Study: NCT00127036

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 1 on Arm A also experienced vomiting and dehydration
Frequency: 1 affected / 34 at risk

Adverse event: Choking incident while taking tablet
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 34 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Also experienced vomiting and abdominal pain
Frequency: 1 affected / 34 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 2 in Arm A and 1 in Arm B also had vomiting. 2 in Arm B also had nausea.
Frequency: 3 affected / 34 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9/L)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 2 in Arm A and 3 in Arm B also experienced vomiting. 2 in Arm B also experienced diarrhea.
Frequency: 2 affected / 34 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 2 in Arm A and 3 in Arm B also experienced nausea. 1 in Arm B also experienced diarrhea.
Frequency: 5 affected / 34 at risk

Adverse event: Abdominal distention
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Also experienced pain
Frequency: 1 affected / 31 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 1 on Arm A also experienced vomiting and dehydration
Frequency: 1 affected / 31 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Bilirubin - hospitalized
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 31 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Death due to disease progression - liver
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 31 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 31 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 2 in Arm A and 1 in Arm B also had vomiting. 2 in Arm B also had nausea.
Frequency: 3 affected / 31 at risk

Adverse event: Diarrhea - persistent
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Hemorrhage, GI - Rectum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 2 in Arm A and 3 in Arm B also experienced vomiting. 2 in Arm B also experienced diarrhea.
Frequency: 4 affected / 31 at risk

Adverse event: Obstructing lesion of the colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pain - headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Perforation, GI - Duodenum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 2 in Arm A and 3 in Arm B also experienced nausea. 1 in Arm B also experienced diarrhea.
Frequency: 3 affected / 31 at risk