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 @ 12:13 AM
Ignite Modification Date: 2025-12-25 @ 10:14 PM
NCT ID: NCT04717258
Description: Only serious adverse events reportable to the regulatory body Health Research Authority (https://www.hra.nhs.uk/), were reportable on this study.
Frequency Threshold: 0
Time Frame: Adverse events were collected throughout the study. The start of the adverse event reporting period for each participant was from the date the participant gave consent to be in the study. Adverse events were due to be collected over the 12 month duration the participant was in the study.
Study: NCT04717258
Study Brief: Safe and Well Visits by the Fire and Rescue Service to Prevent Falls and Improve Quality of Life in Older People
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Main FIREFLI Trial: Intervention Arm Usual care from healthcare professionals; falls prevention leaflet; Safe and Well Visits (SWVs) offered by the Fire and Rescue Service (FRS) (either a firefighter, day duty safety advocate or home safety officer) once randomised. Fire and Rescue Service Safe and Well Visit: Safe and Well Visits by the Fire and Rescue Service to prevent falls and improve quality of life in an older population 0 None 0 32 0 32 View
Main FIREFLI Trial: Control Arm Usual care from healthcare professionals; falls prevention leaflet; Safe and Well Visits (SWVs) by the Fire and Rescue Service (FRS) (either a firefighter, day duty safety advocate or home safety officer offered 12 months post-randomisation) 0 None 0 31 0 31 View
SWAT Intervention Participants received a study invitation letter based on Self-Determination theory 0 None 0 37 0 37 View
SWAT Control Group Participants received a study invitation letter based on 'standard' invitation letter sent out by the York Trials Unit 0 None 0 26 0 26 View
Serious Events(If Any):
Other Events(If Any):