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 @ 5:19 AM
Ignite Modification Date: 2025-12-26 @ 4:26 AM
NCT ID: NCT04250727
Description: None
Frequency Threshold: 0
Time Frame: Up to 4 weeks
Study: NCT04250727
Study Brief: Switching to Potential Reduced Exposure Products 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
3mg Nicotine Concentration 15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration. ZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts. 0 None 0 15 13 15 View
6mg Nicotine Concentration 15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration. ZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts. 0 None 0 15 13 15 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
rapid heartbeat SYSTEMATIC_ASSESSMENT Cardiac disorders None View
vision problems SYSTEMATIC_ASSESSMENT Eye disorders None View
abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
appetite changes SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
fatigue SYSTEMATIC_ASSESSMENT General disorders None View
fever SYSTEMATIC_ASSESSMENT General disorders None View
other SYSTEMATIC_ASSESSMENT General disorders None View
sore throat SYSTEMATIC_ASSESSMENT Infections and infestations None View
weight loss SYSTEMATIC_ASSESSMENT Investigations None View
dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
fainting SYSTEMATIC_ASSESSMENT Nervous system disorders None View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
vivid dreams SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
difficulty sleeping SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
coughing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
itching or rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
sweating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View