Study: NCT00522548

Adverse event: graft dysfunction due to rejection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 18 at risk

Adverse event: non-infectious related diarrhea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 18 at risk

Adverse event: graft failure due to antibody mediated rejection
Serious: yes
Organ System: Renal and urinary disorders
Notes: Occurred during 30 day safety follow-up period when patient was found to be non-adherent with immunosuppression. Antibody mediated rejection was considered non-reversible and patient progressed to graft failure.
Frequency: 1 affected / 18 at risk

Adverse event: dialysis fistula thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: Patient had dialysis fistula thrombosis during treatment for antibody mediated rejection that progressed to graft failure in 30 day safety follow-up period due to non-adherence.
Frequency: 1 affected / 18 at risk

Adverse event: diabetic complications
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 18 at risk

Adverse event: graft dysfunction not found to be related to rejection
Serious: yes
Organ System: Renal and urinary disorders
Notes: causes included acute tubular necrosis, chronic allograft nephropathy, recurrent focal segmental glomerulosclerosis
Frequency: 3 affected / 18 at risk

Adverse event: anemia managed during hospitalization
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 18 at risk

Adverse event: high potassium (hyperkalemia) requiring hospitalization for management
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 18 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: patient redmitted for dehydration and vomiting
Frequency: 1 affected / 18 at risk

Adverse event: Bacterial infections
Serious: yes
Organ System: Infections and infestations
Notes: infection
Frequency: 6 affected / 18 at risk

Adverse event: Viral infections
Serious: yes
Organ System: Infections and infestations
Notes: infection
Frequency: 1 affected / 18 at risk

Adverse event: wound seroma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: wound seroma
Frequency: 1 affected / 18 at risk

Adverse event: heart complications
Serious: yes
Organ System: Cardiac disorders
Notes: non-sustained ventricular tachycardia, pericardial effusion, myocardial infarction
Frequency: 2 affected / 18 at risk

Adverse event: wound complications
Serious: yes
Organ System: Surgical and medical procedures
Notes: wound vac placement
Frequency: 1 affected / 18 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated to vascular complications or infection
Frequency: 1 affected / 18 at risk

Adverse event: high blood pressure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 18 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 18 at risk

Adverse event: Diabetic Complications
Serious: no
Organ System: Endocrine disorders
Notes: worsening pre-transpalnt diabets blood sugar control
Frequency: 4 affected / 18 at risk

Adverse event: Superior vena cava syndrome
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 18 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 18 at risk

Adverse event: bacterial infection not requiring hospitalization
Serious: no
Organ System: Infections and infestations
Notes: urinary tract infection
Frequency: 3 affected / 18 at risk

Adverse event: soft stools without diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: high potassium (hyperkalemia) not requiring hospitalization
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 18 at risk

Adverse event: urinary retention not requiring hospitalization
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 18 at risk

Adverse event: low white blood cell count (leukopenia)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 18 at risk

Adverse event: accidental anti-anxiety pill overdose not requiring inpatient hospitalization
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 18 at risk

Adverse event: increased bowel movement frequency
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: delayed graft function of renal transplant
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 18 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: nausea resulted in subsequent weight loss not requiring hospitalization in one cellcept patient and associated also with vomiting in one patient on cellcept
Frequency: 1 affected / 18 at risk

Adverse event: low red blood cell count (anemia)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 18 at risk

Adverse event: shortness of breath and fluid related weight gain not requiring hospitalization
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 18 at risk

Adverse event: hemmorhoids
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: back pain after fall on ice
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: viral cold infection
Serious: no
Organ System: Infections and infestations
Notes: resolved on its own without treatment
Frequency: 2 affected / 18 at risk

Adverse event: hip-pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: no source found in one patient and other patient had history of pre-transplant avascular necrosis
Frequency: 2 affected / 18 at risk

Adverse event: tertiary hyperparathyroidism
Serious: no
Organ System: Endocrine disorders
Notes: treated with oral medication as outpatient
Frequency: 1 affected / 18 at risk

Adverse event: root canal
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 18 at risk

Adverse event: high hemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: treated with outpatient phlebotomy
Frequency: 1 affected / 18 at risk

Adverse event: mild increase in liver function tests (transaminitis)
Serious: no
Organ System: Hepatobiliary disorders
Notes: patient had history of pre-transplant hepatitis B infection
Frequency: 1 affected / 18 at risk

Adverse event: hypoglycemia (low blood sugars)
Serious: no
Organ System: Endocrine disorders
Notes: patient was using sliding scale for elevated blood sugars but experienced hypoglycemia-resolved upon stopping insulin and patient did not need any further therapy
Frequency: 1 affected / 18 at risk

Adverse event: BK virus infection
Serious: no
Organ System: Infections and infestations
Notes: was BKV nephropathy in one myfortic patient
Frequency: 1 affected / 18 at risk

Adverse event: skin itching thought to be related to dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Renal and urinary disorders
Notes: treated as outpatient with oral bicarbonate and resolved
Frequency: 1 affected / 18 at risk

Adverse event: blood in urine and mild transplant rejection
Serious: no
Organ System: Renal and urinary disorders
Notes: treated as outpatient with pulse steroid doses
Frequency: 1 affected / 18 at risk

Adverse event: renal dysfunction and edema
Serious: no
Organ System: Renal and urinary disorders
Notes: found to be related to SVC in 30+ day follow-up in MMF group patient
Frequency: 1 affected / 18 at risk

Adverse event: low phosphorous
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: corrected with diet
Frequency: 1 affected / 18 at risk

Adverse event: bowel urgency
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: unilateral lower leg swelling
Serious: no
Organ System: General disorders
Notes: not transplant related and negative for deep vein thrombosis
Frequency: 1 affected / 18 at risk

Adverse event: low potassium
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: resolved with change in diet
Frequency: 1 affected / 18 at risk

Adverse event: neck itching
Serious: no
Organ System: Immune system disorders
Notes: patient thought symptoms may be related to allergy and resolved with otc medication product change.
Frequency: 1 affected / 18 at risk

Adverse event: muscle leg pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: resolved with prescription muscle relaxant
Frequency: 1 affected / 18 at risk

Adverse event: ongoing high blood pressure
Serious: no
Organ System: Cardiac disorders
Notes: ongoing high blood pressure on medications
Frequency: 1 affected / 18 at risk

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: lymphocele or seroma
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: stable on outpatient ultrasound
Frequency: 1 affected / 18 at risk

Adverse event: graft dysfunction due to rejection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 19 at risk

Adverse event: non-infectious related diarrhea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 19 at risk

Adverse event: Lymphocele
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 19 at risk

Adverse event: urinary leak post renal transplant
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 19 at risk

Adverse event: diabetic complications
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 19 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 19 at risk

Adverse event: graft dysfunction not found to be related to rejection
Serious: yes
Organ System: Renal and urinary disorders
Notes: causes included acute tubular necrosis, chronic allograft nephropathy, recurrent focal segmental glomerulosclerosis
Frequency: 6 affected / 19 at risk

Adverse event: anemia managed during hospitalization
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 19 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 19 at risk

Adverse event: high potassium (hyperkalemia) requiring hospitalization for management
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 19 at risk

Adverse event: cervical arthritis and related neuropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Bacterial infections
Serious: yes
Organ System: Infections and infestations
Notes: infection
Frequency: 5 affected / 19 at risk

Adverse event: Viral infections
Serious: yes
Organ System: Infections and infestations
Notes: infection
Frequency: 2 affected / 19 at risk

Adverse event: heart complications
Serious: yes
Organ System: Cardiac disorders
Notes: non-sustained ventricular tachycardia, pericardial effusion, myocardial infarction
Frequency: 1 affected / 19 at risk

Adverse event: recurrence of renal disease
Serious: yes
Organ System: Renal and urinary disorders
Notes: recurrent primary disease FSGS
Frequency: 1 affected / 19 at risk

Adverse event: drug induced rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: thought to be related to rabbit anti-thymocyte globulin induction
Frequency: 1 affected / 19 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 19 at risk

Adverse event: Superior vena cava syndrome
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 19 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 19 at risk

Adverse event: soft stools without diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: high potassium (hyperkalemia) not requiring hospitalization
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 19 at risk

Adverse event: urinary retention not requiring hospitalization
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 19 at risk

Adverse event: low white blood cell count (leukopenia)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 19 at risk

Adverse event: delayed graft function of renal transplant
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 19 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: nausea resulted in subsequent weight loss not requiring hospitalization in one cellcept patient and associated also with vomiting in one patient on cellcept
Frequency: 2 affected / 19 at risk

Adverse event: low platelet count (thrombocytopenia)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 19 at risk

Adverse event: nephrotic range protein in urine (proteinuria)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 19 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: did not require any intervention and resolved on own
Frequency: 1 affected / 19 at risk

Adverse event: low red blood cell count (anemia)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 19 at risk

Adverse event: high hemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: treated with outpatient phlebotomy
Frequency: 1 affected / 19 at risk

Adverse event: bled through non-functioning dialysis graft not requiring inpatient hospitalization
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 19 at risk

Adverse event: BK virus infection
Serious: no
Organ System: Infections and infestations
Notes: was BKV nephropathy in one myfortic patient
Frequency: 2 affected / 19 at risk

Adverse event: high cholesterol (hyperlipidemia)
Serious: no
Organ System: Cardiac disorders
Notes: Patient was on maximum statin dose. Symptoms resolved with diet, exercise and decreased prednisone dose.
Frequency: 1 affected / 19 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: symptoms improved over time without any specific treatment
Frequency: 1 affected / 19 at risk

Adverse event: skin itching thought to be related to dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: renal dysfunction and edema
Serious: no
Organ System: Renal and urinary disorders
Notes: found to be related to SVC in 30+ day follow-up in MMF group patient
Frequency: 1 affected / 19 at risk

Adverse event: ongoing high blood pressure
Serious: no
Organ System: Cardiac disorders
Notes: ongoing high blood pressure on medications
Frequency: 1 affected / 19 at risk