Study: NCT00245037

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Notes: Related to regimen
Frequency: 1 affected / 147 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Notes: Related to regimen
Frequency: 2 affected / 147 at risk

Adverse event: Atrial fibrillation/flutter
Serious: yes
Organ System: Cardiac disorders
Notes: Related to regimen
Frequency: 3 affected / 147 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Notes: Related to regimen
Frequency: 1 affected / 147 at risk

Adverse event: Respiratory pulseless electrical activity (PEA) arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Related to regimen
Frequency: 1 affected / 147 at risk

Adverse event: Event associated with CsA
Serious: yes
Organ System: Renal and urinary disorders
Notes: Related to regimen
Frequency: 1 affected / 147 at risk

Adverse event: Organising pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Related to regimen
Frequency: 1 affected / 147 at risk

Adverse event: Eosinophilic pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Related to regimen
Frequency: 1 affected / 147 at risk

Adverse event: CsA toxicity
Serious: yes
Organ System: Nervous system disorders
Notes: Related to regimen
Frequency: 5 affected / 147 at risk

Adverse event: Posterior-reversible encephalopathy syndrome
Serious: yes
Organ System: Nervous system disorders
Notes: Related to regimen
Frequency: 2 affected / 147 at risk

Adverse event: Veno-occlusive disease
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Related to regimen
Frequency: 1 affected / 147 at risk

Adverse event: Iron overload
Serious: yes
Organ System: General disorders
Notes: Related to regimen
Frequency: 1 affected / 147 at risk

Adverse event: Myopathy
Serious: yes
Organ System: General disorders
Notes: Related to regimen
Frequency: 3 affected / 147 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: General disorders
Notes: Related to regimen
Frequency: 5 affected / 147 at risk

Adverse event: ABO incompatability
Serious: yes
Organ System: General disorders
Notes: Related to regimen
Frequency: 1 affected / 147 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: General disorders
Notes: Related to regimen
Frequency: 2 affected / 147 at risk

Adverse event: Thrombosis/deep vein thrombosis
Serious: yes
Organ System: General disorders
Notes: Related to regimen
Frequency: 5 affected / 147 at risk

Adverse event: Thrombotic thrombocytopenic purpura (TTP)
Serious: yes
Organ System: General disorders
Notes: Related to regimen
Frequency: 1 affected / 147 at risk

Adverse event: Refractory ascites
Serious: yes
Organ System: General disorders
Notes: Related to regimen
Frequency: 1 affected / 147 at risk

Adverse event: Intestinal pseudo-obstruction
Serious: yes
Organ System: General disorders
Notes: Related to regimen
Frequency: 1 affected / 147 at risk

Adverse event: Fractures/musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Related to regimen
Frequency: 3 affected / 147 at risk

Adverse event: Death Caused by Bacterial Infection
Serious: yes
Organ System: Infections and infestations
Notes: Unrelated to regimen
Frequency: 7 affected / 147 at risk

Adverse event: Death Caused by Fungal Infection
Serious: yes
Organ System: Infections and infestations
Notes: Unrelated to regimen
Frequency: 3 affected / 147 at risk

Adverse event: Death Caused by Sepsis/Septic Shock
Serious: yes
Organ System: Infections and infestations
Notes: Unrelated to regimen
Frequency: 3 affected / 147 at risk

Adverse event: Death Caused by Viral Infection
Serious: yes
Organ System: Infections and infestations
Notes: Unrelated to regimen
Frequency: 3 affected / 147 at risk

Adverse event: Death Caused by Nonspecified Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Unrelated to regimen
Frequency: 1 affected / 147 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Notes: Unrelated to Regimen
Frequency: 14 affected / 147 at risk

Adverse event: Hyperbilirubinemia or transaminitis
Serious: no
Organ System: Hepatobiliary disorders
Notes: Related to regimen
Frequency: 38 affected / 147 at risk