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 @ 4:26 AM
Ignite Modification Date: 2025-12-26 @ 3:30 AM
NCT ID: NCT00712920
Description: 0 participants were at risk for an SAE. No SAE's were observed
Frequency Threshold: 2
Time Frame: None
Study: NCT00712920
Study Brief: A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Perennial 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
Placebo Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks None None 0 192 21 192 View
Astepro 0.1% 0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks None None 0 194 27 194 View
Astepro 0.15% 0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks None None 0 192 32 192 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Nasal Discomfort NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Dysgesusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Sneezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Upper Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View