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 @ 1:22 AM
Ignite Modification Date: 2025-12-25 @ 11:31 PM
NCT ID: NCT01671293
Description: None
Frequency Threshold: 1
Time Frame: During the intervention time frame
Study: NCT01671293
Study Brief: Multicomponent Telecare Model for Supporting Prediabetes Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Multicomponent Remote Care Model Multicomponent remote care model: A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer and measuring tape to check waist circumference). The phone counseling was made by professionals working at health centers who have been trained to apply theories on behavioral change and decision-making. A Mean of 5 phone counseling calls were done by participant. Messages were sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- sought to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process. None None 0 36 2 36 View
Usual Care Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments. None None 0 34 0 34 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
falls NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View