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 @ 7:13 PM
Ignite Modification Date: 2025-12-25 @ 4:49 PM
NCT ID: NCT02380703
Description: This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.
Frequency Threshold: 5
Time Frame: Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study.
Study: NCT02380703
Study Brief: Aggression Prevention Training for Caregivers of Persons With Dementia (APT)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Aggression Prevention Training (APT) APT will use active learning tools, including didactics, role-playing, and multimedia (eg, books and DVDs) to educate and provide skill training for the caregiver. The 6-8 modules in the intervention will include 4 core modules that address 4 main aggression risk factors: a) recognizing pain, b) treating pain, c) increasing pleasant activities, and d) improving patient-caregiver communication. Caregivers can select 2 to 3 additional elective sessions; elective selection is guided by the needs of the dyad to further enhance skills related to these core topics. Sessions will take place in the patient's home. Aggression Prevention Training (APT) 7 None 15 114 0 0 View
Enhanced Usual Primary Care (EU-PC) EU-PC provides the patient and caregiver educational materials on pain, notifies the primary care provider of the PWD's level of pain and depression, and provides 8 weekly supportive telephone calls to caregivers. Enhanced Usual Primary Care (EU-PC) 7 None 18 114 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Death NON_SYSTEMATIC_ASSESSMENT General disorders None View
Death NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Death NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Death NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Death NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Death NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Death NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):