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 @ 10:56 PM
Ignite Modification Date: 2025-12-25 @ 8:24 PM
NCT ID: NCT00149669
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00149669
Study Brief: Employment-based Reinforcement of Naltrexone Ingestion and Abstinence
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Work Plus Naltrexone Prescription Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work. None None 0 32 4 32 View
Work Plus Naltrexone Contingency Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work. None None 1 35 7 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
death by narcotic intoxication SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
E.R. for adnominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ejaculation difficulty SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
General medical treatment, SYSTEMATIC_ASSESSMENT General disorders None View
Inpatient heroin detoxification SYSTEMATIC_ASSESSMENT General disorders None View
Jitters or shakes SYSTEMATIC_ASSESSMENT General disorders None View
Abnormal Liver Function Test SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Abdominal cramps SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting, diarrhea, chills SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
E.R. for nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rapid heart rate SYSTEMATIC_ASSESSMENT Cardiac disorders None View
headache SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Withdrawal SYSTEMATIC_ASSESSMENT General disorders None View