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 @ 11:25 PM
Ignite Modification Date: 2025-12-24 @ 11:25 PM
NCT ID: NCT00699556
Description: None
Frequency Threshold: 0
Time Frame: During laboratory session, subjects responded to a list of potential symptoms. Symptoms were assessed 5 hours after nicotine administration.
Study: NCT00699556
Study Brief: Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Patch+Spray Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray. 21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch 1mg nicotine nasal spray: two 0.5mg/sprays, one to each nostril (dose = 1mg) The nicotine nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital. It is similar in concentration to Nicotrol. 0 None 0 22 17 22 View
Patch+Placebo Spray Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray. 21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch placebo nasal spray: saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray The placebo nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital. 0 None 0 22 11 22 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Skin Irritation SYSTEMATIC_ASSESSMENT General disorders None View
Heart rate > 100 SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dizziness/light headed SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal discomfort SYSTEMATIC_ASSESSMENT General disorders None View
Nasal irritation SYSTEMATIC_ASSESSMENT General disorders None View
Throat irritation SYSTEMATIC_ASSESSMENT General disorders None View
Eyes watering SYSTEMATIC_ASSESSMENT General disorders None View
hands or feet cold SYSTEMATIC_ASSESSMENT General disorders None View