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 @ 9:06 PM
Ignite Modification Date: 2025-12-25 @ 6:57 PM
NCT ID: NCT03494504
Description: None
Frequency Threshold: 2
Time Frame: The period of time over which adverse events were collected for each subject in the clinical trial was approximately two months.
Study: NCT03494504
Study Brief: ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic Conjunctivitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Reproxalap Ophthalmic Solution (0.25%) Reproxalap administered once 10 minutes prior to pollen exposure 0 None 0 109 31 109 View
Reproxalap Ophthalmic Solution (0.5%) Reproxalap administered once 10 minutes prior to pollen exposure 0 None 0 100 41 100 View
Vehicle Ophthalmic Solution Vehicle administered once 10 minutes prior to pollen exposure 0 None 0 109 1 109 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
General disorders and administration site conditions SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View