Study: NCT00627393

Adverse event: Abdominal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: Abdominal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: Activated partial thromboplastin time shortened
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: PTT (Grade 2)
Frequency: 1 affected / 58 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 58 at risk

Adverse event: Increased blast cell count
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Increased blood creatinine
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 58 at risk

Adverse event: Cardiopulmonary failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 58 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Febrile infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Fungaemia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 58 at risk

Adverse event: Gastric haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Hallucination
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Hypokalaemic syndrome
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Infection in an immunocompromised host
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 58 at risk

Adverse event: Metabolic disorder
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 58 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 58 at risk

Adverse event: Increased prothrombin level
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 58 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Sepsis neonatal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: Sepsis syndrome
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

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

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

Adverse event: Abdominal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 56 at risk

Adverse event: Abdominal symptom
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Nausea, vomiting and abdominal pain.
Frequency: 1 affected / 56 at risk

Adverse event: Acute lung injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 56 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 56 at risk

Adverse event: Cytomegalovirus viraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 56 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 56 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 56 at risk

Adverse event: Fungaemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 56 at risk

Adverse event: Graft versus host disease
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Hydraemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Hypotension
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 56 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 56 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 56 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Pelvic abscess
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 56 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 56 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 56 at risk

Adverse event: Sepsis neonatal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 56 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 56 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Sepsis syndrome
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 56 at risk

Adverse event: Allergic reaction/ hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 5 affected / 51 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 17 affected / 51 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Frequency: 9 affected / 51 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 10 affected / 51 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 51 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 51 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Rigors and Chills
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 51 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 28 affected / 51 at risk