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 @ 4:56 AM
Ignite Modification Date: 2025-12-26 @ 3:56 AM
NCT ID: NCT01032018
Description: None
Frequency Threshold: 0
Time Frame: 2, 4, and 6 months after enrollment
Study: NCT01032018
Study Brief: Comparison of Depression Interventions After Acute Coronary Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Referred Care The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist. None None 8 77 63 77 View
Stepped Care The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen. None None 7 73 59 73 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
MRSA Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Internal bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
GI bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Worsened anxiety/nervousness SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Blood in stool SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Worsened decreased appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Worsened diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diverticulitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Worsened dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Worsened drowsiness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Worsened dry mouth SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ear bleeding SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Fall SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
GI problems SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gum bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Headaches SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Heavy menstrual bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hip pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Worsened increase in appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Worsened indigestion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Worsened insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Irregular menstrual period SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Joint pains SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Joint stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Knee injury SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Leg edema SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Low potassium SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Middle ear effusion SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Mood disturbance SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Worsened nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nosebleed SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Numbness of arms and legs SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Oral bleedin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pain SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rectal bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Worsened sexual side effects SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Strep throat SYSTEMATIC_ASSESSMENT Infections and infestations None View
Worsened sweating SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Tingling of fingers and toes SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Worsened tremors SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upset stomach SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vaginal bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Varicose veins SYSTEMATIC_ASSESSMENT Vascular disorders None View
Abdominal hernia SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Worsened agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View