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 @ 5:07 PM
Ignite Modification Date: 2025-12-25 @ 2:45 PM
NCT ID: NCT04147650
Description: None
Frequency Threshold: 5
Time Frame: Day 1 to Week 13
Study: NCT04147650
Study Brief: Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
0.05% Voclosporin Ophthalmic Solution (VOS) 0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks 0.05% Voclosporin Ophthalmic Solution (VOS): 0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks 0 None 1 127 29 127 View
0.10% VOS 0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks 0.10% VOS: 0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks 1 None 3 126 42 126 View
0.20% VOS 0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks 0.20% VOS: 0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks 0 None 2 128 44 128 View
Vehicle Ophthalmic Solution Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks Vehicle Ophthalmic Solution: Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks 0 None 3 127 8 127 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Carotid artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (22.0) View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (22.0) View
Fluid overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (22.0) View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (22.0) View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (22.0) View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (22.0) View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (22.0) View
Systemic inflammatory response syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA (22.0) View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (22.0) View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (22.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Instillation site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (22.0) View