Study: NCT02490475

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 6 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 6 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Glossitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 6 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Extravasation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Ageusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 6 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Skin disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 6 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 6 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Nasal mucosal disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 6 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 6 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 6 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2 at risk

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

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

Adverse event: Tongue ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Extravasation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Suprapubic pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 2 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 6 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 6 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

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

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 6 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 6 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 6 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 6 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Rash follicular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Eye infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 6 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 6 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 6 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 6 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 6 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 6 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Lymph node pain
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Ventricular disfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

Adverse event: Gential Haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 5 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 5 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Anal fissure
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

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

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 5 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 5 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 5 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Drug eruption
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Periorbital oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 5 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

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

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 5 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Limb discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 5 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 5 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 5 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 5 at risk

Adverse event: Cancer pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 5 at risk