Study: NCT00657917

Adverse event: Left calf pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to study drug
Frequency: 1 affected / 1 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: Not related to study drug
Frequency: 1 affected / 1 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not related to study drug
Frequency: 1 affected / 1 at risk

Adverse event: Elevated BP readings
Serious: no
Organ System: Investigations
Notes: Not related to study drug
Frequency: 1 affected / 1 at risk

Adverse event: Right gluteal pain
Serious: no
Organ System: General disorders
Notes: Not related to study drug
Frequency: 1 affected / 1 at risk

Adverse event: Right groin rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Not related to study drug
Frequency: 1 affected / 1 at risk

Adverse event: Left foot edema
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Not related to study drug
Frequency: 1 affected / 1 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Not related to study drug
Frequency: 1 affected / 1 at risk

Adverse event: Burning sensation at site
Serious: no
Organ System: Nervous system disorders
Notes: Possibly related to study drug
Frequency: 1 affected / 1 at risk

Adverse event: Worsening pain at ulcer site
Serious: no
Organ System: General disorders
Notes: Possibly related to study drug
Frequency: 1 affected / 1 at risk

Adverse event: Vesicle formation at ulcer site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Definitely related to study drug
Frequency: 1 affected / 1 at risk

Adverse event: Intermittent tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Not related to study drug
Frequency: 1 affected / 1 at risk

Adverse event: Blood-tinged secretions from nares
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to study drug
Frequency: 1 affected / 1 at risk

Adverse event: Decreased sodium level
Serious: no
Organ System: Investigations
Notes: Not related to study drug
Frequency: 1 affected / 1 at risk

Adverse event: Insufficient hypertension control
Serious: no
Organ System: Vascular disorders
Notes: Not related to study drug
Frequency: 1 affected / 1 at risk

Adverse event: Cracked skin surrounding ulcer area
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Possibly related to study drug
Frequency: 1 affected / 1 at risk

Adverse event: Erosive areas around ulcer border
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Definitely related to study drug
Frequency: 1 affected / 1 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to study drug
Frequency: 1 affected / 1 at risk

Adverse event: Rash above surrounding area of ulcer/lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Not related to study drug
Frequency: 1 affected / 1 at risk

Adverse event: Blister-like formation above border of ulcer/lesion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Not related to study drug
Frequency: 1 affected / 1 at risk

Adverse event: Small cut on left shin
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Not related to study drug
Frequency: 1 affected / 1 at risk

Adverse event: Numbness (slight) above ulcer/lesion
Serious: no
Organ System: Nervous system disorders
Notes: Not related to study drug
Frequency: 1 affected / 1 at risk

Adverse event: Lymphadenopathy (right inguinal area)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Not related to study drug
Frequency: 1 affected / 1 at risk

Adverse event: Incomplete healing of ulcer/lesion
Serious: no
Organ System: General disorders
Notes: Definitely related to study drug
Frequency: 1 affected / 1 at risk

Adverse event: Persistent lymphedema, left lower extremity
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Not related to study drug
Frequency: 1 affected / 1 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Not related to study drug
Frequency: 1 affected / 1 at risk

Adverse event: Hyperemic left leg
Serious: no
Organ System: Vascular disorders
Notes: Not related to study drug
Frequency: 1 affected / 1 at risk

Adverse event: Edema, left leg to mid thigh
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Not related to study drug
Frequency: 1 affected / 1 at risk

Adverse event: Elevated percentage of monocytes in blood
Serious: no
Organ System: Investigations
Notes: Not related to study drug
Frequency: 1 affected / 1 at risk

Adverse event: Elevated percentage of WBC in urine
Serious: no
Organ System: Investigations
Notes: Not related to study drug
Frequency: 1 affected / 1 at risk

Adverse event: Increased drainage from wound
Serious: no
Organ System: Surgical and medical procedures
Notes: Possibly related to study drug
Frequency: 1 affected / 1 at risk