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 @ 11:49 PM
Ignite Modification Date: 2025-12-25 @ 9:43 PM
NCT ID: NCT00725751
Description: All participants who received at least one dose of study therapy.
Frequency Threshold: 5
Time Frame: None
Study: NCT00725751
Study Brief: Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Participants With/Without Substitution Therapy (P05255)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PegIFN-2b/Ribavirin With Substitution Therapy Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects \[methadone + buprenorphine\] or morphine) None None 1 90 18 90 View
PegIFN-2b/Ribavirin Without Substitution Therapy Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects \[methadone + buprenorphine\] or morphine) None None 10 258 35 258 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hepatic neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Blood disorder SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 14.0 View
Accidental death SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Staphylococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View