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 @ 5:08 AM
Ignite Modification Date: 2025-12-26 @ 4:11 AM
NCT ID: NCT01038427
Description: Any signs or symptoms that occurs during randomized treatment period plus the 1-4 days post treatment.
Frequency Threshold: 2
Time Frame: From first dose of randomized treatment until last dose plus 1-4 days (up to Day 15 + 3).
Study: NCT01038427
Study Brief: A Study Comparing the Clinical Equivalence of Two Mometasone Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Reference Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days. 0 None 0 320 5 320 View
Test Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 200 mcg (4 actuations) for 14 days. 0 None 0 317 5 317 View
Placebo Placebo nasal spray administered once daily for 14 days. 0 None 0 158 5 158 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (12.1) View