Study: NCT01177735

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 71 at risk

Adverse event: Hospitalization for sinus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 71 at risk

Adverse event: Hospialization for progressive disease, sepsis and pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 71 at risk

Adverse event: Hospitalization for removal of port
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 71 at risk

Adverse event: Hospitalization for fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 71 at risk

Adverse event: RSV Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 71 at risk

Adverse event: Fever neutropenia dehydration
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 71 at risk

Adverse event: Hospitalization for neutropenic fever
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 71 at risk

Adverse event: Hospitalization due to acute liver failure hepatitis B flare
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 71 at risk

Adverse event: Hospitalization for pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 71 at risk

Adverse event: Atrial Fibrilation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 71 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 71 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 71 at risk

Adverse event: Hospitalization dyspnea due to congestive heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 71 at risk

Adverse event: Hospitalization for shortness of breath
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Dyspnea on exertion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 71 at risk

Adverse event: Hospitalization for bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 71 at risk

Adverse event: Hospitalization for hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 71 at risk

Adverse event: Respiratory failure secondary to opioid overdose
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Hospitalization for intractable pain, low fever
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 71 at risk

Adverse event: Hospitalization for acute respiratory distress syndrome, encephalopathy, fatigue
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 71 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 71 at risk

Adverse event: Intrahepatic chemotherapy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 71 at risk

Adverse event: Paraparesis, spinal cord compression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 71 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Fracture of T7 with possible cord compression
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 71 at risk

Adverse event: Deep vein thrombosis and cerebrovascular accident
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 71 at risk

Adverse event: Transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 71 at risk

Adverse event: Wrong dosage dispensed
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 71 at risk

Adverse event: Hospitalization with fever and low blood pressure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 71 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Hospitalization for Pneumonia and gastrointestinal bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Hospitalization for diarrhea and dizziness
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Elevated liver function test
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 71 at risk

Adverse event: Deep vein thrombosis diagnosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 71 at risk

Adverse event: Hospitalization for sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 71 at risk

Adverse event: Worsening renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 71 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 71 at risk

Adverse event: Pneumonia, fever and altered mental status
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 71 at risk

Adverse event: Severe cough, shortness of breath and hypoxemia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Shortness of breath fever chills
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Hospitalization for parainfluenza type 2
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 71 at risk

Adverse event: Mental status changes and bacteremia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 71 at risk

Adverse event: Recurrent multifocal pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 71 at risk

Adverse event: Upper respiratory infection and fever
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Acute onset diarrhea and acute renal insufficiency
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 71 at risk

Adverse event: Hospitalization due to transient ischemic attack
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 71 at risk

Adverse event: Shortness of breath with wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Recurrent bilateral pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 71 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 71 affected / 71 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 71 affected / 71 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 71 affected / 71 at risk

Adverse event: Blood/Bone Marrow
Serious: no
Organ System: General disorders
Notes: For some "Other" (non-serious) adverse events, only the affected organ system was recorded/reported.
Frequency: 71 affected / 71 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 71 at risk

Adverse event: Cardiac General
Serious: no
Organ System: Cardiac disorders
Notes: For some "Other" (non-serious) adverse events, only the affected organ system was recorded/reported.
Frequency: 12 affected / 71 at risk

Adverse event: Constitutional Symptoms
Serious: no
Organ System: General disorders
Frequency: 55 affected / 71 at risk

Adverse event: Dermatology / Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: For some "Other" (non-serious) adverse events, only the affected organ system was recorded/reported.
Frequency: 31 affected / 71 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: For some "Other" (non-serious) adverse events, only the affected organ system was recorded/reported.
Frequency: 44 affected / 71 at risk

Adverse event: Hemorrhage / Bleeding
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 71 at risk

Adverse event: Hepatobiliary / Pancreas
Serious: no
Organ System: Hepatobiliary disorders
Notes: For some "Other" (non-serious) adverse events, only the affected organ system was recorded/reported.
Frequency: 70 affected / 71 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 71 at risk

Adverse event: Lymphatics
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: For some "Other" (non-serious) adverse events, only the affected organ system was recorded/reported.
Frequency: 10 affected / 71 at risk

Adverse event: Metabolic/Laboratory
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: For some "Other" (non-serious) adverse events, only the affected organ system was recorded/reported.
Frequency: 66 affected / 71 at risk

Adverse event: Musculoskeletal / Soft Tissue
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: For some "Other" (non-serious) adverse events, only the affected organ system was recorded/reported.
Frequency: 24 affected / 71 at risk

Adverse event: Neurology
Serious: no
Organ System: Nervous system disorders
Notes: For some "Other" (non-serious) adverse events, only the affected organ system was recorded/reported.
Frequency: 55 affected / 71 at risk

Adverse event: Ocular / Vision
Serious: no
Organ System: Eye disorders
Notes: For some "Other" (non-serious) adverse events, only the affected organ system was recorded/reported.
Frequency: 6 affected / 71 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 40 affected / 71 at risk

Adverse event: Pulmonary / Upper Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: For some "Other" (non-serious) adverse events, only the affected organ system was recorded/reported.
Frequency: 40 affected / 71 at risk

Adverse event: Renal / Genitourinary
Serious: no
Organ System: Renal and urinary disorders
Notes: For some "Other" (non-serious) adverse events, only the affected organ system was recorded/reported.
Frequency: 45 affected / 71 at risk