Observational Study
Copyright ©2014 Baishideng Publishing Group Inc.
World J Gastroenterol. Oct 21, 2014; 20(39): 14479-14487
Published online Oct 21, 2014. doi: 10.3748/wjg.v20.i39.14479
Table 3 Safety data n (%)
Group IGroup IIAll patientsP value
(n = 38)(n = 39)(n = 77)
Patients with any adverse events34 (89.5)33 (84.6)77 (87.0)0.737
Adverse events leading to discontinuation of study drug5 (13.2)4 (10.3)9 (11.7)0.663
Infusion reaction5 (13.2)---
Serum-sickness-like reactions0---
Infection4 (10.5)4 (10.3)8 (10.4)1.000
Headache6 (15.8)7 (17.9)13 (16.9)1.000
Nausea6 (15.8)9 (23.1)15 (19.5)0.420
Abdominal pain7 (18.4)11 (28.2)18 (23.4)0.310
Acute pancreatitis1 (2.6)01 (1.3)0.494
Alopecia01 (2.6)1 (1.3)1.000
Amenorrhea2 (5.3)1 (2.6)3 (3.9)0.615
Elevation of transaminase1 (2.6)1 (2.6)2 (2.6)1.000
Leukopenia7 (18.4)9 (23.1)16 (20.8)0.615
Tuberculosis000-
Colon cancer000-
Hematologic cancer000-
Death000-