Study: NCT00201409

Adverse event: Sepsis or Multi-organ failure
Serious: yes
Organ System: Immune system disorders
Frequency: 11 affected / 64 at risk

Adverse event: Pulmonary SAE
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 64 at risk

Adverse event: Infection SAE
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 64 at risk

Adverse event: Miscellaneous
Serious: yes
Organ System: General disorders
Notes: These events were not documented specifically in the records available
Frequency: 2 affected / 64 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 25 affected / 64 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Immune system disorders
Frequency: 15 affected / 64 at risk

Adverse event: GI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 64 at risk

Adverse event: Hematologic
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 26 affected / 64 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 64 at risk

Adverse event: Neurologic
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 64 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 64 at risk

Adverse event: Renal/Hepatic
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 64 at risk

Adverse event: Metabolic
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 64 at risk

Adverse event: Miscellaneous
Serious: no
Organ System: General disorders
Frequency: 7 affected / 64 at risk

Adverse event: Sepsis or Multi-organ failure
Serious: yes
Organ System: Immune system disorders
Frequency: 13 affected / 66 at risk

Adverse event: Pulmonary SAE
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 66 at risk

Adverse event: Infection SAE
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 66 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 25 affected / 66 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Immune system disorders
Frequency: 11 affected / 66 at risk

Adverse event: GI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 66 at risk

Adverse event: Hematologic
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 66 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 66 at risk

Adverse event: Neurologic
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 66 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 66 at risk

Adverse event: Renal/Hepatic
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 66 at risk

Adverse event: Metabolic
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 66 at risk

Adverse event: Miscellaneous
Serious: no
Organ System: General disorders
Frequency: 4 affected / 66 at risk