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 @ 11:29 PM
Ignite Modification Date: 2025-12-25 @ 9:16 PM
NCT ID: NCT05454956
Description: None
Frequency Threshold: 1
Time Frame: 200 days
Study: NCT05454956
Study Brief: Pilot Study Comparing the Safety and Efficacy of Two Dosing Regimens of TP-03 for the Treatment of MGD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BID Dosing TP-03, lotilaner ophthalmic solution, 0.25% administered topically twice a day and TP-03 vehicle administered once a day 0 None 1 21 8 21 View
TID Dosing TP-03, lotilaner ophthalmic solution, 0.25% administered topically three times a day 0 None 0 18 1 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Ocular discomfort NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25.0 View
Conjunctivochalasis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25.0 View
Vitreous floaters NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25.0 View
Gastroesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Hordeolum NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Chemical burns of eye NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Hypercholesterolemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Intervertebral Disc Protrusion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.0 View