Study: NCT02207439

Adverse event: Dysgeusia
Serious: yes
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: 1 affected / 17 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Notes: A disorder characterized by an adverse local or general response from exposure to an allergen.
Frequency: 1 affected / 17 at risk

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: 1 affected / 17 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: A disorder characterized by a loss of appetite.
Frequency: 2 affected / 17 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
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: 1 affected / 17 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A disorder characterized by inhalation of solids or liquids into the lungs.
Frequency: 2 affected / 17 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: A disorder characterized by inflammation involving the gallbladder. It may be associated with the presence of gallstones.
Frequency: 1 affected / 17 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by difficulty in swallowing.
Frequency: 2 affected / 17 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by inflammation of the esophageal wall.
Frequency: 1 affected / 17 at risk

Adverse event: Headache
Serious: yes
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: 1 affected / 17 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: A disorder characterized by laboratory test results that indicate an elevation in the concentration of blood sugar.
Frequency: 1 affected / 17 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Notes: A disorder characterized by a pathological increase in blood pressure
Frequency: 1 affected / 17 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 / 17 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: 3 affected / 17 at risk

Adverse event: Lymphocyte count decreased
Serious: yes
Organ System: Investigations
Notes: A finding based on laboratory test results that indicate a decrease in number of lymphocytes in a blood specimen.
Frequency: 5 affected / 17 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by inflammation of the oral mucosal.
Frequency: 3 affected / 17 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 / 17 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: 1 affected / 17 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Notes: A disorder characterized by a dysrhythmia with a heart rate less than 60 beats per minute that originates in the sinus node.
Frequency: 1 affected / 17 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 / 17 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Notes: A disorder characterized by a state of restlessness associated with unpleasant feelings of irritability and tension.
Frequency: 1 affected / 17 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: 3 affected / 17 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: 2 affected / 17 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: 1 affected / 17 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 / 17 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: 8 affected / 17 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: A disorder characterized by a loss of appetite.
Frequency: 9 affected / 17 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: 3 affected / 17 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: 1 affected / 17 at risk

Adverse event: Aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A disorder characterized by inhalation of solids or liquids into the lungs.
Frequency: 2 affected / 17 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 / 17 at risk

Adverse event: Dermatitis bullous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: A disorder characterized by inflammation of the skin characterized by the presence of bullae which are filled with fluid.
Frequency: 1 affected / 17 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: 8 affected / 17 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: 4 affected / 17 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: 2 affected / 17 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: 2 affected / 17 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: A disorder characterized by melancholic feelings of grief or unhappiness.
Frequency: 2 affected / 17 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: A finding of cutaneous inflammatory reaction occurring as a result of exposure to biologically effective levels of ionizing radiation.
Frequency: 14 affected / 17 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by frequent and watery bowel movements.
Frequency: 8 affected / 17 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: 3 affected / 17 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: 8 affected / 17 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: 15 affected / 17 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by difficulty in swallowing.
Frequency: 11 affected / 17 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: 2 affected / 17 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: A disorder characterized by a sensation of marked discomfort in the ear.
Frequency: 1 affected / 17 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 / 17 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: 2 affected / 17 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: A disorder characterized by target lesions (a pink-red ring around a pale center).
Frequency: 4 affected / 17 at risk

Adverse event: Oesophageal pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: A disorder characterized by a sensation of marked discomfort in the esophageal region.
Frequency: 1 affected / 17 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: 11 affected / 17 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: 2 affected / 17 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by reflux of the gastric and/or duodenal contents into the distal esophagus.
Frequency: 1 affected / 17 at risk

Adverse event: Impaired gastric emptying
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by an incomplete paralysis of the muscles of the stomach wall resulting in delayed emptying of the gastric contents into the small intestine.
Frequency: 1 affected / 17 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: 2 affected / 17 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 / 17 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A disorder characterized by repeated gulp sounds that result from an involuntary opening and closing of the glottis. This is attributed to a spasm of the diaphragm.
Frequency: 1 affected / 17 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A disorder characterized by harsh and raspy voice arising from or spreading to the larynx.
Frequency: 2 affected / 17 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.
Frequency: 1 affected / 17 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 / 17 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: 1 affected / 17 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 in the blood.
Frequency: 4 affected / 17 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: 2 affected / 17 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: 4 affected / 17 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: 5 affected / 17 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 / 17 at risk

Adverse event: Laryngeal oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A disorder characterized by swelling due to an excessive accumulation of fluid in the larynx.
Frequency: 1 affected / 17 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Notes: A disorder characterized by swelling due to excessive fluid accumulation at a specific anatomic site.
Frequency: 1 affected / 17 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 / 17 at risk

Adverse event: Lymphocyte count increased
Serious: no
Organ System: Investigations
Notes: A finding based on laboratory test results that indicate an abnormal increase in the number of lymphocytes in the blood, effusions or bone marrow.
Frequency: 1 affected / 17 at risk

Adverse event: Middle ear inflammation
Serious: no
Organ System: Ear and labyrinth disorders
Notes: A disorder characterized by inflammation (physiologic response to irritation), swelling and redness to the middle ear.
Frequency: 1 affected / 17 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by inflammation of the oral mucosal.
Frequency: 9 affected / 17 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: 7 affected / 17 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Notes: A disorder characterized by swelling due to an accumulation of excessive fluid in the neck.
Frequency: 7 affected / 17 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: A disorder characterized by marked discomfort sensation in the neck area.
Frequency: 3 affected / 17 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: 3 affected / 17 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: 5 affected / 17 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: 2 affected / 17 at risk

Adverse event: Prostatic pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: A disorder characterized by a sensation of marked discomfort in the prostate gland.
Frequency: 1 affected / 17 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)
Frequency: 1 affected / 17 at risk

Adverse event: Salivary duct inflammation
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by inflammation of the salivary duct.
Frequency: 10 affected / 17 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: A disorder characterized by characterized by excessive sleepiness and drowsiness.
Frequency: 1 affected / 17 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A disorder characterized by of marked discomfort in the throat
Frequency: 1 affected / 17 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 / 17 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Notes: A disorder characterized by occlusion of a vessel by a thrombus that has migrated from a distal site via the blood stream.
Frequency: 1 affected / 17 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: 3 affected / 17 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Notes: A disorder characterized by the uncontrolled shaking movement of the whole body or individual parts.
Frequency: 3 affected / 17 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A disorder characterized by a change in the sound and/or speed of the voice.
Frequency: 6 affected / 17 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: 2 affected / 17 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: 4 affected / 17 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: 17 affected / 17 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Notes: Infections and infestations
Frequency: 2 affected / 17 at risk

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