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 @ 11:54 PM
Ignite Modification Date: 2025-12-25 @ 9:49 PM
NCT ID: NCT02869451
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected for approximately seven months, from informed consent signature to 6-month follow-up (which occurred 6 months after substance cessation date).
Study: NCT02869451
Study Brief: Mobile Contingency Management for Marijuana and Tobacco 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
Treatment Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months. bupropion: Prescribed one week prior to quit and continued until the 6 month follow-up visit. transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant Nicotine polacrilex: Initiated at smoking quit date. nicotine lozenge: Initiated at smoking quit date. counseling for marijuana and smoking cessation: 5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention mobile contingency management: treatment that provides money rewards for abstinence from smoking and marijuana 0 None 0 5 1 5 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea with bupropion use NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View