Study: NCT01097655

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 3039 at risk

Adverse event: Eosinophilia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Haemolytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Macrocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3039 at risk

Adverse event: Plasmacytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Arteriosclerosis coronary artery
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Atrioventricular block second degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Atrioventricular dissociation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Bundle branch block right
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Cardiac valve disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Degenerative mitral valve disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Extrasystoles
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 3039 at risk

Adverse event: Pleuropericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Eye swelling
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Abdominal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 3039 at risk

Adverse event: Alcoholic pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Anal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3039 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Chronic gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 3039 at risk

Adverse event: Diarrhoea haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Gingivitis ulcerative
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3039 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3039 at risk

Adverse event: Leukoplakia oral
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 3039 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Pancreatic cyst
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Proctalgia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Salivary gland cyst
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3039 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Drug intolerance
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Drug withdrawal syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3039 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 3039 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 3039 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 3039 at risk

Adverse event: Hepatic cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Hepatic lesion
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Immune reconstitution inflammatory syndrome
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 3039 at risk

Adverse event: HIV-associated neurocognitive disorder
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3039 at risk

Adverse event: Acquired immunodeficiency syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3039 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3039 at risk

Adverse event: Chlamydial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3039 at risk

Adverse event: Cytomegalovirus colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3039 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3039 at risk

Adverse event: Fungal oesophagitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3039 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3039 at risk

Adverse event: Gastrointestinal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3039 at risk

Adverse event: Helicobacter gastritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3039 at risk

Adverse event: Herpes virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3039 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3039 at risk

Adverse event: Leishmaniasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3039 at risk

Adverse event: Lymph node tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3039 at risk

Adverse event: Lymphogranuloma venereum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3039 at risk

Adverse event: Mycobacterium avium complex infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3039 at risk

Adverse event: Oesophageal candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3039 at risk

Adverse event: Ophthalmic herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3039 at risk

Adverse event: Oral candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3039 at risk

Adverse event: Oral herpes
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3039 at risk

Adverse event: Pneumocystis jirovecii pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3039 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 3039 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3039 at risk

Adverse event: Salmonellosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3039 at risk

Adverse event: Secondary transmission
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3039 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3039 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3039 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3039 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3039 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3039 at risk

Adverse event: Lumbar vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3039 at risk

Adverse event: Blood triglycerides increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 3039 at risk

Adverse event: Cytomegalovirus test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3039 at risk

Adverse event: General physical condition abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3039 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3039 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Inguinal mass
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 3039 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Osteoporosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Spinal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Anal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3039 at risk

Adverse event: ANAPLASTIC LARGE CELL LYMPHOMA T- AND NULL-CELL TYPE STAGE IV
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3039 at risk

Adverse event: Anogenital warts
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3039 at risk

Adverse event: Burkitt's lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 3039 at risk

Adverse event: Extranodal marginal zone B-cell lymphoma (MALT type)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3039 at risk

Adverse event: Hepatic cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3039 at risk

Adverse event: Kaposi's sarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3039 at risk

Adverse event: Papilloma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3039 at risk

Adverse event: Plasmablastic lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3039 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Balance disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Cerebral arteriosclerosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Cerebral atrophy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3039 at risk

Adverse event: Disturbance in attention
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Facial paresis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 3039 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Memory impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Meningeal disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Abortion
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3039 at risk

Adverse event: Abortion missed
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3039 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 3039 at risk

Adverse event: Maternal condition affecting foetus
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3039 at risk

Adverse event: Placental insufficiency
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3039 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3039 at risk

Adverse event: Apathy
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Disorientation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Nocturia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Renal cyst
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Urinary bladder polyp
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Adenomyosis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Menometrorrhagia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Prostatic mass
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 3039 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 3039 at risk

Adverse event: Lung infiltration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Oropharyngeal pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Rales
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3039 at risk

Adverse event: Abortion induced
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3039 at risk