Study: NCT00454571

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 18 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 18 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 18 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: A disorder characterized by an reduction in the amount of hemoglobin in 100 ml of blood.
Frequency: 4 affected / 18 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Notes: A disorder characterized by noise in the ears, such as ringing, buzzing, roaring or clicking.
Frequency: 1 affected / 18 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: A disorder characterized by visual perception of unclear or fuzzy images.
Frequency: 1 affected / 18 at risk

Adverse event: Eye disorders - Other
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 18 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by a sensation of marked discomfort in the abdominal region.
Frequency: 2 affected / 18 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by irregular and infrequent or difficult evacuation of the bowels.
Frequency: 2 affected / 18 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by frequent and watery bowel movements.
Frequency: 12 affected / 18 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by an uncomfortable, often painful feeling in the stomach, resulting from impaired digestion. Symptoms include burning stomach, bloating, heartburn, nausea and vomiting.
Frequency: 3 affected / 18 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by inflammation of the esophageal wall.
Frequency: 1 affected / 18 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by a state of excessive gas in the alimentary canal.
Frequency: 2 affected / 18 at risk

Adverse event: Gastrointestinal disorders - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by the presence of dilated veins in the rectum and surrounding area.
Frequency: 1 affected / 18 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by inflammation of the oral mucosal.
Frequency: 1 affected / 18 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by a queasy sensation and/or the urge to vomit.
Frequency: 3 affected / 18 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by a sensation of marked discomfort in the mouth, tongue or lips.
Frequency: 1 affected / 18 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by a sensation of marked discomfort in the stomach.
Frequency: 1 affected / 18 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by the reflexive act of ejecting the contents of the stomach through the mouth.
Frequency: 1 affected / 18 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Notes: A disorder characterized by swelling due to excessive fluid accumulation in facial tissues.
Frequency: 1 affected / 18 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: A disorder characterized by a state of generalized weakness with a pronounced inability to summon sufficient energy to accomplish daily activities.
Frequency: 9 affected / 18 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: A disorder characterized by the sensation of marked discomfort, distress or agony.
Frequency: 3 affected / 18 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: A finding based on laboratory test results that indicate an increase in the level of alanine aminotransferase (ALT or SGPT) in the blood specimen.
Frequency: 7 affected / 18 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Notes: A finding based on laboratory test results that indicate an increase in the level of alkaline phosphatase in a blood specimen.
Frequency: 1 affected / 18 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: A finding based on laboratory test results that indicate an increase in the level of aspartate aminotransferase (AST or SGOT) in a blood specimen.
Frequency: 8 affected / 18 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Notes: A finding based on laboratory test results that indicate an abnormally high level of bilirubin in the blood. Excess bilirubin is associated with jaundice.
Frequency: 1 affected / 18 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: A finding based on laboratory test results that indicate increased levels of creatinine in a biological specimen.
Frequency: 1 affected / 18 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: A finding based on laboratory test results that indicate a decrease in number of lymphocytes in a blood specimen.
Frequency: 2 affected / 18 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: A finding based on laboratory test results that indicate a decrease in number of platelets in a blood specimen.
Frequency: 3 affected / 18 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: A finding characterized by a decrease in overall body weight; for pediatrics, less than the baseline growth curve.
Frequency: 3 affected / 18 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: A finding based on laboratory test results that indicate an decrease in number of white blood cells in a blood specimen.
Frequency: 2 affected / 18 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: A disorder characterized by a loss of appetite.
Frequency: 4 affected / 18 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: A disorder characterized by laboratory test results that indicate an elevation in the concentration of blood sugar. It is usually an indication of diabetes mellitus or glucose intolerance.
Frequency: 4 affected / 18 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: A disorder characterized by laboratory test results that indicate an elevation in the concentration of potassium in the blood; associated with kidney failure or sometimes with the use of diuretic drugs.
Frequency: 1 affected / 18 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: A disorder characterized by laboratory test results that indicate a low concentration of albumin in the blood.
Frequency: 3 affected / 18 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: A disorder characterized by laboratory test results that indicate a low concentration of glucose in the blood.
Frequency: 1 affected / 18 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: A disorder characterized by laboratory test results that indicate a low concentration of magnesium in the blood.
Frequency: 1 affected / 18 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: A disorder characterized by laboratory test results that indicate a low concentration of sodium in the blood.
Frequency: 2 affected / 18 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: A disorder characterized by laboratory test results that indicate a low concentration of phosphates in the blood.
Frequency: 2 affected / 18 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: A disorder characterized by a sensation of marked discomfort in a joint.
Frequency: 1 affected / 18 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: A disorder characterized by marked discomfort sensation in the back region.
Frequency: 1 affected / 18 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: A disorder characterized by marked discomfort sensation in the chest wall region.
Frequency: 1 affected / 18 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: A disorder characterized by a disturbing sensation of lightheadedness, unsteadiness, giddiness, spinning or rocking.
Frequency: 1 affected / 18 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: A disorder characterized by abnormal sensual experience with the taste of foodstuffs; it can be related to a decrease in the sense of smell.
Frequency: 3 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: A disorder characterized by a sensation of marked discomfort in various parts of the head, not confined to the area of distribution of any nerve.
Frequency: 4 affected / 18 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Notes: A disorder characterized by a deterioration in memory function.
Frequency: 1 affected / 18 at risk

Adverse event: Nervous system disorders - Other
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: A disorder characterized by inflammation or degeneration of the peripheral sensory nerves.
Frequency: 1 affected / 18 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: A disorder characterized by apprehension of danger and dread accompanied by restlessness, tension, tachycardia, and dyspnea unattached to a clearly identifiable stimulus.
Frequency: 1 affected / 18 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Notes: A disorder characterized by laboratory test results that indicate the presence of excessive protein in the urine. It is predominantly albumin, but also globulin.
Frequency: 1 affected / 18 at risk

Adverse event: Renal and urinary disorders - Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: A disorder characterized by urination at short intervals.
Frequency: 2 affected / 18 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Notes: A disorder characterized by inability to control the flow of urine from the bladder.
Frequency: 2 affected / 18 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A disorder characterized by an inflammation of the nasal mucous membranes caused by an IgE-mediated response to external allergens.
Frequency: 1 affected / 18 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A disorder characterized by sudden, often repetitive, spasmodic contraction of the thoracic cavity, resulting in violent release of air from the lungs and usually accompanied by a distinctive sound.
Frequency: 1 affected / 18 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A disorder characterized by an uncomfortable sensation of difficulty breathing.
Frequency: 4 affected / 18 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: A disorder characterized by a decrease in density of hair compared to normal for a given individual at a given age and body location.
Frequency: 3 affected / 18 at risk

Adverse event: Photosensitivity reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: A disorder characterized by an increase in sensitivity of the skin to light.
Frequency: 1 affected / 18 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: A disorder characterized by an intense itching sensation.
Frequency: 1 affected / 18 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 18 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: A disorder characterized by circumscribed, inflammatory and necrotic erosive lesion on the skin.
Frequency: 1 affected / 18 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Notes: A disorder characterized by an uncomfortable and temporary sensation of intense body warmth, flushing, sometimes accompanied by sweating upon cooling.
Frequency: 3 affected / 18 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: A disorder characterized by a pathological increase in blood pressure; a repeatedly elevation in the blood pressure exceeding 140 over 90 mm Hg.
Frequency: 9 affected / 18 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: A disorder characterized by a blood pressure that is below the normal expected for an individual in a given environment.
Frequency: 1 affected / 18 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by irregular and infrequent or difficult evacuation of the bowels.
Frequency: 1 affected / 19 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: A disorder characterized by the sensation of marked discomfort, distress or agony.
Frequency: 1 affected / 19 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Notes: A finding characterized by an increase in overall body weight; for pediatrics, greater than the baseline growth curve.
Frequency: 1 affected / 19 at risk

Adverse event: Musculoskeletal and connective tissue disorder - Other, specify
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Libido decreased
Serious: no
Organ System: Psychiatric disorders
Notes: A disorder characterized by a decrease in sexual desire.
Frequency: 1 affected / 19 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Notes: A disorder characterized by inability to control the flow of urine from the bladder.
Frequency: 1 affected / 19 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Notes: A disorder characterized by an uncomfortable and temporary sensation of intense body warmth, flushing, sometimes accompanied by sweating upon cooling.
Frequency: 1 affected / 19 at risk