Study: NCT01457118

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Appendix cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 20 at risk

Adverse event: Cancer pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 20 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk

Adverse event: Total Number of TESAEs
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 20 at risk

Adverse event: # of subjects with Anemia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 20 at risk

Adverse event: # of subjects with Neutropenia
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 20 at risk

Adverse event: # of subjects with Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Vision Blurred
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 20 at risk

Adverse event: # of subjects with Photophobia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 20 at risk

Adverse event: # of subjects with Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 20 at risk

Adverse event: # of subjects with Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 20 at risk

Adverse event: # of subjects with Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 20 at risk

Adverse event: # of subjects with Abdominal Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: # of subjects with Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: # of subjects with Upper Abdominal Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Hypoesthesia Oral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Mouth Ulceration
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Stomatitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 20 at risk

Adverse event: # of subjects with Oedema Peripheral
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 20 at risk

Adverse event: # of subjects with Non-Cardiac Chest Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Urinary Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 20 at risk

Adverse event: # of subjects with Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Gingival Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Weight Decreased
Serious: no
Organ System: General disorders
Frequency: 5 affected / 20 at risk

Adverse event: # of subjects with Neutrophil Count Decreased
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Aspartate Aminotransferase Increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with White Blood Cell count decreased
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Alanine Aminotransferase Increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Blood Bilirubin Increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Liver Function Test Abnormal
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Prothrombin Time Prolonged
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Decreased Appetite
Serious: no
Organ System: General disorders
Frequency: 4 affected / 20 at risk

Adverse event: # of subjects with Hypoalbuminemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 20 at risk

Adverse event: # of subjects with Hypokalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 20 at risk

Adverse event: # of subjects with Hypoglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Hyponatremia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 20 at risk

Adverse event: # of subjects with Hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Hypocalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Hypomagenesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Hypophosphatemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Back Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Flank Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Appendix Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Cancer Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Aphonia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Dysgeusia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Hypoesthesia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Depressed Mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Acute Renal Failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Vaginal Hemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Oropharyngeal Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: # of subjects with Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Dyspnea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Productive Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Pulmonary Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Decubitus Ulcer
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 20 at risk

Adverse event: # of subjects with Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: # of subjects with Alopecia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Pelvic Venous Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Peritonitis Bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: # of subjects with Blood Creatine Increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: Abdominal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Peritonitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Total Number of TESAEs
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: # of subjects with Anemia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 4 at risk

Adverse event: # of subjects with Vision Blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 4 at risk

Adverse event: # of subjects with Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4 at risk

Adverse event: # of subjects with Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4 at risk

Adverse event: # of subjects with Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: # of subjects with Abdominal Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: # of subjects with Dry Mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: # of subjects with Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: # of subjects with Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: # of subjects with Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: # of subjects with Abdominal Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: # of subjects with Neutrophil Count Decreased
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 4 at risk

Adverse event: # of subjects with Aspartate Aminotransferase Increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: # of subjects with White Blood Cell count decreased
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 4 at risk

Adverse event: # of subjects with Activated Partial Thromboplastin Time Prolonged
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: # of subjects with Hypoalbuminemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: # of subjects with Hypokalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: # of subjects with Hypoglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: # of subjects with Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: # of subjects with Muscular Weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: # of subjects with Musculoskeletal Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: # of subjects with Oropharyngeal Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: # of subjects with Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1 at risk

Adverse event: # of subjects with Neutrophil Count Decreased
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 1 at risk

Adverse event: # of subjects with Decreased Appetite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1 at risk

Adverse event: Herpex simplex encephalitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Total Number of TESAEs
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: # of subjects with Abdominal Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: # of subjects with Ascites
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 2 at risk

Adverse event: # of subjects with Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: # of subjects with Herpes Simplex Encephalitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: # of subjects with Decreased Appetite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: # of subjects with Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2 at risk

Adverse event: # of subjects with Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk