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 @ 7:11 PM
Ignite Modification Date: 2025-12-25 @ 4:45 PM
NCT ID: NCT02301403
Description: Adverse events (AEs) and serious AEs (SAEs) were assessed with the question "Since your last contact with us, have there been any changes in your medical condition or health?" * For each nicotine-medication-related symptom reported, severity was assessed and whether the symptom has resolved. * For any non-nicotine-medication-related symptoms that are reported as a concern, participants were advised to contact their primary care provider in the clinic as per IRB approval.
Frequency Threshold: 5
Time Frame: Adverse event data was collected for participants using the nicotine patch during 8 weeks of active patch treatment. Adverse event data was collected for participants using the nicotine patch and nicotine mini-lozenge during 26 weeks of active use of these 2 medications post-quit.
Study: NCT02301403
Study Brief: A Comparative Effectiveness RCT of Optimized Cessation Treatments
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Modern Usual Care Participants assigned to the M-UC will receive 8 weeks of nicotine patch, a single brief, in-person counseling session, a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), and will be signed up for either the QUITNOW app or the Web Coach (both provided by Alere Wellbeing, the vendor that provides the WTQL services). Nicotine patch: 8 weeks of nicotine patch in-person counseling and quitline counseling: a single brief, in-person counseling session plus a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), for counseling, including the QUITNOW app and the Website 0 None 0 315 66 315 View
Abstinence-Optimized Cessation Treatment There are 5 intervention components to include in the AOCT package: 1) Preparation Nicotine Mini-Lozenges; 2) 26-week postquit Combination NRT (nicotine patch + nicotine mini-lozenges); 3) Intensive In-Person Cessation Counseling; 4) Extended Maintenance Counseling Calls; and 5) Automated Adherence Calls. Preparation Nicotine Mini-Lozenges: Nicotine lozenge prior to attempting to quit smoking Combination NRT (nicotine patch + nicotine mini-lozenges): 26 weeks of combination NRT as part of a quit smoking attempt Intensive In-Person Cessation Counseling: three 20-min In-person Cessation Counseling sessions Extended Maintenance Counseling Calls: 8 Maintenance-phase smoking cessation counseling sessions Automated Adherence Calls: 11 brief, automated calls reminding them to use their medications properly 0 None 0 308 139 308 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Persistent Indigestion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Itching or Hives SYSTEMATIC_ASSESSMENT Immune system disorders None View
Sore Throat SYSTEMATIC_ASSESSMENT General disorders None View
Skin rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Vivid Dreams SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hiccups SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mouth Problem SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View