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: 2025-12-25 @ 3:32 AM
Ignite Modification Date: 2025-12-26 @ 2:15 AM
NCT ID: NCT01087905
Description: This study used FDA-approved, over-the-counter nicotine replacement therapies (NRTs) that were dispensed according to standard protocols that were in use by Free \& Clear at the time of the study. Free \& Clear was responsible for assessing and managing any AEs related to study medication as per their existing Nicotine Replacement Therapy Protocols.
Frequency Threshold: 5
Time Frame: Information about adverse events was collected during the 6-week post-quit period of study interventions. The quitline vendor for the study, Free & Clear (Seattle, WA), dispensed all study medications and addressed adverse events.
Study: NCT01087905
Study Brief: Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Two Weeks of Nicotine Patch Only Participants in this treatment group received Two Weeks of Nicotine Patch Only. None None 0 245 0 245 View
Two Weeks of Combination NRT (Nicotine Patch + Nicotine Gum) Participants in this treatment group received Two Weeks of Nicotine Patch plus Nicotine Gum. None None 0 245 0 245 View
Six Weeks of Nicotine Patch Only Participants in this treatment group received Six Weeks of Nicotine Patch Only. None None 0 249 0 249 View
Six Weeks of Combination NRT (Nicotine Patch + Nicotine Gum) Participants in this treatment group received Six Weeks of Nicotine Patch plus Nicotine Gum. None None 0 248 0 248 View
Serious Events(If Any):
Other Events(If Any):