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 @ 5:44 PM
Ignite Modification Date: 2025-12-25 @ 3:12 PM
NCT ID: NCT01602068
Description: None
Frequency Threshold: 0
Time Frame: AEs were collected from the point that the ICF was signed. All AEs until the last day of the study, through resolution, stabilization, or at least 30 days after treatment, whichever occurs first.
Study: NCT01602068
Study Brief: Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Delivery Prior to Implantation of a Posterior Chamber IOL
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dexamethasone Phosphate Ophthalmic Dexamethasone Phosphate Ophthalmic: (40 mg/mL) solution delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery) None None 0 23 21 23 View
100 mM Sodium Citrate Buffer Placebo (100 mM sodium citrate buffer solution) delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery) None None 3 22 20 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Respiratory Distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ocular AE SYSTEMATIC_ASSESSMENT Eye disorders None View