Study: NCT02945150

Adverse event: Lymphocele
Serious: yes
Organ System: Surgical and medical procedures
Notes: Lymphocele post kidney transplant requiring drain placement, and subsequent laparoscopic fenestration of peri-nephric lymphocele (x2).
Frequency: 1 affected / 8 at risk

Adverse event: Renal vein thrombosis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Immediate graft failure due to renal vein thrombosis. Allograft explanted on post-operative day 1. Patient anticoagulated and returned to dialysis. Workup for coagulopathy demonstrated positive test for lupus anticoagulant. Achieved SVR12.
Frequency: 1 affected / 8 at risk

Adverse event: Delayed graft function
Serious: yes
Organ System: Renal and urinary disorders
Notes: Patient readmitted to hospital for one day for delayed graft function. Graft function improved and patient was discharged.
Frequency: 1 affected / 8 at risk

Adverse event: Acute kidney injury (AKI)
Serious: yes
Organ System: Renal and urinary disorders
Notes: Admitted to hospital for AKI. Discharged after one day upon improvement.
Frequency: 1 affected / 8 at risk

Adverse event: Elevated alanine transaminase (ALT)
Serious: no
Organ System: Hepatobiliary disorders
Notes: ALT measured at baseline, day 1, day 3, day 7, day 14, day 28, day 42, day 56, day 70, day 84, day 112, day 168, day 252, and day 365

High ALT defined as being above 55 U/L for males and 33 U/L for females
Frequency: 3 affected / 8 at risk

Adverse event: Elevated aspartate transaminase (AST)
Serious: no
Organ System: Hepatobiliary disorders
Notes: AST measured at baseline, day 1, day 3, day 7, day 14, day 28, day 42, day 56, day 70, day 84, day 112, day 168, day 252, and day 365

High AST defined as being above 40 U/L for males and 32 U/L for females
Frequency: 3 affected / 8 at risk

Adverse event: Elevated total bilirubin
Serious: no
Organ System: Hepatobiliary disorders
Notes: Bilirubin measured at baseline, day 1, day 3, day 7, day 14, day 28, day 42, day 56, day 70, day 84, day 112, day 168, day 252, and day 365

High bilirubin defined as being above 1.0 mg/dL
Frequency: 1 affected / 8 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Patient who was admitted for AKI also had diarrhea during admission. Was discharged after 1 day upon improvement.
Frequency: 1 affected / 8 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Patient who was admitted for AKI also had abdominal pain during admission. Was discharged after 1 day upon improvement.
Frequency: 1 affected / 8 at risk

Adverse event: Hematoma at surgical site
Serious: no
Organ System: Surgical and medical procedures
Notes: Patient who was admitted for AKI also had hematoma at surgical site during admission. Was discharged after 1 day upon improvement.
Frequency: 1 affected / 8 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Patient who was admitted for AKI also had hypophosphatemia during admission. Was discharged after 1 day upon improvement.
Frequency: 1 affected / 8 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Patient who was admitted for AKI also had hypomagnesemia during admission. Was discharged after 1 day upon improvement.
Frequency: 1 affected / 8 at risk