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 @ 5:23 PM
Ignite Modification Date: 2025-12-25 @ 2:58 PM
NCT ID: NCT02371850
Description: The definition does not differ.
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT02371850
Study Brief: Transdermal Patch CVD 1000: The Effect of Heat on Nicotine Release From Nicotine Patches in Adult Smokers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Nicoderm Patch 4 h Heat Application Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days) 0 None 0 10 5 10 View
Aveva Patch 4 h Heat Application Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days) 0 None 0 10 7 10 View
Aveva Patch 8 h Heat Application Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days) 0 None 0 10 4 10 View
Nicoderm Patch 8 h Heat Application Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days) 0 None 0 10 6 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Elevated systolic SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Elevated Respiratory Rate SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Heat rash SYSTEMATIC_ASSESSMENT General disorders None View
Erythema at the site of patch placement SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Numbness SYSTEMATIC_ASSESSMENT General disorders None View
Skin redness SYSTEMATIC_ASSESSMENT General disorders None View