Study: NCT03619837

Adverse event: Graft versus host disease
Serious: yes
Organ System: Immune system disorders
Notes: Subject was diagnosed with GVHD beginning day 19 following transplant. Study drug was started 8 days post_LT but was permanently discontinued after only 7 weeks of treatment per investigator discretion due to multisystem organ complications.
Frequency: 1 affected / 24 at risk

Adverse event: Rejection
Serious: yes
Organ System: Immune system disorders
Notes: Subject received an A2→O graft and began the study drug 5 days post-transplant developed early antibody-mediated rejection that was treated with intravenous immunoglobulin G with normalization of liver biochemistries by day 36 after transplant.
Frequency: 1 affected / 24 at risk

Adverse event: Biliary sclerosis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Subject who began the study drug 6 days after surgery developed a progressive, intrahepatic biliary sclerosis starting by day 31. An ischemic etiology was excluded. No other clinical sequelae other than elevated ALKP.
Frequency: 1 affected / 24 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Notes: Subject started study treatment 6 days after surgery and found to have idiopathic pericardial effusion with decreased left-ventricular ejection fraction about 1 month after transplant that resolved with pericardiocentesis.
Frequency: 1 affected / 24 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Notes: N=5 without origin; n=1 with diarrhea and n=1 with UTI
Frequency: 5 affected / 24 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 24 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: N=1 hip; N=1 humerus
Frequency: 2 affected / 24 at risk

Adverse event: Delayed graft function
Serious: yes
Organ System: Renal and urinary disorders
Notes: Required hemodialysis but recovered.
Frequency: 1 affected / 24 at risk

Adverse event: Ureteric stenosis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Associated with acute kidney injury, treated with nephrostomy with resolution
Frequency: 1 affected / 24 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Intraoperative with liver transplantation; treated with amiodarone
Frequency: 1 affected / 24 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Secondary to C. difficle
Frequency: 1 affected / 24 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Surgical and medical procedures
Notes: Intraabdominal bleeding (post-op - N=2 liver transplant recipients)
Frequency: 2 affected / 24 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Surgical and medical procedures
Notes: Post procedural
Frequency: 1 affected / 24 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 24 at risk

Adverse event: abnormal liver tests
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 24 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: with vomiting
Frequency: 1 affected / 24 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: post kidney biopsy
Frequency: 1 affected / 24 at risk

Adverse event: Elevated creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 24 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 24 at risk