Study: NCT00376688

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by a sensation of marked discomfort in the abdominal region.
Frequency: 2 affected / 31 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: 3 affected / 31 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: 5 affected / 31 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 / 31 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: 2 affected / 31 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: 2 affected / 31 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: 2 affected / 31 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 / 31 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: 2 affected / 31 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 / 31 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: 2 affected / 31 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: 2 affected / 31 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: 2 affected / 31 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: 3 affected / 31 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: 7 affected / 31 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: 2 affected / 31 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 / 31 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: 2 affected / 31 at risk