Study: NCT00478699

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 108 at risk

Adverse event: Thrombolysis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 108 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 108 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 108 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 108 at risk

Adverse event: Anorexy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 108 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 108 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 108 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 108 at risk

Adverse event: Broken arm
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 108 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 108 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 108 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 108 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 32 affected / 108 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 20 affected / 108 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 108 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 108 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 81 affected / 108 at risk

Adverse event: Leukocites
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 108 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 108 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 108 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 108 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 108 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 82 affected / 108 at risk

Adverse event: Sensitivity in sensory processing
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 108 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 108 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 108 at risk

Adverse event: Anorexy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 108 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 108 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 108 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 108 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 108 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 108 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 108 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 108 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 108 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 108 at risk

Adverse event: GGT alteration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 90 affected / 108 at risk

Adverse event: Creatinine alteration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 108 at risk

Adverse event: GPT/ GOT alterations
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 31 affected / 108 at risk

Adverse event: LDH alteration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 108 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 108 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 392 at risk

Adverse event: Thrombolysis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 392 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 392 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 29 affected / 392 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 392 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 392 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 392 at risk

Adverse event: Vomits
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 392 at risk

Adverse event: Palmoplantar disease
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 392 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 392 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 392 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 15 affected / 392 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 266 affected / 392 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 20 affected / 392 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 11 affected / 392 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 392 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 220 affected / 392 at risk

Adverse event: Leukocites
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 80 affected / 392 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 138 affected / 392 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 50 affected / 392 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 392 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 12 affected / 392 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 392 at risk

Adverse event: Sensitivity in sensory processing
Serious: no
Organ System: Nervous system disorders
Frequency: 47 affected / 392 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 392 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 392 at risk

Adverse event: Anorexy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 63 affected / 392 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 57 affected / 392 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 110 affected / 392 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 93 affected / 392 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 180 affected / 392 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 126 affected / 392 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 392 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 142 affected / 392 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 25 affected / 392 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 392 at risk

Adverse event: GGT alteration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 42 affected / 392 at risk

Adverse event: Creatinine alteration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 33 affected / 392 at risk

Adverse event: GPT/ GOT alterations
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 37 affected / 392 at risk

Adverse event: LDH alteration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 392 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 51 affected / 392 at risk