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: 2025-12-25 @ 2:32 AM
Ignite Modification Date: 2025-12-26 @ 1:07 AM
NCT ID: NCT00984334
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00984334
Study Brief: Naloxone SR Capsules in Patients With Opioid Induced Constipation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Naloxone SR 2.5 mg Capsules Naloxone SR 2.5 mg capsules once daily for three weeks then twice daily for three weeks. Naloxone SR 2.5 mg capsules : None None 0 8 5 8 View
Capsules With no Active Drug Placebo capsules once daily for three weeks then twice daily for three weeks. Placebo : None None 0 8 8 8 View
Naloxone SR 10mg Capsules Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks. Naloxone SR 10 mg capsules : None None 0 8 5 8 View
Naloxone SR 20 mg Capsules Two Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks. Naloxone SR 20mg capsules : None None 1 8 6 8 View
Naloxone SR 5mg Capsules Naloxone SR 5 mg capsules once daily for three weeks then twice daily for three weeks. Naloxone SR 5 mg capsules : None None 0 8 6 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Panic attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastrointestinal disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
General disorders and administration site conditions SYSTEMATIC_ASSESSMENT General disorders None View
Nervous system disorders SYSTEMATIC_ASSESSMENT Nervous system disorders None View