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 @ 2:38 AM
Ignite Modification Date: 2025-12-26 @ 1:16 AM
NCT ID: NCT02502734
Description: On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) are reported for the ITT Population, which comprises of all randomized participants who received at least one dose of study treatment.
Frequency Threshold: 3
Time Frame: SAEs and non-serious AEs were collected from start of study medication through the Study Phase (7 weeks post-dose) and assessed up to 54 days. AEs reported during the wash-out and follow-up period are considered post-treatment and are not presented.
Study: NCT02502734
Study Brief: Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With 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
Placebo Participants received oral inhalation of placebo OD for 14 days +/- 4 days during Period 1 or Period 2 None None 1 60 15 60 View
Fluticasone Furoate Participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days during Period 1 or Period 2 None None 0 58 7 58 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 18.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 18.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 18.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 18.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 18.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA version 18.1 View