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 @ 1:43 AM
Ignite Modification Date: 2025-12-26 @ 12:00 AM
NCT ID: NCT03195894
Description: None
Frequency Threshold: 5
Time Frame: Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).
Study: NCT03195894
Study Brief: Clinical Study of TripleA for Treatment of Alcohol Addiction in Outpatient Care
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Conventional Treatment and TripleA Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver 0 None 12 59 5 59 View
Conventional Treatment Conventional treatment consisting of medication treatment or the Minnesota model of addiction treatment 0 None 6 56 4 56 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ascites NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bleeding NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sepsis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Abstinence NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Fainting, dizziness and nausea NON_SYSTEMATIC_ASSESSMENT General disorders None View
Suspected transient ischemic attack (TIA) NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Infection in foot NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Breast cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Alcohol intoxication NON_SYSTEMATIC_ASSESSMENT General disorders None View
Suicide attempts NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Recurrent ischemic pain NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Myocardial Infarction NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cold, fever, flu NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View