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: 2025-12-25 @ 2:27 AM
Ignite Modification Date: 2025-12-26 @ 1:01 AM
NCT ID: NCT02946034
Description: Adverse events data collection was done at each study visit.
Frequency Threshold: 5
Time Frame: Each patient was followed for one year after initiation of treatment.
Study: NCT02946034
Study Brief: Viekira Pak or Mavyret Treatment for Patient With Chronic Kidney Disease and 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
Viekira Pak ± Ribavirin or Mavyret 12 week therapy with Viekira Pak ± ribavirin (2 patients) 8 or 12 week therapy with Mavyret (8 patients 0 None 5 10 8 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fall / loss of consciousness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cryoglobulinemic glomerulonephritis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Heart block NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertensive emergency NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
muscle pain in leg NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
fatigue NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
cryoglobulinemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
slow ventricular response NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
high potassium NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View