Study: NCT00630396

Adverse event: Death
Serious: yes
Organ System: Nervous system disorders
Notes: Five individuals died during the study. Three occurred during hospitalization(all three were attributed to the patient's underlying illness). The other two deaths after discharge were from gastric cancer and worsening congestive heart failure.
Frequency: 5 affected / 60 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 60 at risk

Adverse event: Acute Ischemic Stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 60 at risk

Adverse event: Worsening hallucinations and agitation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Congestive Heart Failure exacerbation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Rule out myocardial infarction (chest pain, nausea, shortness of breath)
Serious: yes
Organ System: Cardiac disorders
Notes: Subject complained of chest pain at home. Subject was hospitalized. Cardiac enzymes and chest x-ray were negative. Chest pain resolved, and myocardial infarction was ruled out.
Frequency: 1 affected / 60 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Neuroworsening
Serious: yes
Organ System: Nervous system disorders
Notes: Neuroworsening is an increase in the severity of a subject's stroke (defined as an increase in a subjects National Institutes of Health Stroke Scale by 4 or more points).
Frequency: 3 affected / 60 at risk

Adverse event: Left hip fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary emboli secondary to left lower extremity deep vein thrombosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Carotid endarterectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 60 at risk

Adverse event: Rule out pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Subject hospitalized and thought to have left lower lobe pneumonia based on chest x-ray. He received 1 dose of 2 different antibiotics. Subject improved; however, subject not thought to have pneumonia. Subject was discharged home without antibiotics.
Frequency: 1 affected / 60 at risk

Adverse event: Scrotal oedema
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Depression/suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 60 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hemorrhagic transformation
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 60 at risk

Adverse event: Neurological worsening
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 60 at risk

Adverse event: GI Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea, vomiting, diarrhea, stomach pain, epigastric pain, abdominal pain, excessive belching, worsening dyspepsia
Frequency: 12 affected / 60 at risk

Adverse event: Skin reactions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Phlebitis (0), Burning at the IV site during infusion, Stage I \& II skin breakdown, rash and bruising.
Frequency: 13 affected / 60 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 60 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 60 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Renal and urinary disorders
Notes: Elevated liver enzymes (2), elevated LFTs (1), and hepatic toxicity (1).
Frequency: 4 affected / 60 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 60 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: There were 13 complaints of headache and 2 complaints of worsening of headache.
Frequency: 15 affected / 60 at risk

Adverse event: Vertigo
Serious: no
Organ System: Nervous system disorders
Notes: Disequilibrium (1) and dizziness (3)
Frequency: 3 affected / 60 at risk

Adverse event: Hypotension
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 60 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Complaints of pain occurred in the: shoulder, neck, foot, knee, back, hand, leg, left lower extremity and penis (1).
Frequency: 10 affected / 60 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 60 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 60 at risk

Adverse event: Pneumonia aspiration
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 60 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Notes: Peripheral edema (1 case); mild pulmonary edema (1 case); bilateral upper extremity edema (1 case); lower extremity edema (1 case)
Frequency: 3 affected / 60 at risk