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: 2025-12-25 @ 3:28 AM
Ignite Modification Date: 2025-12-26 @ 2:09 AM
NCT ID: NCT03088605
Description: None
Frequency Threshold: 0
Time Frame: 4 months
Study: NCT03088605
Study Brief: Safety and Efficacy of TOP1630 for 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
Active TOP1630 Ophthalmic Solution TOP1630 Ophthalmic Solution: Bilateral ocular drug administration 0 None 0 37 6 37 View
Placebo Placebo (Vehicle) Ophthalmic Solution Placebo to TOP1630 Ophthalmic Solution: Bilateral ocular drug administration 0 None 0 32 4 32 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Visual acuity reduced NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.0 View
Eye Discharge NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.0 View
Vision blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.0 View
Vitreous floaters NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.0 View
Ocular itching NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.0 View
Instillation site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Instillation site discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Procedural pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Common cold NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View