Study: NCT01060384

Adverse event: Injury, poisoning and prcedural complications - Other, specify
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: spinal cord compression
Frequency: 1 affected / 6 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Notes: Neutropenia
Frequency: 1 affected / 6 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Notes: line infection
Frequency: 1 affected / 6 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: thrombocytopenia
Frequency: 1 affected / 6 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Testicular pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 6 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Notes: E. Coli bacteremia
Frequency: 1 affected / 6 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Neutropenia
Frequency: 3 affected / 6 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: thrombocytopenia
Frequency: 1 affected / 6 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: leukopenia
Frequency: 1 affected / 6 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Notes: creatinine
Frequency: 1 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Notes: Pneumonia
Frequency: 1 affected / 4 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Vascular access complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: deep vein thrombosis left upper extremity
Frequency: 1 affected / 4 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 4 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Notes: multidrug resistant pseudomonas aeurignosa
Frequency: 1 affected / 4 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Notes: chronic sino-pulmonary infection
Frequency: 1 affected / 4 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Notes: neutropenia
Frequency: 2 affected / 4 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Notes: Neutropenia
Frequency: 2 affected / 4 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4 at risk

Adverse event: Nervous system disorders - )ther, specify
Serious: yes
Organ System: Nervous system disorders
Notes: dysmetria
Frequency: 1 affected / 4 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Neutropenia
Frequency: 4 affected / 4 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: thrombocytopenia
Frequency: 1 affected / 4 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: leukopenia
Frequency: 2 affected / 4 at risk

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

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Notes: Pneumonia
Frequency: 1 affected / 36 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Respiratory, thoracic and medicastinal disorders - Other, specify
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Shortness of breath
Frequency: 1 affected / 36 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Notes: Neutropenia
Frequency: 2 affected / 36 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 36 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: acute hypoxic respiratory failure
Frequency: 1 affected / 36 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: lactic acidosis
Frequency: 1 affected / 36 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Injury, poisoning and procedural complications - Other, specify
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: bowel perforation
Frequency: 1 affected / 36 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: malignant pleural effusion
Frequency: 1 affected / 36 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: thrombocytopenia
Frequency: 1 affected / 36 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Notes: positive cultures from bronch organisms; bronchoalveolar lavage positive for aspergillum in addition to candidiases
Frequency: 1 affected / 36 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: harsh cough
Frequency: 1 affected / 36 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Notes: E. Coli bacteremia
Frequency: 1 affected / 36 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Notes: acute metabolic encephalopathy, likely secondary to bacteremia
Frequency: 1 affected / 36 at risk

Adverse event: Renal and urinary disorders - Other, specify
Serious: yes
Organ System: Renal and urinary disorders
Notes: Acute renal failure
Frequency: 1 affected / 36 at risk

Adverse event: Aortic valve disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 36 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 36 at risk

Adverse event: Respiatory, thoracic and mediastinal disorders - Other, specify
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: reactive airway disease
Frequency: 1 affected / 36 at risk

Adverse event: Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 36 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Neutropenia
Frequency: 16 affected / 36 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: thrombocytopenia
Frequency: 2 affected / 36 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: General disorders
Frequency: 3 affected / 36 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Notes: Rash
Frequency: 2 affected / 36 at risk