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 @ 3:30 AM
Ignite Modification Date: 2025-12-26 @ 2:12 AM
NCT ID: NCT01903005
Description: Safety population (N=665)
Frequency Threshold: 3
Time Frame: Day 1 through Week 24 of Open-Label Extension Study
Study: NCT01903005
Study Brief: Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid 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
Safety Population Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses of buprenorphine/naloxone between 5.7/1.4 mg and 17.1/4.2 mg mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects. None None 15 665 41 665 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Heroin toxicity SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0. View
Hypertensive and atherosclerotic cardiovascular disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0. View
Non-small cell lung cancer SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0. View
Respiratory syncytial virus bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0. View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16.0. View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0. View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0. View
Anal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0. View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0. View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0. View
Metabolic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0. View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0. View
Multiple fractures SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0. View
Intentional overdose SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 16.0. View
Worsening of opioid dependence SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16.0. View
Bipolar depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16.0. View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0. View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0. View