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 @ 5:30 PM
Ignite Modification Date: 2025-12-25 @ 3:03 PM
NCT ID: NCT01498068
Description: None
Frequency Threshold: 2
Time Frame: 60 weeks
Study: NCT01498068
Study Brief: Open-Label, Bridging Study of Telaprevir in Treatment-Naïve and Treatment-Experienced Russian Patients With Genotype 1 Chronic Hepatitis C
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment-naïve Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study. None None 0 16 16 16 View
Treatment-experienced Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study. None None 0 20 19 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA version 14.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA version 14.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 14.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 14.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 14.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 14.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 14.1 View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 14.1 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 14.1 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 14.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 14.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 14.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 14.1 View
Anal pruritus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 14.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 14.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 14.1 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA version 14.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA version 14.1 View