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 @ 12:36 AM
Ignite Modification Date: 2025-12-25 @ 10:45 PM
NCT ID: NCT04433767
Description: None
Frequency Threshold: 5
Time Frame: Fifteen weeks
Study: NCT04433767
Study Brief: Depressed Mood Improvement Through Nicotine Dosing 2
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Transdermal Nicotine Patch Participants will wear open label transdermal nicotine patch daily for 12-15 weeks. They will apply study patch each morning and remove at bedtime. Dosage will begin at 3.5mg patch / day, increasing to a possible maximum of 21mg patch / day. Transdermal Nicotine patch: Participants will begin a 12- week open label trial of transdermal nicotine patch during the day and remove it at night (16 hours). Dose titration starting at 3.5 mg patch/daily to maximum of 21mg patch/daily. After week 12 , dose will be slowly tapered over 3 weeks. 0 None 1 29 26 29 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Skin reaction NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Increased tension and inner restlessness NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Increased dream activity NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View