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 @ 10:49 PM
Ignite Modification Date: 2025-12-25 @ 8:19 PM
NCT ID: NCT01128569
Description: SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study drug.
Frequency Threshold: 3
Time Frame: Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up/Early Withdrawal (up to 197 days).
Study: NCT01128569
Study Brief: Randomised Study Comparing the Effects of Inhaled Fluticasone Furoate (FF)/Vilanterol (VI; GW642444M) Combination and FF on an Allergen Induced Asthmatic Response
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 Placebo OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from the Day 28 dose) and a maximum of 35 days. None None 0 51 15 51 View
FF 100 µg OD Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days. None None 0 51 18 51 View
FF/VI 100/25 µg OD Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days. None None 0 51 11 51 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA View