Study: NCT00546377

Adverse event: Allerg react/hypersens (incl drug fever)
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Allerg rhinitis (w sneez, nas stuff, postnas drip)
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Dermatology/Skin, other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Dysphagia (Difficulty swallowing)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 43 at risk

Adverse event: Fever (in the absence of neutropenia)
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 43 at risk

Adverse event: Hot flashes/flushes
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 43 at risk

Adverse event: Incontinence, urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 43 at risk

Adverse event: Inf norm ANC/gr1/2 neut-Pneumonia(lung)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 43 at risk

Adverse event: Infection w/ Gr 3/4 neut, Colon
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: Infection w/ Gr 3/4 neut, Sinus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: Infection w/ Gr 3/4 neut, Skin (cellulites)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: Infection, other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: Muscle weakness - Whole body/general
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 43 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Pain - Abdomen NOS
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 43 at risk

Adverse event: Pain - Head/headache
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 43 at risk

Adverse event: Pain - Neck
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 43 at risk

Adverse event: Pain - Pelvis
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 43 at risk

Adverse event: Pain - Throat/pharynx/larynx
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 43 at risk

Adverse event: Sweating (diaphoresis)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Vasovagal episode
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 43 at risk

Adverse event: Vision-photophobia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 43 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 43 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 43 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 43 at risk

Adverse event: Albumin, low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 43 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 43 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 43 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 43 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 43 at risk

Adverse event: Fever (in the absence of neutropenia)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 43 at risk

Adverse event: Glucose, high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 31 affected / 43 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 31 affected / 43 at risk

Adverse event: International normalised ratio
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 43 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 31 affected / 43 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 28 affected / 43 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 43 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 31 affected / 43 at risk

Adverse event: Phosphate, low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 43 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 43 at risk

Adverse event: Potassium, high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 43 at risk

Adverse event: Potassium, low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 43 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 43 at risk