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 @ 3:15 PM
Ignite Modification Date: 2025-12-25 @ 1:37 PM
NCT ID: NCT05367492
Description: Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.
Frequency Threshold: 5
Time Frame: Adverse event data were collected over 24 weeks.
Study: NCT05367492
Study Brief: Varenicline for Nicotine Vaping Cessation in Adolescents
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Double Blind Varenicline (V+BC) Participants will... * Receive the drug varenicline, in tablet form, up to 1 mg BID for 12 weeks. * Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents. 0 None 1 88 78 88 View
Single Blind Enhanced Usual Care (EUC) Participants will... * Receive NO drug intervention. * Attend NO behavioral support sessions. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents. 0 None 1 86 69 86 View
Double Blind Placebo (P+BC) Participants will... * Receive placebo tablets, identical in appearance to varenicline, up to 1 mg BID for 12 weeks. * Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents. 0 None 3 86 73 86 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Psychiatric Hospitalization SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Motor Vehicle Accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Snowboarding Accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cold symptoms SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nausea and vomiting symptoms SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vivid dreams SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Anxiety disorders and symptoms SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Mood disorders and disturbances SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Withdrawal symptom SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Appetite increased SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View