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 @ 5:01 PM
Ignite Modification Date: 2025-12-25 @ 2:42 PM
NCT ID: NCT04889950
Description: A total of 12 device not related AEs were observed in 7 subjects (4 Tixel subjects (3.6%) and 3 (3%) LipiFlow subjects). One moderate AE ('Conjunctival deposit') was reported in one subject and resolved after medication administration and removal of conjunctival concretions. All other AEs were mild and resolved.
Frequency Threshold: 0
Time Frame: 15 months and 13 days
Study: NCT04889950
Study Brief: Evaluate the Safety and Effectiveness of The Tixel Fractional System in the Treatment of Meibomian Gland Disfunction
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tixel Group Tixel C Group: Screening and baseline visits, Treatment- 3 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire. Tixel C: Tixel C )Novoxel®, Israel) is a thermomechanical system developed for fractional treatment. The system is designed for the treatment of soft tissue by direct conduction of heat, enabling tissue coagulation combined with micro ablation with low thermal damage to the surrounding tissue. 0 None 0 11 4 11 View
LipiFlow LipiFlow: Screening and baseline visits, Treatment- 1 single treatment session, followed by 2 Follow up sessions, 1and 3 months after the last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire. LipiFlow: LipiFlow 0 None 0 10 3 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctival scar SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (10.0) View
Conjunctival deposit SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (10.0) View
Corneal opacity SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (10.0) View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
Pulpitis dental SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10.0) View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
Rash papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10.0) View
Chalazion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (10.0) View