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 @ 10:56 PM
Ignite Modification Date: 2025-12-25 @ 8:24 PM
NCT ID: NCT00644969
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: Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
Study: NCT00644969
Study Brief: Smoking Cessation Study for Patients With Schizophrenia or Schizoaffective Disorder
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 Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12. None None 5 84 48 84 View
Placebo Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12. None None 4 43 25 43 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Aggression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Psychiatric symptom SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Irritability SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Abnormal dreams SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View