Study: NCT01083641

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 17 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Pain- back
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Supraventricular and nodal arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 17 at risk

Adverse event: Thrombosis/Thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 17 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 17 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia) Count
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 17 at risk

Adverse event: Alkaline phosphatase Count
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 17 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase) Count
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 17 at risk

Adverse event: Anorexia Count
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 17 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase) Count
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 17 at risk

Adverse event: Calcium, serum-low (hypocalcemia) Count
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 17 at risk

Adverse event: Confusion Count
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Constipation Count
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 17 at risk

Adverse event: Cough Count
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 17 at risk

Adverse event: Creatinine Count
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 17 at risk

Adverse event: Dermal change lymphedema, phlebolymphedema Count
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Dermatology/Skin Count
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Diarrhea Count
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Distension/bloating, abdominal Count
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 17 at risk

Adverse event: Dizziness Count
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 17 at risk

Adverse event: Dry mouth/salivary gland (xerostomia) Count
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Dyspnea (shortness of breath) Count
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 17 at risk

Adverse event: Edema: limb Count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 17 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise) Count
Serious: no
Organ System: General disorders
Frequency: 13 affected / 17 at risk

Adverse event: Glucose, serum-high (hyperglycemia) Count
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 17 at risk

Adverse event: Glucose, serum-low (hypoglycemia) Count
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 17 at risk

Adverse event: Hair loss/alopecia (scalp or body) Count
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Hemoglobin Count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 17 at risk

Adverse event: Hemorrhage Count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 17 at risk

Adverse event: Hypertension Count
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 17 at risk

Adverse event: Infection Count
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 17 at risk

Adverse event: Leukocytes (total WBC) Count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 17 at risk

Adverse event: Lymphedema-related fibrosis Count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 17 at risk

Adverse event: Lymphopenia Count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Mood alteration - Anxiety Count
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Mood alteration - Depression Count
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 17 at risk

Adverse event: Nausea Count
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 17 at risk

Adverse event: Neuropathy: sensory Count
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 17 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC) Count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Pain Count
Serious: no
Organ System: General disorders
Frequency: 14 affected / 17 at risk

Adverse event: Potassium, serum-low (hypokalemia) Count
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 17 at risk

Adverse event: Pruritus/itching Count
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Pulmonary/Upper Respiratory - Other (Specify, __) Count
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Sodium, serum-low (hyponatremia) Count
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 17 at risk

Adverse event: Vaginal discharge (non-infectious) Count
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 17 at risk

Adverse event: Vision-flashing lights/floaters Count
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 17 at risk

Adverse event: Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) Count
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Vomiting Count
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 17 at risk

Adverse event: Weight gain Count
Serious: no
Organ System: General disorders
Frequency: 2 affected / 17 at risk