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: 2025-12-24 @ 7:09 PM
Ignite Modification Date: 2025-12-25 @ 4:42 PM
NCT ID: NCT03333057
Description: None
Frequency Threshold: 1
Time Frame: whole study duration (8 weeks per patient)
Study: NCT03333057
Study Brief: Perfluorohexyloctane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo BID/QID Saline solution (0.9% sodium chloride solution) 2/4 times daily (BID/QID) Placebo: Saline solution (0.9% sodium chloride solution) 0 None 0 111 3 111 View
NOV03 2 Times Daily (BID) Perfluorohexyloctance solution 2 times daily (BID) NOV03: Perfluorohexyloctane 0 None 1 111 1 111 View
NOV03 4 Times Daily (QID) Perfluorohexyloctance solution 4 times daily NOV03: Perfluorohexyloctane 0 None 3 114 4 114 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Endometrial adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.1 View
Abortion spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 20.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Diverticulum SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.1 View
Instillation site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Instillation site irritation SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View