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 @ 5:39 PM
Ignite Modification Date: 2025-12-25 @ 3:09 PM
NCT ID: NCT01863368
Description: An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the product. AEs were obtained as solicited and spontaneous comments from the study subjects, and as observations by the Investigator, as outlined in the protocol.
Frequency Threshold: 5
Time Frame: Adverse events (AEs) were collected for the duration of the study (Sep 2013 - Jun 2014). AEs are reported as pre-treatment and treatment-emergent. One subject was randomized to Optive, but was never exposed to product.
Study: NCT01863368
Study Brief: Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pre-treatment All subjects who consented to participate in the study prior to exposure to investigational product None None 1 105 1 105 View
Systane Ultra All subjects who were exposed to Systane Ultra or run-in therapy None None 1 46 2 46 View
Optive All subjects who were exposed to Optive or run-in therapy None None 0 47 3 47 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.0) View
Spinal column injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (16.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (16.0) View