Study: NCT02443805

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 800 at risk

Adverse event: Tick-borne viral encephalitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 800 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 800 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 800 at risk

Adverse event: Invasive ductal breast carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 800 at risk

Adverse event: Thyroid neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 800 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 800 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 800 at risk

Adverse event: Pharyngeal disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 800 at risk

Adverse event: Dermatitis atopic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 800 at risk

Adverse event: Chondromalacia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 800 at risk

Adverse event: Plica syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 800 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 800 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 800 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 800 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 800 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 800 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 800 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 800 at risk

Adverse event: Ovarian cyst ruptured
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 800 at risk

Adverse event: Oral pruritus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 189 affected / 800 at risk

Adverse event: Oedema mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 112 affected / 800 at risk

Adverse event: Tongue oedema
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 68 affected / 800 at risk

Adverse event: Lip oedema
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 61 affected / 800 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 53 affected / 800 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 47 affected / 800 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 800 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 107 affected / 800 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 136 affected / 800 at risk

Adverse event: Pharyngeal oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 46 affected / 800 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 45 affected / 800 at risk

Adverse event: Ear pruritus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 115 affected / 800 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 57 affected / 800 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 801 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 801 at risk

Adverse event: Hodgkin's disease
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 801 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 801 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 801 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 801 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 801 at risk

Adverse event: Chronic fatigue syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 801 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 801 at risk

Adverse event: Meniere's disease
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 801 at risk

Adverse event: Intracranial aneurysm
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 801 at risk

Adverse event: Oral pruritus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 801 at risk

Adverse event: Oedema mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 801 at risk

Adverse event: Tongue oedema
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 801 at risk

Adverse event: Lip oedema
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 801 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 801 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 801 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 801 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 117 affected / 801 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 801 at risk

Adverse event: Pharyngeal oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 801 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 801 at risk

Adverse event: Ear pruritus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 13 affected / 801 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 68 affected / 801 at risk