Study: NCT01172639

Adverse event: Bone marrow supression
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 98 at risk

Adverse event: Abdominal discomfort
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Volvulus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 98 at risk

Adverse event: Post procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 98 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 98 at risk

Adverse event: Intervertebral disc disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 98 at risk

Adverse event: Ischialgy leg
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 98 at risk

Adverse event: Rheumatoid arthritis flare
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 98 at risk

Adverse event: Synovial cyst
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 98 at risk

Adverse event: Breast cancer malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 98 at risk

Adverse event: Intestinal polyps
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 98 at risk

Adverse event: Lung cancer malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 98 at risk

Adverse event: Lung noduli
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 98 at risk

Adverse event: Pain
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 98 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: Product Issues
Notes: induced by MTX
Frequency: 1 affected / 98 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 98 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Orthopaedic surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 98 at risk

Adverse event: Abdominal surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 98 at risk

Adverse event: Amygdalectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 98 at risk

Adverse event: Hysterectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 98 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 98 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 98 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 98 at risk

Adverse event: Liver function disturbance
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 17 affected / 98 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 98 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 98 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 98 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 98 at risk

Adverse event: Vertigo
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 98 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 98 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 98 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 9 affected / 98 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 98 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 98 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 98 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 98 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 98 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 98 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 98 at risk

Adverse event: Hairloss
Serious: no
Organ System: General disorders
Frequency: 7 affected / 98 at risk

Adverse event: Increased transpiration
Serious: no
Organ System: General disorders
Frequency: 7 affected / 98 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 98 at risk

Adverse event: Agitation
Serious: no
Organ System: General disorders
Frequency: 6 affected / 98 at risk

Adverse event: Flushes
Serious: no
Organ System: General disorders
Frequency: 6 affected / 98 at risk

Adverse event: Eye infection
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 98 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 98 at risk

Adverse event: Rotator cuff lesion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 98 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 98 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 98 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 98 at risk

Adverse event: Influenza infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 98 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 98 at risk

Adverse event: Tendon disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 98 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 98 at risk

Adverse event: Aphtosis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 98 at risk

Adverse event: Genital infection
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 98 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 98 at risk

Adverse event: Sjogren's syndrome
Serious: no
Organ System: General disorders
Frequency: 5 affected / 98 at risk

Adverse event: Peripheral venous disease
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 98 at risk

Adverse event: Tooth extraction
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 98 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 98 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 98 at risk

Adverse event: Syncope
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 98 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 98 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 98 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 98 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 98 at risk

Adverse event: Sinus venosus defect
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 98 at risk

Adverse event: Abdominal discomfort
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 98 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 98 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 98 at risk

Adverse event: Rheumatoid arthritis flare
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 98 at risk

Adverse event: Septic bursitis olecrani
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 98 at risk

Adverse event: Cervixcarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 98 at risk

Adverse event: Noduli submandibular salivary glands
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 98 at risk

Adverse event: Severe depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 98 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Orthopaedic surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 98 at risk

Adverse event: Abdominal surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 98 at risk

Adverse event: Liposuction arms
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 98 at risk

Adverse event: Pulmonary embolisms
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 98 at risk

Adverse event: Peripheral vascular ischemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 98 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 42 affected / 98 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 98 at risk

Adverse event: Liver function disturbance
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 15 affected / 98 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 98 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 98 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 98 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 98 at risk

Adverse event: Vertigo
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 98 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 98 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 98 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 4 affected / 98 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 98 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 98 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 98 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 98 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 98 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 98 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 98 at risk

Adverse event: Hairloss
Serious: no
Organ System: General disorders
Frequency: 12 affected / 98 at risk

Adverse event: Increased transpiration
Serious: no
Organ System: General disorders
Frequency: 3 affected / 98 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 98 at risk

Adverse event: Agitation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 98 at risk

Adverse event: Flushes
Serious: no
Organ System: General disorders
Frequency: 4 affected / 98 at risk

Adverse event: Eye infection
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 98 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 98 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 98 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 98 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 98 at risk

Adverse event: Influenza infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 98 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 98 at risk

Adverse event: Tendon disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 98 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 98 at risk

Adverse event: Aphtosis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 98 at risk

Adverse event: Genital infection
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 98 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 98 at risk

Adverse event: Sjogren's syndrome
Serious: no
Organ System: General disorders
Frequency: 2 affected / 98 at risk

Adverse event: Peripheral venous disease
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 98 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 98 at risk

Adverse event: Tooth extraction
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 98 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 98 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 98 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 93 at risk

Adverse event: Uncontrolled diabetes mellitus
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 93 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Post procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 93 at risk

Adverse event: Hernia diaphragmatica
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 93 at risk

Adverse event: Intervertebral disc disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 93 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 93 at risk

Adverse event: Rheumatoid arthritis flare
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 93 at risk

Adverse event: Cholesteatoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 93 at risk

Adverse event: Neoplasms parotid gland
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 93 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Orthopaedic surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 93 at risk

Adverse event: Abdominal surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 93 at risk

Adverse event: Hysterectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 93 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 29 affected / 93 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 93 at risk

Adverse event: Liver function disturbance
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 24 affected / 93 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 93 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 93 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 93 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 93 at risk

Adverse event: Vertigo
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 93 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 93 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 93 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 5 affected / 93 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 93 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 93 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 93 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 93 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 93 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 93 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 93 at risk

Adverse event: Hairloss
Serious: no
Organ System: General disorders
Frequency: 19 affected / 93 at risk

Adverse event: Increased transpiration
Serious: no
Organ System: General disorders
Frequency: 6 affected / 93 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 93 at risk

Adverse event: Agitation
Serious: no
Organ System: General disorders
Frequency: 10 affected / 93 at risk

Adverse event: Flushes
Serious: no
Organ System: General disorders
Frequency: 2 affected / 93 at risk

Adverse event: Eye infection
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 93 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 93 at risk

Adverse event: Rotator cuff lesion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 93 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 93 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 93 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 93 at risk

Adverse event: Influenza infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 93 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 93 at risk

Adverse event: Tendon disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 93 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 93 at risk

Adverse event: Aphtosis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 93 at risk

Adverse event: Genital infection
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 8 affected / 93 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 93 at risk

Adverse event: Sjogren's syndrome
Serious: no
Organ System: General disorders
Frequency: 6 affected / 93 at risk

Adverse event: Peripheral venous disease
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 93 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 93 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 93 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 93 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 43 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 43 at risk

Adverse event: Intervertebral disc disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Endometrial adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 43 at risk

Adverse event: Kidney cancer malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 43 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 43 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 43 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 43 at risk

Adverse event: Liver function disturbance
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 43 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 43 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 43 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 43 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 43 at risk

Adverse event: Vertigo
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 43 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 43 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 2 affected / 43 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 43 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 43 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 43 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 43 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 43 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 43 at risk

Adverse event: Hairloss
Serious: no
Organ System: General disorders
Frequency: 7 affected / 43 at risk

Adverse event: Increased transpiration
Serious: no
Organ System: General disorders
Frequency: 3 affected / 43 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 43 at risk

Adverse event: Agitation
Serious: no
Organ System: General disorders
Frequency: 3 affected / 43 at risk

Adverse event: Flushes
Serious: no
Organ System: General disorders
Frequency: 2 affected / 43 at risk

Adverse event: Eye infection
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 43 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 43 at risk

Adverse event: Rotator cuff lesion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Influenza infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 43 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 43 at risk

Adverse event: Tendon disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 43 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Genital infection
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 43 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 43 at risk

Adverse event: Sjogren's syndrome
Serious: no
Organ System: General disorders
Frequency: 2 affected / 43 at risk

Adverse event: Peripheral venous disease
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 43 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 43 at risk

Adverse event: Tooth extraction
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 43 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 47 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 47 at risk

Adverse event: Anaphylaxis after a wasp sting
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 47 at risk

Adverse event: Ischialgy leg
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 47 at risk

Adverse event: Orthopaedic surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 47 at risk

Adverse event: Abdominal surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 47 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 47 at risk

Adverse event: Peripheral vascular ischemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 47 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 47 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 47 at risk

Adverse event: Liver function disturbance
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 47 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 47 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 47 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 47 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 47 at risk

Adverse event: Vertigo
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 47 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 47 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 47 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 47 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 47 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 47 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 47 at risk

Adverse event: Hairloss
Serious: no
Organ System: General disorders
Frequency: 6 affected / 47 at risk

Adverse event: Increased transpiration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 47 at risk

Adverse event: Rotator cuff lesion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 47 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 47 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 47 at risk

Adverse event: Influenza infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 47 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 47 at risk

Adverse event: Tendon disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 47 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 47 at risk

Adverse event: Aphtosis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 47 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 47 at risk

Adverse event: Sjogren's syndrome
Serious: no
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Peripheral venous disease
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 47 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 47 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 47 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 47 at risk

Adverse event: Syncope
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 47 at risk