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 @ 12:38 AM
Ignite Modification Date: 2025-12-25 @ 10:49 PM
NCT ID: NCT02351167
Description: Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
Frequency Threshold: 0
Time Frame: Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Study: NCT02351167
Study Brief: Genetically Informed Smoking Cessation Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Medicine and Counseling Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment. 4 None 27 273 175 273 View
Combination NRT and Counseling Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment. 3 None 23 275 193 275 View
Varenicline (Chantix) and Counseling Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment. 2 None 17 274 204 274 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Severe tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Left knee replacement SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Death due to cardiorespiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Death due to congestive heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Left bundle branch block SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Death due to diabetic coma SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Type 2 Diabetes SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Crohn's disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diverticulosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemorrhoid SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Death, unknown SYSTEMATIC_ASSESSMENT General disorders None View
Death due to natural causes SYSTEMATIC_ASSESSMENT General disorders None View
Ammonia poisoning of liver SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Antibiotic spacer for MRSA infection in knee SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis, right hand SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Surgical incision site infection (post-surgery) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection of second toe on left foot SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
MRSA infection in knee SYSTEMATIC_ASSESSMENT Infections and infestations None View
Malaria SYSTEMATIC_ASSESSMENT Infections and infestations None View
Severe sinus infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Broken arm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Broken collarbone SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Broken ribs SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cervical disc fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Complication from gastric bypass surgery SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Death due to heroin overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Gunshot wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Homicide by gunshot SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Motor vehicle accident (injury of intervertebral discs T10-12) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Partial amputation of leg due to MRSA infection SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Struck by vehicle SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Sternum fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Inter-vertebral dis herniation SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Death due to Lung cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Death due to brain tumor complications SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Lung cancer (stage 4) SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Bell's palsy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Multiple sclerosis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Alcohol dependence SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Bipolar depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Panic attack SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Unspecified mood disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Death due to kidney failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Kidney stone SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Stage 4 endometriosis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Asthmatic episode SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
COPD SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chronic sinus necrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Thoracic outlet syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Trouble breathing due to COPD SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Abdominal hysterectomy due to endometriosis SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Foot surgery to fix broken toes on right foot SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hip replacement surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hysterectomy due to cervical cancer SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hysterectomy due to enlarged fallopian tubes SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Knee surgery for osteoarthritis SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Minor procedure to clean wound on right foot SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Surgery for aortic valve stenosis and cardiac bypass SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Urethral sling surgery due to urinary incontinence SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Abdominal aortic aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders None View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Rapid, slow, pounding, or irregular heartbeat SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Vivid dreams SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Weakness SYSTEMATIC_ASSESSMENT General disorders None View
Sweating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Itching/hives SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Mouth problems (e.g. pain or sore) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Indigestion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chest tightness SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Trouble breathing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Feeling worried, nervous, scared, or anxious SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Feeling panicky or having panic attacks SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Feeling agitated and restless SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Feeling hostile or angry towards others SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Feeling significantly down, depressed, or hopeless SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Swelling in face or hands SYSTEMATIC_ASSESSMENT Immune system disorders None View
Swelling or tingling in mouth or throat SYSTEMATIC_ASSESSMENT Immune system disorders None View