Study: NCT00754845

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 959 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 959 at risk

Adverse event: Melena/GI bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 959 at risk

Adverse event: Rectal bleeding/ hematochezia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 959 at risk

Adverse event: Liver dysfunction/ failure (clinical)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 959 at risk

Adverse event: Hepatic - Other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 959 at risk

Adverse event: Infection without neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 959 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 959 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 959 at risk

Adverse event: Second malignacy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 959 at risk

Adverse event: Ventricular arrhythmia (PVCs/bigeminy/trigeminy/ ventricular tachycardia)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 959 at risk

Adverse event: Oedema
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 959 at risk

Adverse event: Cardiac left ventricular function
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 959 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 959 at risk

Adverse event: Supraventricular arrhythmias (SVT/atrial fibrillation/ flutter)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 959 at risk

Adverse event: Cardiovascular/ General - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 959 at risk

Adverse event: Oedema
Serious: no
Organ System: Cardiac disorders
Frequency: 158 affected / 959 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 157 affected / 959 at risk

Adverse event: Hot flashes/ flushes
Serious: no
Organ System: Endocrine disorders
Frequency: 360 affected / 959 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 346 affected / 959 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 176 affected / 959 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 959 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 117 affected / 959 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 105 affected / 959 at risk

Adverse event: Dyspepsia/heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 86 affected / 959 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 69 affected / 959 at risk

Adverse event: Infection w/o neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 81 affected / 959 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 317 affected / 959 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 203 affected / 959 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 56 affected / 959 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 54 affected / 959 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 145 affected / 959 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 269 affected / 959 at risk

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 152 affected / 959 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 110 affected / 959 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 51 affected / 959 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 151 affected / 959 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 513 affected / 959 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 268 affected / 959 at risk

Adverse event: Bone pain
Serious: no
Organ System: General disorders
Frequency: 174 affected / 959 at risk

Adverse event: Pain-Other
Serious: no
Organ System: General disorders
Frequency: 73 affected / 959 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 63 affected / 959 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 148 affected / 959 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 61 affected / 959 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 102 affected / 959 at risk

Adverse event: Cardiac troponin I (cTnI)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 954 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 954 at risk

Adverse event: Constitutional Symptoms - Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 954 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 954 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 954 at risk

Adverse event: CNS hemorrhage/bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 954 at risk

Adverse event: Infection without neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 954 at risk

Adverse event: Infection with unknown ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 954 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 954 at risk

Adverse event: Neuropathy-motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 954 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 954 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 954 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 954 at risk

Adverse event: Pulmonary - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 954 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 954 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 954 at risk

Adverse event: Second malignacy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 954 at risk

Adverse event: Ventricular arrhythmia (PVCs/bigeminy/trigeminy/ ventricular tachycardia)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 954 at risk

Adverse event: Cardiac left ventricular function
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 954 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 954 at risk

Adverse event: Oedema
Serious: no
Organ System: Cardiac disorders
Frequency: 136 affected / 954 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 145 affected / 954 at risk

Adverse event: Hot flashes/ flushes
Serious: no
Organ System: Endocrine disorders
Frequency: 354 affected / 954 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 355 affected / 954 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 175 affected / 954 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 52 affected / 954 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 140 affected / 954 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 81 affected / 954 at risk

Adverse event: Dyspepsia/heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 79 affected / 954 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 76 affected / 954 at risk

Adverse event: Infection w/o neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 82 affected / 954 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 288 affected / 954 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 184 affected / 954 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 66 affected / 954 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 56 affected / 954 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 139 affected / 954 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 243 affected / 954 at risk

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 150 affected / 954 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 107 affected / 954 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 38 affected / 954 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 138 affected / 954 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 475 affected / 954 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 240 affected / 954 at risk

Adverse event: Bone pain
Serious: no
Organ System: General disorders
Frequency: 133 affected / 954 at risk

Adverse event: Pain-Other
Serious: no
Organ System: General disorders
Frequency: 77 affected / 954 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 69 affected / 954 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 165 affected / 954 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 64 affected / 954 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 96 affected / 954 at risk