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 @ 12:08 AM
Ignite Modification Date: 2025-12-25 @ 10:08 PM
NCT ID: NCT01270958
Description: Serious adverse events (SAEs) and adverse events (AEs) were collected in the ITT Population.
Frequency Threshold: 0
Time Frame: During treatment period and a phone call questioning participants about adverse events 3-5 days after the end of study treatment (up to week 7)
Study: NCT01270958
Study Brief: A Phase-IV, Open-label Study to Evaluate Safety/Tolerability of Once-daily AVAMYS (TM) Aqueous Nasal Spray 110mcg Among Vietnamese Adult Patients With Established Perennial 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
Fluticasone Furoate 110 mcg Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily None None 0 56 13 56 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Sleepy SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Dry nose SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Burning urination SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Itchy nose SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sneeze SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Congested nose SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Eyelid swelling SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View