Study: NCT01209195

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 3 affected / 10 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Onychomadesis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 9 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 5 affected / 10 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 5 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 4 affected / 10 at risk

Adverse event: Small intestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 3 affected / 10 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 2 affected / 10 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 2 affected / 10 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 2 affected / 10 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Gastrointestinal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Gingival bleeding
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Intestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Intestinal perforation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Any Relationship
Frequency: 7 affected / 10 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Notes: Any Relationship
Frequency: 2 affected / 10 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Any Relationship
Frequency: 2 affected / 10 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Notes: Any Relationship
Frequency: 2 affected / 10 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Any Relationship
Frequency: 2 affected / 10 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Any Relationship
Frequency: 2 affected / 10 at risk

Adverse event: Catheter site pain
Serious: no
Organ System: General disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Death
Serious: no
Organ System: General disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Disease progression
Serious: no
Organ System: General disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Early satiety
Serious: no
Organ System: General disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Facial pain
Serious: no
Organ System: General disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Any Relationship
Frequency: 5 affected / 10 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Any Relationship
Frequency: 5 affected / 10 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Any Relationship
Frequency: 3 affected / 10 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Notes: Any Relationship
Frequency: 2 affected / 10 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Any Relationship
Frequency: 2 affected / 10 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Nail infection
Serious: no
Organ System: Infections and infestations
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Onychomycosis
Serious: no
Organ System: Infections and infestations
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Urinary tract infection pseudomonal
Serious: no
Organ System: Infections and infestations
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 6 affected / 10 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 3 affected / 10 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 3 affected / 10 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 2 affected / 10 at risk

Adverse event: Skin hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 2 affected / 10 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Hyperkeratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Nail discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Onychalgia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Onychomadesis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Rash macular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: Any Relationship
Frequency: 4 affected / 10 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: Any Relationship
Frequency: 3 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Any Relationship
Frequency: 2 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Visual field defect
Serious: no
Organ System: Nervous system disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Any Relationship
Frequency: 5 affected / 10 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Any Relationship
Frequency: 2 affected / 10 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Any Relationship
Frequency: 2 affected / 10 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Nasal dryness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Any Relationship
Frequency: 3 affected / 10 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Any Relationship
Frequency: 3 affected / 10 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Any Relationship
Frequency: 2 affected / 10 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Any Relationship
Frequency: 2 affected / 10 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Any Relationship
Frequency: 2 affected / 10 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Any Relationship
Frequency: 2 affected / 10 at risk

Adverse event: Groin pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Any Relationship
Frequency: 2 affected / 10 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Any Relationship
Frequency: 2 affected / 10 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Bacterial test
Serious: no
Organ System: Investigations
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Haematocrit decreased
Serious: no
Organ System: Investigations
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Heart rate increased
Serious: no
Organ System: Investigations
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Skin turgor decreased
Serious: no
Organ System: Investigations
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Any Relationship
Frequency: 2 affected / 10 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Any Relationship
Frequency: 2 affected / 10 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Any Relationship
Frequency: 2 affected / 10 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Any Relationship
Frequency: 2 affected / 10 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Notes: Any Relationship
Frequency: 2 affected / 10 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Urethritis noninfective
Serious: no
Organ System: Renal and urinary disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Urinary tract pain
Serious: no
Organ System: Renal and urinary disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Any Relationship
Frequency: 2 affected / 10 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Rib fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Ear disorder
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Conjunctival irritation
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Vulvovaginal discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: Any Relationship
Frequency: 1 affected / 10 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 1 affected / 31 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 1 affected / 31 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 1 affected / 31 at risk

Adverse event: Peptic ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 1 affected / 31 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Notes: Any Relationship
Frequency: 3 affected / 31 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Any Relationship
Frequency: 1 affected / 31 at risk

Adverse event: Accidental overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Hepatic haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Any Relationship
Frequency: 1 affected / 31 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Any Relationship
Frequency: 1 affected / 31 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Any Relationship
Frequency: 1 affected / 31 at risk

Adverse event: Malignant pleural effusion
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Any Relationship
Frequency: 1 affected / 31 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: Any Relationship
Frequency: 1 affected / 31 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 7 affected / 31 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 18 affected / 31 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 9 affected / 31 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 13 affected / 31 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 8 affected / 31 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 3 affected / 31 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 8 affected / 31 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 4 affected / 31 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 5 affected / 31 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 1 affected / 31 at risk

Adverse event: Melaena
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Oral disorder
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 3 affected / 31 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 6 affected / 31 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Any Relationship
Frequency: 22 affected / 31 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Notes: Any Relationship
Frequency: 1 affected / 31 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Any Relationship
Frequency: 1 affected / 31 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Notes: Any Relationship
Frequency: 5 affected / 31 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Any Relationship
Frequency: 12 affected / 31 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Any Relationship
Frequency: 4 affected / 31 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Any Relationship
Frequency: 9 affected / 31 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Any Relationship
Frequency: 12 affected / 31 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Any Relationship
Frequency: 3 affected / 31 at risk

Adverse event: Pancytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Any Relationship
Frequency: 3 affected / 31 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Any Relationship
Frequency: 7 affected / 31 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Any Relationship
Frequency: 1 affected / 31 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Notes: Any Relationship
Frequency: 1 affected / 31 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Notes: Any Relationship
Frequency: 1 affected / 31 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Any Relationship
Frequency: 8 affected / 31 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 11 affected / 31 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 15 affected / 31 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 6 affected / 31 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 7 affected / 31 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 1 affected / 31 at risk

Adverse event: Onychalgia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 1 affected / 31 at risk

Adverse event: Onychomadesis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 1 affected / 31 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 1 affected / 31 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 1 affected / 31 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 3 affected / 31 at risk

Adverse event: Ingrowing nail
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: Any Relationship
Frequency: 22 affected / 31 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Any Relationship
Frequency: 6 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Any Relationship
Frequency: 5 affected / 31 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: Any Relationship
Frequency: 4 affected / 31 at risk

Adverse event: Dysarthria
Serious: no
Organ System: Nervous system disorders
Notes: Any Relationship
Frequency: 3 affected / 31 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Any Relationship
Frequency: 10 affected / 31 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Any Relationship
Frequency: 6 affected / 31 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Any Relationship
Frequency: 8 affected / 31 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Any Relationship
Frequency: 1 affected / 31 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Any Relationship
Frequency: 1 affected / 31 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Any Relationship
Frequency: 5 affected / 31 at risk

Adverse event: RHINORROEA
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Any Relationship
Frequency: 4 affected / 31 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Any Relationship
Frequency: 3 affected / 31 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Any Relationship
Frequency: 9 affected / 31 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Any Relationship
Frequency: 5 affected / 31 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Any Relationship
Frequency: 6 affected / 31 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Any Relationship
Frequency: 5 affected / 31 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Any Relationship
Frequency: 3 affected / 31 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Any Relationship
Frequency: 5 affected / 31 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Any Relationship
Frequency: 4 affected / 31 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Any Relationship
Frequency: 7 affected / 31 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Any Relationship
Frequency: 3 affected / 31 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Any Relationship
Frequency: 4 affected / 31 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Any Relationship
Frequency: 3 affected / 31 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Any Relationship
Frequency: 3 affected / 31 at risk

Adverse event: Bacterial test
Serious: no
Organ System: Investigations
Notes: Any Relationship
Frequency: 1 affected / 31 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: Any Relationship
Frequency: 1 affected / 31 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Any Relationship
Frequency: 1 affected / 31 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Any Relationship
Frequency: 5 affected / 31 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Notes: Any Relationship
Frequency: 4 affected / 31 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Any Relationship
Frequency: 3 affected / 31 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Notes: Any Relationship
Frequency: 3 affected / 31 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: Any Relationship
Frequency: 3 affected / 31 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Any Relationship
Frequency: 5 affected / 31 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Any Relationship
Frequency: 5 affected / 31 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Notes: Any Relationship
Frequency: 1 affected / 31 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Any Relationship
Frequency: 1 affected / 31 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Any Relationship
Frequency: 1 affected / 31 at risk

Adverse event: Accidental overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Notes: Any Relationship
Frequency: 3 affected / 31 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Notes: Any Relationship
Frequency: 2 affected / 31 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: Any Relationship
Frequency: 2 affected / 31 at risk