Study: NCT01106586

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 353 at risk

Adverse event: Congenital ureteric anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 353 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 353 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 353 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 353 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 353 at risk

Adverse event: Diverticulum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 353 at risk

Adverse event: Erosive oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 353 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 353 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 353 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 353 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 353 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 353 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 353 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 353 at risk

Adverse event: Appendicitis perforated
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 353 at risk

Adverse event: Arthritis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 353 at risk

Adverse event: Breast abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 353 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 353 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 353 at risk

Adverse event: Gastroenteritis cryptosporidial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 353 at risk

Adverse event: Large intestine infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 353 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 353 at risk

Adverse event: Lymphogranuloma venereum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 353 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 353 at risk

Adverse event: Malignant syphilis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 353 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 353 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 353 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 353 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 353 at risk

Adverse event: Pneumonia streptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 353 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 353 at risk

Adverse event: Salpingitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 353 at risk

Adverse event: Secondary syphilis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 353 at risk

Adverse event: Shigella infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 353 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 353 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 353 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 353 at risk

Adverse event: Alcohol poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 353 at risk

Adverse event: Clavicle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 353 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 353 at risk

Adverse event: Lumbar vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 353 at risk

Adverse event: Muscle rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 353 at risk

Adverse event: Muscle strain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 353 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 353 at risk

Adverse event: Post concussion syndrome
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 353 at risk

Adverse event: Skull fractured base
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 353 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 353 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 353 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 353 at risk

Adverse event: Arthritis reactive
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 353 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 353 at risk

Adverse event: Anal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 353 at risk

Adverse event: Anal squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 353 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 353 at risk

Adverse event: Bladder neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 353 at risk

Adverse event: Burkitt's lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 353 at risk

Adverse event: Hodgkin's disease
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 353 at risk

Adverse event: Cervical radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 353 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 353 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 353 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 353 at risk

Adverse event: Tension headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 353 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 353 at risk

Adverse event: Alcohol withdrawal syndrome
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 353 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 353 at risk

Adverse event: Drug dependence
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 353 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 353 at risk

Adverse event: Post-traumatic stress disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 353 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 353 at risk

Adverse event: Substance-induced psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 353 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 353 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 353 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 353 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 353 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 353 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 353 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 353 at risk

Adverse event: Tonsillar hypertrophy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 353 at risk

Adverse event: Peripheral embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 353 at risk

Adverse event: Thrombophlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 353 at risk

Adverse event: Peripheral vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 353 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 353 at risk

Adverse event: Ocular icterus
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 353 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 353 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 353 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 99 affected / 353 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 353 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 353 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 80 affected / 353 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 353 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 60 affected / 353 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 23 affected / 353 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 17 affected / 353 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 47 affected / 353 at risk

Adverse event: Chlamydial infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 353 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 353 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 353 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 353 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 353 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 53 affected / 353 at risk

Adverse event: Onychomycosis
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 353 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 353 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 353 at risk

Adverse event: Syphilis
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 353 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 86 affected / 353 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 353 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 353 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 353 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 35 affected / 353 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 46 affected / 353 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 353 at risk

Adverse event: Anorectal human papilloma virus infection
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 21 affected / 353 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 353 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 67 affected / 353 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 353 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 22 affected / 353 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 47 affected / 353 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 37 affected / 353 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 38 affected / 353 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 353 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 353 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 30 affected / 353 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 24 affected / 353 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 355 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 355 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 355 at risk

Adverse event: Iridocyclitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 355 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 355 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 355 at risk

Adverse event: Gastritis erosive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 355 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 355 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 355 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 355 at risk

Adverse event: Peptic ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 355 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 355 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 355 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 355 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 355 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 355 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 355 at risk

Adverse event: Abscess neck
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 355 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 355 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 355 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 355 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 355 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 355 at risk

Adverse event: Ear infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 355 at risk

Adverse event: Epididymitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 355 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 355 at risk

Adverse event: Gastrointestinal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 355 at risk

Adverse event: Herpes zoster oticus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 355 at risk

Adverse event: Impetigo
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 355 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 355 at risk

Adverse event: Meningitis aseptic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 355 at risk

Adverse event: Meningitis enteroviral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 355 at risk

Adverse event: Meningitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 355 at risk

Adverse event: Orchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 355 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 355 at risk

Adverse event: Pilonidal disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 355 at risk

Adverse event: Pneumocystis jirovecii pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 355 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 355 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 355 at risk

Adverse event: Scrotal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 355 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 355 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 355 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 355 at risk

Adverse event: Hand fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 355 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 355 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 355 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 355 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 355 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 355 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 355 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 355 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 355 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 355 at risk

Adverse event: Foot deformity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 355 at risk

Adverse event: Intervertebral disc displacement
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 355 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 355 at risk

Adverse event: Pain in jaw
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 355 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 355 at risk

Adverse event: Anal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 355 at risk

Adverse event: Anogenital warts
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 355 at risk

Adverse event: B-cell lymphoma stage II
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 355 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 355 at risk

Adverse event: Hodgkin's disease
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 355 at risk

Adverse event: Coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 355 at risk

Adverse event: Intensive care unit acquired weakness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 355 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 355 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 355 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 355 at risk

Adverse event: Facial paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 355 at risk

Adverse event: Alcohol withdrawal syndrome
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 355 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 355 at risk

Adverse event: Depressed mood
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 355 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 355 at risk

Adverse event: Depressive symptom
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 355 at risk

Adverse event: Mania
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 355 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 355 at risk

Adverse event: Substance abuse
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 355 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 355 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 355 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 355 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 355 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 355 at risk

Adverse event: Respiratory depression
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 355 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 355 at risk

Adverse event: Drug eruption
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 355 at risk

Adverse event: Psoriasis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 355 at risk

Adverse event: Treatment noncompliance
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 355 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 355 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 355 at risk

Adverse event: Ocular icterus
Serious: no
Organ System: Eye disorders
Frequency: 52 affected / 355 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 355 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 355 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 121 affected / 355 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 355 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 355 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 78 affected / 355 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 355 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 60 affected / 355 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 22 affected / 355 at risk

Adverse event: Jaundice
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 34 affected / 355 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 19 affected / 355 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 42 affected / 355 at risk

Adverse event: Chlamydial infection
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 355 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 355 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 355 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 355 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 355 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 57 affected / 355 at risk

Adverse event: Onychomycosis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 355 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 355 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 38 affected / 355 at risk

Adverse event: Syphilis
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 355 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 97 affected / 355 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 355 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 355 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 355 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 32 affected / 355 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 37 affected / 355 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 355 at risk

Adverse event: Anorectal human papilloma virus infection
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 12 affected / 355 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 355 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 55 affected / 355 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 355 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 29 affected / 355 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 52 affected / 355 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 36 affected / 355 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 46 affected / 355 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 355 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 355 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 37 affected / 355 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 355 at risk