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 @ 2:22 AM
Ignite Modification Date: 2025-12-26 @ 12:54 AM
NCT ID: NCT04430634
Description: None
Frequency Threshold: 0
Time Frame: 9 days
Study: NCT04430634
Study Brief: A Study to Evaluate Nicotine Uptake and Biomarkers in Smokers Using mybluTM Electronic Cigarettes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Product Variant F MyBlu e-cigarette variant F (2.4% nicotine) 0 None 0 19 2 19 View
Product Variant G MyBlu e-cigarette variant G (4.0% nicotine) 0 None 0 20 0 20 View
Product Variant H MyBlu e-cigarette variant H (3.6% nicotine) 0 None 0 20 3 20 View
Product Variant A MyBlu e-cigarette variant A (2.4% nicotine) 0 None 0 19 1 19 View
Product Variant B MyBlu e-cigarette variant B (3.6% nicotine) 0 None 0 19 4 19 View
Product Variant C MyBlu e-cigarette variant C (2.5% nicotine) 0 None 0 19 3 19 View
Product Variant D MyBlu e-cigarette variant D (4.0% nicotine) 0 None 0 20 2 20 View
Product Variant E MyBlu e-cigarette variant E (3.6% nicotine) 0 None 0 19 3 19 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA® Version 22.1 View
Abnormal sensation in eye NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA® Version 22.1 View
Eyelid irritation NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA® Version 22.1 View
Eyelid pain NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA® Version 22.1 View
Swelling of eyelid NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA® Version 22.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA® Version 22.1 View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA® Version 22.1 View
Feeling hot NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA® Version 22.1 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA® Version 22.1 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA® Version 22.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA® Version 22.1 View
Nervousness NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA® Version 22.1 View
Dysphonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA® Version 22.1 View
Throat tightness NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA® Version 22.1 View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA® Version 22.1 View
Blister NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA® Version 22.1 View