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: 2025-12-26 @ 11:07 AM
Ignite Modification Date: 2025-12-26 @ 11:07 AM
NCT ID: NCT01865812
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data were collected from the time of the first dose of investigational product until the participant fully completed participation in the study, up to 2 years.
Study: NCT01865812
Study Brief: Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary 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
Primary Treatment Phase All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. 0 None 1 26 18 26 View
Long-term Safety Extension Phase Participants received OCA 10 mg QD for up to 2 years. 0 None 5 21 17 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.0 View
Stress cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Aortic aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Pruritus generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Vitamin D deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Low density lipoprotein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Hiatus hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.0 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View