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 @ 3:38 AM
Ignite Modification Date: 2025-12-26 @ 2:21 AM
NCT ID: NCT01476202
Description: None
Frequency Threshold: 1
Time Frame: AEs were collected from the start of the smoking abstinence sequestration period and until 5 days following last administration of the investigational product.
Study: NCT01476202
Study Brief: Provoked Craving Relief Study by NRT
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Nicotine Mouth Strip 2.5 mg Participants self administered single dose of 2.5 mg nicotine mouth strip. None None 0 40 1 40 View
Nicotine Lozenge 2 mg Participants self administered single dose of 2 mg nicotine lozenge. None None 0 40 4 40 View
Nicotine Gum 2 mg Participants self administered single dose of 2 mg nicotine gum. None None 0 40 0 40 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausae SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Throat Irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View