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 @ 2:15 AM
Ignite Modification Date: 2025-12-26 @ 12:45 AM
NCT ID: NCT04316260
Description: None
Frequency Threshold: 5
Time Frame: 1 month and 3 month assessments (3 total months)
Study: NCT04316260
Study Brief: Smoking Cessation E-Visit
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Smoking Cessation Electronic Visit (E-visit) This group will be sent 1) an invitation to complete an electronic visit (e-visit) focused on cigarette smoking and 2) an invitation to complete a follow-up e-visit one-month after the initial e-visit. Smoking cessation e-visit: electronic visits (e-visits) for smoking cessation 0 None 0 34 4 34 View
Treatment As Usual This group will be provided information about the state quitline and about the importance of quitting smoking and it will be recommended that they contact their PCP to schedule a medical visit to discuss quitting smoking. Treatment As Usual: Information about the state quitline and about the importance of quitting smoking and a recommendation to contact one's PCP to schedule a medical visit to discuss quitting smoking 0 None 0 17 3 17 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headaches NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Muscle pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Insomnia/trouble sleeping NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sleep problems NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depressed mood NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Appetite change NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight loss/gain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Agitation/hostility NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Heartburn NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ringing in the ears NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View