Study: NCT01352845

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2471 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 2471 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2471 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2471 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2471 at risk

Adverse event: Mastoiditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2471 at risk

Adverse event: Otosalpingitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2471 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2471 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2471 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2471 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2471 at risk

Adverse event: Tendon injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2471 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2471 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2471 at risk

Adverse event: Idiopathic intracranial hypertension
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2471 at risk

Adverse event: Dystonia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2471 at risk

Adverse event: Multiple sclerosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2471 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 2471 at risk

Adverse event: Abortion missed
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 2471 at risk

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 2471 at risk

Adverse event: Hyperemesis gravidarum
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 2471 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2471 at risk

Adverse event: Dissociative disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2471 at risk

Adverse event: Eating disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2471 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2471 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2471 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 46 affected / 2471 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 12 affected / 2471 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 98 affected / 2471 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 77 affected / 2471 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 45 affected / 2471 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 2471 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 2471 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 2471 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 2471 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 31 affected / 2471 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 22 affected / 2471 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 55 affected / 2471 at risk

Adverse event: Pain at injection site - Any (reactogenicity event)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2184 affected / 2438 at risk

Adverse event: Redness -Any (reactogenicity event)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 537 affected / 2438 at risk

Adverse event: Swelling -Any (reactogenicity event)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 612 affected / 2438 at risk

Adverse event: Fever >=38.0 degrees C -Any (reactogenicity event)
Serious: no
Organ System: General disorders
Frequency: 108 affected / 2432 at risk

Adverse event: Vomiting - Any (reactogenicity event)
Serious: no
Organ System: General disorders
Frequency: 130 affected / 2438 at risk

Adverse event: Diarrhea-Any (reactogenicity event)
Serious: no
Organ System: General disorders
Frequency: 497 affected / 2438 at risk

Adverse event: Headache - Any (reactogenicity event)
Serious: no
Organ System: General disorders
Frequency: 1440 affected / 2438 at risk

Adverse event: Fatigue -Any (reactogenicity event)
Serious: no
Organ System: General disorders
Frequency: 1576 affected / 2438 at risk

Adverse event: Chills - Any (reactogenicity event)
Serious: no
Organ System: General disorders
Frequency: 697 affected / 2438 at risk

Adverse event: Muscle pain -Any (reactogenicity event)
Serious: no
Organ System: General disorders
Frequency: 916 affected / 2438 at risk

Adverse event: Joint pain -Any (reactogenicity event)
Serious: no
Organ System: General disorders
Frequency: 723 affected / 2438 at risk

Adverse event: Sudden hearing loss
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 822 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 822 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 822 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 822 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 822 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 822 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 822 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 822 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 822 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 822 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 822 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 822 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 822 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 822 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 822 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 822 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 822 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 822 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 822 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 822 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 822 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 822 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 822 at risk

Adverse event: Pain at injection site - Any (reactogenicity event)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 147 affected / 808 at risk

Adverse event: Redness -Any (reactogenicity event)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 808 at risk

Adverse event: Swelling -Any (reactogenicity event)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 808 at risk

Adverse event: Fever >=38.0 degrees C -Any (reactogenicity event)
Serious: no
Organ System: General disorders
Frequency: 14 affected / 807 at risk

Adverse event: Vomiting - Any (reactogenicity event)
Serious: no
Organ System: General disorders
Frequency: 37 affected / 808 at risk

Adverse event: Diarrhea-Any (reactogenicity event)
Serious: no
Organ System: General disorders
Frequency: 158 affected / 808 at risk

Adverse event: Headache - Any (reactogenicity event)
Serious: no
Organ System: General disorders
Frequency: 391 affected / 808 at risk

Adverse event: Fatigue -Any (reactogenicity event)
Serious: no
Organ System: General disorders
Frequency: 411 affected / 808 at risk

Adverse event: Chills - Any (reactogenicity event)
Serious: no
Organ System: General disorders
Frequency: 133 affected / 808 at risk

Adverse event: Muscle pain -Any (reactogenicity event)
Serious: no
Organ System: General disorders
Frequency: 170 affected / 808 at risk

Adverse event: Joint pain -Any (reactogenicity event)
Serious: no
Organ System: General disorders
Frequency: 136 affected / 808 at risk