Study: NCT00959374

Adverse event: Haematoma
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 229 at risk

Adverse event: Suture Extrusion
Serious: no
Organ System: Surgical and medical procedures
Notes: Suture extrusion without purulent discharge or abcess
Frequency: 41 affected / 229 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 229 at risk

Adverse event: Haematoma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 229 at risk

Adverse event: Granuloma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 229 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Surgical and medical procedures
Notes: Adjudicated and required surgery
Frequency: 2 affected / 229 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Surgical and medical procedures
Notes: Did NOT require surgery
Frequency: 13 affected / 229 at risk

Adverse event: Suture Extrusion
Serious: no
Organ System: Surgical and medical procedures
Notes: with purulent drainage
Frequency: 1 affected / 229 at risk

Adverse event: Seroma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 229 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 229 at risk

Adverse event: Incision Pain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 229 at risk

Adverse event: Oedema
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 229 at risk

Adverse event: Erythema
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 229 at risk

Adverse event: Other - ecchymosis, light headedness and nausea
Serious: no
Organ System: General disorders
Frequency: 16 affected / 229 at risk

Adverse event: Bleeding Artery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 229 at risk

Adverse event: Suture Extrusion
Serious: no
Organ System: Surgical and medical procedures
Notes: Suture extrusion without purulent discharge or abcess
Frequency: 17 affected / 229 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 229 at risk

Adverse event: Haematoma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 229 at risk

Adverse event: Granuloma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 229 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Surgical and medical procedures
Notes: Did NOT require surgery
Frequency: 10 affected / 229 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 229 at risk

Adverse event: Incision Pain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 229 at risk

Adverse event: Oedema
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 229 at risk

Adverse event: Erythema
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 229 at risk

Adverse event: Other - ecchymosis, light headedness and nausea
Serious: no
Organ System: General disorders
Frequency: 6 affected / 229 at risk

Adverse event: Suture Extrusion
Serious: no
Organ System: Surgical and medical procedures
Notes: Suture extrusion without purulent discharge or abcess
Frequency: 7 affected / 229 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 229 at risk

Adverse event: Haematoma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 229 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Surgical and medical procedures
Notes: Did NOT require surgery
Frequency: 7 affected / 229 at risk

Adverse event: Seroma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 229 at risk

Adverse event: Erythema
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 229 at risk

Adverse event: Other - ecchymosis, light headedness and nausea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 229 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 229 at risk

Adverse event: Wound Dehiscence (Adjudicated to Yes)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 229 at risk

Adverse event: Abcess
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 229 at risk

Adverse event: Seroma
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 229 at risk

Adverse event: Respiratory/Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 229 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 229 at risk

Adverse event: Other - ecchymosis, light headedness and nausea
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 229 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 229 at risk

Adverse event: Suture Extrusion
Serious: no
Organ System: Surgical and medical procedures
Notes: Suture extrusion without purulent discharge or abcess
Frequency: 21 affected / 229 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 229 at risk

Adverse event: Haematoma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 229 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Surgical and medical procedures
Notes: Adjudicated and required surgery
Frequency: 1 affected / 229 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Surgical and medical procedures
Notes: Did NOT require surgery
Frequency: 9 affected / 229 at risk

Adverse event: Seroma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 6 affected / 229 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 229 at risk

Adverse event: Incision Pain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 229 at risk

Adverse event: Oedema
Serious: no
Organ System: Surgical and medical procedures
Frequency: 9 affected / 229 at risk

Adverse event: Erythema
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 229 at risk

Adverse event: Other - ecchymosis, light headedness and nausea
Serious: no
Organ System: General disorders
Frequency: 57 affected / 229 at risk