Study: NCT03200704

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: A subject may have reported more than one Adverse Events.
Frequency: 1 affected / 151 at risk

Adverse event: Oxygen saturation decreased
Serious: yes
Organ System: Investigations
Notes: A subject may have reported more than one Adverse Events.

\*Five serious adverse events, of which one ("Apneic Episode Desaturation") was split into two different terms, 'Oxygen Saturation Decreased' and 'Apnea', therefore resulting in six SAEs.
Frequency: 1 affected / 151 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A subject may have reported more than one Adverse Events.

\*Five serious adverse events, of which one ("Apneic Episode Desaturation") was split into two different terms, 'Oxygen Saturation Decreased' and 'Apnea', therefore resulting in six SAEs.
Frequency: 1 affected / 151 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A subject may have reported more than one Adverse Events.
Frequency: 1 affected / 1 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Notes: A subject may have reported more than one Adverse Events.
Frequency: 1 affected / 151 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: A subject may have reported more than one Adverse Events.
Frequency: 1 affected / 151 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Notes: A subject may have reported more than one Adverse Events.
Frequency: 1 affected / 151 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Notes: A subject may have reported more than one Adverse Events.
Frequency: 2 affected / 151 at risk

Adverse event: Goitre
Serious: no
Organ System: Endocrine disorders
Notes: A subject may have reported more than one Adverse Events.
Frequency: 1 affected / 151 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: A subject may have reported more than one Adverse Events.
Frequency: 1 affected / 151 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: A subject may have reported more than one Adverse Events.
Frequency: 1 affected / 151 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: A subject may have reported more than one Adverse Events.
Frequency: 2 affected / 151 at risk

Adverse event: Injection site discolouration
Serious: no
Organ System: General disorders
Notes: A subject may have reported more than one Adverse Events.
Frequency: 1 affected / 151 at risk

Adverse event: Clostridium difficile colitis
Serious: no
Organ System: Infections and infestations
Notes: A subject may have reported more than one Adverse Events.
Frequency: 1 affected / 151 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Notes: A subject may have reported more than one Adverse Events.
Frequency: 4 affected / 151 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: A subject may have reported more than one Adverse Events.
Frequency: 1 affected / 151 at risk

Adverse event: Procedural nausea
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: A subject may have reported more than one Adverse Events.
Frequency: 1 affected / 151 at risk

Adverse event: Seroma
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: A subject may have reported more than one Adverse Events.
Frequency: 4 affected / 151 at risk

Adverse event: Skin flap necrosis
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: A subject may have reported more than one Adverse Events.
Frequency: 1 affected / 151 at risk

Adverse event: Wound secretion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: A subject may have reported more than one Adverse Events.
Frequency: 1 affected / 151 at risk

Adverse event: Oxygen saturation decreased
Serious: no
Organ System: Investigations
Notes: A subject may have reported more than one Adverse Events.
Frequency: 1 affected / 151 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: A subject may have reported more than one Adverse Events.
Frequency: 1 affected / 151 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: A subject may have reported more than one Adverse Events.
Frequency: 1 affected / 151 at risk

Adverse event: Chest wall haematoma
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: A subject may have reported more than one Adverse Events.
Frequency: 1 affected / 151 at risk

Adverse event: Device occlusion
Serious: no
Organ System: Product Issues
Notes: A subject may have reported more than one Adverse Events.
Frequency: 2 affected / 151 at risk

Adverse event: Apnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A subject may have reported more than one Adverse Events.
Frequency: 1 affected / 151 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A subject may have reported more than one Adverse Events.
Frequency: 1 affected / 151 at risk

Adverse event: Ischaemic skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: A subject may have reported more than one Adverse Events.
Frequency: 1 affected / 151 at risk

Adverse event: Skin discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: A subject may have reported more than one Adverse Events.
Frequency: 1 affected / 151 at risk

Adverse event: Skin necrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: A subject may have reported more than one Adverse Events.
Frequency: 1 affected / 151 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Notes: A subject may have reported more than one Adverse Events.
Frequency: 1 affected / 151 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Notes: A subject may have reported more than one Adverse Events.
Frequency: 1 affected / 151 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: A subject may have reported more than one Adverse Events.
Frequency: 1 affected / 151 at risk