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 @ 4:08 AM
Ignite Modification Date: 2025-12-26 @ 3:05 AM
NCT ID: NCT02902120
Description: None
Frequency Threshold: 0
Time Frame: Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
Study: NCT02902120
Study Brief: HCV Treatment Immune Response With Grazoprevir/Elbasvir Before or After Renal 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
Post-transplant This arm will evaluate the treatment of patients with HCV and chronic kidney disease (GFR \<50) who have had a kidney transplant using grazoprevir and elbasvir. Post-transplant Grazoprevir and Elbasvir: Treatment will be started in the post-transplant patients on day 0 with the combination pill zepatier, containing grazoprevir 100mg/elbasvir 50mg by mouth once daily. The medications will be continued for a total of 12 weeks (16 weeks if resistance mutations, RAVs, are detected) 0 None 6 21 21 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Nausea, vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
CMV Viremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Decreased appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
UTI, sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Shingles SYSTEMATIC_ASSESSMENT Infections and infestations None View
URI SYSTEMATIC_ASSESSMENT Infections and infestations None View
Community acquired pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Elevated tacrolimus level SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Decreased Tacrolimus levels SYSTEMATIC_ASSESSMENT Investigations None View
Microalbuminuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
ankle swelling SYSTEMATIC_ASSESSMENT Vascular disorders None View
Elevated WBCs SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
seasonal allergies SYSTEMATIC_ASSESSMENT Immune system disorders None View
pruritis SYSTEMATIC_ASSESSMENT Immune system disorders None View
dry cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
decreased appetite SYSTEMATIC_ASSESSMENT General disorders None View
orchitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
mild antibody mediated rejection SYSTEMATIC_ASSESSMENT Immune system disorders None View
increased glucose SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Groin strain or pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
fall SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Elevated Blood Pressure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
osteoporosis SYSTEMATIC_ASSESSMENT Endocrine disorders None View
pyuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
cold sweats SYSTEMATIC_ASSESSMENT Endocrine disorders None View
neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Stye SYSTEMATIC_ASSESSMENT Infections and infestations None View
URI, pharyngitis, rhinitis, bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
indigestion, GERD SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
muscle cramps SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
otitis media SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Elevated creatinine or AKI SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Low platelets SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
nausea, vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
UTI SYSTEMATIC_ASSESSMENT Infections and infestations None View
candida infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
CMV viremia, syndrome SYSTEMATIC_ASSESSMENT Infections and infestations None View
anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
shingles SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View