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 @ 11:36 PM
Ignite Modification Date: 2025-12-25 @ 9:25 PM
NCT ID: NCT05343156
Description: None
Frequency Threshold: 0
Time Frame: Subjects were monitored for safety on all study visits. Assessment of AEs, including definition of seriousness, severity and causality was performed at each visit : day 1 (visit 2), week 2 (visit 3), week 4 (visit 4), week 8 (visit 5) , week 12 (visit 6) and week 16 (visit 7)
Study: NCT05343156
Study Brief: Efficacy and Safety of Dexamethasone Nanoparticles Eye Drops in Diabetic Macular Edema
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DexNP Eye Drop The study eye received 1 DexNP eye drop 3 times a day (every 8 hours) for 12 weeks. Dexamethasone nanoparticles eye drops: DexNP 15 mg/mL eye drops 3 times a day (every 8 hours) for 12 weeks 2 None 11 99 32 99 View
Vehicle Eye Drop The study eye received 1 vehicle eye drop 3 times a day (every 8 hours) for 12 weeks. Dexamethasone nanoparticles eye drops: DexNP 15 mg/mL eye drops 3 times a day (every 8 hours) for 12 weeks 0 None 1 45 9 45 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 21.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 21.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 21.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 21.0 View
Retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 21.0 View
diabetic ulcer SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA Version 21.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 21.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 21.0 View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 21.0 View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA Version 21.0 View
Sudden cardiac death SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 21.0 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 21.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ocular hypertension SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 21.0 View
Cataract subcapscular SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 21.0 View
conjunctival hemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 21.0 View
Diabetic retinal edema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 21.0 View
erythema of eyelid SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 21.0 View
eyelid ptosis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 21.0 View
glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 21.0 View
noninfective conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 21.0 View
Ocular hyperemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 21.0 View
photophobia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 21.0 View
posterior capsule opacification SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 21.0 View
conjunctival hyperemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 21.0 View
conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 21.0 View
corneal edema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 21.0 View
eye infection bacterial SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 21.0 View
eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 21.0 View
foreign body sensation in eyes SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 21.0 View
keratopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 21.0 View
retinal pigment epitheliopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 21.0 View
dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 21.0 View
dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 21.0 View
insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 21.0 View
conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 21.0 View
eye infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 21.0 View
Blood glucose fluctuation SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 21.0 View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 21.0 View
Intraocular pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 21.0 View