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 @ 7:47 PM
Ignite Modification Date: 2025-12-25 @ 5:24 PM
NCT ID: NCT02219503
Description: None
Frequency Threshold: 5
Time Frame: AEs and SAEs were collected from the time of study drug administration to 30 days after last dose of study drug (12 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (up to 42 weeks).
Study: NCT02219503
Study Brief: A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks. None None 1 60 39 60 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders 18.0 View
HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders 18.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 18.0 View
DYSPEPSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 18.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 18.0 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders 18.0 View
INFLUENZA SYSTEMATIC_ASSESSMENT Infections and infestations 18.0 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations 18.0 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 18.0 View
MYALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 18.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders 18.0 View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders 18.0 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 18.0 View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 18.0 View
PRURITUS GENERALISED SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 18.0 View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders 18.0 View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 18.0 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders 18.0 View