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: 2025-12-25 @ 4:57 AM
Ignite Modification Date: 2025-12-26 @ 3:57 AM
NCT ID: NCT04297618
Description: Regular investigator assessment
Frequency Threshold: 0
Time Frame: 12 weeks
Study: NCT04297618
Study Brief: The Effect of Xiidra on Comfort and Dryness in Symptomatic Contact Lens Wearers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ocular Adverse Events (After Xiidra Was Dispensed) Ocular adverse events in all participants who were dispensed with the study product. 0 None 0 42 3 42 View
Systemic Adverse Events (After Xiidra Was Dispensed) Systemic adverse events in all participants who were dispensed with the study product. 0 None 0 42 6 42 View
Ocular Adverse Events (Before Xiidra Was Dispensed) Ocular adverse events that occurred in all participants that were eligible for the study prior to the study product being dispensed. 1 None 0 43 1 43 View
Systemic Adverse Events (Before Xiidra Was Dispensed) Systemic adverse events that occurred in all participants that were eligible for the study prior to the study product being dispensed. 0 None 0 43 0 43 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leukocytoclastic vasculitis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Infiltrative keratitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Irritated, red eye & purulent discharge SYSTEMATIC_ASSESSMENT Eye disorders None View
Bacterial conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Watery eye SYSTEMATIC_ASSESSMENT Eye disorders None View
COVID SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinus infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Ear infection SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Dryness around periorbital eyelid skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Corneal sterile infiltrates SYSTEMATIC_ASSESSMENT Eye disorders None View