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 @ 12:05 PM
Ignite Modification Date: 2025-12-25 @ 11:58 AM
NCT ID: NCT01466361
Description: None
Frequency Threshold: 1
Time Frame: All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.
Study: NCT01466361
Study Brief: Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving
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 Lozenge 1.5mg (Light Smokers Group) Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route. None None 0 60 1 60 View
Nicotine Lozenge 4mg (Heavy Smokers Group) Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route. None None 0 52 11 52 View
Placebo Lozenge 2 (Light Smokers Group) Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route. None None 0 41 1 41 View
Placebo Lozenge 1 (Heavy Smokers Group) Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route. None None 0 34 0 34 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Retching 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
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View