Study: NCT01034397

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Gluteal cleft cyst
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 35 at risk

Adverse event: Hepatotoxicity
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 35 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 35 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 35 at risk

Adverse event: Hepatic toxicity
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 35 at risk

Adverse event: Liver Enzyme Elevation
Serious: no
Organ System: Investigations
Frequency: 2 affected / 35 at risk

Adverse event: Elevated ALT
Serious: no
Organ System: Investigations
Frequency: 2 affected / 35 at risk

Adverse event: Transaminase Elevation
Serious: no
Organ System: Investigations
Frequency: 1 affected / 35 at risk

Adverse event: Bilirubin Elevation
Serious: no
Organ System: Investigations
Frequency: 1 affected / 35 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Blood Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Dislipidemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 35 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 35 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Facial paralysis on the right side
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Finger cut
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 35 at risk

Adverse event: Hematoma cyclid of the right eye
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Herpes simplex in the lips
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Dysphonia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 35 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Infected traumatic right leg ulcer
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Inter-digital wound
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Left leg cellulitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 35 at risk

Adverse event: Mild renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Oral aftosis
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 35 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 35 at risk

Adverse event: Toothache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Upper airways infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Vaginal labial folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Hepatotoxicity
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 10 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Butterfly rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Hepatic toxicity
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 10 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Left leg cellulitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nitritis Elevation
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Odynophagia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Urine Leukocyte elevation
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Varicose vein rupture
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Gingivorrhagea in patient with low platelets
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Mouth mucositis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Productive cough
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk