Months from entry to study | |||
---|---|---|---|
36 | 48 | 60 | |
No of patients (active/placebo) | 52/57 | 49/51 | 38/50 |
Disease extent (active/placebo) | |||
Small bowel | 16/19 | 15/18 | 10/17 |
Large bowel | 14/14 | 14/14 | 11/11 |
Mixed | 22/24 | 20/19 | 17/22 |
Number of acute relapses (active/placebo) | 29/35 | 19/22 | 10/26 |
Surgery (active/placebo)1-150 | 10/11 | 5/7 | 3/9 |
Perianal | 3/2 | 2/3 | 0/0 |
Laparotomy | 1/1 | 0/0 | 1/1 |
Right hemicolectomy | 0/2 | 0/1 | 1/0 |
Ileocaecectomy | 5/2 | 1/0 | 1/5 |
Partial colectomy | 1/3 | 1/0 | 0/0 |
Total colectomy | 0/1 | 1/1 | 0/1 |
Stricturoplasty | 0/2 | 1/2 | 0/0 |
Small bowel | 0/0 | 0/0 | 1/2 |
Admission (active/placebo) | 12/15 | 10/9 | 6/6 |
Total disease activity (active/placebo)1-151 | 5/4 | 3/5 | 5/4 |
Blood results (active/placebo) | |||
Haemoglobin (g/dl) | 13/12 | 13/13 | 13/13 |
White cell count (×109/l) | 8/8 | 8/8 | 9/9 |
Platelet count (×109/l) | 291/302 | 291/329 | 290/330 |
Albumin (g/l) | 43/44 | 44/44 | 41/42 |
↵1-150 A number of patients had two surgical procedures, thus in some cases the numbers are greater than the total number of patients who underwent surgery.
↵1-151 Disease activity score is based on a modification of the Harvey-Bradshaw Index7 with a maximum total score of 17 plus the number of motions/24 h.