Study: NCT01260688

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pending Spinal Cord compression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 11 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 11 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 11 affected / 11 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 11 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 11 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 11 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 11 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 11 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 11 at risk

Adverse event: Obesity
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 11 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 11 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 11 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 11 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 11 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 11 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 11 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 2 affected / 11 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 11 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 11 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 11 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 11 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 11 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 11 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 11 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 11 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 11 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 11 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 11 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 11 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 11 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 11 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 11 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 11 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 11 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 11 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 11 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 11 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Glucose tolerance impaired
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 11 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 11 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 11 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 11 at risk

Adverse event: Ventricular Diastolic disorder
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dry throat
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Osteonecrosis of jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Ventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Anal fissure
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 11 at risk

Adverse event: Lip pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Low T3
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Dyskinesia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 11 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 11 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Impaired gastric emptying
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Low T4
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Mucosal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Palmar-Plantar Erythrodysesthesia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Bile obstruction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 11 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Disease progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 11 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 11 at risk

Adverse event: Retroperitoneal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: In Arm II (Cediranib alone), 1 patient presented retroperitoneal hemorrhage (Grade 5)
Frequency: 1 affected / 11 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 11 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 11 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 11 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 11 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 11 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 11 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 11 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 11 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 11 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 11 at risk

Adverse event: Obesity
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 11 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 11 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 11 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 11 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 11 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 11 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 11 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 11 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 11 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 4 affected / 11 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 11 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 11 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 11 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 11 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 11 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 11 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 5 affected / 11 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 11 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 11 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 11 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 11 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 11 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 11 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 11 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 11 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 11 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 11 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 11 at risk

Adverse event: Oral dysaesthesia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 11 at risk

Adverse event: Red blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Scalp dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 11 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 11 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 11 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 11 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 11 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 11 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Diminished breath sounds
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 11 at risk

Adverse event: Anal incontinence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Oedema genital
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 11 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 11 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Restless legs syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Bilateral rales
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Irregular heart rate and rhythm
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Lymphocyte count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 11 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Muscle spasticity
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Biliary obstruction
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 11 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 11 at risk

Adverse event: Disease progression
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 11 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 11 at risk

Adverse event: Glucose tolerance impaired
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 11 at risk

Adverse event: hemorrhoidal hemorhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Retroperitoneal haemorrhage
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Urinary tract obstruction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 11 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk