Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 4:52 AM
Ignite Modification Date: 2025-12-26 @ 3:53 AM
NCT ID: NCT00935818
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT00935818
Study Brief: Varenicline and Bupropion for Smoking Cessation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Varenicline and Buproprion SR Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year. varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks None None 6 249 165 249 View
Varenicline and Placebo Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year. varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks None None 6 257 161 257 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
acute coronary syndrome NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
prostate cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
coronary artery disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
death None Immune system disorders None View
attempted suicide NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
lung cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
diverticulitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
breast cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
trauma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
food poisining NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
sleep disturbance None General disorders None View
nausea None Gastrointestinal disorders None View
constipation None Gastrointestinal disorders None View
headache None Nervous system disorders None View
irritability None General disorders None View
anxiety None General disorders None View
difficulty concentrating None General disorders None View
mood disturbance None General disorders None View
dizziness None General disorders None View
abnormal dreams None General disorders None View
restlessness None General disorders None View
depressive symptoms None Psychiatric disorders None View
fatigue None General disorders None View
dry mouth None General disorders None View
dispepsia None Gastrointestinal disorders None View
flatulance None Gastrointestinal disorders None View