Study: NCT02527161

Adverse event: Non-Operative site
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 96 at risk

Adverse event: Non-operative site
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 96 at risk

Adverse event: Non-operative site
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 96 at risk

Adverse event: Non-operative site
Serious: yes
Organ System: Eye disorders
Frequency: 5 affected / 96 at risk

Adverse event: Non-operative site
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 96 at risk

Adverse event: Non-operative site
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 96 at risk

Adverse event: Non-operative site
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 96 at risk

Adverse event: Non-operative site
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 96 at risk

Adverse event: Operative site
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 96 at risk

Adverse event: Non-Operative site
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 96 at risk

Adverse event: Operative Site
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 96 at risk

Adverse event: Non-operative site
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 96 at risk

Adverse event: Non-operative site
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 28 affected / 96 at risk

Adverse event: Operative site
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 96 at risk

Adverse event: Non-operative site
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 96 at risk

Adverse event: Non-operative site
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 96 at risk

Adverse event: Non-operative site
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 96 at risk

Adverse event: Non-operative site
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 96 at risk

Adverse event: Non-operative site
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 96 at risk

Adverse event: Non-operative site
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 96 at risk

Adverse event: Operative site
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 96 at risk

Adverse event: Non-operative site
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 22 affected / 96 at risk

Adverse event: Operative site
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 6 affected / 96 at risk

Adverse event: Non-operative side
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 96 at risk

Adverse event: Non-operative site
Serious: no
Organ System: General disorders
Frequency: 8 affected / 96 at risk

Adverse event: Non-operative site
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 96 at risk

Adverse event: Operative site
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 96 at risk

Adverse event: Non-operative site
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 96 at risk

Adverse event: Non-operative site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 96 at risk