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 @ 4:49 PM
Ignite Modification Date: 2025-12-24 @ 4:49 PM
NCT ID: NCT02945150
Description: Adverse event data collection is still ongoing for two participants who have yet to reach the one year-post transplant mark.
Frequency Threshold: 5
Time Frame: Adverse event data were collected from time of consent to 1 year post-transplant
Study: NCT02945150
Study Brief: Preemptive Treatment With Grazoprevir and Elbasvir for Donor HCV Positive to Recipient HCV Negative Kidney Transplant
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Elbasvir/Grazoprevir for HCV+ Kidney Transplant Recipients Elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor Subjects receive first dose on-call to operating room, and continue daily for 12 weeks. Treatment length is extended to 16 weeks and ribavirin (daily dose 1000 mg for those \<75 kg and 1200 mg for those ≥75 kg) if subject receives a kidney from a donor who is infected with HCV containing resistance-associated variants (RAV). 0 None 4 8 4 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lymphocele NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Renal vein thrombosis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Delayed graft function NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Acute kidney injury (AKI) NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Elevated alanine transaminase (ALT) NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Elevated aspartate transaminase (AST) NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Elevated total bilirubin NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hematoma at surgical site NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hypophosphatemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypomagnesemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View