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 @ 10:22 PM
Ignite Modification Date: 2025-12-25 @ 7:54 PM
NCT ID: NCT00937235
Description: Participants were assessed at each visit for adverse events (which typically occurred weekly).
Frequency Threshold: 0
Time Frame: Adverse event data was collected over the entire duration of data collection (2009-2015).
Study: NCT00937235
Study Brief: Treatment of Smoking Among Individuals With PTSD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Integrated Treatment Prolonged Exposure + Varenicline + Medication Management Counseling Varenicline: 1 mg tablets, orally, twice daily x 12 weeks Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation Prolonged Exposure: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders 0 None 6 72 64 72 View
Varenicline Varenicline + Medication Management Counseling Varenicline: 1 mg tablets, orally, twice daily x 12 weeks Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation 0 None 4 70 58 70 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suicidal Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hospitalization secondary to drug or alcohol relapse NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Respiratory issue SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cocaine relapse with no hospitalization SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Broken ankle + hospitalization SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hospitalization (unrelated) SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Miscellaneous SYSTEMATIC_ASSESSMENT General disorders None View