Study: NCT01365130

Adverse event: Diarrhea, nausea, vomiting
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: neutropenia, fever , weakness
Serious: yes
Organ System: Investigations
Notes: neutropenia (4), fever (1), weakness(3)
Frequency: 1 affected / 13 at risk

Adverse event: pneumonia and anemia
Serious: yes
Organ System: Investigations
Notes: pneumonia (4) anemia (3)
Frequency: 1 affected / 13 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Investigations
Notes: PE (3)
Frequency: 1 affected / 13 at risk

Adverse event: neutopenia, WBC, febrile neutropenia and fever
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: 1 patient experienced grade 1 ANC, 2 patients experienced grade 3 ANC, 2 pts experienced grade 4 ANC
Frequency: 3 affected / 13 at risk

Adverse event: abd pain
Serious: no
Organ System: Investigations
Frequency: 4 affected / 13 at risk

Adverse event: Alk
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Anaemia
Serious: no
Organ System: Investigations
Frequency: 12 affected / 13 at risk

Adverse event: barret esophagus
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Bone pain
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Blood calcium
Serious: no
Organ System: Investigations
Frequency: 2 affected / 13 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Investigations
Frequency: 5 affected / 13 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Dizziness
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Oedema
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Erythema
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Fatigue
Serious: no
Organ System: Investigations
Frequency: 5 affected / 13 at risk

Adverse event: Blood glucose
Serious: no
Organ System: Investigations
Frequency: 6 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: hypoalbumin
Serious: no
Organ System: Investigations
Frequency: 7 affected / 13 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 13 at risk

Adverse event: Liver function test
Serious: no
Organ System: Investigations
Frequency: 2 affected / 13 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 13 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Nausea
Serious: no
Organ System: Investigations
Frequency: 6 affected / 13 at risk

Adverse event: Pain
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: RBC
Serious: no
Organ System: Investigations
Frequency: 3 affected / 13 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Cough
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 13 at risk

Adverse event: Thursh
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Typhilitis
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Vomiting
Serious: no
Organ System: Investigations
Frequency: 3 affected / 13 at risk

Adverse event: White blood cell count
Serious: no
Organ System: Investigations
Frequency: 3 affected / 13 at risk

Adverse event: Asthenia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: wt loss/anorexia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 13 at risk