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 @ 4:33 AM
Ignite Modification Date: 2025-12-26 @ 3:35 AM
NCT ID: NCT02446418
Description: On-treatment SAEs and non-serious adverse drug reactions were collected for the Safety Population comprised of all enrolled participants who received at least one dose of study medication (either FF/VI or usual ICS/LABA) and considered as-treated.
Frequency Threshold: 5
Time Frame: On-treatment serious adverse events (SAEs) and non-serious adverse drug reactions were collected from start of study treatment up to Week 24
Study: NCT02446418
Study Brief: A Study to Compare the Efficacy of Fluticasone Furoate/Vilanterol Inhalation Powder With Usual Inhaled Corticosteroids (ICS)/Long Acting Beta Agonists (LABA) in Persistent Asthma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Usual ICS/LABA Eligible participants received fixed combination ICS/LABA (FP/S 250/50 mcg or 500/50 mcg, 1 inhalation twice daily; or BUD/F 200/6 mcg or 400/12 mcg, 1 or 2 inhalations twice daily) for 24 weeks. 0 None 4 210 0 210 View
FF/VI Eligible participants received Fluticasone FF/Vilanterol VI 100 mcg/22 mcg or FF/VI 200 mcg/25 mcg 1 inhalation once daily for 24 weeks. 0 None 3 209 0 209 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chronic sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Labyrinthitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Ovarian abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Adnexa uteri pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 20.0 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Varicose vein ruptured SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Other Events(If Any):