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 @ 5:54 PM
Ignite Modification Date: 2025-12-25 @ 3:18 PM
NCT ID: NCT00324168
Description: None
Frequency Threshold: 0
Time Frame: 3 months from enrollment
Study: NCT00324168
Study Brief: Steroids for Corneal Ulcers 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
Steroid Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization None None 15 250 44 250 View
Placebo Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization None None 13 250 34 250 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Corneal perforation None Eye disorders None View
Death None General disorders None View
Systemic infection None Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Increase in hypopyon None Eye disorders None View
Increase in infiltrate size >50% None Eye disorders None View
No healing of epithelial defect by 21 days None Eye disorders None View
Intraocular pressure (IOP) elevated >25mm Hg by <35 mm Hg None Eye disorders None View
Progressive corneal thinning None Eye disorders None View
Other None General disorders None View