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 @ 12:19 PM
Ignite Modification Date: 2025-12-26 @ 12:19 PM
NCT ID: NCT00423800
Description: Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).
Frequency Threshold: 5
Time Frame: None
Study: NCT00423800
Study Brief: Efficacy and Safety of 24 vs 48 Weeks of Pegetron® (Peginterferon Alfa-2b + Ribavirin) in Naïve Genotype 1 Hepatitis C (Study P05016)(TERMINATED)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Screen Failures Two participants on commercial Pegetron® who were screen fails and were never randomized had SAEs. Both SAEs were are reported here. None None 2 2 0 2 View
Pegetron® - 24 Weeks Participants are treated for 8 weeks with Pegetron® and then randomized to an additional 16 weeks of treatment. None None 0 3 2 3 View
Pegetron® - 48 Weeks Participants are treated for 8 weeks with Pegetron® and then randomized to an additional 40 weeks of treatment. None None 0 2 1 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
GROIN ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
HYPOGLYCAEMIC SEIZURE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
EYE IRRITATION SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.0 View
VISION BLURRED SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.0 View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
CHILLS SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
IRRITABILITY SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
DECREASED APPETITE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
MYALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
DYSGEUSIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
HYPOAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
AFFECT LABILITY SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
NASAL CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
OROPHARYNGEAL PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
ALOPECIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
PSORIASIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View