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 @ 12:14 AM
Ignite Modification Date: 2025-12-25 @ 10:16 PM
NCT ID: NCT01378858
Description: None
Frequency Threshold: 5
Time Frame: 12 week intervention period, and 12 week post intervention follow up
Study: NCT01378858
Study Brief: Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients
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 Treatment as Usual (TAU) Subjects in the TAU arm will self administer varenicline for 12 weeks. Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks. 0 None 2 50 50 50 View
Varenicline Directly Observed Therapy Subjects in the directly observed therapy (DOT) arm will receive varenicline directly administered by methadone clinic nurses 4-6 times per week at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends. Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks. 0 None 3 50 50 50 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Incident major depressive episode SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Incident psychotic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Change in appetite SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Vomiting SYSTEMATIC_ASSESSMENT General disorders None View
Gas SYSTEMATIC_ASSESSMENT General disorders None View
Constipation SYSTEMATIC_ASSESSMENT General disorders None View
Change in concentration SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Irritability SYSTEMATIC_ASSESSMENT General disorders None View
Vivid/more frequent dreams SYSTEMATIC_ASSESSMENT General disorders None View
Change in taste SYSTEMATIC_ASSESSMENT General disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT General disorders None View