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 @ 4:03 PM
Ignite Modification Date: 2025-12-25 @ 2:05 PM
NCT ID: NCT01299766
Description: We reported hospitalizations
Frequency Threshold: 0
Time Frame: 2 years
Study: NCT01299766
Study Brief: Preventing Cognitive Decline in African Americans With Mild Cognitive Impairment
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Behavior Activation BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment. Behavioral Activation (BA): BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment. 5 None 40 111 0 111 View
Supportive Therapy (ST) ST is a person-centered treatment in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions. Supportive Therapy (ST): ST is a person-centered psychotherapy in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions. 4 None 35 110 0 110 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death SYSTEMATIC_ASSESSMENT Infections and infestations None View
Death NOS SYSTEMATIC_ASSESSMENT Investigations None View
Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Broken shoulder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chrohn's Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hernia repair SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Valve replacement SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pacemaker implanted SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Seziure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
UTI SYSTEMATIC_ASSESSMENT Infections and infestations None View
Asthma Attack SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Heart attack SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Stroke SYSTEMATIC_ASSESSMENT Vascular disorders None View
bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
bypass surgery SYSTEMATIC_ASSESSMENT Cardiac disorders None View
hypoglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
COPD SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Edema SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
GI bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acid reflux SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Blood clot SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
CHF SYSTEMATIC_ASSESSMENT Cardiac disorders None View
GI symptoms SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders None View
Knee replacement SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
internal bleeding SYSTEMATIC_ASSESSMENT Eye disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):