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 @ 3:11 AM
Ignite Modification Date: 2025-12-26 @ 1:50 AM
NCT ID: NCT02956005
Description: No difference from clinicaltrials.gov definition
Frequency Threshold: 0
Time Frame: Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
Study: NCT02956005
Study Brief: Envarsus XR in African American Renal Transplant Recipients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Envarsus Open Label; Envarsus XR started at the time of transplant. Initial dosing of 0.17mg/kg. Target trough level of 8-10 ng/mL ENVARSUS®: ENVARSUS XR is a form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant 0 None 10 18 13 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute Kidney Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Acute Hypoxic Respiratory Failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary Edema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypertension Urgency NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Muscle Tremor NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Disorientation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Delayed Graft Function NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Wound Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Adenocarcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Liver Resection of HCC NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Acute Kidney Failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Elevated Creatinine NON_SYSTEMATIC_ASSESSMENT Investigations None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Flu NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Worsening Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Worsening Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Delayed Graft Function NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Slow Graft Function NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Myocardial Infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Metabolic Acidosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperparathyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Coronary Artery Disease NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hyperphosphatemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diabetes NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
CMV NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
BK Viremia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Chest Pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Incisional Pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Weakness/Fatiugue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypercalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Pancytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypomagnesemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Secondary Hyperparathyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hyperlipidemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Nausea/Emesis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Urinary Retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Genital Ulcer NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Shortness of Breath NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Neurological Symptoms NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Edema NON_SYSTEMATIC_ASSESSMENT General disorders None View
Acidosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Seroma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypercholesterolemia NON_SYSTEMATIC_ASSESSMENT Investigations None View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypovolemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Electrolyte Imbalance NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DSA NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Elevated intra-operative blood pressure NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Acute Kidney Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Frequent Urination NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Burning after Urination NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Wound Tear NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Improper Wound Healing NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Elevated Creatinine NON_SYSTEMATIC_ASSESSMENT Investigations None View
Leukocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pulmonary Edema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dry Mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Transplant Adhesion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hemolytic Syndrome NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Chronic Anticoagulation NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
GERD NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bacteremia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
HCV NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lack of appetite NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View