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 @ 7:00 PM
Ignite Modification Date: 2025-12-25 @ 4:33 PM
NCT ID: NCT03524157
Description: the treatment is a topical drug, the subjects of investigation with this intervention are not in danger of death.
Frequency Threshold: 1
Time Frame: The monitoring of the adverse events was made throughout the 10 days of intervention of the product and 3 days later by means of a safety telephone call, totaling 13 days of pharmacovigilance.
Study: NCT03524157
Study Brief: Safety and Tolerability of PRO-087 Versus Xyel Ofteno® and Systane Ultra®, on the Ocular Surface of Healthy Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PRO-087 Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: chondroitin sulfate 0.18%, sodium hyaluronate 0.1% ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle. PRO-087: The intervention period consists of a therapy with PRO-087administered 4 times a day in the waking period for 10 days. with a security call to day 13. 0 None 0 10 5 10 View
Xyel Ofteno Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days, Active principles: Xanthan gum 0.9 mg, sodium chondroitin sulfate 1.0 ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle. Xyel Ofteno: The intervention period with active comparator drug consists of a therapy with Xyel administered 4 times a day in the waking period for 10 days. with a security call to day 13. 0 None 0 10 4 10 View
Systane Ultra Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Ophthalmic solution, multi-dose dropper bottle, made by Alcon Laboratories, Inc. Systane Ultra: The intervention period with active comparator drug consists of a therapy with systane administered 4 times a day in the waking period for 10 days. with a security call to day 13. 0 None 0 10 5 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
hypertransaminasemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 20.1 View
ocular burning NON_SYSTEMATIC_ASSESSMENT Eye disorders 20.1 View
ocular itching NON_SYSTEMATIC_ASSESSMENT Eye disorders 20.1 View
ocular discharge NON_SYSTEMATIC_ASSESSMENT Eye disorders 20.1 View
dry eye NON_SYSTEMATIC_ASSESSMENT Eye disorders 20.1 View
skin rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 20.1 View
hyperglycemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 20.1 View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders 20.1 View
ocular foreign body sensation NON_SYSTEMATIC_ASSESSMENT Eye disorders 20.1 View