Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 10:14 PM
Ignite Modification Date: 2025-12-25 @ 7:49 PM
NCT ID: NCT04310735
Description: None
Frequency Threshold: 0
Time Frame: Adverse data were collected for the duration of each of the two study visits, which were held an average of approximately 12 days apart.
Study: NCT04310735
Study Brief: Examining Brain Responses Linked to Emotion in Individuals Who Smoke 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
Experimental: Expect-Yes Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will perceive an opportunity to smoke during the experimental session. Verbal smoking expectancy manipulation: Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session. 0 None 0 14 0 14 View
Experimental: Expect-No Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will not perceive an opportunity to smoke during the experimental session. Verbal smoking expectancy manipulation: Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session. 0 None 0 13 0 13 View
Behavioral Testing Participants asked to complete behavioral testing only during experimental session for initial piloting, to allow progress toward the aims of the project while research was initially shut down and then subsequently restricted due to the COVID-19 pandemic, and to troubleshoot technical challenges. 0 None 0 35 0 35 View
Serious Events(If Any):
Other Events(If Any):