Study: NCT00176488

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 31 at risk

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

Adverse event: Fatigue (lethargy, malaise, asthenia)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Stomatitis/pharyngitis (oral/pharyngeal mucositis)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
Serious: yes
Organ System: General disorders
Frequency: 12 affected / 31 at risk

Adverse event: Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC <1.0 x 10e
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Infection without neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

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

Adverse event: Pulmonary-Other (Specify, malignant pleural effusion)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Other Toxicity - Bilateral Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 31 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 31 at risk

Adverse event: Dermatology/Skin-Other (Specify,_____)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 31 at risk

Adverse event: Bruising (in absence of grade 3 or 4 thrombocytopenia)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 31 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 31 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 31 at risk

Adverse event: Stomatitis/pharyngitis (oral/pharyngeal mucositis)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 31 at risk

Adverse event: Taste disturbance (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 31 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 31 at risk

Adverse event: Dyspepsia/heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 31 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 31 at risk

Adverse event: Diarrhea patients without colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 31 at risk

Adverse event: Gastrointestinal-Other (Specify,_____)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 31 at risk

Adverse event: Dysphagia, esophagitis, odynophagia (painful swallowing)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Fatigue (lethargy, malaise, asthenia)
Serious: no
Organ System: General disorders
Frequency: 25 affected / 31 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
Serious: no
Organ System: General disorders
Frequency: 7 affected / 31 at risk

Adverse event: Pain-Other (Specify,___)
Serious: no
Organ System: General disorders
Frequency: 18 affected / 31 at risk

Adverse event: Bone pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 31 at risk

Adverse event: Myalgia (muscle pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 31 at risk

Adverse event: Abdominal pain or cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Arthralgia (joint pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 31 at risk

Adverse event: Chest pain (non-cardiac and non-pleuritic)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 31 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 31 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 31 at risk

Adverse event: Blood/Bone Marrow-Other (Specify,_____)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 31 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 31 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 31 at risk

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

Adverse event: Mood alteration-anxiety, agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 31 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 31 at risk

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

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 6 affected / 31 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 6 affected / 31 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 31 at risk

Adverse event: Metabolic/Laboratory-Other (Specify,_____)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 31 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 31 at risk

Adverse event: Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
Serious: no
Organ System: General disorders
Frequency: 9 affected / 31 at risk

Adverse event: Infection without neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 31 at risk

Adverse event: Oedema
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 31 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 31 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 31 at risk

Adverse event: SGOT (AST) (serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 31 at risk

Adverse event: SGPT (ALT) (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 31 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 31 at risk

Adverse event: Tearing (watery eyes)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 31 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 31 at risk

Adverse event: Hemorrhage-Other (Specify,_____)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 31 at risk