Study: NCT00588809

Adverse event: Anaemia
Serious: yes
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: 2 affected / 47 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: A disorder characterized by an ANC \<1000/mm3 and a single temperature of \>38.3 degrees C (101 degrees F) or a sustained temperature of \>=38 degrees C (100.4 degrees F) for more than one hour
Frequency: 8 affected / 47 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: A disorder characterized by a dysrhythmia with a heart rate greater than 100 beats per minute that originates distal to the bundle of His.
Frequency: 1 affected / 47 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by frequent and watery bowel movements.
Frequency: 2 affected / 47 at risk

Adverse event: Dry mouth
Serious: yes
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by reduced salivary flow in the oral cavity.
Frequency: 1 affected / 47 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by inflammation of the oral mucosal.
Frequency: 2 affected / 47 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by a queasy sensation and/or the urge to vomit.
Frequency: 2 affected / 47 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by the reflexive act of ejecting the contents of the stomach through the mouth.
Frequency: 3 affected / 47 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: A cessation of life that cannot be attributed to a CTCAE term associated with Grade 5.
Frequency: 10 affected / 47 at risk

Adverse event: Fatigue
Serious: yes
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: 3 affected / 47 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: A disorder characterized by elevation of the body's temperature above the upper limit of normal.
Frequency: 2 affected / 47 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 47 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 47 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Rectum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Salivary gland
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 47 at risk

Adverse event: Infections and infestations - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 47 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: A disorder characterized by an infectious process involving the lungs.
Frequency: 3 affected / 47 at risk

Adverse event: Peritonsillar abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Notes: A disorder characterized by inflammation of the throat.
Frequency: 1 affected / 47 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: A disorder characterized by the presence of pathogenic microorganisms in the blood stream that cause a rapidly progressing systemic reaction that may lead to shock.
Frequency: 1 affected / 47 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: A disorder characterized by an infectious process involving the upper respiratory tract (nose, paranasal sinuses, pharynx, larynx, or trachea).
Frequency: 1 affected / 47 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: A disorder characterized by an infectious process involving the urinary tract, most commonly the bladder and the urethra.
Frequency: 1 affected / 47 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
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: 1 affected / 47 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Notes: A finding based on laboratory test results that indicate increased levels of creatinine in a biological specimen.
Frequency: 1 affected / 47 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Notes: A finding based on laboratory test results that indicate a decrease in number of neutrophils in a blood specimen.
Frequency: 1 affected / 47 at risk

Adverse event: Platelet count decreased
Serious: yes
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 / 47 at risk

Adverse event: White blood cell count decreased
Serious: yes
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: 1 affected / 47 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: A disorder characterized by abnormally high acidity (high hydrogen-ion concentration) of the blood and other body tissues.
Frequency: 1 affected / 47 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: A disorder characterized by a loss of appetite.
Frequency: 1 affected / 47 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: A disorder characterized by excessive loss of water from the body. It is usually caused by severe diarrhea, vomiting or diaphoresis.
Frequency: 5 affected / 47 at risk

Adverse event: Hyperuricaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: A disorder characterized by laboratory test results that indicate an elevation in the concentration of uric acid.
Frequency: 1 affected / 47 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
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: 1 affected / 47 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: A disorder characterized by laboratory test results that indicate a low concentration of potassium in the blood.
Frequency: 1 affected / 47 at risk

Adverse event: Hyponatraemia
Serious: yes
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: 1 affected / 47 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: A disorder characterized by a reduction in the strength of the lower limb muscles.
Frequency: 1 affected / 47 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Notes: A disorder characterized by a disturbing sensation of lightheadedness, unsteadiness, giddiness, spinning or rocking.
Frequency: 2 affected / 47 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Notes: A disorder characterized by impairment of verbal communication skills, often resulting from brain damage.
Frequency: 1 affected / 47 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Notes: A disorder characterized by bleeding from the cranium.
Frequency: 4 affected / 47 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Notes: A disorder characterized by personality change, impaired functioning, and loss of touch with reality. It may be a manifestation of schizophrenia, bipolar disorder or brain tumor.
Frequency: 1 affected / 47 at risk

Adverse event: Chromaturia
Serious: yes
Organ System: Renal and urinary disorders
Notes: A disorder characterized by a change in the color of the urine.
Frequency: 1 affected / 47 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A disorder characterized by bleeding from the bronchial wall and/or lung parenchyma.
Frequency: 1 affected / 47 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A disorder characterized by an uncomfortable sensation of difficulty breathing.
Frequency: 2 affected / 47 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A disorder characterized by bleeding from the nose.
Frequency: 1 affected / 47 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A disorder characterized by a decrease in the level of oxygen in the body.
Frequency: 1 affected / 47 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A disorder characterized by inflammation focally or diffusely affecting the lung parenchyma.
Frequency: 3 affected / 47 at risk

Adverse event: Hypotension
Serious: yes
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: 3 affected / 47 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: 24 affected / 47 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: A disorder characterized by an ANC \<1000/mm3 and a single temperature of \>38.3 degrees C (101 degrees F) or a sustained temperature of \>=38 degrees C (100.4 degrees F) for more than one hour
Frequency: 3 affected / 47 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Notes: A disorder characterized by a dysrhythmia without discernible P waves and an irregular ventricular response due to multiple reentry circuits. The rhythm disturbance originates above the ventricles.
Frequency: 3 affected / 47 at risk

Adverse event: Atrial tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: A disorder characterized by a dysrhythmia with abrupt onset and sudden termination of atrial contractions with a rate of 150-250 beats per minute. The rhythm disturbance originates in the atria.
Frequency: 4 affected / 47 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: A disorder characterized by a dysrhythmia with a heart rate greater than 100 beats per minute that originates in the sinus node.
Frequency: 13 affected / 47 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by swelling of the abdomen.
Frequency: 7 affected / 47 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: 13 affected / 47 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: 4 affected / 47 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by frequent and watery bowel movements.
Frequency: 29 affected / 47 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by reduced salivary flow in the oral cavity.
Frequency: 6 affected / 47 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 / 47 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: 4 affected / 47 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by inflammation of the oral mucosal.
Frequency: 9 affected / 47 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: 24 affected / 47 at risk

Adverse event: Mouth haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by bleeding from the mouth.
Frequency: 5 affected / 47 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: 15 affected / 47 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: A disorder characterized by a sensation of cold that often marks a physiologic response to sweating after a fever.
Frequency: 16 affected / 47 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: A disorder characterized by swelling due to excessive fluid accumulation in the upper or lower extremities.
Frequency: 21 affected / 47 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: 32 affected / 47 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: A disorder characterized by elevation of the body's temperature above the upper limit of normal.
Frequency: 21 affected / 47 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Notes: A disorder characterized by discomfort in the chest unrelated to a heart disorder.
Frequency: 7 affected / 47 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: 6 affected / 47 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: A disorder characterized by an adverse local or general response from exposure to an allergen.
Frequency: 5 affected / 47 at risk

Adverse event: Infections and infestations - Other
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 47 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: A disorder characterized by an infectious process involving the urinary tract, most commonly the bladder and the urethra.
Frequency: 3 affected / 47 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: A finding of injury of the soft tissues or bone characterized by leakage of blood into surrounding tissues.
Frequency: 3 affected / 47 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: 16 affected / 47 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: 7 affected / 47 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: 19 affected / 47 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: 5 affected / 47 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: 7 affected / 47 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: 8 affected / 47 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: A finding based on laboratory test results that indicate a decrease in number of neutrophils in a blood specimen.
Frequency: 20 affected / 47 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: 24 affected / 47 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 / 47 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: 13 affected / 47 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: A disorder characterized by abnormally high acidity (high hydrogen-ion concentration) of the blood and other body tissues.
Frequency: 5 affected / 47 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: A disorder characterized by a loss of appetite.
Frequency: 19 affected / 47 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: A disorder characterized by excessive loss of water from the body. It is usually caused by severe diarrhea, vomiting or diaphoresis.
Frequency: 4 affected / 47 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: 17 affected / 47 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: A disorder characterized by laboratory test results that indicate an elevation in the concentration of uric acid.
Frequency: 3 affected / 47 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: 20 affected / 47 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: A disorder characterized by laboratory test results that indicate a low concentration of calcium (corrected for albumin) in the blood.
Frequency: 13 affected / 47 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: 3 affected / 47 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: A disorder characterized by laboratory test results that indicate a low concentration of potassium in the blood.
Frequency: 12 affected / 47 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: 9 affected / 47 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: 15 affected / 47 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: 5 affected / 47 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: 3 affected / 47 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: 9 affected / 47 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: A disorder characterized by a reduction in the strength of muscles in multiple anatomic sites.
Frequency: 4 affected / 47 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: A disorder characterized by a reduction in the strength of the lower limb muscles.
Frequency: 4 affected / 47 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: 10 affected / 47 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: 12 affected / 47 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Notes: A disorder characterized by a lack of clear and orderly thought and behavior.
Frequency: 4 affected / 47 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: A disorder characterized by melancholic feelings of grief or unhappiness.
Frequency: 4 affected / 47 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: 4 affected / 47 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Notes: A disorder characterized by accumulation of urine within the bladder because of the inability to urinate.
Frequency: 3 affected / 47 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: 18 affected / 47 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: 19 affected / 47 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A disorder characterized by bleeding from the nose.
Frequency: 9 affected / 47 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A disorder characterized by a decrease in the level of oxygen in the body.
Frequency: 5 affected / 47 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A disorder characterized by marked discomfort sensation in the pharyngolaryngeal region.
Frequency: 4 affected / 47 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A disorder characterized by an increase in amounts of fluid within the pleural cavity. Symptoms include shortness of breath, cough and marked chest discomfort.
Frequency: 5 affected / 47 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A disorder characterized by inflammation focally or diffusely affecting the lung parenchyma.
Frequency: 3 affected / 47 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, specify
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 47 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: A disorder characterized by flaky and dull skin; the pores are generally fine, the texture is a papery thin texture.
Frequency: 3 affected / 47 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: A disorder characterized by excessive perspiration.
Frequency: 4 affected / 47 at risk

Adverse event: Purpura
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: A disorder characterized by hemorrhagic areas of the skin and mucous membrane. Newer lesions appear reddish in color. Older lesions are usually a darker purple color and eventually become a brownish-yellow color.
Frequency: 4 affected / 47 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: A disorder characterized by the presence of macules (flat) and papules (elevated). Also known as morbillform rash.
Frequency: 10 affected / 47 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 47 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 / 47 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: 7 affected / 47 at risk

Adverse event: Vascular disorders - Other
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 47 at risk