Study: NCT00530348

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 187 at risk

Adverse event: Malocclusion
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 187 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 187 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 187 at risk

Adverse event: Hepatitis toxic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 187 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 187 at risk

Adverse event: Hepatitis A
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 187 at risk

Adverse event: Accidental overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 187 at risk

Adverse event: Forearm fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 187 at risk

Adverse event: Hand fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 187 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 187 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 187 at risk

Adverse event: Osteitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 187 at risk

Adverse event: Multiple sclerosis relapse
Serious: yes
Organ System: Nervous system disorders
Frequency: 13 affected / 187 at risk

Adverse event: Mood altered
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 187 at risk

Adverse event: Ovarian haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 187 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 187 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 187 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 187 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 187 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 187 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 187 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 187 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 187 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 187 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 187 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 187 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 6 affected / 187 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 187 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 23 affected / 187 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 59 affected / 187 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 56 affected / 187 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 12 affected / 187 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 10 affected / 187 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 14 affected / 187 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 187 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 18 affected / 187 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 187 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 187 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 187 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 187 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 187 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 187 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 187 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 187 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 187 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 19 affected / 187 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 187 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Investigations
Frequency: 6 affected / 187 at risk

Adverse event: CD4 lymphocytes decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 187 at risk

Adverse event: CD8 lymphocytes decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 187 at risk

Adverse event: T-lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 187 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 187 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 187 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 187 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 187 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 187 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 187 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 187 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 187 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 52 affected / 187 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 187 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 187 at risk

Adverse event: Multiple sclerosis relapse
Serious: no
Organ System: Nervous system disorders
Frequency: 64 affected / 187 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 187 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 187 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 187 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 31 affected / 187 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 187 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 187 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 187 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 187 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 187 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 187 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 187 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 187 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 187 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 187 at risk

Adverse event: Agranulocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 376 at risk

Adverse event: Immune thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 376 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 376 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 376 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 376 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 376 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 376 at risk

Adverse event: Graves' disease
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 376 at risk

Adverse event: Goitre
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 376 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 376 at risk

Adverse event: Thyrotoxic crisis
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 376 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 376 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 376 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 376 at risk

Adverse event: Anaphylactic shock
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 376 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 376 at risk

Adverse event: Disseminated tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 376 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 376 at risk

Adverse event: Meningitis herpes
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 376 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 376 at risk

Adverse event: Tooth infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 376 at risk

Adverse event: Uterine infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 376 at risk

Adverse event: Abdominal wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 376 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 376 at risk

Adverse event: Incorrect dose administered
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 376 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 376 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 376 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 376 at risk

Adverse event: Thyroxine free increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 376 at risk

Adverse event: Tri-iodothyronine free increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 376 at risk

Adverse event: Selective eating disorder
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 376 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 376 at risk

Adverse event: Bladder papilloma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 376 at risk

Adverse event: Thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 376 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 376 at risk

Adverse event: Brain stem syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 376 at risk

Adverse event: Cerebrovascular insufficiency
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 376 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 376 at risk

Adverse event: Hypoxic-ischaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 376 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 376 at risk

Adverse event: Multiple sclerosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 376 at risk

Adverse event: Multiple sclerosis relapse
Serious: yes
Organ System: Nervous system disorders
Frequency: 19 affected / 376 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 376 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 376 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 376 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 376 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 376 at risk

Adverse event: Menometrorrhagia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 376 at risk

Adverse event: Heavy menstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 376 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 376 at risk

Adverse event: Uterine polyp
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 376 at risk

Adverse event: Pleurisy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 376 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 376 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 376 at risk

Adverse event: Throat tightness
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 376 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 376 at risk

Adverse event: Increased tendency to bruise
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 376 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 376 at risk

Adverse event: Physical assault
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 376 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 376 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 376 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 376 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 26 affected / 376 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 376 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 34 affected / 376 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 376 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 376 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 376 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 376 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 65 affected / 376 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 376 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 25 affected / 376 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 38 affected / 376 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 68 affected / 376 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 19 affected / 376 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 376 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 23 affected / 376 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 138 affected / 376 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 376 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 376 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 74 affected / 376 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 40 affected / 376 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 376 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 376 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 57 affected / 376 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 64 affected / 376 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 38 affected / 376 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 376 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 376 at risk

Adverse event: B-lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 19 affected / 376 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Investigations
Frequency: 20 affected / 376 at risk

Adverse event: CD4 lymphocytes decreased
Serious: no
Organ System: Investigations
Frequency: 26 affected / 376 at risk

Adverse event: CD8 lymphocytes decreased
Serious: no
Organ System: Investigations
Frequency: 26 affected / 376 at risk

Adverse event: T-lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 22 affected / 376 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 41 affected / 376 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 48 affected / 376 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 376 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 29 affected / 376 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 376 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 35 affected / 376 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 33 affected / 376 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 39 affected / 376 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 189 affected / 376 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 376 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 376 at risk

Adverse event: Multiple sclerosis relapse
Serious: no
Organ System: Nervous system disorders
Frequency: 65 affected / 376 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 32 affected / 376 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 24 affected / 376 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 28 affected / 376 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 56 affected / 376 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 24 affected / 376 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 39 affected / 376 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 376 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 42 affected / 376 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 376 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 52 affected / 376 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 174 affected / 376 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 28 affected / 376 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 50 affected / 376 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 44 affected / 376 at risk