Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:01 AM
Ignite Modification Date: 2025-12-26 @ 12:25 AM
NCT ID: NCT02188160
Description: One Subject was randomized to KPI-121 0.25% but received vehicle. Therefore, 72 subjects are included in the KPI-121 0.25% group and 78 subjects are included in the vehicle group in the safety analyses.
Frequency Threshold: 3
Time Frame: Adverse event data was collected from Visit 2 (Day 1) through Visit 6 (Day 29).
Study: NCT02188160
Study Brief: Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
KPI-121 0.25% Ophthalmic Suspension KPI-121 0.25% ophthalmic suspension dosed QID for 28 days in subjects with dry eye disease KPI-121: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate. 0 None 1 72 7 72 View
Vehicle Vehicle (placebo) dosed QID for 28 days in subjects with dry eye disease Placebo: Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate. 0 None 0 78 8 78 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA Version 16.1. View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Instillation site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 16.1. View