Study: NCT00235495

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 422 at risk

Adverse event: SEPTICEMIA OR SEPTIC SHOCK
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 422 at risk

Adverse event: OROLINGUAL ANGIOEDEMA
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 422 at risk

Adverse event: LOCALIZED PAIN
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 422 at risk

Adverse event: SYSTEMIC HEMORRHAGE
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 422 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 422 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 22 affected / 422 at risk

Adverse event: ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) OR RESPIRATORY FAILURE
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 422 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 422 at risk

Adverse event: APNEA OR RESPIRATORY ARREST
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 422 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 422 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 422 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 422 at risk

Adverse event: OTHER RESPIRATORY DISORDER OR COMPLICATION
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 422 at risk

Adverse event: ANGINA PECTORIS (STABLE)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 422 at risk

Adverse event: ACUTE CORONARY SYNDROME - MYOCARDIAL INFARCTION
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 422 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 422 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 422 at risk

Adverse event: "CONGESTIVE HEART FAILURE, PULMONARY EDEMA"
Serious: yes
Organ System: Cardiac disorders
Frequency: 21 affected / 422 at risk

Adverse event: PERIPHERAL ARTERIAL OCCLUSION
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 422 at risk

Adverse event: ATRIAL FIBRILLATION/FLUTTER
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 422 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 422 at risk

Adverse event: "CONDUCTION BLOCKS (ATRIO-VENTRICULAR BLOCKS, BUNDLE-BRANCH BLOCKS)"
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 422 at risk

Adverse event: DEEP VENOUS THROMBOSIS
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 422 at risk

Adverse event: HYPERTENSION-NOT INTENDED
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 422 at risk

Adverse event: HYPOTENSION-NOT INTENDED
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 422 at risk

Adverse event: ACUTE CORONARY SYNDROME - UNSTABLE ANGINA
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 422 at risk

Adverse event: CHEST PAIN (INCLUDING ATYPICAL) WITHOUT MENTION OF CARDIAC ORIGEN
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 422 at risk

Adverse event: TROPONIN LEAK
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 422 at risk

Adverse event: VALVULAR HEART DISEASE
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 422 at risk

Adverse event: PRE-CEREBRAL OR CEREBRAL VASCULAR DISEASE (INCLUDING STENOSIS OR OCCLUSION)
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 422 at risk

Adverse event: OTHER CARDIAC ARRHYTHMIAS
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 422 at risk

Adverse event: OTHER CARDIOVASCULAR DISORDER OR COMPLICATION
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 422 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 422 at risk

Adverse event: GASTRIC OR DUODENAL ULCER
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 422 at risk

Adverse event: NAUSEA/VOMITING
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 422 at risk

Adverse event: GASTROINTESTINAL TRACT BLEEDING
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 422 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 422 at risk

Adverse event: PARALYTIC ILEUS/ BOWEL PSEUDO-OSTRUCTION
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 422 at risk

Adverse event: BOWEL OSBTRUCTION
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 422 at risk

Adverse event: OTHER DIGESTIVE DISORDER OR COMPLICATION
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 422 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 422 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 422 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 422 at risk

Adverse event: OTHER ENDOCRINE OR METABOLIC DISORDER OR COMPLICATION
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 422 at risk

Adverse event: NON-CEREBRAL HEMORRHAGE
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 422 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 422 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 422 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 422 at risk

Adverse event: RECURRENT STROKE NOT SPECIFIED AS HEMORRHAGE OR INFARCTION
Serious: yes
Organ System: Nervous system disorders
Frequency: 16 affected / 422 at risk

Adverse event: DEPRESSION OF CONSCIOUSNESS
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 422 at risk

Adverse event: BRAIN ABSCESS OR ENCEPHALITIS
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 422 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 422 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 422 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 422 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 422 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Frequency: 16 affected / 422 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 18 affected / 422 at risk

Adverse event: CONFUSION/ENCEPHALOPATHY/DELIRIUM
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 422 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 422 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 422 at risk

Adverse event: INCREASED INTRA-CRANIAL PRESSURE
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 422 at risk

Adverse event: PROGRESSION OF STROKE
Serious: yes
Organ System: Nervous system disorders
Frequency: 15 affected / 422 at risk

Adverse event: SYNCOPE OR PRE-SYNCOPE
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 422 at risk

Adverse event: OTHER NEUROLOGICAL DISORDER OR COMPLICATION
Serious: yes
Organ System: Nervous system disorders
Frequency: 16 affected / 422 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 422 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 422 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 422 at risk

Adverse event: OTHER UROGENITAL DISORDER OR COMPLICATION
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 422 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 422 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 422 at risk

Adverse event: SURGICAL WOUND HEMATOMA
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 422 at risk

Adverse event: OTHER NON-INFECTIOUS SURGICAL WOUND COMPLICATION
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 422 at risk

Adverse event: DECUBITUS ULCERS/PRESSURE SORES
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 422 at risk

Adverse event: MALIGNANT NEOPLASM (EXCEPT SKIN)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 8 affected / 422 at risk

Adverse event: PSYCHIATRIC DEPRESSION
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 422 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 422 at risk

Adverse event: "HEMATOMA, NOT OTHERWISE SPECIFIED"
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 422 at risk

Adverse event: PSYCHIATRIC DISORDER
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 422 at risk

Adverse event: CELLULITIS/NON-SURGICAL SKIN INFECTION
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 422 at risk

Adverse event: OTHER UNCLASSIFIED ADVERSE EVENT
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 422 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 38 affected / 422 at risk

Adverse event: Bacteraemia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 422 at risk

Adverse event: SEPTICEMIA OR SEPTIC SHOCK
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 422 at risk

Adverse event: OROLINGUAL ANGIOEDEMA
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 422 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 422 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 422 at risk

Adverse event: ALLERGIC REACTION TO STUDY DRUG
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 422 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 422 at risk

Adverse event: LOCALIZED PAIN
Serious: no
Organ System: General disorders
Frequency: 54 affected / 422 at risk

Adverse event: GENERALIZED PAIN
Serious: no
Organ System: General disorders
Frequency: 9 affected / 422 at risk

Adverse event: CRAMPING
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 422 at risk

Adverse event: SYSTEMIC HEMORRHAGE
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 422 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 422 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 422 at risk

Adverse event: OTHER SYSTEMIC ADVERSE EVENT OR COMPLICATION
Serious: no
Organ System: General disorders
Frequency: 17 affected / 422 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 422 at risk

Adverse event: ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) OR RESPIRATORY FAILURE
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 422 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 422 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 422 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 422 at risk

Adverse event: Hypercapnia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 422 at risk

Adverse event: CRACKLES/RALES
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 422 at risk

Adverse event: APNEA OR RESPIRATORY ARREST
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 422 at risk

Adverse event: Tachypnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 422 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 422 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 422 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 422 at risk

Adverse event: UPPER REPIRATORY INFECTION
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 422 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 422 at risk

Adverse event: OTHER RESPIRATORY DISORDER OR COMPLICATION
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 33 affected / 422 at risk

Adverse event: ANGINA PECTORIS (STABLE)
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 422 at risk

Adverse event: ACUTE CORONARY SYNDROME - MYOCARDIAL INFARCTION
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 422 at risk

Adverse event: "CONGESTIVE HEART FAILURE, PULMONARY EDEMA"
Serious: no
Organ System: Cardiac disorders
Frequency: 41 affected / 422 at risk

Adverse event: VENTRICULAR FIBRILLATION OR TACHYCARDIA
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 422 at risk

Adverse event: ATRIAL FIBRILLATION/FLUTTER
Serious: no
Organ System: Cardiac disorders
Frequency: 40 affected / 422 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 27 affected / 422 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 422 at risk

Adverse event: "CONDUCTION BLOCKS (ATRIO-VENTRICULAR BLOCKS, BUNDLE-BRANCH BLOCKS)"
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 422 at risk

Adverse event: SUPRAVENTRICULAR ARRHYTHMIAS
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 422 at risk

Adverse event: DEEP VENOUS THROMBOSIS
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 422 at risk

Adverse event: SUPERFICIAL VENOUS THROMBOSIS
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 422 at risk

Adverse event: ARTERIAL DISSECTION
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 422 at risk

Adverse event: HYPERTENSION-NOT INTENDED
Serious: no
Organ System: Vascular disorders
Frequency: 39 affected / 422 at risk

Adverse event: HYPOTENSION-NOT INTENDED
Serious: no
Organ System: Vascular disorders
Frequency: 19 affected / 422 at risk

Adverse event: CHEST PAIN (INCLUDING ATYPICAL) WITHOUT MENTION OF CARDIAC ORIGEN
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 422 at risk

Adverse event: TROPONIN LEAK
Serious: no
Organ System: Cardiac disorders
Frequency: 51 affected / 422 at risk

Adverse event: VALVULAR HEART DISEASE
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 422 at risk

Adverse event: EKG ABNORMALITIES
Serious: no
Organ System: Investigations
Frequency: 8 affected / 422 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 422 at risk

Adverse event: PRE-CEREBRAL OR CEREBRAL VASCULAR DISEASE (INCLUDING STENOSIS OR OCCLUSION)
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 422 at risk

Adverse event: FLUID OVERLOAD ALONE
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 422 at risk

Adverse event: OTHER CARDIAC ARRHYTHMIAS
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 422 at risk

Adverse event: OTHER CARDIOVASCULAR DISORDER OR COMPLICATION
Serious: no
Organ System: Cardiac disorders
Frequency: 23 affected / 422 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 422 at risk

Adverse event: GASTRITIS/ ESOPHAGITIS/GERD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 422 at risk

Adverse event: NAUSEA/VOMITING
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 70 affected / 422 at risk

Adverse event: GASTROINTESTINAL TRACT BLEEDING
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 422 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 422 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 422 at risk

Adverse event: Anal incontinence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 422 at risk

Adverse event: LIVER ENZYMES ELEVATION
Serious: no
Organ System: Investigations
Frequency: 6 affected / 422 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 422 at risk

Adverse event: OTHER DIGESTIVE DISORDER OR COMPLICATION
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 422 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 422 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 34 affected / 422 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 422 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 422 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 422 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 93 affected / 422 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 422 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 422 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 422 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 422 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 422 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 422 at risk

Adverse event: ACID-BASE IMBALANCE
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 422 at risk

Adverse event: Hyperchloraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 422 at risk

Adverse event: OTHER ENDOCRINE OR METABOLIC DISORDER OR COMPLICATION
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 36 affected / 422 at risk

Adverse event: NON-CEREBRAL HEMORRHAGE
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 422 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 422 at risk

Adverse event: Coagulopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 422 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 39 affected / 422 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 422 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 422 at risk

Adverse event: TROMBOCYTOSIS
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 422 at risk

Adverse event: OTHER COAGULATION OR HEMATOLOGIC DISORDER OR COMPLICATION
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 422 at risk

Adverse event: DEPRESSION OF CONSCIOUSNESS
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 422 at risk

Adverse event: Haemorrhage intracranial
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 422 at risk

Adverse event: Haemorrhage intracranial
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 45 affected / 422 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 422 at risk

Adverse event: Brain oedema
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 422 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 422 at risk

Adverse event: CONFUSION/ENCEPHALOPATHY/DELIRIUM
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 422 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 422 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 81 affected / 422 at risk

Adverse event: Agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 422 at risk

Adverse event: Aphasia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 422 at risk

Adverse event: INCREASED INTRA-CRANIAL PRESSURE
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 422 at risk

Adverse event: PROGRESSION OF STROKE
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 422 at risk

Adverse event: Retinal vascular occlusion
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 422 at risk

Adverse event: SYNCOPE OR PRE-SYNCOPE
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 422 at risk

Adverse event: OTHER NEUROLOGICAL DISORDER OR COMPLICATION
Serious: no
Organ System: Nervous system disorders
Frequency: 31 affected / 422 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 73 affected / 422 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 19 affected / 422 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 11 affected / 422 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 422 at risk

Adverse event: UROGENITAL INCONTINENCE (WAS 410)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 422 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 11 affected / 422 at risk

Adverse event: OTHER UROGENITAL DISORDER OR COMPLICATION
Serious: no
Organ System: Renal and urinary disorders
Frequency: 21 affected / 422 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 422 at risk

Adverse event: INFILTRATION OF IV SITE
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 422 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 422 at risk

Adverse event: SURGICAL WOUND HEMATOMA
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 422 at risk

Adverse event: OTHER NON-INFECTIOUS SURGICAL WOUND COMPLICATION
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 422 at risk

Adverse event: DECUBITUS ULCERS/PRESSURE SORES
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 422 at risk

Adverse event: MALIGNANT NEOPLASM (EXCEPT SKIN)
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 422 at risk

Adverse event: MALIGNANT NEOPLASM (SKIN)
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 422 at risk

Adverse event: PSYCHIATRIC DEPRESSION
Serious: no
Organ System: Psychiatric disorders
Frequency: 32 affected / 422 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 14 affected / 422 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 16 affected / 422 at risk

Adverse event: OTHER ENZYME/S ELEVATION
Serious: no
Organ System: Investigations
Frequency: 3 affected / 422 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 19 affected / 422 at risk

Adverse event: "HEMATOMA, NOT OTHERWISE SPECIFIED"
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 422 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 422 at risk

Adverse event: PSYCHIATRIC DISORDER
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 422 at risk

Adverse event: CELLULITIS/NON-SURGICAL SKIN INFECTION
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 422 at risk

Adverse event: OTHER UNCLASSIFIED ADVERSE EVENT
Serious: no
Organ System: General disorders
Frequency: 40 affected / 422 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 419 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 419 at risk

Adverse event: SEPTICEMIA OR SEPTIC SHOCK
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 419 at risk

Adverse event: OROLINGUAL ANGIOEDEMA
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 419 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 419 at risk

Adverse event: LOCALIZED PAIN
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: SYSTEMIC HEMORRHAGE
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 419 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: OTHER SYSTEMIC ADVERSE EVENT OR COMPLICATION
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 419 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 419 at risk

Adverse event: ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) OR RESPIRATORY FAILURE
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 419 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 419 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 419 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 419 at risk

Adverse event: OTHER RESPIRATORY DISORDER OR COMPLICATION
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 419 at risk

Adverse event: ANGINA PECTORIS (STABLE)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 419 at risk

Adverse event: ACUTE CORONARY SYNDROME - MYOCARDIAL INFARCTION
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 419 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 419 at risk

Adverse event: "CONGESTIVE HEART FAILURE, PULMONARY EDEMA"
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 419 at risk

Adverse event: VENTRICULAR FIBRILLATION OR TACHYCARDIA
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 419 at risk

Adverse event: ATRIAL FIBRILLATION/FLUTTER
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 419 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 419 at risk

Adverse event: SUPRAVENTRICULAR ARRHYTHMIAS
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 419 at risk

Adverse event: DEEP VENOUS THROMBOSIS
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 419 at risk

Adverse event: ARTERIAL DISSECTION
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 419 at risk

Adverse event: ARTERIAL EMBOLUS
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 419 at risk

Adverse event: HYPERTENSION-NOT INTENDED
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 419 at risk

Adverse event: HYPOTENSION-NOT INTENDED
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 419 at risk

Adverse event: CHEST PAIN (INCLUDING ATYPICAL) WITHOUT MENTION OF CARDIAC ORIGEN
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 419 at risk

Adverse event: VALVULAR HEART DISEASE
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 419 at risk

Adverse event: PRE-CEREBRAL OR CEREBRAL VASCULAR DISEASE (INCLUDING STENOSIS OR OCCLUSION)
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 419 at risk

Adverse event: OTHER CARDIAC ARRHYTHMIAS
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 419 at risk

Adverse event: OTHER CARDIOVASCULAR DISORDER OR COMPLICATION
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 419 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 419 at risk

Adverse event: GASTROINTESTINAL TRACT BLEEDING
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 419 at risk

Adverse event: OTHER DIGESTIVE DISORDER OR COMPLICATION
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 419 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 419 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 419 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 419 at risk

Adverse event: NON-CEREBRAL HEMORRHAGE
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 419 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 419 at risk

Adverse event: Thrombotic thrombocytopenic purpura
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 419 at risk

Adverse event: RECURRENT STROKE NOT SPECIFIED AS HEMORRHAGE OR INFARCTION
Serious: yes
Organ System: Nervous system disorders
Frequency: 16 affected / 419 at risk

Adverse event: MENINGITIS OR VENTRICULITIS
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 419 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 419 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 419 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 419 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 12 affected / 419 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Frequency: 16 affected / 419 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 15 affected / 419 at risk

Adverse event: CONFUSION/ENCEPHALOPATHY/DELIRIUM
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 419 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 419 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 419 at risk

Adverse event: PROGRESSION OF STROKE
Serious: yes
Organ System: Nervous system disorders
Frequency: 16 affected / 419 at risk

Adverse event: SYNCOPE OR PRE-SYNCOPE
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 419 at risk

Adverse event: OTHER NEUROLOGICAL DISORDER OR COMPLICATION
Serious: yes
Organ System: Nervous system disorders
Frequency: 13 affected / 419 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 419 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 419 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 419 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 419 at risk

Adverse event: OTHER UROGENITAL DISORDER OR COMPLICATION
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 419 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 419 at risk

Adverse event: DECUBITUS ULCERS/PRESSURE SORES
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 419 at risk

Adverse event: MALIGNANT NEOPLASM (EXCEPT SKIN)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 8 affected / 419 at risk

Adverse event: PSYCHIATRIC DEPRESSION
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 419 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 419 at risk

Adverse event: "HEMATOMA, NOT OTHERWISE SPECIFIED"
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 419 at risk

Adverse event: PSYCHIATRIC DISORDER
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 419 at risk

Adverse event: CELLULITIS/NON-SURGICAL SKIN INFECTION
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 419 at risk

Adverse event: OTHER UNCLASSIFIED ADVERSE EVENT
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 419 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 34 affected / 419 at risk

Adverse event: Bacteraemia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 419 at risk

Adverse event: SEPTICEMIA OR SEPTIC SHOCK
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 419 at risk

Adverse event: OROLINGUAL ANGIOEDEMA
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 419 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 419 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 419 at risk

Adverse event: ALLERGIC REACTION TO STUDY DRUG
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 419 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 419 at risk

Adverse event: LOCALIZED PAIN
Serious: no
Organ System: General disorders
Frequency: 55 affected / 419 at risk

Adverse event: GENERALIZED PAIN
Serious: no
Organ System: General disorders
Frequency: 9 affected / 419 at risk

Adverse event: CRAMPING
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 419 at risk

Adverse event: SYSTEMIC HEMORRHAGE
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 419 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 419 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 419 at risk

Adverse event: OTHER SYSTEMIC ADVERSE EVENT OR COMPLICATION
Serious: no
Organ System: General disorders
Frequency: 12 affected / 419 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 419 at risk

Adverse event: ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) OR RESPIRATORY FAILURE
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 419 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 419 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 419 at risk

Adverse event: Hypercapnia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 419 at risk

Adverse event: CRACKLES/RALES
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 419 at risk

Adverse event: Tachypnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 419 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 419 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 419 at risk

Adverse event: UPPER REPIRATORY INFECTION
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 419 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 419 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 419 at risk

Adverse event: OTHER RESPIRATORY DISORDER OR COMPLICATION
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 36 affected / 419 at risk

Adverse event: ANGINA PECTORIS (STABLE)
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 419 at risk

Adverse event: "CONGESTIVE HEART FAILURE, PULMONARY EDEMA"
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 419 at risk

Adverse event: VENTRICULAR FIBRILLATION OR TACHYCARDIA
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 419 at risk

Adverse event: ATRIAL FIBRILLATION/FLUTTER
Serious: no
Organ System: Cardiac disorders
Frequency: 35 affected / 419 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 32 affected / 419 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 17 affected / 419 at risk

Adverse event: "CONDUCTION BLOCKS (ATRIO-VENTRICULAR BLOCKS, BUNDLE-BRANCH BLOCKS)"
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 419 at risk

Adverse event: SUPRAVENTRICULAR ARRHYTHMIAS
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 419 at risk

Adverse event: DEEP VENOUS THROMBOSIS
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 419 at risk

Adverse event: SUPERFICIAL VENOUS THROMBOSIS
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 419 at risk

Adverse event: Arterial thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 419 at risk

Adverse event: HYPERTENSION-NOT INTENDED
Serious: no
Organ System: Vascular disorders
Frequency: 29 affected / 419 at risk

Adverse event: HYPOTENSION-NOT INTENDED
Serious: no
Organ System: Vascular disorders
Frequency: 33 affected / 419 at risk

Adverse event: CHEST PAIN (INCLUDING ATYPICAL) WITHOUT MENTION OF CARDIAC ORIGEN
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 419 at risk

Adverse event: TROPONIN LEAK
Serious: no
Organ System: Cardiac disorders
Frequency: 20 affected / 419 at risk

Adverse event: VALVULAR HEART DISEASE
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 419 at risk

Adverse event: EKG ABNORMALITIES
Serious: no
Organ System: Investigations
Frequency: 7 affected / 419 at risk

Adverse event: PRE-CEREBRAL OR CEREBRAL VASCULAR DISEASE (INCLUDING STENOSIS OR OCCLUSION)
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 419 at risk

Adverse event: FLUID OVERLOAD ALONE
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 419 at risk

Adverse event: OTHER CARDIAC ARRHYTHMIAS
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 419 at risk

Adverse event: OTHER CARDIOVASCULAR DISORDER OR COMPLICATION
Serious: no
Organ System: Cardiac disorders
Frequency: 23 affected / 419 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 419 at risk

Adverse event: GASTRITIS/ ESOPHAGITIS/GERD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 419 at risk

Adverse event: GASTRIC OR DUODENAL ULCER
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 419 at risk

Adverse event: NAUSEA/VOMITING
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 419 at risk

Adverse event: GASTROINTESTINAL TRACT BLEEDING
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 419 at risk

Adverse event: "HEPATITIS, JAUNDICE, OR LIVER FAILURE"
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 419 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 419 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 419 at risk

Adverse event: Anal incontinence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 419 at risk

Adverse event: LIVER ENZYMES ELEVATION
Serious: no
Organ System: Investigations
Frequency: 9 affected / 419 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 419 at risk

Adverse event: PARALYTIC ILEUS/ BOWEL PSEUDO-OSTRUCTION
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 419 at risk

Adverse event: BOWEL OSBTRUCTION
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 419 at risk

Adverse event: OTHER DIGESTIVE DISORDER OR COMPLICATION
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 419 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 419 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 31 affected / 419 at risk

Adverse event: Diabetes insipidus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 419 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 419 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 419 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 419 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 66 affected / 419 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 419 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 419 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 419 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 419 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 419 at risk

Adverse event: ACID-BASE IMBALANCE
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 419 at risk

Adverse event: Hypochloraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 419 at risk

Adverse event: Hyperchloraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 419 at risk

Adverse event: OTHER ENDOCRINE OR METABOLIC DISORDER OR COMPLICATION
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 42 affected / 419 at risk

Adverse event: NON-CEREBRAL HEMORRHAGE
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 419 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 25 affected / 419 at risk

Adverse event: Coagulopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 419 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 29 affected / 419 at risk

Adverse event: POLYCYTEMIA
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 419 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 419 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 419 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 419 at risk

Adverse event: OTHER COAGULATION OR HEMATOLOGIC DISORDER OR COMPLICATION
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 419 at risk

Adverse event: RECURRENT STROKE NOT SPECIFIED AS HEMORRHAGE OR INFARCTION
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 419 at risk

Adverse event: DEPRESSION OF CONSCIOUSNESS
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 419 at risk

Adverse event: Haemorrhage intracranial
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 419 at risk

Adverse event: Haemorrhage intracranial
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 35 affected / 419 at risk

Adverse event: Cranial nerve injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 419 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 419 at risk

Adverse event: Cerebral infarction
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 419 at risk

Adverse event: Brain oedema
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 419 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 419 at risk

Adverse event: CONFUSION/ENCEPHALOPATHY/DELIRIUM
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 419 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 419 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 76 affected / 419 at risk

Adverse event: Agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 419 at risk

Adverse event: Aphasia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 419 at risk

Adverse event: PROGRESSION OF STROKE
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 419 at risk

Adverse event: SYNCOPE OR PRE-SYNCOPE
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 419 at risk

Adverse event: OTHER NEUROLOGICAL DISORDER OR COMPLICATION
Serious: no
Organ System: Nervous system disorders
Frequency: 39 affected / 419 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 72 affected / 419 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 18 affected / 419 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 419 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 419 at risk

Adverse event: UROGENITAL INCONTINENCE (WAS 410)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 419 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 419 at risk

Adverse event: OTHER UROGENITAL DISORDER OR COMPLICATION
Serious: no
Organ System: Renal and urinary disorders
Frequency: 25 affected / 419 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 419 at risk

Adverse event: INFILTRATION OF IV SITE
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 419 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 419 at risk

Adverse event: SURGICAL WOUND HEMATOMA
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 419 at risk

Adverse event: OTHER NON-INFECTIOUS SURGICAL WOUND COMPLICATION
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 419 at risk

Adverse event: DECUBITUS ULCERS/PRESSURE SORES
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 419 at risk

Adverse event: Blister
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 419 at risk

Adverse event: ACCIDENTAL TRAUMA
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 419 at risk

Adverse event: PSYCHIATRIC DEPRESSION
Serious: no
Organ System: Psychiatric disorders
Frequency: 35 affected / 419 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 419 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 16 affected / 419 at risk

Adverse event: OTHER ENZYME/S ELEVATION
Serious: no
Organ System: Investigations
Frequency: 2 affected / 419 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 29 affected / 419 at risk

Adverse event: "HEMATOMA, NOT OTHERWISE SPECIFIED"
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 419 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 419 at risk

Adverse event: PSYCHIATRIC DISORDER
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 419 at risk

Adverse event: CELLULITIS/NON-SURGICAL SKIN INFECTION
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 419 at risk

Adverse event: OTHER UNCLASSIFIED ADVERSE EVENT
Serious: no
Organ System: General disorders
Frequency: 40 affected / 419 at risk