Thalidomide for refractory hemorrhagic chronic radiation proctitis secondary to pelvic malignancy radiotherapy: A phase II clinical trial

Table 1 Clinical characteristics and demographic information on the study patients, n (%)/median (interquartile range)

Characteristic	Patients (n = 62)
Age, years	61.8 (9.1)
Sex
Male	4 (6.5)
Female	58 (93.5)
Primary cancer
Cervical	54 (87.1)
Endometrium	2 (3.2)
Prostatic	4 (6.5)
Rectal	1 (1.6)
Anal	1 (1.6)
Comorbidities
Coronary artery heart disease	1 (1.6)
Hypertension	5 (8.1)
Diabetes mellitus	2 (3.2)
History of abdominopelvic operation	13 (21.0)
Time from the end of radiotherapy to enrollment, months	16.2 (10.3, 23.7)
Time from ceasing radiotherapy to bleeding, months	8.2 (6.1, 13.2)
Duration of bleeding, months	5.3 (2.4, 13.1)
Transfusion dependent	8 (12.9)
Grade of bleeding (SOMA)	3 (3, 4)
Pre-enrollment hemoglobin, g/L	117 (100, 127)
Pre-enrollment VRS	3 (3, 3)
Mucosal congestion	2 (2, 2)
Telangiectasia	3 (2, 3)
Ulceration	0 (0, 1.5)
Stenosis	0 (0, 0)
Necrosis	0 (0, 0)

SOMA: Subjective Objective Management Analysis system; VRS: Vienna Rectoscopy Score.