Study: NCT00519077

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Acute kidney failure is the rapid loss the kidneys' ability to remove waste and help balance fluids and electrolytes in the body.
Frequency: 1 affected / 44 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: "Aspiration pneumonia isbronchopneumonia that develops due to the entrance of foreign materials into the bronchial tree,\[1\] usually oral or gastric contents (including food, saliva, or nasal secretions). "
Frequency: 1 affected / 44 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: "Atrial fibrillation is an irregular and often rapid heart rate that commonly causes poor blood flow to the body. During atrial fibrillation, the heart's atria beat chaotically and irregularly, out of coordination with the ventricles of the heart"
Frequency: 2 affected / 44 at risk

Adverse event: Bleeding from tumor site
Serious: yes
Organ System: General disorders
Notes: Bleeding from tumor site
Frequency: 1 affected / 44 at risk

Adverse event: Bleeding from unspecified region
Serious: yes
Organ System: General disorders
Notes: Bleeding from unspecified region
Frequency: 2 affected / 44 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: 1 affected / 44 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 / 44 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Dysphagia is the medical term for the symptom of difficulty in swallowing.
Frequency: 1 affected / 44 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 degrees C (97.7-99.5 degrees F) due to an increase in the temperature regulatory set-point.
Frequency: 1 affected / 44 at risk

Adverse event: G-tube malfunction
Serious: yes
Organ System: General disorders
Notes: A gastrostomy tube (also called a G-tube) is a tube inserted through the abdomen that delivers nutrition directly to the stomach. One patient was hospitalized because the G-tube stopped working properly.
Frequency: 1 affected / 44 at risk

Adverse event: G-tube placement
Serious: yes
Organ System: General disorders
Notes: A gastrostomy tube (also called a G-tube) is a tube inserted through the abdomen that delivers nutrition directly to the stomach. Two patients were hospitalized because their gastrointestinal function declined and warranted G-tube placement.
Frequency: 2 affected / 44 at risk

Adverse event: GI bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal (GI) bleeding refers to any bleeding that starts in the gastrointestinal tract.
Frequency: 1 affected / 44 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 / 44 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: "Hypoxia, or hypoxiation, is apathological condition in which the body as a whole (generalized hypoxia) or a region of the body (tissue hypoxia, or less commonly regional hypoxia) is deprived of adequate oxygen supply. "
Frequency: 2 affected / 44 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 / 44 at risk

Adverse event: Neck bleeding
Serious: yes
Organ System: General disorders
Notes: Bleeding from neck region
Frequency: 1 affected / 44 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Notes: Patient experienced pain at grades 4 or higher.
Frequency: 1 affected / 44 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 / 44 at risk

Adverse event: Pleurodesis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pleurodesis is a procedure used to cause the layers of the lung lining (the pleura) to stick together.
Frequency: 1 affected / 44 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pneumonia is an inflammatorycondition of the lungaffecting primarily the microscopic air sacs known as alveoli.
Frequency: 4 affected / 44 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: "Respiratory distress is a medical term that refers to both difficulty in breathing, and to the psychological experience associated with such difficulty, even if there is no physiological basis for experiencing such distress."
Frequency: 1 affected / 44 at risk

Adverse event: Retroperitoneal haemorrhage
Serious: yes
Organ System: General disorders
Notes: "Bleeding in the retroperitoneal space (retroperitoneum), i.e. the anatomical space in the abdominal cavity behind (retro) the peritoneum."
Frequency: 1 affected / 44 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: 2 affected / 44 at risk

Adverse event: Stridor
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Stridor is a high-pitched wheezing sound resulting fromturbulent air flow in the upper airway.
Frequency: 1 affected / 44 at risk

Adverse event: Subacute hemorrhage of thalamus
Serious: yes
Organ System: General disorders
Notes: Subacute (between chronic and acute) hemorrhagic bleeding into the thalamus
Frequency: 1 affected / 44 at risk

Adverse event: Tracheitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Bacterial tracheitis is a bacterial infection of the trachea and is capable of producing airway obstruction.
Frequency: 1 affected / 44 at risk

Adverse event: Unresponsiveness
Serious: yes
Organ System: General disorders
Notes: Poor response or total loss of response to questions or other stimuli
Frequency: 1 affected / 44 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
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: 1 affected / 44 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: 1 affected / 44 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Notes: "Dehydration (hypohydration) is the excessive loss of body water, with an accompanying disruption of metabolic processes."
Frequency: 3 affected / 44 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: 4 affected / 44 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Shortness of breath
Frequency: 4 affected / 44 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Nosebleed
Frequency: 3 affected / 44 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 / 44 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 44 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Xerostomia is the medical term for the subjective symptom of dryness in the mouth.
Frequency: 3 affected / 44 at risk