Study: NCT02284126

Adverse event: Deafness
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 552 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 552 at risk

Adverse event: Gastrointestinal Changes
Serious: yes
Organ System: Gastrointestinal disorders
Notes: E. Coli
Frequency: 1 affected / 552 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 552 at risk

Adverse event: Unplanned Medical Visit
Serious: yes
Organ System: General disorders
Frequency: 21 affected / 552 at risk

Adverse event: Urinary Tract Infeciton
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 552 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 552 at risk

Adverse event: Vision Impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 552 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 552 at risk

Adverse event: Facial Sensory Loss
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 552 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 552 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 552 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 552 at risk

Adverse event: Stroke/Cerebrovasular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 552 at risk

Adverse event: Hallucination
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 552 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 552 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 552 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 552 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 552 at risk

Adverse event: Pneumocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 552 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 552 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 552 at risk

Adverse event: Extradural abscess
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 552 at risk

Adverse event: Discharge
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 552 at risk

Adverse event: Allergy Symptoms
Serious: no
Organ System: Immune system disorders
Frequency: 32 affected / 552 at risk

Adverse event: Gastrointestinal changes
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Diarrhea, nausea, constipation, vomiting, etc
Frequency: 30 affected / 552 at risk

Adverse event: Hearing Change
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 24 affected / 552 at risk

Adverse event: Unplanned Medical Visit
Serious: no
Organ System: General disorders
Frequency: 35 affected / 552 at risk

Adverse event: Deafness
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 551 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 551 at risk

Adverse event: Allergy Symptoms
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 551 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 551 at risk

Adverse event: Unplanned Medical Visit
Serious: yes
Organ System: General disorders
Frequency: 37 affected / 551 at risk

Adverse event: Urinary Tract Infeciton
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 551 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 551 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 551 at risk

Adverse event: Vision Impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 551 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 551 at risk

Adverse event: Pancreatitis necrotising
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 551 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 551 at risk

Adverse event: Bleeding at drain site
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 551 at risk

Adverse event: Left Ventricular Thrombus
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 551 at risk

Adverse event: Facial Sensory Loss
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 551 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 551 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 551 at risk

Adverse event: Dysarthria/Dysphagia
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 551 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 551 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 551 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 551 at risk

Adverse event: Stroke/Cerebrovasular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 551 at risk

Adverse event: Gait disturbance
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 551 at risk

Adverse event: Drop foot
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 551 at risk

Adverse event: Allergy Symptoms
Serious: no
Organ System: Immune system disorders
Frequency: 33 affected / 551 at risk

Adverse event: Gastrointestinal changes
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Diarrhea, nausea, constipation, vomiting, etc
Frequency: 34 affected / 551 at risk

Adverse event: Hearing Change
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 26 affected / 551 at risk

Adverse event: Unplanned Medical Visit
Serious: no
Organ System: General disorders
Frequency: 26 affected / 551 at risk