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 @ 8:03 PM
Ignite Modification Date: 2025-12-25 @ 5:36 PM
NCT ID: NCT00491504
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00491504
Study Brief: This Study Contains an Active Drug Treatment Group With Mometasone Furoate Nasal Spray and a Placebo (Dummy) Treatment Group for Seasonal Allergic Rhinitis (SAR). (Study P05073)(COMPLETED)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Mometasone Furoate Nasal Spray Day 1 Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (total 200 mcg) for 1 dose None None 0 77 1 77 View
Placebo Day 1 Placebo: 2 sprays each nostril for 1 dose None None 0 78 1 78 View
Mometasone Furoate Nasal Spray Day 8 Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (200 mcg daily) for 7 days None None 0 78 6 78 View
Placebo Day 8 Placebo: 2 sprays each nostril for 7 days None None 0 77 4 77 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View