmitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Iridocyclitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Visual acuity reduced SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Vitritis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Fibrin SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Intraocular pressure decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Medication residue SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Device dislocation SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Cataract traumatic SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Corneal abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Iridocyclitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Uveitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Intermediate uveitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Cystoid macular oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Choroiditis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Cataract subcapsular SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Macular oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Intraocular pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Conjunctival hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Vitreous opacities SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.0 View