Study: NCT00504153

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Notes: Pain in the abdominal region
Frequency: 2 affected / 19 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Acute kidney injury (AKI), previously called acute renal failure (ARF), is a rapid loss of kidney function.
Frequency: 1 affected / 19 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Anorexia is the decreased sensation of appetite.
Frequency: 1 affected / 19 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Ascites is a gastroenterological term for an accumulation of fluid in the peritoneal cavity.
Frequency: 1 affected / 19 at risk

Adverse event: Blood infection
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Blood infection with normal ANC or Grade 1 or 2 neutrophils
Frequency: 1 affected / 19 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Increased levels of creatinine
Frequency: 1 affected / 19 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Dehydration (hypohydration) is the excessive loss of body water, with an accompanying disruption of metabolic processes.
Frequency: 2 affected / 19 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Diarrhea is the condition of having three or more loose or liquid bowel movements per day.
Frequency: 1 affected / 19 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Shortness of breath
Frequency: 1 affected / 19 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Fever is characterized by an elevation of body temperature above the normal range of 36.5-37.5 °C (97.7-99.5 °F) due to an increase in the temperature regulatory set-point
Frequency: 1 affected / 19 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Gastritis is an inflammation of the lining of the stomach.
Frequency: 1 affected / 19 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Notes: A headache or cephalalgia is pain anywhere in the region of the head or neck.
Frequency: 1 affected / 19 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 (K+) in the blood is elevated.
Frequency: 1 affected / 19 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Hypokalemia refers to the condition in which the concentration of potassium (K+) in the blood is low.
Frequency: 1 affected / 19 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Hyponatremia is an electrolyte disturbance in which the sodium ion concentration in the serum is lower than normal.
Frequency: 1 affected / 19 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: Hypotension is low blood pressure, especially in the arteries of the systemic circulation
Frequency: 2 affected / 19 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Nausea is a sensation of unease and discomfort in the upper stomach with an involuntary urge to vomit.
Frequency: 2 affected / 19 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Pancreatitis is an inflammation of the pancreas
Frequency: 1 affected / 19 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: 1 affected / 19 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pneumonitis or pulmonitis is a general term that refers to inflammation of lung tissue.
Frequency: 1 affected / 19 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Notes: Syncope (fainting) is a transient loss of consciousness and postural tone, characterized by rapid onset, short duration, and spontaneous recovery.
Frequency: 1 affected / 19 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: A urinary tract infection (UTI) (also known as acute cystitis or bladder infection) is an infection that affects part of the urinary tract.
Frequency: 2 affected / 19 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Ventricular fibrillation (V-fib or VF) is a condition in which there is uncoordinated contraction of the cardiac muscle of the ventricles in the heart, making them quiver rather than contract properly.
Frequency: 1 affected / 19 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Vomiting (known medically as emesis and informally as throwing up and numerous other terms) is the forceful expulsion of the contents of one's stomach through the mouth and sometimes the nose.
Frequency: 2 affected / 19 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Increased levels of alanine aminotransferase, indicative of liver damage or disease.
Frequency: 1 affected / 19 at risk

Adverse event: Alkaline phosphatase (ALP) increased
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Increased levels of Alkaline phosphatase
Frequency: 1 affected / 19 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: 2 affected / 19 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: Anorexia is the decreased sensation of appetite.
Frequency: 1 affected / 19 at risk

Adverse event: Aspartate aminotransferase (AST) increased
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Increased levels of aspartate aminotransferase (AST)
Frequency: 1 affected / 19 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Increased levels of bilirubin in the blood
Frequency: 1 affected / 19 at risk

Adverse event: Blood infection
Serious: no
Organ System: Infections and infestations
Notes: Blood infection with normal absolute neutrophil count (ANC) or Grade 1 or 2 neutrophils
Frequency: 1 affected / 19 at risk

Adverse event: Duodenal stenosis
Serious: no
Organ System: Gastrointestinal disorders
Notes: A rare birth defect where a portion of the small intestine is narrowed which prevents the stomach contents from flowing through at a normal rate.
Frequency: 1 affected / 19 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Shortness of breath
Frequency: 1 affected / 19 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: 3 affected / 19 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Notes: Hemorrhoids, also called piles, are swollen and inflamed veins in your anus and lower rectum.
Frequency: 1 affected / 19 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: 1 affected / 19 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: 1 affected / 19 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hypokalemia refers to the condition in which the concentration of potassium (K+) in the blood is low.
Frequency: 1 affected / 19 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hyponatremia is an electrolyte disturbance in which the sodium ion concentration in the serum is lower than normal.
Frequency: 1 affected / 19 at risk

Adverse event: International normalised ratio increased
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Above normal international normalized ratio (INR)
Frequency: 1 affected / 19 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Lymphocyte count decreased
Frequency: 1 affected / 19 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: Inflammation or degeneration of the sensory nerves.
Frequency: 1 affected / 19 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Rectal pain is the symptom of pain in the area of the rectum.
Frequency: 1 affected / 19 at risk