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 @ 11:13 PM
Ignite Modification Date: 2025-12-25 @ 8:49 PM
NCT ID: NCT02851069
Description: TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.
Frequency Threshold: 5
Time Frame: Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug.
Study: NCT02851069
Study Brief: Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Colombia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ABBVIE REGIMEN ABBVIE REGIMEN: ombitasvir/paritaprevir/ritonavir with or without dasabuvir for 12 or 24 weeks in Hepatitis C Virus Genotype 1 (HCV + GT1) participants according to standard of care within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). 0 None 5 49 5 49 View
ABBVIE REGIMEN Plus Ribavirin (RBV) ABBVIE REGIMEN plus ribavirin (RBV): ombitasvir/paritaprevir/ritonavir with or without dasabuvir and with weight-based RBV for 12 or 24 weeks in HCV + GT1 participants according to standard of care within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). 0 None 2 16 9 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (21.0) View
CORONARY ARTERY DISEASE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (21.0) View
HAEMORRHOIDAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
RECTAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
HEPATIC CIRRHOSIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (21.0) View
HEPATIC FIBROSIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (21.0) View
HEPATOTOXICITY SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (21.0) View
HYPERBILIRUBINAEMIA SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (21.0) View
PERITONITIS BACTERIAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (21.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (21.0) View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.0) View
TREATMENT FAILURE SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.0) View
HEPATITIS C SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (21.0) View
CYSTITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (21.0) View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View