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 @ 3:38 PM
Ignite Modification Date: 2025-12-25 @ 1:49 PM
NCT ID: NCT00570492
Description: None
Frequency Threshold: 3
Time Frame: None
Study: NCT00570492
Study Brief: Phase 4 Fluticasone Furoate Nasal Spray (VERAMYST) Long Term Pediatric Growth Study.
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 Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period. None None 4 237 135 237 View
FFNS 110 mcg Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period. None None 2 237 129 237 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia Primary Atypical SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory Tract Infection Viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Head Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Acute Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis Viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory Tract Infection Viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View