Study: NCT02007200

Adverse event: Cardiopulmonary arrest, cause unknown (non-fatal)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 52 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Infection, Lung
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Infection, Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Pain, Bone
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pulmonary/Upper Respiratory - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 52 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 52 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 52 at risk

Adverse event: Fever in the absence of neutropenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 4 affected / 52 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 3 affected / 52 at risk

Adverse event: Dermatology/Skin - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 52 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 52 at risk

Adverse event: Dysphagia (difficulty swallowing)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 52 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Hemorrhage, Esophagus
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 52 at risk

Adverse event: Hemorrhage, Oral Cavity
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 52 at risk

Adverse event: Infection, Blood
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Infection, Neck NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Infection, Skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Edema: head and neck
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 52 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 52 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 52 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 52 at risk

Adverse event: Amylase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 52 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 52 at risk

Adverse event: Calcium, serum-high (hypercalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 52 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 52 at risk

Adverse event: Cholesterol, serum-high (hypercholestremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 52 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 52 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 52 at risk

Adverse event: Lipase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 52 at risk

Adverse event: Magnesium, serum-high (hypermagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 52 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 52 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 52 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 52 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 52 at risk

Adverse event: Sodium, serum-high (hypernatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 52 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 52 at risk

Adverse event: Triglyceride, serum-high (hypertriglyceridemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 52 at risk

Adverse event: Extremity-upper (function)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Joint-function
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Muscle weakness, Extraocular
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Muscle weakness, facial
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Muscle weakness, Whole Body
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Mood alteration, Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Neurology - Other
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pain, Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 52 at risk

Adverse event: Pain, Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pain, Face
Serious: no
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pain, Head
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pain, Neck
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pain, Oral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 52 at risk

Adverse event: Pain, Throat
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pain - Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: Aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Bronchospasm, wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 52 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Urinary retention (including neurogenic bladder)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 52 at risk

Adverse event: Intra-operative injury
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 52 at risk

Adverse event: Syndromes - Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: Vessel injury-vein
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 52 at risk