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 @ 3:26 AM
Ignite Modification Date: 2025-12-26 @ 2:06 AM
NCT ID: NCT00725205
Description: The All Patients as Treated (APAT) population included all enrolled participants who took at least one dose of Peginterferon alfa-2b or Ribavirin.
Frequency Threshold: 5
Time Frame: None
Study: NCT00725205
Study Brief: Patient Compliance During PegIntron and Rebetol Combination Therapy in Chronic Hepatitis C (Study P04690)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Peginterferon Alfa-2b and Ribavirin Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype. None None 9 292 109 292 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia None Blood and lymphatic system disorders MedDRA (14.0) View
Eosinophilia None Blood and lymphatic system disorders MedDRA (14.0) View
Pneumonia None Infections and infestations MedDRA (14.0) View
Hepatic Neoplasm Malignant None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (14.0) View
Depression None Psychiatric disorders MedDRA (14.0) View
Asphyxia None Respiratory, thoracic and mediastinal disorders MedDRA (14.0) View
Toxic Skin Eruption None Skin and subcutaneous tissue disorders MedDRA (14.0) View
Thrombocytopenia None Blood and lymphatic system disorders MedDRA (14.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia None Blood and lymphatic system disorders MedDRA (14.0) View
Pyrexia None General disorders MedDRA (14.0) View
Weight Decreased None Investigations MedDRA (14.0) View
Thrombocytopenia None Blood and lymphatic system disorders MedDRA (14.0) View