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 @ 9:34 PM
Ignite Modification Date: 2025-12-25 @ 7:18 PM
NCT ID: NCT01733732
Description: An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Reports of AEs were obtained through volunteered and elicited comments from the subjects.
Frequency Threshold: 5
Time Frame: Adverse events (AEs) were collected for the duration of the study (7 months). This analysis group includes all subjects exposed to the test product.
Study: NCT01733732
Study Brief: SYSTANE® BALANCE Symptoms (OSDI) & Inflammatory Biomarkers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Systane Balance One drop in each eye 4 times a day for 30 days None None 0 27 0 27 View
Systane Gel One drop in each eye 4 times a day for 30 days None None 1 27 0 27 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Metastasis to central nervous system NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16.0 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Other Events(If Any):