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 @ 11:51 AM
Ignite Modification Date: 2025-12-26 @ 10:21 AM
NCT ID: NCT01244061
Description: The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold: 5
Time Frame: 2 years
Study: NCT01244061
Study Brief: A Multi-National Study To Assess How Effective And Safe The Smoking Cessation Medicine Varenicline Is In Smokers Who Have Already Tried Varenicline In The Past As A Prescription Medicine From Their Usual Healthcare Provider
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 Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12. None None 7 249 145 249 View
Placebo Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12. None None 4 245 70 245 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 15.1 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Ligament rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Hyperventilation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Allergy to chemicals SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 15.1 View
Knee arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 15.1 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Abnormal dreams SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View