Study: NCT00324272

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 18 at risk

Adverse event: Wound Seroma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-infected post-operative seroma requiring outpatient aspiration. In this category the seroma is neither infected nor does it require inpatient treatment (e.g. surgical drainage).
Frequency: 4 affected / 18 at risk

Adverse event: Wound cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Wound necrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Surgical seroma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Infected post-operative seroma requiring admission to hospital for incision \& drainage procedure.
Frequency: 3 affected / 18 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Post-operative haematoma requiring surgical drainage.
Frequency: 1 affected / 18 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 12 affected / 20 at risk

Adverse event: Wound Seroma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-infected post-operative seroma requiring outpatient aspiration. In this category the seroma is neither infected nor does it require inpatient treatment (e.g. surgical drainage).
Frequency: 2 affected / 20 at risk

Adverse event: Wound cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 20 at risk

Adverse event: Infected seroma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Infected post-operative seroma requiring admission for intravenous antibiotics but not requiring surgical drainage.
Frequency: 2 affected / 20 at risk

Adverse event: Surgical seroma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Infected post-operative seroma requiring admission to hospital for incision \& drainage procedure.
Frequency: 6 affected / 20 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Post-operative haematoma requiring surgical drainage.
Frequency: 1 affected / 20 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 18 at risk

Adverse event: Wound Seroma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-infected post-operative seroma requiring outpatient aspiration. In this category the seroma is neither infected nor does it require inpatient treatment (e.g. surgical drainage).
Frequency: 5 affected / 18 at risk

Adverse event: Wound cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Wound necrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 18 at risk

Adverse event: Surgical seroma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Infected post-operative seroma requiring admission to hospital for incision \& drainage procedure.
Frequency: 3 affected / 18 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 18 at risk

Adverse event: Wound Seroma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-infected post-operative seroma requiring outpatient aspiration. In this category the seroma is neither infected nor does it require inpatient treatment (e.g. surgical drainage).
Frequency: 5 affected / 18 at risk

Adverse event: Wound necrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Infected seroma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Infected post-operative seroma requiring admission for intravenous antibiotics but not requiring surgical drainage.
Frequency: 2 affected / 18 at risk