Study: NCT00510835

Adverse event: Cardiac dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 439 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 439 at risk

Adverse event: Metabolic/laboratory
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 439 at risk

Adverse event: neurology
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 439 at risk

Adverse event: pulmonary/upper respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 439 at risk

Adverse event: renal/genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 439 at risk

Adverse event: vascular
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 439 at risk

Adverse event: blood/bone marrow
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 439 at risk

Adverse event: Cardiac dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 439 at risk

Adverse event: coagulation
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 439 at risk

Adverse event: gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 439 at risk

Adverse event: hepatobiliary/pancreas
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 439 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 439 at risk

Adverse event: metabolic/laboratory
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 439 at risk

Adverse event: neurology
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 439 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 439 at risk

Adverse event: pulmonary/upper respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 439 at risk

Adverse event: renal/genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 439 at risk

Adverse event: vascular
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 439 at risk

Adverse event: Line issue
Serious: no
Organ System: Surgical and medical procedures
Notes: Old line removed but unable to thread new line resulting in loss of CVL. Unable to access R IJ as shunt in place. Pt was to have central line surgically for hypotension, places upon admission to ICU and was determined not meet the criteria for SAE.
Frequency: 1 affected / 439 at risk

Adverse event: Cardiac dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 446 at risk

Adverse event: hepatobiliary/pancreas
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 446 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 446 at risk

Adverse event: Metabolic/laboratory
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 446 at risk

Adverse event: neurology
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 446 at risk

Adverse event: pulmonary/upper respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 446 at risk

Adverse event: renal/genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 446 at risk

Adverse event: vascular
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 446 at risk

Adverse event: allergy/immunology
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 446 at risk

Adverse event: blood/bone marrow
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 446 at risk

Adverse event: Cardiac dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 446 at risk

Adverse event: coagulation
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 446 at risk

Adverse event: gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 446 at risk

Adverse event: hemorrhage/bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 446 at risk

Adverse event: hepatobiliary/pancreas
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 446 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 446 at risk

Adverse event: metabolic/laboratory
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 446 at risk

Adverse event: neurology
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 446 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 446 at risk

Adverse event: pulmonary/upper respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 446 at risk

Adverse event: renal/genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 446 at risk

Adverse event: Cardiac dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 456 at risk

Adverse event: gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 456 at risk

Adverse event: hemorrhage/bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 456 at risk

Adverse event: hepatobiliary/pancreas
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 456 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 456 at risk

Adverse event: Metabolic/laboratory
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 456 at risk

Adverse event: neurology
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 456 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Notes: Pain NOS
Frequency: 1 affected / 456 at risk

Adverse event: pulmonary/upper respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 456 at risk

Adverse event: renal/genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 456 at risk

Adverse event: vascular
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 456 at risk

Adverse event: allergy/immunology
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 456 at risk

Adverse event: blood/bone marrow
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 456 at risk

Adverse event: Cardiac dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 456 at risk

Adverse event: dermatology/skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 456 at risk

Adverse event: endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 456 at risk

Adverse event: gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 456 at risk

Adverse event: hemorrhage/bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 456 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 456 at risk

Adverse event: lymphatics
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 456 at risk

Adverse event: metabolic/laboratory
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 456 at risk

Adverse event: neurology
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 456 at risk

Adverse event: ocular/visual
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 456 at risk

Adverse event: pulmonary/upper respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 456 at risk

Adverse event: renal/genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 456 at risk

Adverse event: vascular
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 456 at risk

Adverse event: Haematoma
Serious: no
Organ System: Surgical and medical procedures
Notes: While remaining in the ICU, the subject developed a large hematoma in the right groin at the site of the femoral line and the line was removed. As this arm of the study is observational only this adverse event is considered unrelated to the study.
Frequency: 1 affected / 456 at risk