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 @ 10:41 PM
Ignite Modification Date: 2025-12-25 @ 8:12 PM
NCT ID: NCT02503735
Description: None
Frequency Threshold: 5
Time Frame: Data was collected over 52 week study period (which includes 12 weeks of treatment with Harvoni, and 40 weeks of post-treatment follow-up).
Study: NCT02503735
Study Brief: Effect of Harvoni on Proteinuria and eGFR in Hepatitis C Virus Associated Chronic Kidney Disease (CKD)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg) Sofosbuvir/Ledipasvir FDC: 12 weeks treatment with Harvoni (10 total dosed on protocol) Patients were followed for one year following treatment initiation 0 None 1 10 7 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
intestinal blockage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
reduced appetite NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
acid reflux NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
back/joint pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
elevated blood prsesure NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
mouth pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
forgetfulness NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
frequent urination NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
elevated creatinine NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
nausea NON_SYSTEMATIC_ASSESSMENT General disorders None View
rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
fall / twisted ankle NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View