Study: NCT02213380

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 471 at risk

Adverse event: acute left heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 471 at risk

Adverse event: acute gastric perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 471 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 471 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 471 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 471 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 471 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 471 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 47 affected / 471 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 471 at risk

Adverse event: Acute gastric perforation*
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 471 at risk

Adverse event: Headache and dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 471 at risk

Adverse event: Numbness in the back
Serious: no
Organ System: General disorders
Frequency: 1 affected / 471 at risk

Adverse event: Shiver
Serious: no
Organ System: General disorders
Frequency: 11 affected / 471 at risk

Adverse event: Skin allergy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 471 at risk

Adverse event: Hematoma in neck
Serious: no
Organ System: General disorders
Frequency: 1 affected / 471 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 471 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 471 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 471 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 471 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 471 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 471 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 471 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 471 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 471 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 471 at risk

Adverse event: Headache and dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 471 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 471 at risk

Adverse event: Shiver
Serious: no
Organ System: General disorders
Frequency: 11 affected / 471 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 471 at risk

Adverse event: Skin allergy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 471 at risk

Adverse event: Mild burns of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 471 at risk

Adverse event: Cerebrospinal fluid leak
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 471 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: General disorders
Notes: Hyperglycaemia (The elevated blood glucose is clinically significant compared to the baseline value, judged by the investigator)
Frequency: 1 affected / 471 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 471 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Anemia (myoglobin\< 81g/L)
Frequency: 1 affected / 471 at risk