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 @ 7:58 PM
Ignite Modification Date: 2025-12-25 @ 5:32 PM
NCT ID: NCT01536704
Description: None
Frequency Threshold: 5
Time Frame: Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.
Study: NCT01536704
Study Brief: Nicotine Lozenge Bioequivalence Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
2mg Cherry Lozenge Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge. None None 0 47 6 47 View
2mg Mint Lozenge Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge. None None 0 46 9 46 View
4mg Cherry Lozenge Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge None None 0 45 13 45 View
4mg Mint Lozenge Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge None None 1 47 15 47 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Throat Irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View