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 @ 6:51 PM
Ignite Modification Date: 2025-12-25 @ 4:23 PM
NCT ID: NCT02997657
Description: None
Frequency Threshold: 0
Time Frame: 52 weeks
Study: NCT02997657
Study Brief: Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Positive Psychotherapy for Smoking Cessation Smoking cessation treatment that incorporates exercises and text messages derived from positive psychology interventions that are designed to boost positive moods, cognitions, and behaviors. Positive Psychotherapy: Exercises designed to boost moods, positive behaviors, and positive cognitions. Standard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation 1 None 0 140 0 140 View
Standard Smoking Cessation Treatment Smoking cessation counseling that provides support and problem solving skills for avoiding smoking. Standard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation 0 None 0 131 2 131 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View