Study: NCT00408902

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

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

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

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Blood urea
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Chest pain (non-cardiac and non-pleuritic)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 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: 2 affected / 10 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 3 affected / 10 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Diarrhea patients without colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 10 at risk

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

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

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 10 at risk

Adverse event: Oedema
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 10 at risk

Adverse event: Fatigue (lethargy, malaise, asthenia)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 10 at risk

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

Adverse event: Hearing w/o monitoring
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 10 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 10 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 10 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 10 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 10 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypouricaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 10 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Mood alteration-anxiety, agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Muscle weakness (not due to neuropathy)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 10 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 10 at risk

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

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

Adverse event: Prolonged QTc interval (QTc > 0.48 seconds)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Protein total
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

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

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

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

Adverse event: Tearing (watery eyes)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 10 at risk

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

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