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 @ 12:39 PM
Ignite Modification Date: 2025-12-25 @ 12:12 PM
NCT ID: NCT00435461
Description: SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all participants randomized to double-blind treatment.
Frequency Threshold: 3
Time Frame: Adverse events (AEs) and Serious adverse events (SAEs) were collected from the time the first dose of study medication until the follow up contact (Up to Day 20)
Study: NCT00435461
Study Brief: Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine
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 vehicle placebo nasal spray and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment. 0 None 0 313 11 313 View
FFNS 110 mcg Participants received FFNS 110 mcg and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment. 0 None 0 312 12 312 View
Fex 180 mg Participants received oral capsule (overencapsulated Fex 180 mg oral tablet) and vehicle placebo nasal spray each morning once daily for two weeks following pre-dose symptom assessment. 0 None 1 311 10 311 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 9.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.1 View