Study: NCT01095796

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 348 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 348 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 348 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 348 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 348 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 348 at risk

Adverse event: Intestinal mass
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 348 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 348 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 348 at risk

Adverse event: Proctalgia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 348 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 348 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 348 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 348 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 348 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 348 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 348 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 348 at risk

Adverse event: Systemic inflammatory response syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 348 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 348 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 348 at risk

Adverse event: Hepatitis alcoholic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 348 at risk

Adverse event: Liver injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 348 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 348 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 348 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 348 at risk

Adverse event: Bronchitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 348 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 348 at risk

Adverse event: Cellulitis staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 348 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 348 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 348 at risk

Adverse event: H1N1 influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 348 at risk

Adverse event: Herpes simplex
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 348 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 348 at risk

Adverse event: Meningitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 348 at risk

Adverse event: Muscle abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 348 at risk

Adverse event: Neurosyphilis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 348 at risk

Adverse event: Ovarian abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 348 at risk

Adverse event: Pelvic inflammatory disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 348 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 348 at risk

Adverse event: Pneumonia legionella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 348 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 348 at risk

Adverse event: Rectal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 348 at risk

Adverse event: Secondary syphilis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 348 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 348 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 348 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 348 at risk

Adverse event: Craniofacial fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 348 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 348 at risk

Adverse event: Fibula fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 348 at risk

Adverse event: Gun shot wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 348 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 348 at risk

Adverse event: Intentional overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 348 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 348 at risk

Adverse event: Lumbar vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 348 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 348 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 348 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 348 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 348 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 348 at risk

Adverse event: Transaminases increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 348 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 348 at risk

Adverse event: Synovitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 348 at risk

Adverse event: Anorectal human papilloma virus infection
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 348 at risk

Adverse event: Bladder cancer recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 348 at risk

Adverse event: Burkitt's lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 348 at risk

Adverse event: Hodgkin's disease
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 348 at risk

Adverse event: Kaposi's sarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 348 at risk

Adverse event: Lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 348 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 348 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 348 at risk

Adverse event: Hepatic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 348 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 348 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 348 at risk

Adverse event: Alcoholism
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 348 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 348 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 348 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 348 at risk

Adverse event: Depression suicidal
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 348 at risk

Adverse event: Suicidal behaviour
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 348 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 348 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 348 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 348 at risk

Adverse event: Testicular mass
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 348 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 348 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 348 at risk

Adverse event: Pulmonary thrombosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 348 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 348 at risk

Adverse event: Alcohol use
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 348 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 348 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 348 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 348 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 348 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 348 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 348 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 93 affected / 348 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 348 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 348 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 348 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 80 affected / 348 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 348 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 53 affected / 348 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 21 affected / 348 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 348 at risk

Adverse event: Chlamydial infection
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 348 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 348 at risk

Adverse event: Gonorrhoea
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 348 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 348 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 348 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 38 affected / 348 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 348 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 348 at risk

Adverse event: Syphilis
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 348 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 92 affected / 348 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 348 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 33 affected / 348 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 38 affected / 348 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 348 at risk

Adverse event: Anorectal human papilloma virus infection
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 20 affected / 348 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 29 affected / 348 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 62 affected / 348 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 348 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 56 affected / 348 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 30 affected / 348 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 56 affected / 348 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 47 affected / 348 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 13 affected / 348 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 39 affected / 348 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 348 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 348 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 348 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 348 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 21 affected / 348 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 352 at risk

Adverse event: Antiphospholipid syndrome
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 352 at risk

Adverse event: Splenic vein thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 352 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 352 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 352 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 352 at risk

Adverse event: Intracardiac mass
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 352 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 352 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 352 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 352 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 352 at risk

Adverse event: Inflammatory bowel disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 352 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 352 at risk

Adverse event: Mesenteric vein thrombosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 352 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 352 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 352 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 352 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 352 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 352 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 352 at risk

Adverse event: Acute sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 352 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 352 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 352 at risk

Adverse event: Diarrhoea infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 352 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 352 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 352 at risk

Adverse event: Giardiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 352 at risk

Adverse event: Neurosyphilis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 352 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 352 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 352 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 352 at risk

Adverse event: Sepsis syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 352 at risk

Adverse event: Skin bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 352 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 352 at risk

Adverse event: Cervical vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 352 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 352 at risk

Adverse event: Limb injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 352 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 352 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 352 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 352 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 352 at risk

Adverse event: Adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 352 at risk

Adverse event: Anal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 352 at risk

Adverse event: Anal cancer recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 352 at risk

Adverse event: Colorectal cancer stage IV
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 352 at risk

Adverse event: Diffuse large B-cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 352 at risk

Adverse event: Immune reconstitution inflammatory syndrome associated Kaposi's sarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 352 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 352 at risk

Adverse event: Metastatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 352 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 352 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 352 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 352 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 352 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 352 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 352 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 352 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 352 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 352 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 352 at risk

Adverse event: Drug dependence
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 352 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 352 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 352 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 352 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 352 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 352 at risk

Adverse event: Pelvic pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 352 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 352 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 352 at risk

Adverse event: Dyspnoea exertional
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 352 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 352 at risk

Adverse event: Pneumomediastinum
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 352 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 352 at risk

Adverse event: Rash maculo-papular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 352 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 352 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 352 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 352 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 352 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 91 affected / 352 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 352 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 352 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 352 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 59 affected / 352 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 352 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 61 affected / 352 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 23 affected / 352 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 352 at risk

Adverse event: Chlamydial infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 352 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 352 at risk

Adverse event: Gonorrhoea
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 352 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 352 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 352 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 352 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 352 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 46 affected / 352 at risk

Adverse event: Syphilis
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 352 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 78 affected / 352 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 352 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 352 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 352 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 352 at risk

Adverse event: Anorectal human papilloma virus infection
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 13 affected / 352 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 94 affected / 352 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 45 affected / 352 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 352 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 101 affected / 352 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 33 affected / 352 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 59 affected / 352 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 63 affected / 352 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 21 affected / 352 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 352 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 352 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 352 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 352 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 53 affected / 352 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 22 affected / 352 at risk