Study: NCT00309946

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Abdominal distension occurs when substances, such as air (gas) or fluid, accumulate in the abdomen causing its outward expansion beyond the normal girth of the stomach and waist.
Frequency: 1 affected / 51 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Notes: Pain in the abdominal region
Frequency: 1 affected / 51 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Increased levels of alanine aminotransferase, indicative of liver damage or disease.
Frequency: 1 affected / 51 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Notes: Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death.
Frequency: 1 affected / 51 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Anorexia is the decreased sensation of appetite.
Frequency: 1 affected / 51 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Increased levels of aspartate aminotransferase (AST)
Frequency: 1 affected / 51 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Atelectasis is defined as the collapse or closure of the lung resulting in reduced or absent gas exchange.
Frequency: 1 affected / 51 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Notes: Atrial flutter (AFL) is an abnormal heart rhythm that occurs in the atria of the heart.
Frequency: 1 affected / 51 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Bronchopulmonary hemorrhage is a disorder characterized by bleeding from the bronchial wall and/or lung parenchyma.
Frequency: 1 affected / 51 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac arrest, also known as cardiopulmonary arrest or circulatory arrest, is the cessation of normal circulation of the blood due to failure of the heart to contract effectively.
Frequency: 1 affected / 51 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: General disorders
Notes: Pain in the chest wall not attributed to any cardiac disorder.
Frequency: 3 affected / 51 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Notes: A disorder characterized by a conspicuous change in cognitive function.
Frequency: 1 affected / 51 at risk

Adverse event: Conduction disorder
Serious: yes
Organ System: Cardiac disorders
Notes: Impairment of conduction in heart excitation; often applied specifically to atrioventricular heart block.
Frequency: 1 affected / 51 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Notes: Loss of orientation (ability to place oneself correctly in the world by time, location, and/or personal identity sometimes accompanied by disordered consciousness and often memory (ability to correctly recall previous events or learn new material).
Frequency: 2 affected / 51 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Constipation (also known as costiveness or dyschezia) refers to bowel movements that are infrequent or hard to pass.
Frequency: 2 affected / 51 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Increased levels of creatinine
Frequency: 1 affected / 51 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Dehydration is the excessive loss of body water
Frequency: 2 affected / 51 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Notes: A neurologic state characterized by decreased ability to perceive and respond.
Frequency: 1 affected / 51 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Condition of having three or more loose or liquid bowel movements per day
Frequency: 2 affected / 51 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Notes: Dizziness is an impairment in spatial perception and stability.
Frequency: 1 affected / 51 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dyspnea - shortness of breath.
Frequency: 7 affected / 51 at risk

Adverse event: ECG QTc interval prolonged
Serious: yes
Organ System: Cardiac disorders
Notes: Electrocardiogram QT corrected interval prolonged
Frequency: 1 affected / 51 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Notes: Syndrome of global brain dysfunction
Frequency: 1 affected / 51 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: General disorders
Notes: Insufficient weight gain or inappropriate weight loss.
Frequency: 1 affected / 51 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: Fatigue (also called exhaustion, tiredness, lethargy, languidness, languor, lassitude, and listlessness) is a subjective feeling of tiredness which is distinct from weakness, and has a gradual onset.
Frequency: 2 affected / 51 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Notes: Pain in the head or neck region.
Frequency: 1 affected / 51 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Hyperglycemia, or high blood sugar is a condition in which an excessive amount of glucose circulates in the blood plasma.
Frequency: 1 affected / 51 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Hyperkalemia refers to the condition in which the concentration of the electrolyte potassium in the blood is elevated.
Frequency: 1 affected / 51 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Notes: Elevated blood pressure in the arteries
Frequency: 4 affected / 51 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Hypoalbuminemia is a medical condition where levels of albumin in blood serum are abnormally low.
Frequency: 1 affected / 51 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Hypoglycemia is an abnormally diminished content of glucose in the blood.
Frequency: 1 affected / 51 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Hyponatremia - An electrolyte disturbance in which the sodium ion concentration in the serum is lower than normal.
Frequency: 1 affected / 51 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: Hypotension is low blood pressure.
Frequency: 1 affected / 51 at risk

Adverse event: Infection with unknown ANC: Blood
Serious: yes
Organ System: Infections and infestations
Notes: Blood infection with unknown Absolute Neutrophil Count (ANC)
Frequency: 1 affected / 51 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: General disorders
Notes: An intracranial hemorrhage (ICH) is a hemorrhage, or bleeding, within the skull.
Frequency: 1 affected / 51 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Infection in the lung
Frequency: 1 affected / 51 at risk

Adverse event: Lymphocyte count decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Lymphocyte count decreased
Frequency: 1 affected / 51 at risk

Adverse event: Atrioventricular block second degree
Serious: yes
Organ System: Cardiac disorders
Notes: Second-degree atrioventricular (AV) block is a disease of the electrical conduction system of the heart. It refers to a conduction block between the atria and ventricles.
Frequency: 1 affected / 51 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Muscle weakness or myasthenia is a lack of muscle strength.
Frequency: 1 affected / 51 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Notes: Pericardial effusion ("fluid around the heart") is an abnormal accumulation of fluid in the pericardial cavity.
Frequency: 1 affected / 51 at risk

Adverse event: Peripheral motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Notes: A disorder characterized by inflammation or degeneration of the peripheral motor nerves.
Frequency: 1 affected / 51 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pleural effusion is excess fluid that accumulates between the two pleural layers, the fluid-filled space that surrounds the lungs.
Frequency: 2 affected / 51 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A pneumothorax is an abnormal collection of air or gas in the pleural space that separates the lung from the chest wall and which may interfere with normal breathing.
Frequency: 1 affected / 51 at risk

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Notes: Proteinuria-also called albuminuria or urine albumin-is a condition in which urine contains an abnormal amount of protein
Frequency: 2 affected / 51 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pulmonary embolism (PE) is a blockage of the main artery of the lung or one of its branches by a substance that has traveled from elsewhere in the body through the bloodstream (embolism).
Frequency: 1 affected / 51 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: A seizure is the physical findings or changes in behavior that occur after an episode of abnormal electrical activity in the brain.
Frequency: 2 affected / 51 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Sepsis is a potentially deadly medical condition characterized by a whole-body inflammatory state (called a systemic inflammatory response syndrome or SIRS) caused by severe infection.
Frequency: 1 affected / 51 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Sinus tachycardia is a heart rhythm with elevated rate of impulses originating from the sinoatrial node, defined as a rate greater than 100 beats/min (bpm) in an average adult.
Frequency: 1 affected / 51 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Intestinal obstruction is a blockage that keeps food or liquid from passing through the small intestine.
Frequency: 1 affected / 51 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Notes: Formation of a blood clot inside a blood vessel, obstructing the flow of blood through the circulatory system.
Frequency: 4 affected / 51 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Notes: Urinary retention is the inability to empty the bladder.
Frequency: 1 affected / 51 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Notes: Pain in the abdominal region.
Frequency: 8 affected / 51 at risk

Adverse event: Alanine aminotransferase (ALT) increased
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Increased levels of alanine aminotransferase, indicative of liver damage or disease.
Frequency: 11 affected / 51 at risk

Adverse event: Alkaline phosphatase (ALP) increased
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Increased levels of Alkaline phosphatase
Frequency: 9 affected / 51 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Immune system disorders
Notes: Allergic rhinitis is an allergic inflammation of the nasal airways.
Frequency: 4 affected / 51 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Anemia is a decrease in number of red blood cells (RBCs) or less than the normal quantity of hemoglobin in the blood.
Frequency: 23 affected / 51 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: Anorexia is the decreased sensation of appetite.
Frequency: 28 affected / 51 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Notes: Anxiety is an unpleasant state of inner turmoil and apprehension, often accompanied by nervous behavior, such as pacing back and forth, somatic complaints and rumination.
Frequency: 5 affected / 51 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Notes: Joint pain.
Frequency: 4 affected / 51 at risk

Adverse event: Aspartate aminotransferase (AST) increased
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Increased levels of aspartate aminotransferase (AST)
Frequency: 10 affected / 51 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Notes: Pain in the back.
Frequency: 10 affected / 51 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: General disorders
Notes: Pain in chest wall
Frequency: 23 affected / 51 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Constipation (also known as costiveness or dyschezia) refers to bowel movements that are infrequent or hard to pass.
Frequency: 13 affected / 51 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A cough is a sudden and often repetitively occurring reflex which helps to clear the large breathing passages from secretions, irritants, foreign particles and microbes.
Frequency: 12 affected / 51 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Increased levels of creatinine
Frequency: 6 affected / 51 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dehydration is the excessive loss of body water
Frequency: 3 affected / 51 at risk

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Notes: Depression is a mental disorder characterized by episodes of all-encompassing low mood accompanied by low self-esteem and loss of interest or pleasure in normally enjoyable activities.
Frequency: 4 affected / 51 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea is the condition of having three or more loose or liquid bowel movements per day.
Frequency: 30 affected / 51 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dry mouth is associated a change in the composition of saliva or reduced salivary flow (hyposalivation).
Frequency: 4 affected / 51 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dysgeusia is a distortion of the sense of taste
Frequency: 5 affected / 51 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dyspepsia is a condition of impaired digestion characterized by chronic or recurrent pain in the upper abdomen, upper abdominal fullness and feeling full earlier than expected when eating.
Frequency: 9 affected / 51 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dysphagia is the medical term for the symptom of difficulty in swallowing.
Frequency: 6 affected / 51 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dyspnea - shortness of breath.
Frequency: 15 affected / 51 at risk

Adverse event: Edema (limb)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Swelling of tissues in the limbs due to the accumulation of fluids.
Frequency: 5 affected / 51 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Nosebleed
Frequency: 6 affected / 51 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Fatigue (also called exhaustion, tiredness, lethargy, languidness, languor, lassitude, and listlessness) is a subjective feeling of tiredness which is distinct from weakness, and has a gradual onset.
Frequency: 35 affected / 51 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Pain in the head or neck region.
Frequency: 9 affected / 51 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Hematuria is blood in the urine.
Frequency: 4 affected / 51 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hyperglycemia, or high blood sugar is a condition in which an excessive amount of glucose circulates in the blood plasma.
Frequency: 26 affected / 51 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hyperkalemia refers to the condition in which the concentration of the electrolyte potassium in the blood is elevated.
Frequency: 7 affected / 51 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: Elevated blood pressure in the arteries.
Frequency: 29 affected / 51 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hypoalbuminemia is a medical condition where levels of albumin in blood serum are abnormally low.
Frequency: 20 affected / 51 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hypocalcemia is the presence of low serum calcium levels in the blood, usually taken as less than 2.1 mmol/L or 9 mg/dl or an ionized calcium level of less than 1.1 mmol/L or 4.5 mg/dL.
Frequency: 4 affected / 51 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hypoglycemia is an abnormally diminished content of glucose in the blood.
Frequency: 4 affected / 51 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hypomagnesemia (or hypomagnesaemia) is an electrolyte disturbance in which there is an abnormally low level of magnesium in the blood.
Frequency: 7 affected / 51 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hyponatremia - An electrolyte disturbance in which the sodium ion concentration in the serum is lower than normal.
Frequency: 18 affected / 51 at risk

Adverse event: Hypotension
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Hypotension is low blood pressure.
Frequency: 3 affected / 51 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Notes: Hypothyroidism is a state in which the thyroid gland does not produce a sufficient amount of the thyroid hormones thyroxine (T4) and triiodothyronine (T3).
Frequency: 11 affected / 51 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: Insomnia, or sleeplessness, is a sleep disorder in which there is an inability to fall asleep or to stay asleep as long as desired.
Frequency: 5 affected / 51 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Low lymphocyte count
Frequency: 14 affected / 51 at risk

Adverse event: Mucositis (oral)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Inflammation and ulceration that occurs in the mouth
Frequency: 12 affected / 51 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Muscle weakness is a lack of muscle strength.
Frequency: 4 affected / 51 at risk

Adverse event: Onychomadesis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Fingernail loss is a removal of the whole or part of the nail from the bed.
Frequency: 4 affected / 51 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea a sensation of unease and discomfort in the upper stomach with an involuntary urge to vomit.
Frequency: 17 affected / 51 at risk

Adverse event: Oral pain
Serious: no
Organ System: General disorders
Notes: Pain in the mouth.
Frequency: 4 affected / 51 at risk

Adverse event: Pain - Other
Serious: no
Organ System: General disorders
Notes: Pain in unspecified region.
Frequency: 6 affected / 51 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Notes: Pain in extremity
Frequency: 6 affected / 51 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Palmar-plantar erythrodysesthesia (hand-foot) syndrome results when a small amount of drug leaks out of the blood vessels, damaging tissues.
Frequency: 5 affected / 51 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: Inflammation or degeneration of the sensory nerves.
Frequency: 4 affected / 51 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by marked discomfort sensation in the pharyngolaryngeal (pharynx/larynx) region.
Frequency: 5 affected / 51 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Low platelet count
Frequency: 8 affected / 51 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Proteinuria-also called albuminuria or urine albumin-is a condition in which urine contains an abnormal amount of protein.
Frequency: 14 affected / 51 at risk

Adverse event: Rash (maculo-papular)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: A maculopapular rash is a type of rash characterized by a flat, red area on the skin that is covered with small confluent bumps.
Frequency: 6 affected / 51 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Sinus tachycardia is a heart rhythm with elevated rate of impulses originating from the sinoatrial node, defined as a rate greater than 100 beats/min (bpm) in an average adult.
Frequency: 4 affected / 51 at risk

Adverse event: Voice changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hoarseness, loss or alteration in voice, laryngitis
Frequency: 11 affected / 51 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting is the forceful expulsion of the contents of one's stomach through the mouth and sometimes the nose.
Frequency: 9 affected / 51 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Notes: Weight loss is a reduction of the total body mass, due to a mean loss of fluid, body fat or adipose tissue and/or lean mass, namely bone mineral deposits, muscle, tendon and other connective tissue.
Frequency: 12 affected / 51 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Low white blood cell count
Frequency: 4 affected / 51 at risk