Study: NCT00312208

Adverse event: Abdominal Syndrom Acute
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 1634 at risk

Adverse event: Alopecia
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 1634 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 1634 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1634 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1634 at risk

Adverse event: Arteriosclerosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1634 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 1634 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 1634 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1634 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 1634 at risk

Adverse event: Coagulation disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1634 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Deafness
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 1634 at risk

Adverse event: Delusion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Depression
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1634 at risk

Adverse event: Derm Exfoliating
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 1634 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 1634 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 1634 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 1634 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Affect lability
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Erythema Multiform
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Fever (including serious febrile neutropenia)
Serious: yes
Organ System: General disorders
Frequency: 122 affected / 1634 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Heart Failure Left
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1634 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1634 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1634 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1634 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Infection (including neutropenic infection)
Serious: yes
Organ System: Infections and infestations
Frequency: 86 affected / 1634 at risk

Adverse event: Injection site reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Injury Accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1634 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1634 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 1634 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Menstrual disorder
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 1634 at risk

Adverse event: Myopathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Nail disorder
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 1634 at risk

Adverse event: Uterine neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1634 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 1634 at risk

Adverse event: Skin mass
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1634 at risk

Adverse event: Osteoporosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1634 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Biliary colic
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1634 at risk

Adverse event: Papilloedema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1634 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Proctitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Rash Maculopapular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Rhinitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1634 at risk

Adverse event: SGOT Increase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 1634 at risk

Adverse event: SGPT Increase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 1634 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 1634 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1634 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 14 affected / 1634 at risk

Adverse event: Tinnitus
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Uterine Fibroid Enlargement
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 1634 at risk

Adverse event: Vulvovaginitis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Weight increased
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1634 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 172 affected / 1634 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1601 affected / 1634 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: NCI severity grade was derived based on reported laboratory data
Frequency: 461 affected / 1634 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 370 affected / 1634 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 602 affected / 1634 at risk

Adverse event: Asthenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1328 affected / 1634 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 176 affected / 1634 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 599 affected / 1634 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 211 affected / 1634 at risk

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 160 affected / 1634 at risk

Adverse event: Derm exfoliating
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 143 affected / 1634 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 644 affected / 1634 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 149 affected / 1634 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 87 affected / 1634 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Nervous system disorders
Frequency: 149 affected / 1634 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 339 affected / 1634 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 83 affected / 1634 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 319 affected / 1634 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 488 affected / 1634 at risk

Adverse event: Emotion labil
Serious: no
Organ System: Nervous system disorders
Frequency: 168 affected / 1634 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 123 affected / 1634 at risk

Adverse event: Fever (including febrile neutropenia)
Serious: no
Organ System: General disorders
Frequency: 289 affected / 1634 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 433 affected / 1634 at risk

Adverse event: Infection (including neutropenic infection)
Serious: no
Organ System: Infections and infestations
Frequency: 573 affected / 1634 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 124 affected / 1634 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 334 affected / 1634 at risk

Adverse event: Lacrimation disorder
Serious: no
Organ System: Eye disorders
Frequency: 357 affected / 1634 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 59 affected / 1634 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 101 affected / 1634 at risk

Adverse event: Menses disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 489 affected / 1634 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 834 affected / 1634 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 729 affected / 1634 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1435 affected / 1634 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 723 affected / 1634 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: NCI severity grade was derived based on reported laboratory data
Frequency: 1133 affected / 1634 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 275 affected / 1634 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 256 affected / 1634 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 123 affected / 1634 at risk

Adverse event: Bone pain
Serious: no
Organ System: General disorders
Frequency: 230 affected / 1634 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 93 affected / 1634 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 82 affected / 1634 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 88 affected / 1634 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 82 affected / 1634 at risk

Adverse event: Rash maculopapular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 402 affected / 1634 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 268 affected / 1634 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 107 affected / 1634 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1035 affected / 1634 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 77 affected / 1634 at risk

Adverse event: Taste pervers
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 480 affected / 1634 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: NCI severity grade was derived based on reported laboratory data
Frequency: 52 affected / 1634 at risk

Adverse event: Vasodilatation
Serious: no
Organ System: Nervous system disorders
Frequency: 388 affected / 1634 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 907 affected / 1634 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 116 affected / 1634 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 370 affected / 1634 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 1635 at risk

Adverse event: Alopecia
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1635 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 1635 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1635 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 1635 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1635 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 1635 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1635 at risk

Adverse event: Creatinine increase
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1635 at risk

Adverse event: Cyst
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1635 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1635 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 1635 at risk

Adverse event: Depression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Derm Exfoliating
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1635 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 1635 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1635 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1635 at risk

Adverse event: Oedema
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Affect lability
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Fever (including serious febrile neutropenia)
Serious: yes
Organ System: General disorders
Frequency: 293 affected / 1635 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1635 at risk

Adverse event: Gastro-intestinal Disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1635 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Retinal haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1635 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Infection (including neutropenic infection)
Serious: yes
Organ System: Infections and infestations
Frequency: 143 affected / 1635 at risk

Adverse event: Injection site reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1635 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 56 affected / 1635 at risk

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Lymphoedema
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1635 at risk

Adverse event: Mastitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Melaena
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Intermenstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Mucosal disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1635 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 1635 at risk

Adverse event: Neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1635 at risk

Adverse event: Neuralgia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1635 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1635 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1635 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1635 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Vocal cord paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1635 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Unintended pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1635 at risk

Adverse event: Proctitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Rhinitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 1635 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1635 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 14 affected / 1635 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Urinary tract disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Vaginal infection
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1635 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 1635 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 190 affected / 1635 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1587 affected / 1635 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: NCI severity grade was derived based on reported laboratory data
Frequency: 658 affected / 1635 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 376 affected / 1635 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 382 affected / 1635 at risk

Adverse event: Asthenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1310 affected / 1635 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 131 affected / 1635 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 555 affected / 1635 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 222 affected / 1635 at risk

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 132 affected / 1635 at risk

Adverse event: Derm exfoliating
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 36 affected / 1635 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 606 affected / 1635 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 169 affected / 1635 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 65 affected / 1635 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Nervous system disorders
Frequency: 80 affected / 1635 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 387 affected / 1635 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 65 affected / 1635 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 287 affected / 1635 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 417 affected / 1635 at risk

Adverse event: Emotion labil
Serious: no
Organ System: Nervous system disorders
Frequency: 111 affected / 1635 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 72 affected / 1635 at risk

Adverse event: Fever (including febrile neutropenia)
Serious: no
Organ System: General disorders
Frequency: 467 affected / 1635 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 370 affected / 1635 at risk

Adverse event: Infection (including neutropenic infection)
Serious: no
Organ System: Infections and infestations
Frequency: 457 affected / 1635 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 92 affected / 1635 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 277 affected / 1635 at risk

Adverse event: Lacrimation disorder
Serious: no
Organ System: Eye disorders
Frequency: 212 affected / 1635 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 88 affected / 1635 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 109 affected / 1635 at risk

Adverse event: Menses disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 501 affected / 1635 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 587 affected / 1635 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 363 affected / 1635 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1334 affected / 1635 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 482 affected / 1635 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: NCI severity grade was derived based on reported laboratory data
Frequency: 1049 affected / 1635 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 235 affected / 1635 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 271 affected / 1635 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 121 affected / 1635 at risk

Adverse event: Bone pain
Serious: no
Organ System: General disorders
Frequency: 204 affected / 1635 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 76 affected / 1635 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 84 affected / 1635 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 69 affected / 1635 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 100 affected / 1635 at risk

Adverse event: Rash maculopapular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 314 affected / 1635 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 198 affected / 1635 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 85 affected / 1635 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1026 affected / 1635 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 93 affected / 1635 at risk

Adverse event: Taste pervers
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 426 affected / 1635 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: NCI severity grade was derived based on reported laboratory data
Frequency: 109 affected / 1635 at risk

Adverse event: Vasodilatation
Serious: no
Organ System: Nervous system disorders
Frequency: 437 affected / 1635 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 742 affected / 1635 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 140 affected / 1635 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 240 affected / 1635 at risk