Study: NCT00462865

Adverse event: Left ventricular dysfunction (3)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: infection normal ANC (3)
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 17 at risk

Adverse event: pneumonia (3)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: anxiety, distress, diarrhea, headache, dehydration, dizziness, bilateral SOB
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: abdominal distress/pain
Serious: no
Organ System: Investigations
Frequency: 2 affected / 17 at risk

Adverse event: Agitation
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Blood albumin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 5 affected / 17 at risk

Adverse event: Alopecia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 17 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Investigations
Frequency: 9 affected / 17 at risk

Adverse event: ANC
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Anaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Investigations
Frequency: 3 affected / 17 at risk

Adverse event: anxiety/panic attack
Serious: no
Organ System: Investigations
Frequency: 2 affected / 17 at risk

Adverse event: arthraglias
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Investigations
Frequency: 10 affected / 17 at risk

Adverse event: Bili
Serious: no
Organ System: Investigations
Frequency: 2 affected / 17 at risk

Adverse event: bleeding gums
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: bloat
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Blood calcium
Serious: no
Organ System: Investigations
Frequency: 2 affected / 17 at risk

Adverse event: Constipation
Serious: no
Organ System: Investigations
Frequency: 6 affected / 17 at risk

Adverse event: Cough
Serious: no
Organ System: Investigations
Frequency: 2 affected / 17 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 2 affected / 17 at risk

Adverse event: Dehydration
Serious: no
Organ System: Investigations
Frequency: 2 affected / 17 at risk

Adverse event: diabetic issue
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Investigations
Frequency: 4 affected / 17 at risk

Adverse event: Dizziness
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Dry skin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: dysgeuisa
Serious: no
Organ System: Investigations
Frequency: 4 affected / 17 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Oedema
Serious: no
Organ System: Investigations
Frequency: 5 affected / 17 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Erythema
Serious: no
Organ System: Investigations
Frequency: 2 affected / 17 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Fatigue
Serious: no
Organ System: Investigations
Frequency: 12 affected / 17 at risk

Adverse event: Fibromyalgia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Genital lesion
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: GI other
Serious: no
Organ System: Investigations
Frequency: 2 affected / 17 at risk

Adverse event: Blood glucose
Serious: no
Organ System: Investigations
Frequency: 2 affected / 17 at risk

Adverse event: hand and foot
Serious: no
Organ System: Investigations
Frequency: 7 affected / 17 at risk

Adverse event: hemmarhoids
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Hgb
Serious: no
Organ System: Investigations
Frequency: 4 affected / 17 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: hot flash
Serious: no
Organ System: Investigations
Frequency: 2 affected / 17 at risk

Adverse event: HTN
Serious: no
Organ System: Investigations
Frequency: 7 affected / 17 at risk

Adverse event: hyperbilrubemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: hyperpigmentation
Serious: no
Organ System: Investigations
Frequency: 2 affected / 17 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Hypotension
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: infection normal ANC
Serious: no
Organ System: Investigations
Frequency: 4 affected / 17 at risk

Adverse event: Insomnia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 17 at risk

Adverse event: Blood potassium
Serious: no
Organ System: Investigations
Frequency: 2 affected / 17 at risk

Adverse event: Blood lactate dehydrogenase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: left nostril pain
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Liver function test
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Blindness
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Mg
Serious: no
Organ System: Investigations
Frequency: 6 affected / 17 at risk

Adverse event: mood alteration
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: mouth sores
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Investigations
Frequency: 4 affected / 17 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Nasal dryness
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Nausea
Serious: no
Organ System: Investigations
Frequency: 7 affected / 17 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Investigations
Frequency: 6 affected / 17 at risk

Adverse event: pain- muscosk
Serious: no
Organ System: Investigations
Frequency: 14 affected / 17 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Investigations
Frequency: 2 affected / 17 at risk

Adverse event: Phos
Serious: no
Organ System: Investigations
Frequency: 2 affected / 17 at risk

Adverse event: Plts
Serious: no
Organ System: Investigations
Frequency: 3 affected / 17 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Pruritus
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Rash
Serious: no
Organ System: Investigations
Frequency: 3 affected / 17 at risk

Adverse event: rectal bleed/pain
Serious: no
Organ System: Investigations
Frequency: 3 affected / 17 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Investigations
Frequency: 2 affected / 17 at risk

Adverse event: Chills
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: scalp blisters
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Investigations
Frequency: 2 affected / 17 at risk

Adverse event: somolence
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Tremor
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Blood uric acid
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Urine Protein
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: vomitting
Serious: no
Organ System: Investigations
Frequency: 5 affected / 17 at risk

Adverse event: White blood cell count
Serious: no
Organ System: Investigations
Frequency: 5 affected / 17 at risk

Adverse event: wound healing delay
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk