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 @ 3:30 AM
Ignite Modification Date: 2025-12-26 @ 2:12 AM
NCT ID: NCT05610605
Description: Adverse events were systematically assessed by study personnel at the 6-month and 12-month follow-up visits. All-cause mortality was tracked for all participants.
Frequency Threshold: 0
Time Frame: The data was obtained at the end of the intervention (6 months) and 6 months after the completion of the intervention (12 months)
Study: NCT05610605
Study Brief: Education for Prevention and Treatment of Frailty
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control Group Participants who do not receive attention from the Fragsalud program. The control group follows the usual care and preventive measures in Primary Care, according to different protocols implemented and the criteria of nurses and family doctors responsible for their care. 3 None 0 117 0 117 View
Intervention Group The FRAGSALUD Programme is a multidomain intervention programme, which covers the prevention and treatment of frailty from different aspects, fundamentally from a physical and cognitive aspect and to maintain social integration, although other modifiable factors that are related to the presence of fragility such as hearing impairment, visual deficit or depression. Health intervention programme: FRAGSALUD: The FRAGSALUD Program consists in two parts, a first part of health education that will be taught in a group in four sessions, and a second part of individual treatment and follow-up, individual consultations will have a bimonthly periodicity until reaching one year, at which time that the program ends and a final evaluation will be carried out to assess whether the changes are maintained 15 months after the start. 2 None 0 118 0 118 View
Serious Events(If Any):
Other Events(If Any):