|
Toxicity (grade 3 or 4)
|
742 AE’s a
|
14 AE’s
|
|
Haematological (all grade)
|
|
Thrombocytopenia
|
38.6
|
30
|
|
Leucopenia
|
27.3
|
50
|
|
Neutropenia
|
16.3
|
10
|
|
Anemia
|
11.6
|
10
|
|
Febrile Neutropenia
|
7
|
-
|
|
Non-haematological (all grade)
|
|
Ascites
|
9.9
|
11
|
|
Subileus (severe constipation)
|
8.6
|
11
|
|
Constipation
|
6.2
|
-
|
|
Abdominal pain
|
4.9
|
11
|
|
Ileus (bowel obstruction)
|
4.9
|
-
|
|
Vomiting
|
4.9
|
-
|
|
Nausea
|
3.7
|
-
|
|
Diarrhoea
|
2.5
|
11
|
|
Rectal incontinence
|
2.5
|
-
|
|
Others (< 1%)
|
51.8
|
56
|
|
Dose reduction (27 of all 421 cycles)
|
6.4
|
|
(26 of 376 i.v. cycles vs. 1 of 45 oral cycles)
|
6.9
|
2.2
|
|
Prolongation of treatment interval (> 14d)
|
25
|
4.4
|
|
Reasons for early therapy discontinuation
|
|
Progressive disease
|
42
|
47.1
|
|
Patients preference
|
15.7
|
11.8
|
|
Other reasons
|
15.7
|
11.8
|
|
Haematological toxicity (grade 3/4)
|
11.8
|
-
|
|
Dead of tumour
|
5.9
|
11.8
|
|
Non-haematological toxicity (grade 3/4)
|
2.9
|
11.8
|
|
Concomitant disease
|
2.9
|
5.9
|
|
Complete remission
|
1
|
-
|
|
Main cause of death
|
|
Tumour related
|
80.4
|
82.4
|
|
Others
|
7.8
|
5.9
|
