Study: NCT02726386

Adverse event: Infusion site haematoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 90 at risk

Adverse event: Infusion site infection
Serious: yes
Organ System: General disorders
Notes: Group term
Frequency: 3 affected / 90 at risk

Adverse event: Hepatic function abnormal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 90 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 90 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 90 at risk

Adverse event: Traumatic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 90 at risk

Adverse event: Cervical spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Pancreatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 90 at risk

Adverse event: Acute polyneuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Hyperkinesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: On and off phenomenon
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 90 at risk

Adverse event: Parkinsonism hyperpyrexia syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Impulse-control disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 90 at risk

Adverse event: Paranasal sinus haematoma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Panniculitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Gastrointestinal tube insertion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 90 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 90 at risk

Adverse event: Infusion site oedema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 90 at risk

Adverse event: Infusion site erythema
Serious: no
Organ System: General disorders
Frequency: 9 affected / 90 at risk

Adverse event: Infusion site eschar
Serious: no
Organ System: General disorders
Frequency: 2 affected / 90 at risk

Adverse event: Infusion site haematoma
Serious: no
Organ System: General disorders
Frequency: 24 affected / 90 at risk

Adverse event: Infusion site infection
Serious: no
Organ System: General disorders
Frequency: 13 affected / 90 at risk

Adverse event: Infusion site nodule
Serious: no
Organ System: General disorders
Frequency: 31 affected / 90 at risk

Adverse event: Infusion site pain
Serious: no
Organ System: General disorders
Frequency: 13 affected / 90 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 90 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 90 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 90 at risk

Adverse event: Dyskinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 90 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 90 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 90 at risk

Adverse event: Cardiac disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 124 at risk

Adverse event: Inappropriate antidiuretic hormone secretion
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 124 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Inguinal hernia strangulated
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Subileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Infusion site dermatitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 124 at risk

Adverse event: Infusion site infection
Serious: yes
Organ System: General disorders
Notes: Group term
Frequency: 2 affected / 124 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Escherichia sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Dyskinesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 124 at risk

Adverse event: Dystonia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 124 at risk

Adverse event: On and off phenomenon
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 124 at risk

Adverse event: Delusion
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 124 at risk

Adverse event: Paranoia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 124 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 124 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 124 at risk

Adverse event: Infusion site oedema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 124 at risk

Adverse event: Infusion site erythema
Serious: no
Organ System: General disorders
Frequency: 7 affected / 124 at risk

Adverse event: Infusion site eschar
Serious: no
Organ System: General disorders
Frequency: 15 affected / 124 at risk

Adverse event: Infusion site haematoma
Serious: no
Organ System: General disorders
Frequency: 30 affected / 124 at risk

Adverse event: Infusion site infection
Serious: no
Organ System: General disorders
Frequency: 9 affected / 124 at risk

Adverse event: Infusion site nodule
Serious: no
Organ System: General disorders
Frequency: 35 affected / 124 at risk

Adverse event: Infusion site pain
Serious: no
Organ System: General disorders
Frequency: 15 affected / 124 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 124 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 124 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 124 at risk

Adverse event: Dyskinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 124 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 124 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 124 at risk