Incidence of ≥1 AE, n (%) |
Overall | 291 (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 discontinuation | 2 (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 AE | 41 (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/infestations | 11 (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) |
Death | 1 (0.3) | 0 | 1 (0.4) | 1 (0.4) | 0 | 1 (0.5) | 2 (1.0) | 0 | 0 | 1 (0.7) | 0 |
| | Y1 | Y2 | Y3 | Y4 | Y5 | Y6 | Y7 | Y8 | Y9 | Y10 |
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) |