Study: NCT00290498

Adverse event: ABDOMINAL CRAMPING
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: ALKALINE PHOSPHATASE INCR
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 49 at risk

Adverse event: ALLERGIC REACTION DRUG
Serious: yes
Organ System: Immune system disorders
Frequency: 10 affected / 49 at risk

Adverse event: Rhinitis allergic
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 49 at risk

Adverse event: ALLERGY (OTHER)
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Alopecia
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 49 at risk

Adverse event: ALT,SGPT INCR
Serious: yes
Organ System: Investigations
Frequency: 17 affected / 49 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 49 at risk

Adverse event: AST,SGOT INCR
Serious: yes
Organ System: Investigations
Frequency: 17 affected / 49 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 49 at risk

Adverse event: AUDITORY/EAR (OTHER)
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 49 at risk

Adverse event: AUTOIMMUNE REACTION
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 49 at risk

Adverse event: BILIRUBIN INCREASE
Serious: yes
Organ System: Investigations
Frequency: 9 affected / 49 at risk

Adverse event: BLOOD BONE MARROW (OTHER)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: BRUISING (NON-THROMBOPENIA)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 49 at risk

Adverse event: Candida infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 49 at risk

Adverse event: CHOLESTEROL,SERUM-HIGH
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 49 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 49 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 49 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 49 at risk

Adverse event: CREATININE INCREASE
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 49 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 49 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 49 at risk

Adverse event: DERMATOLOGY/SKIN (OTHER)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 49 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 49 at risk

Adverse event: DISTENSION/BLOATING
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 14 affected / 49 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Dry eye
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 49 at risk

Adverse event: Dry mouth
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: Dry skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 49 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 49 at risk

Adverse event: Dysuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 49 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 49 at risk

Adverse event: EDEMA:HEAD AND NECK
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 49 at risk

Adverse event: EDEMA:LIMB
Serious: yes
Organ System: General disorders
Frequency: 13 affected / 49 at risk

Adverse event: EDEMA:TRUNK/GENITAL
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 49 at risk

Adverse event: EDEMA (LARYNX)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: ELEV LDH (OTHER)
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 49 at risk

Adverse event: ENDOCRINE (OTHER)
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 49 at risk

Adverse event: Erythema multiforme
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 49 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 31 affected / 49 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 27 affected / 49 at risk

Adverse event: FEVER UNKNOWN ORIGIN
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 49 at risk

Adverse event: FEVER WITHOUT NEUTROPENI
Serious: yes
Organ System: General disorders
Frequency: 14 affected / 49 at risk

Adverse event: FLU-LIKE SYNDROME
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Flushing
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 49 at risk

Adverse event: GAIT/WALKING
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 49 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: GASTROINTESTINAL (OTHER)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: HAND-FOOT SYNDROME
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 49 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 49 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 49 at risk

Adverse event: HEMOGLOBIN DECREASE
Serious: yes
Organ System: Investigations
Frequency: 48 affected / 49 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 49 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 49 at risk

Adverse event: Hot flush
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 49 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Investigations
Frequency: 25 affected / 49 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 49 at risk

Adverse event: HYPERPIGMENTATION
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 49 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 49 at risk

Adverse event: Hyperuricaemia
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 49 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Investigations
Frequency: 27 affected / 49 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Investigations
Frequency: 15 affected / 49 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 49 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Investigations
Frequency: 15 affected / 49 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Investigations
Frequency: 14 affected / 49 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 49 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 49 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 49 at risk

Adverse event: Hypothyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 49 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: INFECTION(S)
Serious: yes
Organ System: Infections and infestations
Frequency: 47 affected / 49 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 12 affected / 49 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Investigations
Frequency: 48 affected / 49 at risk

Adverse event: Memory impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Heavy menstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 49 at risk

Adverse event: METABOLIC/LABORATORY (OTHER)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 49 at risk

Adverse event: MOOD ALTERATION
Serious: yes
Organ System: Psychiatric disorders
Frequency: 16 affected / 49 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 49 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 49 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 49 at risk

Adverse event: Myositis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 49 at risk

Adverse event: NEUROPATHY:MOTOR
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 49 at risk

Adverse event: NEUROPATHY:SENSORY
Serious: yes
Organ System: Nervous system disorders
Frequency: 20 affected / 49 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Investigations
Frequency: 46 affected / 49 at risk

Adverse event: Obesity
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 49 at risk

Adverse event: OBSTRUCTION,GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: OCULAR/VISUAL(OTHER)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 49 at risk

Adverse event: Oliguria
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 49 at risk

Adverse event: PAIN (ABDOMEN NOS)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 49 at risk

Adverse event: PAIN (BACK)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 49 at risk

Adverse event: PAIN (BONE)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 49 at risk

Adverse event: PAIN (BREAST)
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 49 at risk

Adverse event: PAIN (CHEST/THORAX)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 49 at risk

Adverse event: PAIN (DENTAL/TEETH/PERID
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 49 at risk

Adverse event: PAIN (EXTREMITY-LIMB)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 49 at risk

Adverse event: PAIN (EYE)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 49 at risk

Adverse event: PAIN( HEAD/HEADACHE)
Serious: yes
Organ System: Nervous system disorders
Frequency: 22 affected / 49 at risk

Adverse event: PAIN (JOINT)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 49 at risk

Adverse event: PAIN (MUSCLE)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 49 at risk

Adverse event: PAIN (NECK)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 49 at risk

Adverse event: PAIN (NEURALGIA/PERIPHERALNER
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 49 at risk

Adverse event: PAIN (NOS)
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 49 at risk

Adverse event: PAIN( ORALCAVITY)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: PAIN (PELVIS)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: PAIN( STOMACH)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: PAIN (TESTICLE)
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 49 at risk

Adverse event: PAIN (THROAT/PHARYNX/LARYNX)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: PAIN (VAGINA)
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 49 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Petechiae
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 49 at risk

Adverse event: Phlebitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 39 affected / 49 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 49 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Polyuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 49 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 49 at risk

Adverse event: PRURITUS/ITCHING
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: PULMONARY(OTHER)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: RASH/DESQUAMATION
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 49 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 49 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Rhinorrhoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 49 at risk

Adverse event: RIGORS/CHILLS
Serious: yes
Organ System: General disorders
Frequency: 18 affected / 49 at risk

Adverse event: SENSORY
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 49 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 49 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 49 at risk

Adverse event: Oropharyngeal pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: Hyperhidrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 49 at risk

Adverse event: SYNCOPE (FAINTING)
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 49 at risk

Adverse event: SYNDROMES (OTHER)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 49 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 49 at risk

Adverse event: Taste disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: TEETH
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 49 at risk

Adverse event: THROMBOSIS/THROMBUS/EMBOLISM
Serious: yes
Organ System: Vascular disorders
Frequency: 12 affected / 49 at risk

Adverse event: Tinnitus
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 49 at risk

Adverse event: Ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: UPPER RESPIRATORY INFECT
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Pollakiuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 49 at risk

Adverse event: Vulvovaginal dryness
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 49 at risk

Adverse event: VASCULAR (OTHER)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 49 at risk

Adverse event: VOICE CHANGES
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 49 at risk

Adverse event: WATERY EYE
Serious: yes
Organ System: Eye disorders
Frequency: 4 affected / 49 at risk

Adverse event: Weight increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 49 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 49 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 46 affected / 49 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 39 affected / 49 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 49 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 49 at risk

Adverse event: Thrombosis/Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 49 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 49 at risk

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

Adverse event: ALKALINE PHOSPHATASE INCR
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: ALLERGIC REACTION DRUG
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Rhinitis allergic
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 10 at risk

Adverse event: ALLERGY (OTHER)
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Alopecia
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 10 at risk

Adverse event: ALT,SGPT INCR
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 10 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: AST,SGOT INCR
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Vision blurred
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 10 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 10 at risk

Adverse event: CREATININE INCREASE
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 10 at risk

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

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 10 at risk

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

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 10 at risk

Adverse event: EDEMA:LIMB
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 10 at risk

Adverse event: ELEV LDH (OTHER)
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 10 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 10 at risk

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

Adverse event: FEVER WITHOUT NEUTROPENI
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 10 at risk

Adverse event: FLU-LIKE SYNDROME
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: GASTROINTESTINAL (OTHER)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Granulocytopenia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 10 at risk

Adverse event: HEMOGLOBIN DECREASE
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 10 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: HORSENESS
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 10 at risk

Adverse event: Hyperuricaemia
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 10 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 10 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 10 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 10 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 10 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: INFECTION(S)
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 10 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 10 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 10 at risk

Adverse event: METABOLIC/LABORATORY (OTHER)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: MOOD ALTERATION
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 10 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 10 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 10 at risk

Adverse event: NEUROPATHY:MOTOR
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 10 at risk

Adverse event: NEUROPATHY:SENSORY
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 10 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 10 at risk

Adverse event: PAIN (ABDOMEN NOS)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: PAIN (ANUS)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: PAIN (BACK)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: PAIN (BONE)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: PAIN (DENTAL/TEETH/PERID
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: PAIN( HEAD/HEADACHE)
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 10 at risk

Adverse event: PAIN (MUSCLE)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: PAIN (NOS)
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: PAIN (PLEURITIC)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 10 at risk

Adverse event: PULMONARY(OTHER)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: RASH/DESQUAMATION
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 10 at risk

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

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

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Hyperhidrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: THROMBOSIS/THROMBUS/EMBOLISM
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: VASCULAR (OTHER)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 10 at risk

Adverse event: VOICE CHANGES
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 10 at risk

Adverse event: WATERY EYE
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 10 at risk

Adverse event: Weight increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 10 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 10 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 10 at risk

Adverse event: Thrombosis/Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 10 at risk