Table 2 Adverse events. Adverse events (by NCI-CTCAE v.3 grade) recorded up to 60 days after the start of protocol therapy, from 61 days onwards and across the whole study period (n = 14)

A.

Gastrointestinal

 Nausea

10

0

4

1

10

1

 Vomiting

7

0

1

0

8

0

 Anorexia

5

0

5

2

6

2

 Diarrhoea

4

0

1

1

4

1

 Stomatitis

1

0

2

0

2

0

 Mucositis

2

0

0

0

2

0

 Constipation

2

0

1

0

2

0

Pain

 Abdominal pain

2

0

1

0

3

0

 Pain (non-abdominal)

0

1

0

0

0

1

Constitutional Symptoms

 Fatigue

6

2

5

5

4

6

 Fever

3

0

0

0

3

0

Hepatobiliary/Pancreas

 Ascites

0

1

0

3

0

3

 Jaundice

0

0

0

1

0

1

 Liver failure

0

0

0

1

0

1

Neurology

 Neuropathy

3

0

1

0

3

0

Pulmonary/Upper Respiratory

 Dyspnoea

1

1

1

1

1

1

 Bruising

1

0

2

0

2

0

 Pneumonia

0

1

1

0

0

1

Vascular

 Pulmonary embolism

0

1

0

0

0

1

 Deep vein thrombosis

0

1

0

1

0

1

Dermatology/Skin

 Dry skin/cracked skin

1

1

0

1

1

1

Haemorrhage/Bleeding

 Epistaxis

1

0

2

0

2

0

Ocular/Visual

 Epiphora

3

0

3

0

3

0

B.

Biochemical/Laboratory

 Hyperbilirubinemia

5

3

2

6

4

7

 Albumin

9

1

8

1

11

1

 Alkaline phosphatase

4

1

8

0

8

1

 Alanine transaminase

8

0

5

0

10

0

 Aspartate aminotransferase

3

0

5

0

6

0

Blood/Bone Marrow

 Haemoglobin

7

0

3

0

8

0

 Platelets

4

2

5

2

4

4

 Leukocytes

8

1

2

0

8

1

 Neutrophils

2

2

1

1

2

2