Maarten Cozijnsen

129 Chapter 6 Benefits and risks of combination therapy in children with IBD Endpoints Results** Serious infections [1] 6.2/100PY vs. [2] 3.5/100PY, P>0.05 Malignancy [1] 4/3599PY=0.11/100PY vs. [2] 0/748PY=0/100PY, P<0.05 ,[3] 3/2411PY=0.12/100PY a) AE b) SAE c) Infections d) Serious infections e) Infusion reactions a) [1] 161/179 (90%) vs. [2] 145/163 (89%), P=1; [3] 144/161 (89%) b) [1] 27/179 (15%) vs. [2] 39/163 (24%), P=0.04 ; [3] 43/161 (27%) c) [1] 75/179 (42%) vs. [2] 75/163 (46.0), P=0.45; [3] 73/161 (45.3) d) [1] 7/179 (4%) vs. [2] 8/163 (5%), P=0.61; [3] 9/161 (6%) e) [1] 9/179 (5%) vs. [2] 27/163 (17%), P<0.001 ; [3] 9/161 (6%) a) AE b) SAE c) Infusion reactions a) [1] 30/80 (38%) vs. [2] 26/78 (33%), P≈0.6; [3] 41/79 (52%) b) [1] 3/80 (4%) vs. [2] 2/78 (3%), P≈0.6; [3] 6/79 (8%) c) [1] 0/80 (0%) vs. [2] 0/78 (0%), P=1; [3] 1/79 (1%) a) AE b) SAE c) Infusion reactions a) A list of most common AEs***, P>0.05 b) [1] 6/63 (10%) vs. [2] 2/63 (3%), P≈0.1 c) [1] 1/63 (2%); [2] 3/63 (5%), P≈0.6 a) AE b) SAE c) Infections d) Infusion reaction a) [1] 24/40 (60%) vs. [2] 25/40 (63%), P≈0.8 b) [1] 3/40 (8%) vs. [2] 3/40 (8%), P≈1.0 c) [1] 12/40 (30%) vs. [2] 10/40 (25%), P≈0.6 d) [1] 3/40 (8%) vs. 2/40 (5%), P≈1.0 a) SAE (OR) b) Infusion reaction (OR) a) [1] vs. [2] 1.11 (0.56-2.20) b) [1a] vs. [2a] 0.43 (0.19-0.97) a) Infections b) Serious infections a) [1] 166/376 (44%) vs. [2] 281/631 (45%), P≈ 0.9 b) [1] 14/376 (4%) vs. [2] 20/631 (3%), P≈ 0.6 a) Malignancy b) Mortality a) [1] 1/300PY=0.33/100PY (0.01-1.86) vs. [2] 1/303PY=0.33/100PY (0.01-1.84) vs [3] 2/170PY=1.17/100PY (0.14-4.24) b) [1] 3/1020PY=0.29/100PY (0.06-0.86) vs. [2] 2/1256PY=0.16/100PY (0.02-0.58)