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 @ 12:33 AM
Ignite Modification Date: 2025-12-25 @ 10:41 PM
NCT ID: NCT01828567
Description: Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.
Frequency Threshold: 5
Time Frame: Through study completion, an average of 6 months.
Study: NCT01828567
Study Brief: Will Veterans Engage in Prevention After HRA-guided Shared Decision Making?
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intervention Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment Shared decision making with a Prevention Coach: A series of two phone sessions with a prevention coach. The first to engage the veteran to choose a preferred prevention program and link them to PACT, and a follow-up call one month later to assess the progress of the prevention plan. None None 65 208 0 208 View
Control Usual care None None 53 209 0 209 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Study Safety Protocol NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Protocol Deviation NON_SYSTEMATIC_ASSESSMENT Investigations None View
Emergency Room Visit NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Important Medical Event NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Important Medical Event NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Important Medical Event NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Important Medical Event NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Emergency Room Visit NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Study Safety Protocol NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Important Medical Event NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):