Study: NCT00369382

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Notes: Body as a Whole
Frequency: 1 affected / 57 at risk

Adverse event: Laboratory test abnormal
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Transplant rejection
Serious: yes
Organ System: General disorders
Notes: Multiple reasons for cardiac biopsies. Refer to outcome measure 10.
Frequency: 1 affected / 57 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiovascular System
Frequency: 1 affected / 57 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 57 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 57 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Musculoskeletal system
Frequency: 1 affected / 57 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin and appendages
Frequency: 1 affected / 57 at risk

Adverse event: Skin cancer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 57 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Notes: Body as a Whole
Frequency: 3 affected / 57 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 57 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 57 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Generalised oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 57 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Transplant rejection
Serious: no
Organ System: General disorders
Notes: Multiple reasons for cardiac biopsies. Refer to outcome measure 10.
Frequency: 1 affected / 57 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: Cardiovascular system
Frequency: 2 affected / 57 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 57 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 57 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 57 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 57 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Metabolic and Nutritional
Frequency: 3 affected / 57 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 57 at risk

Adverse event: Impaired healing
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 57 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 57 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 57 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 57 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Musculoskeletal system
Frequency: 2 affected / 57 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 57 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 57 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 57 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 57 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory system
Frequency: 6 affected / 57 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 57 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 57 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 57 at risk

Adverse event: Uterine leiomyoma
Serious: no
Organ System: Renal and urinary disorders
Notes: Urogenital system
Frequency: 1 affected / 5 at risk

Adverse event: Uterine haemorrhage
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 5 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 57 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 57 at risk

Adverse event: Skin cancer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin and Appendages
Frequency: 1 affected / 57 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Notes: Body as a Whole
Frequency: 1 affected / 57 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Transplant rejection
Serious: yes
Organ System: General disorders
Notes: Multiple reasons for cardiac biopsies. Refer to outcome measure 10.
Frequency: 13 affected / 57 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 57 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 57 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 57 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 57 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 57 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 57 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 57 at risk

Adverse event: Biliary colic
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Digestive System
Frequency: 1 affected / 57 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Gastrointestinal carcinoma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Liver function test abnormal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Hemic and lymphatic system
Frequency: 1 affected / 57 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 57 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Notes: Nervous system
Frequency: 1 affected / 57 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory system
Frequency: 1 affected / 57 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 57 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 57 at risk

Adverse event: Skin cancer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 57 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Notes: Body as a Whole
Frequency: 7 affected / 57 at risk

Adverse event: Injury
Serious: no
Organ System: General disorders
Frequency: 4 affected / 57 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 57 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 57 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 57 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 57 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 57 at risk

Adverse event: Generalised oedema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 57 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 8 affected / 57 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 57 at risk

Adverse event: Transplant rejection
Serious: no
Organ System: General disorders
Notes: Multiple reasons for cardiac biopsies. Refer to outcome measure 10.
Frequency: 4 affected / 57 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: Cardiovascular system
Frequency: 7 affected / 57 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 57 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: Digestive system
Frequency: 3 affected / 57 at risk

Adverse event: Aphthous ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 57 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 57 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 57 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 57 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 57 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 57 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Hemic and Lymphatic system
Frequency: 5 affected / 57 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 57 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 57 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 57 at risk

Adverse event: Impaired healing
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 57 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 57 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 57 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 57 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Musculoskeletal system
Frequency: 6 affected / 57 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 57 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Notes: Nervous system
Frequency: 3 affected / 57 at risk

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 57 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 57 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 57 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 57 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory system
Frequency: 5 affected / 57 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 57 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 57 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 57 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin and Appendages
Frequency: 8 affected / 57 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 57 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 57 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 57 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Notes: Special senses
Frequency: 3 affected / 57 at risk

Adverse event: Infection
Serious: no
Organ System: General disorders
Notes: Body as a whole
Frequency: 5 affected / 57 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Due to infection, Respiratory system
Frequency: 3 affected / 57 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 57 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin and Appendages
Frequency: 4 affected / 57 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 57 at risk

Adverse event: Skin cancer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin and Appendages
Frequency: 3 affected / 57 at risk