Study: NCT00147030

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: Severe hypotension (mean arterial pressure less than 25mmHg), despite full inotrope support and volume replacement.
Frequency: 2 affected / 163 at risk

Adverse event: Cardia arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 163 at risk

Adverse event: Major venous thrombosis not related to an infusion line.
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 163 at risk

Adverse event: Circulatory collapse
Serious: yes
Organ System: Surgical and medical procedures
Notes: Collapse during lumbar puncture
Frequency: 1 affected / 163 at risk

Adverse event: Persistent hypotension
Serious: no
Organ System: Cardiac disorders
Notes: Hypotension was defined as a mean blood pressure of 40 mm Hg or less.
Frequency: 126 affected / 163 at risk

Adverse event: Prolonged coagulation time
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 67 affected / 163 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 94 affected / 163 at risk

Adverse event: Haemorrhage intracranial
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 163 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 163 at risk

Adverse event: Pulmonary air leak
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 163 at risk

Adverse event: Pulmonary haemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 163 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 163 at risk

Adverse event: Necrotising colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 163 at risk

Adverse event: Culture-proven sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 163 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: Severe hypotension (mean arterial pressure less than 25mmHg), despite full inotrope support and volume replacement.
Frequency: 2 affected / 162 at risk

Adverse event: Cardia arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 162 at risk

Adverse event: Persistent hypotension
Serious: no
Organ System: Cardiac disorders
Notes: Hypotension was defined as a mean blood pressure of 40 mm Hg or less.
Frequency: 134 affected / 162 at risk

Adverse event: Prolonged coagulation time
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 72 affected / 162 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 80 affected / 162 at risk

Adverse event: Haemorrhage intracranial
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 162 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 162 at risk

Adverse event: Pulmonary air leak
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 162 at risk

Adverse event: Pulmonary haemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 162 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 162 at risk

Adverse event: Culture-proven sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 162 at risk