Study: NCT01123161

Adverse event: Cardiac Disorders
Serious: yes
Organ System: Cardiac disorders
Notes: arrest, CHF, CAD, cardiomyopathy
Frequency: 3 affected / 57 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: contusion, muscle injury, pelvic fracture
Frequency: 3 affected / 57 at risk

Adverse event: Neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: metastases to meninges
Frequency: 1 affected / 57 at risk

Adverse event: Nervous System Disorders
Serious: yes
Organ System: Nervous system disorders
Notes: agitation, herniation, oedema, carotid artery stenosis, cerebral hemorrhage, confusional state, ICH, sedation, stroke in evolution
Frequency: 13 affected / 57 at risk

Adverse event: Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: ARDs, respiratory failure, pneumonia, PE, resp distress, resp depression, resp failure
Frequency: 2 affected / 57 at risk

Adverse event: vascular
Serious: yes
Organ System: Vascular disorders
Notes: Arterial rupture, deep vein thrombosis, Hemorrhage, or hypotension
Frequency: 3 affected / 57 at risk

Adverse event: Blood and lymphatic
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Total AEs
Frequency: 7 affected / 57 at risk

Adverse event: Cardiac
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 57 at risk

Adverse event: Eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 57 at risk

Adverse event: GI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 57 at risk

Adverse event: General
Serious: no
Organ System: General disorders
Frequency: 17 affected / 57 at risk

Adverse event: immune
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 57 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 57 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 57 at risk

Adverse event: investigations
Serious: no
Organ System: Investigations
Frequency: 34 affected / 57 at risk

Adverse event: Metabolism
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 57 at risk

Adverse event: Muskuloskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 57 at risk

Adverse event: Neoplasms
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 57 at risk

Adverse event: Nervous Systen
Serious: no
Organ System: Nervous system disorders
Frequency: 33 affected / 57 at risk

Adverse event: Psychiatric
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 57 at risk

Adverse event: Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 57 at risk

Adverse event: Reproductive
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 57 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 57 at risk

Adverse event: Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 57 at risk

Adverse event: Vascular
Serious: no
Organ System: Vascular disorders
Frequency: 19 affected / 57 at risk

Adverse event: Cardiac Disorders
Serious: yes
Organ System: Cardiac disorders
Notes: arrest, CHF, CAD, cardiomyopathy
Frequency: 2 affected / 63 at risk

Adverse event: Infections
Serious: yes
Organ System: Infections and infestations
Notes: bacteremia, sepsis, shock
Frequency: 4 affected / 63 at risk

Adverse event: Metabolism
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: dehydration, metabolic acidosis
Frequency: 2 affected / 63 at risk

Adverse event: muskuloskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: ankle fracture
Frequency: 1 affected / 63 at risk

Adverse event: Nervous System Disorders
Serious: yes
Organ System: Nervous system disorders
Notes: agitation, herniation, oedema, carotid artery stenosis, cerebral hemorrhage, confusional state, ICH, sedation, stroke in evolution
Frequency: 13 affected / 63 at risk

Adverse event: psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Notes: delerium
Frequency: 1 affected / 63 at risk

Adverse event: renal
Serious: yes
Organ System: Renal and urinary disorders
Notes: renal failure
Frequency: 1 affected / 63 at risk

Adverse event: Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: ARDs, respiratory failure, pneumonia, PE, resp distress, resp depression, resp failure
Frequency: 9 affected / 63 at risk

Adverse event: vascular
Serious: yes
Organ System: Vascular disorders
Notes: Arterial rupture, deep vein thrombosis, Hemorrhage, or hypotension
Frequency: 1 affected / 63 at risk

Adverse event: Blood and lymphatic
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Total AEs
Frequency: 4 affected / 63 at risk

Adverse event: Cardiac
Serious: no
Organ System: Cardiac disorders
Frequency: 19 affected / 63 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 6 affected / 63 at risk

Adverse event: Eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 63 at risk

Adverse event: GI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 63 at risk

Adverse event: General
Serious: no
Organ System: General disorders
Frequency: 34 affected / 63 at risk

Adverse event: immune
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 63 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 63 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 63 at risk

Adverse event: investigations
Serious: no
Organ System: Investigations
Frequency: 52 affected / 63 at risk

Adverse event: Metabolism
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 63 at risk

Adverse event: Muskuloskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 63 at risk

Adverse event: Nervous Systen
Serious: no
Organ System: Nervous system disorders
Frequency: 37 affected / 63 at risk

Adverse event: Psychiatric
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 63 at risk

Adverse event: Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 63 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 63 at risk

Adverse event: Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 63 at risk

Adverse event: Vascular
Serious: no
Organ System: Vascular disorders
Frequency: 28 affected / 63 at risk