Study: NCT00958711

Adverse event: Osteomyelitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 42 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 42 at risk

Adverse event: Death
Serious: yes
Organ System: Investigations
Notes: Cause of death unknown, arbitrarily selected body system of 'Investigations'
Frequency: 1 affected / 42 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Vomiting
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 42 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 42 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 42 at risk

Adverse event: Osteomyelitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 42 at risk

Adverse event: Blister
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 42 at risk

Adverse event: Breast cancer
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 42 at risk

Adverse event: Influenza
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Back injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 42 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 48 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 48 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 48 at risk

Adverse event: Death
Serious: yes
Organ System: Investigations
Notes: Cause of death unknown, arbitrarily selected body system of 'Investigations'
Frequency: 1 affected / 48 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 48 at risk

Adverse event: Foot amputation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 48 at risk

Adverse event: Acute respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 48 at risk

Adverse event: Ulcer
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 48 at risk

Adverse event: Osteomyelitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 48 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 48 at risk