Study: NCT00003222

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 10 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 10 at risk

Adverse event: Dizziness/Lightheadedness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Oedema
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 10 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 10 at risk

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 10 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 10 at risk

Adverse event: Mood
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Myalgia/Arthralgia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 10 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Other PAIN
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 10 at risk

Adverse event: Rigors, Chills
Serious: no
Organ System: General disorders
Frequency: 5 affected / 10 at risk

Adverse event: SGOT/SGPT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Skin Rash/Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 10 at risk

Adverse event: Stomatitis/Pharyngitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 10 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Blood alkaline phosphatase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 27 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 27 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: General- Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Other
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 27 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 27 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 27 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 27 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 27 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 27 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 27 at risk

Adverse event: Dizziness/Lightheadedness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 27 at risk

Adverse event: Oedema
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 27 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 27 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 26 affected / 27 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 17 affected / 27 at risk

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 17 affected / 27 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 27 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 27 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 27 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 27 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 27 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 27 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 27 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 27 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Mood
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 27 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 27 at risk

Adverse event: Myalgia/Arthralgia
Serious: no
Organ System: General disorders
Frequency: 14 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 27 at risk

Adverse event: Other
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 27 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Other PAIN
Serious: no
Organ System: General disorders
Frequency: 6 affected / 27 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 27 at risk

Adverse event: Rash/Desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 27 at risk

Adverse event: Rigors, Chills
Serious: no
Organ System: General disorders
Frequency: 20 affected / 27 at risk

Adverse event: SGOT (AST)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 27 at risk

Adverse event: SGOT/SGPT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 27 at risk

Adverse event: SGPT (ALT)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 27 at risk

Adverse event: Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 27 at risk

Adverse event: Skin Rash/Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 27 at risk

Adverse event: Stomatitis/Pharyngitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 27 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 11 affected / 27 at risk

Adverse event: Voice Changes/Stridor/Larynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 27 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 27 at risk

Adverse event: Weight Gain/Loss
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk