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: 2025-12-24 @ 4:11 PM
Ignite Modification Date: 2025-12-25 @ 2:11 PM
NCT ID: NCT01995266
Description: Analysis was performed on all treated participants.
Frequency Threshold: 5
Time Frame: Up to 24 weeks within 30 days of discontinuation of dosing
Study: NCT01995266
Study Brief: Phase III China GT 1b Interferon (IFN) Intolerant Prev Exclude Dual
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Subjects Oral dose of daclatasvir (DCV) 60 mg once daily (QD) and asunaprevir (ASV) 100 mg twice daily (BID) was administered for 24 weeks. Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment. 1 None 5 159 66 159 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Asteriosclerosis Coronary Artery SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Coronary Artery Disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Sudden Hearing Loss SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Femoral Neck Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Hepatocellular Carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.0 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Adam-Stokes Syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Platelet Count Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Neutrophil Count Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Monocyte Count Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
White Blood Cell Count Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Aspartate Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View