Study: NCT00971841

Adverse event: neutrophil count decrease
Serious: no
Organ System: Investigations
Notes: 16 events were Grade 1, 26 events were Grade 2 and 2 events were Grade 3
Frequency: 1 affected / 1 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 29 events were Grade 1; 1 event was Grade 2
Frequency: 1 affected / 1 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 events were Grade 1; 2 events were Grade 2
Frequency: 1 affected / 1 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Notes: 1 event Grade 1
Frequency: 1 affected / 1 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Grade 1 event
Frequency: 1 affected / 1 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Grade 1 events
Frequency: 1 affected / 1 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1 events
Frequency: 1 affected / 1 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Notes: one event Grade 1; one event Grade 2
Frequency: 1 affected / 1 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 events
Frequency: 1 affected / 1 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1 events
Frequency: 1 affected / 1 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1 events
Frequency: 1 affected / 1 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: Grade 2 event
Frequency: 1 affected / 1 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 events
Frequency: 1 affected / 1 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1 event
Frequency: 1 affected / 1 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1 events
Frequency: 1 affected / 1 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: one Grade 1 event; two Grade 2 events
Frequency: 1 affected / 1 at risk

Adverse event: Glucose urine present
Serious: no
Organ System: Investigations
Notes: Grade 2 events
Frequency: 1 affected / 1 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Notes: One event Grade 1; 30 events Grade 2
Frequency: 1 affected / 1 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Notes: One Grade 1 event; one Grade 2 event
Frequency: 1 affected / 1 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Notes: 29 Grade 1 events; 1 Grade 2 event
Frequency: 1 affected / 1 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Five were Grade 1 events; one event was Grade 2
Frequency: 1 affected / 1 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1 events
Frequency: 1 affected / 1 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Five events were Grade 1; 2 events were Grade 2
Frequency: 1 affected / 1 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 events
Frequency: 1 affected / 1 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Notes: 19 Grade 1 events; 9 Grade 2 events
Frequency: 1 affected / 1 at risk

Adverse event: Periodontitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 event
Frequency: 1 affected / 1 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1 events
Frequency: 1 affected / 1 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Grade 2 event
Frequency: 1 affected / 1 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Notes: One Grade 1 event; one Grade 2 event
Frequency: 1 affected / 1 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Grade 1 events
Frequency: 1 affected / 1 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: Grade 1 events
Frequency: 1 affected / 1 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: 11 Grade 1 events; 31 Grade 2 events
Frequency: 1 affected / 1 at risk