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 @ 4:42 AM
Ignite Modification Date: 2025-12-26 @ 3:44 AM
NCT ID: NCT01921218
Description: Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Frequency Threshold: 0
Time Frame: Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38).
Study: NCT01921218
Study Brief: Belatacept Therapy for the Failing Renal Allograft
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Belatacept Treatment Group Participants with a failing kidney or failed kidney transplant receiving belatacept therapy 2 None 4 6 6 6 View
Control Group Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression 1 None 5 7 7 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastrointestinal bleed NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Groin abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Initiation of hemodialysis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Deep vein thrombosis and pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Peritoneal dialysis catheter blockage or malfunction NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Exacerbation of hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Acute rejection NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pericardial effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Septic shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Peritonitis with sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypertensive crisis with seizure NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pneumonia related to H1N1 influenza culminating in death NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Infected permacath NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bacteremia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Malfunctionig arteriovenous (AV) fistula with edema NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Increased creatinine NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Escherichia coli urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Atrial flutter NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Acute respiratory failure with hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Posterior Reversible Encephalopathy syndrome NON_SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal cramps, grade 1 NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea, grade 1 NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea, grade 2 NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Arthralgia, grade 2 NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthralgia, grade 1 NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Left leg cramps, grade 2 NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hypoglycemia, grade 2 NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Forgetfulness, grade 1 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Disc protrusion, grade 2 NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Facet joint hypertrophy, grade 2 NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hypertension, grade 3 NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Nervousness, grade 1 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Lesion on upper palate, grade 1 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Upper respiratory infection, grade 2 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory infection, grade 1 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tendonitis bilateral ankles, grade 1 NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chest pain, grade 3 NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest pain, grade 1 NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pruritus, grade 2 NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypocalcemia, grade 2 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Abdominal pain, grade 2 NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Knee meniscus tear, grade 2 NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Osteoarthritis in knee, grade 2 NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fractured toes due to motor vehicle accident, grade 2 NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Leg pain possibly due to sciatica, grade 2 NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Benign right ovarian cysts, grade 1 NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Urinary tract infection with bacteremia, grade 3 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Atrial flutter, grade 1 NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Squamous cell carcinoma, grades 1 and 2 NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Anxiety, grade 1 NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Peritoneal dialysis site infection, grade 2 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Coughing and wheezing, grade 2 NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Burst bursa sac after fall, grade 2 NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Sycopal episode, grade 3 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Graft tenderness, grade 1 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hematuria, grade 1 NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Posterior reversible encephalopathy, grade 3 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Peritoneal dialysis catheter malfunction, grade 3 NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Exacerbation of baseline anemia, grade 2 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Atrial fibrillation, grade 1 NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericardial effusion, grade 3 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Colitis, grade 3 NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cellulitis, grade 2 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis media, grade 2 NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Acute pharyngitis, grade 2 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Eustacian tube dysfunction, grade 2 NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Sinusitis, grade 2 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rise in creatinine, grade 2 NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Viral syndrome, grade 2 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Keratitis dendritic herpes, grade 2 NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Hypotension, grade 1 NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Febrile illness, grade 1 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Shin injury, grade 2 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cold sensitivity, grade 1 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nausea, grade 3 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Vomiting, grade 2 NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Indigestion, grade 1 NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Right clogged ear, grade 1 NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Hyperphosphatemia, grade 2 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypotension, grade 2 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Shortness of breath, grade 1 NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Headache, grade 1 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hot flashes, grade 1 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Intermittent bone pain, grade 1 NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Intermittent jaw pain, grade 1 NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chest wall pain at site of dialysis catheter, grade 1 NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Scapular pain, grade 1 NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chronic pulmonary embolus, grade 2 NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Intermittent hand cramping, grade 1 NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle aches, grade 2 NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hyperparathyroidism, grade 2 NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Asymmetry in right breast, grade 1 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hives bilateral lower leg, grade 1 NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sinus congestion, grade 1 NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sigmoid diverticulosis, grade 1 NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Exacerbation of anemia, grade 1 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Altered mental status, grade 3 NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Joint pain, grade 1 NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Enlarged axillary lymph node, grade 1 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pyelonephritis, grade 1 NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Generalized urticaria, grade 1 NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Lip sore, grade 1 NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Scleral redness, grade 1 NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Lower extremity weakness, grade 2 NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lower spine pain, grade 2 NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hypokalemia, grade 2 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Urinary tract infection, grade 2 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Shoulder pain, grade 1 NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Foot pain, grade 1 NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dry cough, grade 1 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Perihepatic ascites, grade 1 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Weight loss, grade 2 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Bilateral hip edema, grade 1 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypoglycemia, grade 3 NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Pressure ulcers on sacrum and coccyx, grade 3 NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Weakness, grade 1 NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Shaking, grade 1 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Peritoneal catheter removal, grade 1 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Exacerbation of insomnia, grade 2 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Weight gain, grade 2 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypertensive crisis, grade 2 NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension exacerbation, grade 1 NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Syncopal episode, grade 3 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fever, grade 2 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypervolemia, grade 1 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypokalemia, grade 1 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness, grade 1 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Diaphoresis, grade 1 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Peritonitis, grade 1 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Internal hemorrhoids, grade 1 NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Knee replacement, grade 2 NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Knee drainage, grade 1 NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Lower extremity swelling, grade 1 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Aortic stenosis, grade 2 NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Serratia bacteremia, grade 2 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Metatarsal fracture, grade 2 NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Lesions removed from arm, grade 2 NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Pulmonary edema, grade 1 NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fatigue, grade 1 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue, grade 2 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nausea, grade 1 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Bilateral feet cramps, grade 1 NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Peritonitis, grade 2 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bilateral restless legs, grade 1 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Exacerbation of gout, grades 2 and 3 NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Multiple non-malignant skin lesions, grade 1 NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Influenza A and B, grade 2 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia, grade 2 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Shingles, grade 1 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia, grade 3 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomiting, grade 3 NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea, grade 3 NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lower extremity edema, grade 1 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hyperkalemia, grade 2 NON_SYSTEMATIC_ASSESSMENT General disorders None View
Intermittent bilateral foot swelling, grade 1 NON_SYSTEMATIC_ASSESSMENT General disorders None View