Table 1
0–1y1–2y2–3y3–4y4–5y5–6y6–7y7–8y8–9y9–10y10–11y
(N=296)(N=294)(N=276)(N=250)(N=223)(N=209)(N=192)(N=178)(N=169)(N=152)(N=131)
Incidence of ≥1 AE, n (%)
 Overall291 (98.3)283 (96.3)260 (94.2)239 (95.6)203 (91.0)190 (90.9)182 (94.8)162 (91.0)157 (92.9)137 (90.1)105 (80.2)
 Resulting in discontinuation2 (0.7)3 (1.0)3 (1.1)7 (2.8)5 (2.2)6 (2.9)6 (3.1)1 (0.6)3 (1.8)5 (3.3)2 (1.5)
 Serious AE41 (13.9)43 (14.6)50 (18.1)30 (12.0)40 (17.9)33 (15.8)35 (18.2)34 (19.1)28 (16.6)25 (16.4)14 (10.7)
 Serious infections/infestations11 (3.7)13 (4.4)9 (3.3)9 (3.6)6 (2.7)6 (2.9)12 (6.3)10 (5.6)8 (4.7)5 (3.3)5 (3.8)
 Death1 (0.3)01 (0.4)1 (0.4)01 (0.5)2 (1.0)001 (0.7)0
Y1Y2Y3Y4Y5Y6Y7Y8Y9Y10
Prednisone
 median % change from baseline;-0.4;-25.0;-36.9;-50.0;-48.3;-60.0;-62.5;-70.0;-66.7;-65.8;
 25th, 75th percentile (n)-50.0, 0 (186)-74.2, 0 (172)-80.0, 0 (153)100.0, 0 (140)-100.0, 0 (128)0 (115)-100.0, -10.7 (105)-100.0, -1.6 (94)-100.0, -0 (91)-100.0, 0 (84)