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 @ 4:46 PM
Ignite Modification Date: 2025-12-25 @ 2:32 PM
NCT ID: NCT00620750
Description: None
Frequency Threshold: 3
Time Frame: None
Study: NCT00620750
Study Brief: Extended-release Naltrexone for Alcohol Dependence in Primary 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
Extended Release Injectable Naltrexone This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care. None None 2 65 45 65 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Severe injection site reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
unexpected pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
fatigue SYSTEMATIC_ASSESSMENT General disorders None View
headache SYSTEMATIC_ASSESSMENT General disorders None View
flu-like symptoms SYSTEMATIC_ASSESSMENT General disorders None View
insomnia SYSTEMATIC_ASSESSMENT General disorders None View
other complaints SYSTEMATIC_ASSESSMENT General disorders None View
any injection site reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
AST/ALT >5x normal SYSTEMATIC_ASSESSMENT General disorders None View