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 @ 3:16 PM
Ignite Modification Date: 2025-12-25 @ 1:38 PM
NCT ID: NCT00740792
Description: None
Frequency Threshold: 1
Time Frame: None
Study: NCT00740792
Study Brief: A Study Evaluating the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MP29-02 azelastine HCl/fluticasone propionate None None 1 193 24 193 View
Azelastine HCL active comparator of azelastine HCl None None 0 194 33 194 View
Fluticasone Propionate active comparator of fluticasone propionate None None 0 189 15 189 View
Placebo placebo control None None 0 200 13 200 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
hepatitis C SYSTEMATIC_ASSESSMENT Hepatobiliary disorders Medra View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View
oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View
upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
nasal discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
nasopharyingitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
dysgeusia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
mucosal erosion SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View