Study: NCT01702805

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 908 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 908 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 908 at risk

Adverse event: Bell's stage > 2 Necrotizing Enterocolitis (NEC)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 58 affected / 908 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 908 at risk

Adverse event: Spontaneous Intestinal Perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 908 at risk

Adverse event: Severe Hemorrhage
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 908 at risk

Adverse event: Nosocomial Sepsis up to 24 hours post-transfusion
Serious: yes
Organ System: Infections and infestations
Frequency: 31 affected / 908 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 908 at risk

Adverse event: Sepsis Bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 908 at risk

Adverse event: Severe Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 908 at risk

Adverse event: Hyperkalemia -- non-hemolyzed specimen, up to 24 hours post-transfusion
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 908 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 908 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 908 at risk

Adverse event: Persistent Pulmonary Hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 908 at risk

Adverse event: Pulmonary Air Leaks
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 908 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 908 at risk

Adverse event: Respiratory Deterioration up to 24 hours post-transfusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 93 affected / 908 at risk

Adverse event: Severe Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 908 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 908 at risk

Adverse event: Hyperkalemia -- non-hemolyzed specimen, up to 24 hours post-transfusion
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 58 affected / 908 at risk

Adverse event: Respiratory Deterioration up to 24 hours post-transfusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 147 affected / 908 at risk

Adverse event: Bell's stage > 2 Necrotizing Enterocolitis (NEC)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 62 affected / 906 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 906 at risk

Adverse event: Oesophageal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 906 at risk

Adverse event: Ischemic Bowel
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 906 at risk

Adverse event: Spontaneous Intestinal Perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 906 at risk

Adverse event: Severe Hemorrhage
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 906 at risk

Adverse event: Nosocomial Sepsis up to 24 hours post-transfusion
Serious: yes
Organ System: Infections and infestations
Frequency: 22 affected / 906 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 906 at risk

Adverse event: Sepsis Fungal
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 906 at risk

Adverse event: Sepsis Viral
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 906 at risk

Adverse event: Hyperkalemia -- non-hemolyzed specimen, up to 24 hours post-transfusion
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 906 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 906 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 906 at risk

Adverse event: Persistent Pulmonary Hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 906 at risk

Adverse event: Pulmonary Air Leaks
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 906 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 906 at risk

Adverse event: Respiratory Deterioration up to 24 hours post-transfusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 85 affected / 906 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 906 at risk

Adverse event: Severe Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 906 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 906 at risk

Adverse event: Hyperkalemia -- non-hemolyzed specimen, up to 24 hours post-transfusion
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 40 affected / 906 at risk

Adverse event: Respiratory Deterioration up to 24 hours post-transfusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 146 affected / 906 at risk