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: 2025-12-26 @ 10:57 AM
Ignite Modification Date: 2025-12-26 @ 10:57 AM
NCT ID: NCT00365508
Description: Administered a checklist of side effects from NRT and collected any additional information on adverse events.
Frequency Threshold: 1
Time Frame: 6 months
Study: NCT00365508
Study Brief: Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm I Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14. None None 4 321 0 321 View
Arm II Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day). None None 7 321 0 321 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
killed in car accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Heart disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
appendicitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
heart attack NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Abcessed tooth NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Stroke NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):