Study: NCT01691859

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 33 affected / 347 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 347 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 347 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 347 at risk

Adverse event: Asthmatic crisis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 347 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 347 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 347 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 347 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 347 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 347 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 347 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 347 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 347 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 347 at risk

Adverse event: Myelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 347 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 347 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 347 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 347 at risk

Adverse event: Streptococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 347 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 347 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 347 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 347 at risk

Adverse event: Chronic gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 347 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 347 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 347 at risk

Adverse event: Diverticulum intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 347 at risk

Adverse event: Faecaloma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 347 at risk

Adverse event: Gastric polyps
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 347 at risk

Adverse event: Incarcerated inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 347 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 347 at risk

Adverse event: Large intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 347 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 347 at risk

Adverse event: Bursitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 347 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 347 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 347 at risk

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 347 at risk

Adverse event: Neuropathic arthropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 347 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 347 at risk

Adverse event: Rheumatoid arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 347 at risk

Adverse event: Rotator cuff syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 347 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 347 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 347 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 347 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 347 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 347 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 347 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 347 at risk

Adverse event: Comminuted fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 347 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 347 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 347 at risk

Adverse event: Ligament rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 347 at risk

Adverse event: Ligament sprain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 347 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 347 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 347 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 347 at risk

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 347 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 347 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 347 at risk

Adverse event: Peroneal nerve palsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 347 at risk

Adverse event: Spinal claudication
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 347 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 347 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 347 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 347 at risk

Adverse event: Bladder papilloma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 347 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 347 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 347 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 347 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 347 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 347 at risk

Adverse event: Cholestasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 347 at risk

Adverse event: Hepatocellular injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 347 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 347 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 347 at risk

Adverse event: Superficial vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 347 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 347 at risk

Adverse event: Anaphylactic shock
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 347 at risk

Adverse event: Blood glucose increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 347 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 347 at risk

Adverse event: Cystocele
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 347 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 347 at risk

Adverse event: Urinary incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 347 at risk

Adverse event: Cervical polyp
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 347 at risk

Adverse event: Rectocele
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 347 at risk

Adverse event: Lymphocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 347 at risk

Adverse event: Graves' disease
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 347 at risk

Adverse event: Thyroid mass
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 347 at risk

Adverse event: Obesity
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 347 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 169 affected / 347 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 81 affected / 347 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 73 affected / 347 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 57 affected / 347 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 43 affected / 347 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 38 affected / 347 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 347 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 347 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 347 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 347 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 347 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 347 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 347 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 347 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 347 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 347 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 347 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 347 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 69 affected / 347 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 36 affected / 347 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 347 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 347 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 347 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 347 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 347 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 347 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 63 affected / 347 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 58 affected / 347 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 40 affected / 347 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 347 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 347 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 347 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 99 affected / 347 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 347 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 347 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 347 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 347 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 347 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 347 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 347 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 347 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 347 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 347 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 42 affected / 347 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 12 affected / 347 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 15 affected / 347 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 347 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 347 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 32 affected / 347 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 347 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 13 affected / 347 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 347 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 347 at risk