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 @ 11:43 PM
Ignite Modification Date: 2025-12-25 @ 9:35 PM
NCT ID: NCT02730351
Description: ITT Population
Frequency Threshold: 3
Time Frame: The on-treatment adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until the follow-up contact (approximately up to 51 days).
Study: NCT02730351
Study Brief: Crossover Study Comparing Fluticasone Furoate (FF)/Vilanterol (VI) Once Daily Versus Fluticasone Propionate (FP) Twice Daily in Subjects With Asthma and Exercise-Induced Bronchoconstriction (EIB)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
FF/VI 100/25 µg QD Via ELLIPTA + Placebo BID Via DISKUS FF/VI 100/25 µg QD via ELLIPTA + Placebo BID via DISKUS 0 None 1 73 5 73 View
FP 250 µg BID Via DISKUS + Placebo QD Via ELLIPTA FP 250 µg BID via DISKUS + Placebo QD via ELLIPTA 0 None 0 72 4 72 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View