Study: NCT00112242

Adverse event: Nephrectomy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local Reactions
Frequency: 7 affected / 10 at risk

Adverse event: Injection site induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local Reactions
Frequency: 9 affected / 10 at risk

Adverse event: Injection site pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local Reactions
Frequency: 6 affected / 10 at risk

Adverse event: Injection site recall reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local Reactions
Frequency: 4 affected / 10 at risk

Adverse event: Injection site warmth
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local Reactions
Frequency: 4 affected / 10 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Prelisted Systemic Reactions
Frequency: 4 affected / 10 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Notes: Prelisted Systemic Reactions
Frequency: 3 affected / 10 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Prelisted Systemic Reactions
Frequency: 2 affected / 10 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Prelisted Systemic Reactions
Frequency: 2 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Prelisted Systemic Reactions
Frequency: 2 affected / 10 at risk

Adverse event: influenza-like illness
Serious: no
Organ System: General disorders
Notes: Prelisted Systemic Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Prelisted Systemic Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Prelisted Systemic Reactions
Frequency: 5 affected / 10 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Notes: Prelisted Systemic Reactions
Frequency: 4 affected / 10 at risk

Adverse event: Otorrhoea
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Chronic otitis
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Gynaecomastia
Serious: no
Organ System: Endocrine disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Myocardial ischaemia
Serious: no
Organ System: Cardiac disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Heart murmurs
Serious: no
Organ System: Cardiac disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Tachycardi
Serious: no
Organ System: Cardiac disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Cardiac shock
Serious: no
Organ System: Cardiac disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Decrease visual field
Serious: no
Organ System: Eye disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Visual troubles
Serious: no
Organ System: Eye disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Prelisted Reactions
Frequency: 2 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Prelisted Reactions
Frequency: 2 affected / 10 at risk

Adverse event: Colitic lesions
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Oral Aphtha
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Left hypoesthesia mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Hyperaesthesia teeth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Discomfort
Serious: no
Organ System: General disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Prelisted Reactions
Frequency: 5 affected / 10 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Non-Prelisted Reactions
Frequency: 3 affected / 10 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Notes: Non-Prelisted Reactions
Frequency: 3 affected / 10 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Mucosal infection
Serious: no
Organ System: Infections and infestations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Lund injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Anaemia
Serious: no
Organ System: Investigations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Karnofsky scale worsened
Serious: no
Organ System: Investigations
Notes: Non-Prelisted Reactions
Frequency: 5 affected / 10 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: High LDH level
Serious: no
Organ System: Investigations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: Non-Prelisted Reactions
Frequency: 2 affected / 10 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Non-Prelisted Reactions
Frequency: 2 affected / 10 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Dehydratation
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Axillary pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 2 affected / 10 at risk

Adverse event: Malignant melanoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Non-Prelisted Reactions
Frequency: 2 affected / 10 at risk

Adverse event: Metastatic malignant melanoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Non-Prelisted Reactions
Frequency: 4 affected / 10 at risk

Adverse event: Metastasis skin
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Non-Prelisted Reactions
Frequency: 3 affected / 10 at risk

Adverse event: Renal cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Inguinal adenophathy
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Non-Prelisted Reactions
Frequency: 3 affected / 10 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Mediastinal adenopathy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Black nodule on scar
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Increased renal kystis
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Neoplasms benign, malignant and unspecified-subcutaneous nodule
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Non-Prelisted Reactions
Frequency: 4 affected / 10 at risk

Adverse event: Brain oedema
Serious: no
Organ System: Nervous system disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Paresthesi
Serious: no
Organ System: Nervous system disorders
Notes: Non-Prelisted Reactions
Frequency: 3 affected / 10 at risk

Adverse event: Dysarthrya
Serious: no
Organ System: Nervous system disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Aphasia
Serious: no
Organ System: Nervous system disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Sleeping disorders
Serious: no
Organ System: Nervous system disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Nervous Descompensation
Serious: no
Organ System: Nervous system disorders
Notes: Non-Prelisted Reactions
Frequency: 2 affected / 10 at risk

Adverse event: Temporal lobe
Serious: no
Organ System: Nervous system disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Mood alteration
Serious: no
Organ System: Psychiatric disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Anuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Amenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Non-Prelisted Reactions
Frequency: 2 affected / 10 at risk

Adverse event: Hyperhydrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Skin scab
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Skin hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Scar
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Pain scar
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Haematoma post-biopsy
Serious: no
Organ System: Surgical and medical procedures
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Post-operative arythmia
Serious: no
Organ System: Surgical and medical procedures
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Non-Prelisted Reactions
Frequency: 2 affected / 10 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Notes: Non-Prelisted Reactions
Frequency: 3 affected / 10 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Vascular disorders
Notes: Non-Prelisted Reactions
Frequency: 2 affected / 10 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 5 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local Reactions
Frequency: 5 affected / 5 at risk

Adverse event: Injection site induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local Reactions
Frequency: 5 affected / 5 at risk

Adverse event: Injection site pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local Reactions
Frequency: 4 affected / 5 at risk

Adverse event: Injection site recall reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local Reactions
Frequency: 2 affected / 5 at risk

Adverse event: Injection site warmth
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Prelisted Systemic Reactions
Frequency: 2 affected / 5 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Prelisted Systemic Reactions
Frequency: 2 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Prelisted Systemic Reactions
Frequency: 3 affected / 5 at risk

Adverse event: influenza-like illness
Serious: no
Organ System: General disorders
Notes: Prelisted Systemic Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Prelisted Systemic Reactions
Frequency: 2 affected / 5 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Prelisted Systemic Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Prelisted Systemic Reactions
Frequency: 2 affected / 5 at risk

Adverse event: Chest pain-cardiac
Serious: no
Organ System: Cardiac disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Tachycardi
Serious: no
Organ System: Cardiac disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Ventricular arythmia
Serious: no
Organ System: Cardiac disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Prelisted Reactions
Frequency: 3 affected / 5 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Throat glar
Serious: no
Organ System: General disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Immune system disorders
Serious: no
Organ System: Immune system disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Granuloma
Serious: no
Organ System: Immune system disorders
Notes: Non-Prelisted Reactions
Frequency: 3 affected / 5 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: High LDH level
Serious: no
Organ System: Investigations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Metastatic malignant melanoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Metastasis skin
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Non-Prelisted Reactions
Frequency: 3 affected / 5 at risk

Adverse event: Benign prostatic hyperplasia
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Inguinal adenophathy
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Non-Prelisted Reactions
Frequency: 2 affected / 5 at risk

Adverse event: Neoplasms benign, malignant and unspecified-subcutaneous nodule
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Non-Prelisted Reactions
Frequency: 2 affected / 5 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Dysaesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Cerebral ischaemia
Serious: no
Organ System: Nervous system disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Renal colic
Serious: no
Organ System: Renal and urinary disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Keratosis lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Ingrowing nail
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Purpura
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Scar
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Punch-biopsy previous injection site
Serious: no
Organ System: Surgical and medical procedures
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Vascular disorders
Notes: Non-Prelisted Reactions
Frequency: 2 affected / 5 at risk

Adverse event: Varix
Serious: no
Organ System: Vascular disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Pulmonary granuloma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local Reactions
Frequency: 5 affected / 5 at risk

Adverse event: Injection site induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local Reactions
Frequency: 5 affected / 5 at risk

Adverse event: Injection site pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local Reactions
Frequency: 5 affected / 5 at risk

Adverse event: Injection site recall reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local Reactions
Frequency: 2 affected / 5 at risk

Adverse event: Injection site warmth
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local Reactions
Frequency: 4 affected / 5 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Prelisted Systemic Reactions
Frequency: 2 affected / 5 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Prelisted Systemic Reactions
Frequency: 3 affected / 5 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Prelisted Systemic Reactions
Frequency: 3 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Prelisted Systemic Reactions
Frequency: 3 affected / 5 at risk

Adverse event: influenza-like illness
Serious: no
Organ System: General disorders
Notes: Prelisted Systemic Reactions
Frequency: 4 affected / 5 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Prelisted Systemic Reactions
Frequency: 4 affected / 5 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Prelisted Systemic Reactions
Frequency: 2 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Prelisted Systemic Reactions
Frequency: 3 affected / 5 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Notes: Prelisted Systemic Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Localized oedema
Serious: no
Organ System: General disorders
Notes: Non-Prelisted Reactions
Frequency: 2 affected / 5 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Prostate infection
Serious: no
Organ System: Infections and infestations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Elevated liver values (due to Dafalgan)
Serious: no
Organ System: Investigations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: High LDH level
Serious: no
Organ System: Investigations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Metastatic malignant melanoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Non-Prelisted Reactions
Frequency: 3 affected / 5 at risk

Adverse event: Metastasis skin
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Liver hemangiomas
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Neoplasms benign, malignant and unspecified-subcutaneous nodule
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Non-Prelisted Reactions
Frequency: 2 affected / 5 at risk

Adverse event: Brain oedema
Serious: no
Organ System: Nervous system disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Muscle spasticity
Serious: no
Organ System: Nervous system disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Nervous Descompensation
Serious: no
Organ System: Nervous system disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Sensitivity impairment
Serious: no
Organ System: Nervous system disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Itching/Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Keratosis lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Purpura
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Skin depigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Skin hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Motor skills decrease after brain surgery
Serious: no
Organ System: Surgical and medical procedures
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Surgical and medical procedures
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Broken foot toe
Serious: no
Organ System: Surgical and medical procedures
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Non-Prelisted Reactions
Frequency: 2 affected / 5 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Notes: Non-Prelisted Reactions
Frequency: 2 affected / 5 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Vascular disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 5 at risk

Adverse event: Post procedural infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Regional chemotherapy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 10 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Confusional state/ Dysarthria
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local Reactions
Frequency: 9 affected / 10 at risk

Adverse event: Injection site induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local Reactions
Frequency: 10 affected / 10 at risk

Adverse event: Injection site pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local Reactions
Frequency: 10 affected / 10 at risk

Adverse event: Injection site recall reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local Reactions
Frequency: 5 affected / 10 at risk

Adverse event: Injection site warmth
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local Reactions
Frequency: 8 affected / 10 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Prelisted Systemic Reactions
Frequency: 4 affected / 10 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Notes: Prelisted Systemic Reactions
Frequency: 2 affected / 10 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Prelisted Systemic Reactions
Frequency: 7 affected / 10 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Prelisted Systemic Reactions
Frequency: 7 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Prelisted Systemic Reactions
Frequency: 7 affected / 10 at risk

Adverse event: influenza-like illness
Serious: no
Organ System: General disorders
Notes: Prelisted Systemic Reactions
Frequency: 3 affected / 10 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Prelisted Systemic Reactions
Frequency: 4 affected / 10 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Prelisted Systemic Reactions
Frequency: 6 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Prelisted Systemic Reactions
Frequency: 6 affected / 10 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Notes: Prelisted Systemic Reactions
Frequency: 2 affected / 10 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Tachycardi
Serious: no
Organ System: Cardiac disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Prelisted Reactions
Frequency: 2 affected / 10 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Inguinal hernia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Odynosphagia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Prelisted Reactions
Frequency: 4 affected / 10 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Infusion site extravasation
Serious: no
Organ System: General disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Erysipelas
Serious: no
Organ System: Infections and infestations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Infection inguinal scar
Serious: no
Organ System: Infections and infestations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Post-operative infection
Serious: no
Organ System: Infections and infestations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Immune system disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Elevated CK
Serious: no
Organ System: Investigations
Notes: Non-Prelisted Reactions
Frequency: 2 affected / 10 at risk

Adverse event: Karnofsky scale worsened
Serious: no
Organ System: Investigations
Notes: Non-Prelisted Reactions
Frequency: 6 affected / 10 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Non-Prelisted Reactions
Frequency: 2 affected / 10 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 2 affected / 10 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Malignant melanoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Non-Prelisted Reactions
Frequency: 2 affected / 10 at risk

Adverse event: Inguinal adenophathy
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Non-Prelisted Reactions
Frequency: 3 affected / 10 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Sensitivity impairment
Serious: no
Organ System: Nervous system disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Renal colic
Serious: no
Organ System: Renal and urinary disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Menstruation irregular
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Dermohypodermitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Difficult cicatrization
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 2 affected / 10 at risk

Adverse event: Pain scar
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Lymphadenectomy
Serious: no
Organ System: Surgical and medical procedures
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Metastasis resection
Serious: no
Organ System: Surgical and medical procedures
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Surgical and medical procedures
Notes: Non-Prelisted Reactions
Frequency: 2 affected / 10 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 10 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local Reactions
Frequency: 9 affected / 9 at risk

Adverse event: Injection site induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local Reactions
Frequency: 9 affected / 9 at risk

Adverse event: Injection site pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local Reactions
Frequency: 7 affected / 9 at risk

Adverse event: Injection site recall reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local Reactions
Frequency: 4 affected / 9 at risk

Adverse event: Injection site warmth
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local Reactions
Frequency: 6 affected / 9 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Prelisted Systemic Reactions
Frequency: 5 affected / 9 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Notes: Prelisted Systemic Reactions
Frequency: 4 affected / 9 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Prelisted Systemic Reactions
Frequency: 5 affected / 9 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Prelisted Systemic Reactions
Frequency: 3 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Prelisted Systemic Reactions
Frequency: 5 affected / 9 at risk

Adverse event: influenza-like illness
Serious: no
Organ System: General disorders
Notes: Prelisted Systemic Reactions
Frequency: 2 affected / 9 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Prelisted Systemic Reactions
Frequency: 1 affected / 9 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Prelisted Systemic Reactions
Frequency: 5 affected / 9 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Prelisted Systemic Reactions
Frequency: 4 affected / 9 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Notes: Prelisted Systemic Reactions
Frequency: 4 affected / 9 at risk

Adverse event: Tachycardi
Serious: no
Organ System: Cardiac disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 9 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Notes: Non-Prelisted Reactions
Frequency: 2 affected / 9 at risk

Adverse event: Eyelid oedema
Serious: no
Organ System: Eye disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 9 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Prelisted Reactions
Frequency: 2 affected / 9 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Prelisted Reactions
Frequency: 2 affected / 9 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Prelisted Reactions
Frequency: 5 affected / 9 at risk

Adverse event: Glossitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 9 at risk

Adverse event: Hyperaesthesia teeth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 9 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 9 at risk

Adverse event: Discomfort
Serious: no
Organ System: General disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 9 at risk

Adverse event: Fatigue
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-Prelisted Reactions
Frequency: 5 affected / 9 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 9 at risk

Adverse event: Infusion site extravasation
Serious: no
Organ System: General disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 9 at risk

Adverse event: Hepatic cysts
Serious: no
Organ System: Hepatobiliary disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 9 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 9 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 9 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 9 at risk

Adverse event: High ALP level
Serious: no
Organ System: Investigations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 9 at risk

Adverse event: High LDH level
Serious: no
Organ System: Investigations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 9 at risk

Adverse event: High C-Reactive Protein
Serious: no
Organ System: Investigations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 9 at risk

Adverse event: Increased of liver enzymes values
Serious: no
Organ System: Investigations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 9 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 9 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Non-Prelisted Reactions
Frequency: 2 affected / 9 at risk

Adverse event: Metastasis skin
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 9 at risk

Adverse event: Renal cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 9 at risk

Adverse event: Cysts
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 9 at risk

Adverse event: Carpal tunnel symdrome
Serious: no
Organ System: Nervous system disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 9 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 9 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 9 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Non-Prelisted Reactions
Frequency: 2 affected / 9 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 9 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 9 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Non-Prelisted Reactions
Frequency: 2 affected / 9 at risk

Adverse event: Macular skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 9 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 9 at risk

Adverse event: Skin exfoliation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-Prelisted Reactions
Frequency: 3 affected / 9 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Notes: Non-Prelisted Reactions
Frequency: 3 affected / 9 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 9 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Vascular disorders
Notes: Non-Prelisted Reactions
Frequency: 1 affected / 9 at risk