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 @ 9:12 PM
Ignite Modification Date: 2025-12-25 @ 7:01 PM
NCT ID: NCT03368404
Description: Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device. Adverse event reports were elicited from the participants or resulted from the assessments at each study visit and recorded
Frequency Threshold: 3
Time Frame: Adverse events were collected during the whole treatment period from the first instillation until the last study visit (90 ± 10 days).
Study: NCT03368404
Study Brief: A Study to Evaluate the Performance and Safety of CBL-102 Versus Vismed® Multi Eye Drops in the Management of Dry Eye
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CBL-102 Eye Drops Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-102 Eye Drops: CE-marked medical device, tear substitute with 0.24% sodium hyaluronate, carbomer and triglycerides Safety population 0 None 1 47 0 47 View
Vismed® Multi Eye Drops Participants received Vismed® Multi eye drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device, tear substitute with 0.18% sodium hyaluronate Safety population 0 None 0 39 2 39 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eye discharge SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View