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 @ 2:22 PM
Ignite Modification Date: 2025-12-25 @ 12:58 PM
NCT ID: NCT02966795
Description: Adverse events are reported for the overall study population according to the prespecified analysis plan for this study.
Frequency Threshold: 5
Time Frame: From first dose of study drug through 30 days after the last dose of study drug; 12 or 16 weeks depending on the treatment regimen.
Study: NCT02966795
Study Brief: A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Glecaprevir/Pibrentasvir Participants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily for 8 or 12 weeks. 0 None 5 84 26 84 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (21.0) View
ESCHERICHIA PYELONEPHRITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
GASTRIC ULCER HELICOBACTER SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
GIARDIASIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
PULMONARY TUBERCULOSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
VIRAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
MAJOR DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (21.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.0) View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (21.0) View