Study: NCT01545232

Adverse event: Transfusion-associated circulatory overload
Serious: yes
Organ System: Cardiac disorders
Notes: Serious adverse event reportable to FDA
Frequency: 1 affected / 338 at risk

Adverse event: Hypernatremia associated with hypertonic saline use
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Serious adverse events reportable to FDA
Frequency: 1 affected / 338 at risk

Adverse event: Systemic inflammatory response syndrome
Serious: no
Organ System: General disorders
Frequency: 231 affected / 338 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 99 affected / 338 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Includes urinary tract infection, wound infection, line infection and other. Data is not available for the specific types of infection (i.e. urinary, wound, line).
Frequency: 98 affected / 338 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 74 affected / 338 at risk

Adverse event: Ventilator-associated pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 62 affected / 338 at risk

Adverse event: Transfusion-related metabolic complications
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hypocalcemia and hyperkalemia only
Frequency: 53 affected / 338 at risk

Adverse event: Acute lung injury
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 47 affected / 338 at risk

Adverse event: Acute respiratory distress syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 46 affected / 338 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 25 affected / 338 at risk

Adverse event: Abdominal Complication
Serious: no
Organ System: General disorders
Notes: Also includes complications related to injury
Frequency: 24 affected / 338 at risk

Adverse event: Cardiac arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 23 affected / 338 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: no
Organ System: General disorders
Frequency: 20 affected / 338 at risk

Adverse event: Symptomatic pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 338 at risk

Adverse event: Additional bleeding after hemostasis requiring intervention
Serious: no
Organ System: General disorders
Notes: bleeding occurring after hemostasis requiring an interventional radiology or surgical procedure
Frequency: 13 affected / 338 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 338 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 338 at risk

Adverse event: Abdominal compartment syndrome
Serious: no
Organ System: General disorders
Frequency: 3 affected / 338 at risk

Adverse event: Delayed serological transfusion reaction
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 338 at risk

Adverse event: Transfusion-related allergic reaction
Serious: no
Organ System: General disorders
Frequency: 2 affected / 338 at risk

Adverse event: Febrile nonhaemolytic transfusion reaction
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 338 at risk

Adverse event: Hypernatremia associated with hypertonic saline use
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Serious adverse events reportable to FDA
Frequency: 4 affected / 342 at risk

Adverse event: Systemic inflammatory response syndrome
Serious: no
Organ System: General disorders
Frequency: 216 affected / 342 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 91 affected / 342 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Includes urinary tract infection, wound infection, line infection and other. Data is not available for the specific types of infection (i.e. urinary, wound, line).
Frequency: 106 affected / 342 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 85 affected / 342 at risk

Adverse event: Ventilator-associated pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 58 affected / 342 at risk

Adverse event: Transfusion-related metabolic complications
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hypocalcemia and hyperkalemia only
Frequency: 59 affected / 342 at risk

Adverse event: Acute lung injury
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 57 affected / 342 at risk

Adverse event: Acute respiratory distress syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 48 affected / 342 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 24 affected / 342 at risk

Adverse event: Abdominal Complication
Serious: no
Organ System: General disorders
Notes: Also includes complications related to injury
Frequency: 22 affected / 342 at risk

Adverse event: Cardiac arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 27 affected / 342 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: no
Organ System: General disorders
Frequency: 15 affected / 342 at risk

Adverse event: Symptomatic pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 342 at risk

Adverse event: Additional bleeding after hemostasis requiring intervention
Serious: no
Organ System: General disorders
Notes: bleeding occurring after hemostasis requiring an interventional radiology or surgical procedure
Frequency: 16 affected / 342 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 342 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 342 at risk

Adverse event: Abdominal compartment syndrome
Serious: no
Organ System: General disorders
Frequency: 3 affected / 342 at risk

Adverse event: Transfusion-related allergic reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 342 at risk

Adverse event: Febrile nonhaemolytic transfusion reaction
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 342 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 342 at risk