Study: NCT01352715

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 258 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 258 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 258 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 258 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 258 at risk

Adverse event: HIV-associated neurocognitive disorder
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 258 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 258 at risk

Adverse event: Bacterial sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 258 at risk

Adverse event: Leptospirosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 258 at risk

Adverse event: Pelvic inflammatory disease
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 258 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 258 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 258 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 258 at risk

Adverse event: Hypertriglyceridaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 258 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 258 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 258 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 258 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 258 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 22 affected / 258 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 258 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 258 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 258 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 55 affected / 258 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 70 affected / 258 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 67 affected / 258 at risk

Adverse event: Blood bicarbonate decreased
Serious: no
Organ System: Investigations
Frequency: 79 affected / 258 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 27 affected / 258 at risk

Adverse event: Blood calcium decreased
Serious: no
Organ System: Investigations
Frequency: 38 affected / 258 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 150 affected / 258 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 258 at risk

Adverse event: Blood glucose decreased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 258 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 40 affected / 258 at risk

Adverse event: Blood phosphorus decreased
Serious: no
Organ System: Investigations
Frequency: 77 affected / 258 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Investigations
Frequency: 30 affected / 258 at risk

Adverse event: Blood sodium decreased
Serious: no
Organ System: Investigations
Frequency: 149 affected / 258 at risk

Adverse event: Blood sodium increased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 258 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Frequency: 33 affected / 258 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 22 affected / 258 at risk

Adverse event: Low density lipoprotein increased
Serious: no
Organ System: Investigations
Frequency: 124 affected / 258 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 62 affected / 258 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 24 affected / 258 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 44 affected / 258 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 33 affected / 258 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 258 at risk

Adverse event: Oropharyngeal plaque
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 258 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 258 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 254 at risk

Adverse event: Toxic optic neuropathy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 254 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 254 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 254 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 254 at risk

Adverse event: Jaundice cholestatic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 254 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 254 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 254 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 254 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 254 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 254 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 254 at risk

Adverse event: Meningitis cryptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 254 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 254 at risk

Adverse event: Progressive multifocal leukoencephalopathy
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 254 at risk

Adverse event: Tuberculosis gastrointestinal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 254 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 254 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 254 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 254 at risk

Adverse event: Hyperlactacidaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 254 at risk

Adverse event: Hypertriglyceridaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 254 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 254 at risk

Adverse event: Fasciitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 254 at risk

Adverse event: Cervix carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 254 at risk

Adverse event: Kaposi's sarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 254 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 254 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 254 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 254 at risk

Adverse event: Post-traumatic stress disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 254 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 254 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 254 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 254 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 254 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 23 affected / 254 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 254 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 254 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 254 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 40 affected / 254 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 61 affected / 254 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 73 affected / 254 at risk

Adverse event: Blood bicarbonate decreased
Serious: no
Organ System: Investigations
Frequency: 85 affected / 254 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 16 affected / 254 at risk

Adverse event: Blood calcium decreased
Serious: no
Organ System: Investigations
Frequency: 40 affected / 254 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 121 affected / 254 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 254 at risk

Adverse event: Blood glucose decreased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 254 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 36 affected / 254 at risk

Adverse event: Blood phosphorus decreased
Serious: no
Organ System: Investigations
Frequency: 99 affected / 254 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Investigations
Frequency: 41 affected / 254 at risk

Adverse event: Blood sodium decreased
Serious: no
Organ System: Investigations
Frequency: 144 affected / 254 at risk

Adverse event: Blood sodium increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 254 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Frequency: 26 affected / 254 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 22 affected / 254 at risk

Adverse event: Low density lipoprotein increased
Serious: no
Organ System: Investigations
Frequency: 93 affected / 254 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 78 affected / 254 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 254 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 42 affected / 254 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 35 affected / 254 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 254 at risk

Adverse event: Oropharyngeal plaque
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 254 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 254 at risk