Study: NCT00931463

Adverse event: Abdominal Pain- death
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Acute Asthma Attack
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 271 at risk

Adverse event: Asymptomatic neuro-syphillis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 271 at risk

Adverse event: CIN II
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 271 at risk

Adverse event: Cytomegalovirus chorioretinitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Cryptococcal disseminated
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Death, cause unknown
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 271 at risk

Adverse event: Dysentery
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Extrapulmonary TB - resulted in death
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 271 at risk

Adverse event: Gangrenous bowel
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Giardiasis and nocardiasis resulting in death
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Varizella zoster infection and MSSA cervical lymphadenitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Fever and anaemia hospitalization
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 271 at risk

Adverse event: Haematoma inside lower colon
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 271 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 271 at risk

Adverse event: kaposi sarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 271 at risk

Adverse event: Plasmodiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 271 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 271 at risk

Adverse event: Renal failure resulted in death
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 271 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Squamous cell carcinoma of the anal canal - resulted in death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 271 at risk

Adverse event: Supra Condylar fracture of right femur
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 271 at risk

Adverse event: Uveitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 271 at risk

Adverse event: Varizella zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Acute renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 271 at risk

Adverse event: Crytococcal meningitis and giardiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Gestational diabetes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 271 at risk

Adverse event: Right side pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Diarrhoea haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Infective diarrhoea
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Perianal HSV ulcer
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Pneumocystis jirovecii pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Salmonella and PCP
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Allergic conditions
Serious: no
Organ System: General disorders
Frequency: 12 affected / 271 at risk

Adverse event: Anaemias nonhaemolytic and marrow depression
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 271 at risk

Adverse event: Appetite and general nutritional disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 271 at risk

Adverse event: Bacterial infectious disorders
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 271 at risk

Adverse event: Body temperature conditions
Serious: no
Organ System: General disorders
Frequency: 26 affected / 271 at risk

Adverse event: Bone, calcium, magnesium and phosphorus metabolism disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 271 at risk

Adverse event: Decreased and nonspecific blood pressure disorders and shock
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 271 at risk

Adverse event: Dental and gingival conditions
Serious: no
Organ System: General disorders
Frequency: 2 affected / 271 at risk

Adverse event: Epidermal and dermal conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 66 affected / 271 at risk

Adverse event: Female reproductive tract infections and inflammations
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 14 affected / 271 at risk

Adverse event: Fungal infectious disorders
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 271 at risk

Adverse event: Gastrointestinal inflammatory conditions
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 271 at risk

Adverse event: Gastrointestinal motility and defaecation conditions
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 128 affected / 271 at risk

Adverse event: Gastrointestinal signs and symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 72 affected / 271 at risk

Adverse event: General system disorders NEC
Serious: no
Organ System: General disorders
Frequency: 34 affected / 271 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Frequency: 41 affected / 271 at risk

Adverse event: Hepatic and hepatobiliary disorders
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 271 at risk

Adverse event: Infections - pathogen class unspecified
Serious: no
Organ System: Infections and infestations
Frequency: 103 affected / 271 at risk

Adverse event: Injuries NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 271 at risk

Adverse event: Joint disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 271 at risk

Adverse event: Lipid metabolism disorders
Serious: no
Organ System: Endocrine disorders
Frequency: 6 affected / 271 at risk

Adverse event: Menstrual cycle and uterine bleeding disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 271 at risk

Adverse event: Muscle disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 271 at risk

Adverse event: Musculoskeletal and connective tissue disorders NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 39 affected / 271 at risk

Adverse event: Neurological disorders NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 271 at risk

Adverse event: Ocular infections, irritations and inflammations
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 271 at risk

Adverse event: Oral soft tissue conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 271 at risk

Adverse event: Pregnancy, labour, delivery and postpartum conditions
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 271 at risk

Adverse event: Protozoal infectious disorders
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 271 at risk

Adverse event: Renal disorders (excl nephropathies)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 271 at risk

Adverse event: Reproductive tract disorders NEC
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 271 at risk

Adverse event: Respiratory disorders NEC
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 51 affected / 271 at risk

Adverse event: Skin appendage conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 271 at risk

Adverse event: Sleep disorders and disturbances
Serious: no
Organ System: General disorders
Frequency: 12 affected / 271 at risk

Adverse event: Vascular haemorrhagic disorders
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 271 at risk

Adverse event: Vascular hypertensive disorders
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 271 at risk

Adverse event: Viral infectious disorders
Serious: no
Organ System: Infections and infestations
Frequency: 40 affected / 271 at risk

Adverse event: Vulvovaginal disorders (excl infections and inflammations)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 271 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 270 at risk

Adverse event: Acute Asthma Attack
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 270 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 270 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 270 at risk

Adverse event: Cytomegalovirus chorioretinitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Car accident - resulted in death
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 270 at risk

Adverse event: Contusions resulting in hospitalisations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 270 at risk

Adverse event: Cervix carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 270 at risk

Adverse event: Seizure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 270 at risk

Adverse event: Meningitis cryptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Death - unknown, possible due to recurrent anaemia, HIV disease
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 270 at risk

Adverse event: Death, cause unknown
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 270 at risk

Adverse event: Death, probably due to myocardial infarction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 270 at risk

Adverse event: Delirium, secondary alcohol withdrawal
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 270 at risk

Adverse event: Fracture of right ankle
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 270 at risk

Adverse event: HSV meningitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: herpez zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Skin graft detachment
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 270 at risk

Adverse event: Lung abscess resulted in death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 270 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 270 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 270 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 270 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 270 at risk

Adverse event: Probable righ ovarian carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 270 at risk

Adverse event: Genital haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 270 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 270 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 270 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Skin ulcers superinfected
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 270 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 270 at risk

Adverse event: Meningitis tuberculous
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Tension headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 270 at risk

Adverse event: Viral infection (presumptive)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Acute abdomen
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 270 at risk

Adverse event: Cerebral toxoplasmosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Diarrhoea for over consumption of alcohol
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 270 at risk

Adverse event: Hemoptysis, resulted in death
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 270 at risk

Adverse event: Disseminated tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: probable PCP and presumptive mycobacterium TB
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Allergic conditions
Serious: no
Organ System: General disorders
Frequency: 8 affected / 270 at risk

Adverse event: Anaemias nonhaemolytic and marrow depression
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 270 at risk

Adverse event: Appetite and general nutritional disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 270 at risk

Adverse event: Bacterial infectious disorders
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 270 at risk

Adverse event: Body temperature conditions
Serious: no
Organ System: General disorders
Frequency: 23 affected / 270 at risk

Adverse event: Bone, calcium, magnesium and phosphorus metabolism disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 270 at risk

Adverse event: Decreased and nonspecific blood pressure disorders and shock
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 270 at risk

Adverse event: Dental and gingival conditions
Serious: no
Organ System: General disorders
Frequency: 7 affected / 270 at risk

Adverse event: Epidermal and dermal conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 66 affected / 270 at risk

Adverse event: Female reproductive tract infections and inflammations
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 15 affected / 270 at risk

Adverse event: Fungal infectious disorders
Serious: no
Organ System: Infections and infestations
Frequency: 47 affected / 270 at risk

Adverse event: Gastrointestinal inflammatory conditions
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 270 at risk

Adverse event: Gastrointestinal motility and defaecation conditions
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 102 affected / 270 at risk

Adverse event: Gastrointestinal signs and symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 51 affected / 270 at risk

Adverse event: General system disorders NEC
Serious: no
Organ System: General disorders
Frequency: 33 affected / 270 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Frequency: 30 affected / 270 at risk

Adverse event: Hepatic and hepatobiliary disorders
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 270 at risk

Adverse event: Infections - pathogen class unspecified
Serious: no
Organ System: Infections and infestations
Frequency: 124 affected / 270 at risk

Adverse event: Injuries NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 270 at risk

Adverse event: Joint disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 270 at risk

Adverse event: Lipid metabolism disorders
Serious: no
Organ System: Endocrine disorders
Frequency: 7 affected / 270 at risk

Adverse event: Menstrual cycle and uterine bleeding disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 11 affected / 270 at risk

Adverse event: Muscle disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 270 at risk

Adverse event: Musculoskeletal and connective tissue disorders NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 44 affected / 270 at risk

Adverse event: Neurological disorders NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 270 at risk

Adverse event: Ocular infections, irritations and inflammations
Serious: no
Organ System: Eye disorders
Frequency: 17 affected / 270 at risk

Adverse event: Oral soft tissue conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 270 at risk

Adverse event: Pregnancy, labour, delivery and postpartum conditions
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 270 at risk

Adverse event: Protozoal infectious disorders
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 270 at risk

Adverse event: Renal disorders (excl nephropathies)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 270 at risk

Adverse event: Reproductive tract disorders NEC
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 12 affected / 270 at risk

Adverse event: Respiratory disorders NEC
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 58 affected / 270 at risk

Adverse event: Skin appendage conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 270 at risk

Adverse event: Sleep disorders and disturbances
Serious: no
Organ System: General disorders
Frequency: 8 affected / 270 at risk

Adverse event: Vascular haemorrhagic disorders
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 270 at risk

Adverse event: Vascular hypertensive disorders
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 270 at risk

Adverse event: Viral infectious disorders
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 270 at risk

Adverse event: Vulvovaginal disorders (excl infections and inflammations)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 8 affected / 270 at risk