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 @ 11:04 PM
Ignite Modification Date: 2025-12-25 @ 8:34 PM
NCT ID: NCT03698669
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data were collected over the course of the 12-month study period.
Study: NCT03698669
Study Brief: Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treating Opioid Patients' Pain and Sadness (TOPPS) TOPPS, consists of three main components: (1) psychoeducation about pain, depression, opioid use, their interactions, and the maintaining role of avoidance; (2) coaching in being an informed, activated patient (based in part on the chronic care model and on approaches to self-management of chronic illness); and (3) behavioral activation to increase engagement in meaningful activities. 1 None 8 82 40 82 View
Health Education (HE) Participants randomized to the control HE condition are offered six telephone sessions led by the Behavioral Health Specialists. The first health session is around nutrition. At the remaining sessions, participants choose from a menu of topics, including: a second session on nutrition; germs, colds and the flu; preventing cancer; diabetes; protecting your heart; getting a good night's sleep; complementary and alternative medicine; caffeine, or physical activity. 1 None 15 81 54 81 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization due to overdose SYSTEMATIC_ASSESSMENT General disorders None View
Hospitalization due to hernia SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hospitalization- gallbladder removal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hospitalization due to sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalization due to lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalization due to myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hospitalization due to pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalization- psychiatric SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hospitalization due to severe back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hospitalization due to kidney stone SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hospitalization- difficulty breathing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hospitalization due to fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hospitalization due to endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalization for flu symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Hospitalization due to infection in foot SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalization due to pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalization due to lung inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hospitalization for substance use treatment SYSTEMATIC_ASSESSMENT General disorders None View
Hospitalization due to staph infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bladder infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Strep throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Injury from fight SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gallstone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Swollen lymph nodes SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ankle sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hip pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cyst on hand SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Hand fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Finger wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Knee infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Forearm strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vaginal cyst SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Tooth abscess SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Leg infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Shingles SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rib pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Withdrawal symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Paranoia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Shoulder pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hand surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
ER visit- diabetes symptom management SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Tooth pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Influenza SYSTEMATIC_ASSESSMENT General disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
RSV SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Stomach virus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chest congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Blood clot SYSTEMATIC_ASSESSMENT Vascular disorders None View
Fractured nose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Sunburn SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fractured wrist SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Motor vehicle accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Infection in arm SYSTEMATIC_ASSESSMENT Infections and infestations None View
Kidney stones SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Bronchospasms SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neck pain due to ablation SYSTEMATIC_ASSESSMENT Infections and infestations None View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Umbilical hernia SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fatigue SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hip dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Toe infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bleach in wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Stroke symptoms SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Eye disorder- other SYSTEMATIC_ASSESSMENT Eye disorders None View
COVID-19 infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Toe fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Difficulty breathing- asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinus infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Foot wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Folliculitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Facial wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Facial abscess/cyst SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View