Study: NCT01990768

Adverse event: Myocardial infarction (MI)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 309 at risk

Adverse event: Cerebrovascular accident - hemorrhagic
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 309 at risk

Adverse event: Cerebrovascular accident - thrombotic
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 309 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 309 at risk

Adverse event: Pulmonary embolism (PE)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 309 at risk

Adverse event: Cerebral vascular emboli
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 309 at risk

Adverse event: Cerebral venus sinus thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 309 at risk

Adverse event: Deep vein thrombosis (DVT)
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 309 at risk

Adverse event: Internal jugular vein thrombus
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 309 at risk

Adverse event: Left ventricular thrombus
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 309 at risk

Adverse event: Cardiac arrest (non-fatal)^
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 309 at risk

Adverse event: Cardiac failure^
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 309 at risk

Adverse event: Pseudomembranous colitis^
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 309 at risk

Adverse event: Central diabetes insipidus^
Serious: no
Organ System: General disorders
Frequency: 5 affected / 309 at risk

Adverse event: Cerebral vasospams^
Serious: no
Organ System: General disorders
Frequency: 4 affected / 309 at risk

Adverse event: Extremity Compartment Syndrome^
Serious: no
Organ System: General disorders
Frequency: 1 affected / 309 at risk

Adverse event: Bloodstream infection^
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 309 at risk

Adverse event: Intra-abdominal abscess^
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 309 at risk

Adverse event: Meningitis^
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 309 at risk

Adverse event: Pneumonia^
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 309 at risk

Adverse event: Sepsis^
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 309 at risk

Adverse event: Urinary tract infection (UTI)^
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 309 at risk

Adverse event: Wound infection^
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 309 at risk

Adverse event: Hypernatremia^
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 309 at risk

Adverse event: Cerebrovascular accident - hemorrhagic
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 309 at risk

Adverse event: Cerebrovascular accident - thrombotic
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 309 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 309 at risk

Adverse event: Acute kidney injury (AKI)^
Serious: no
Organ System: Renal and urinary disorders
Frequency: 13 affected / 309 at risk

Adverse event: Acute Respiratory Distress Syndrome (ARDS)^
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 309 at risk

Adverse event: Pulmonary embolism (PE)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 309 at risk

Adverse event: Cerebral venus sinus thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 309 at risk

Adverse event: Deep vein throbosis (DVT)
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 309 at risk

Adverse event: Superficial venus thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 309 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 312 at risk

Adverse event: Myocardial infarction (MI)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 312 at risk

Adverse event: Cerebrovascular accident - hemorrhagic
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 312 at risk

Adverse event: Cerebrovascular accident - thrombotic
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 312 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 312 at risk

Adverse event: Pulmonary embolism (PE)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 312 at risk

Adverse event: Deep vein thrombosis (DVT)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 312 at risk

Adverse event: Cardiac arrest (non-fatal)^
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 312 at risk

Adverse event: Myocardial infarction (MI)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 312 at risk

Adverse event: Pseudomembranous colitis^
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 312 at risk

Adverse event: Abdominal Compartment Syndrome^
Serious: no
Organ System: General disorders
Frequency: 1 affected / 312 at risk

Adverse event: Cerebral vasospams^
Serious: no
Organ System: General disorders
Frequency: 2 affected / 312 at risk

Adverse event: Cholecystitis^
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 312 at risk

Adverse event: Bloodstream infection^
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 312 at risk

Adverse event: Intra-abdominal abscess^
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 312 at risk

Adverse event: Pneumonia^
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 312 at risk

Adverse event: Sepsis^
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 312 at risk

Adverse event: Urinary tract infection (UTI)^
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 312 at risk

Adverse event: Hypernatremia^
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 312 at risk

Adverse event: Cerebrovascular accident - hemorrhagic
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 312 at risk

Adverse event: Cerebrovascular accident - thrombotic
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 312 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 312 at risk

Adverse event: Acute kidney injury (AKI)^
Serious: no
Organ System: Renal and urinary disorders
Frequency: 17 affected / 312 at risk

Adverse event: Acute Respiratory Distress Syndrome (ARDS)^
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 312 at risk

Adverse event: Pulmonary embolism (PE)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 312 at risk

Adverse event: Deep vein throbosis (DVT)
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 312 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 345 at risk

Adverse event: Myocardial infarction (MI)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 345 at risk

Adverse event: Cerebrovascular accident - thrombotic
Serious: yes
Organ System: Nervous system disorders
Frequency: 11 affected / 345 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 345 at risk

Adverse event: Pulmonary embolism (PE)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 345 at risk

Adverse event: Cerebral vascular emboli
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 345 at risk

Adverse event: Cerebral venus sinus thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 345 at risk

Adverse event: Deep vein thrombosis (DVT)
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 345 at risk

Adverse event: Embolic infarcts
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 345 at risk

Adverse event: Inferior vena cava thrombus
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 345 at risk

Adverse event: Cardiac arrest (non-fatal)^
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 345 at risk

Adverse event: Cardiac failure^
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 345 at risk

Adverse event: Myocardial infarction (MI)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 345 at risk

Adverse event: Central diabetes insipidus^
Serious: no
Organ System: General disorders
Frequency: 4 affected / 345 at risk

Adverse event: Cerebral vasospams^
Serious: no
Organ System: General disorders
Frequency: 4 affected / 345 at risk

Adverse event: Extremity Compartment Syndrome^
Serious: no
Organ System: General disorders
Frequency: 1 affected / 345 at risk

Adverse event: Liver failure^
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 345 at risk

Adverse event: Bloodstream infection^
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 345 at risk

Adverse event: Empyema^
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 345 at risk

Adverse event: Pneumonia^
Serious: no
Organ System: Infections and infestations
Frequency: 45 affected / 345 at risk

Adverse event: Sepsis^
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 345 at risk

Adverse event: Urinary tract infection (UTI)^
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 345 at risk

Adverse event: Wound infection^
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 345 at risk

Adverse event: Hypernatremia^
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 345 at risk

Adverse event: Cerebrovascular accident - hemorrhagic
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 345 at risk

Adverse event: Cerebrovascular accident - thrombotic
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 345 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 345 at risk

Adverse event: Acute kidney injury (AKI)^
Serious: no
Organ System: Renal and urinary disorders
Frequency: 16 affected / 345 at risk

Adverse event: Renal failure^
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 345 at risk

Adverse event: Acute Respiratory Distress Syndrome (ARDS)^
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 345 at risk

Adverse event: Pulmonary embolism (PE)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 345 at risk

Adverse event: Cerebral venus sinus thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 345 at risk

Adverse event: Deep vein throbosis (DVT)
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 345 at risk

Adverse event: Superficial venus thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 345 at risk