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: 2025-12-26 @ 11:11 PM
Ignite Modification Date: 2025-12-26 @ 11:11 PM
NCT ID: NCT01856712
Description: None
Frequency Threshold: 0
Time Frame: from September 5, 2013 to April 20, 2015, for a total accrual time of 19 months
Study: NCT01856712
Study Brief: Oral vs. Injectable Naltrexone for Hospitalized Veterans With Alcohol Dependence
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Oral Naltrexone an initial 50 mg oral dose of naltrexone prior to hospital discharge plus a 30-day prescription for oral naltrexone Naltrexone: Naltexone was chosen for this study because naltrexone is the only medication available in both oral daily and injectable monthly formulations, which will allow the study to examine issues around medication adherence. None None 0 23 1 23 View
Injectable Naltrexone a single 380 mg intramuscular injection of naltrexone (duration of action = 30 days)prior to hospital discharge followed by a second injection one month later. Naltrexone: Naltexone was chosen for this study because naltrexone is the only medication available in both oral daily and injectable monthly formulations, which will allow the study to examine issues around medication adherence. None None 0 22 0 22 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders SNOMED CT View