DB phase week 0 – week 12 | OL phase week 12 – week 28 | |||
---|---|---|---|---|
(Safety set) | (OL set) | |||
Placebo | CZP | Placebo → CZPa | CZP → CZPa | |
(n = 209) | (n = 846) | (n = 184) | (n = 770) | |
Any AE, incidence/100 pt-yrs (n, %) | 483.2 (129, 61.7) | 522.1 (571, 67.5) | 328.9 (142, 77.2) | 239.1 (521, 67.7) |
Patients discontinuing due to AE, n (%) | 8 (3.8) | 40 (4.7) | 3 (1.6) | 26 (3.4) |
Injection and infusion site reactions, incidence/100 pt-yrs (n, %) | 4.2 (2, 1.0) | 25.3 (49, 5.8) | 8.8 (9, 4.9) | 3.2 (14, 1.8) |
Serious AEs, incidence/100 pt-yrs (n, %) | 25.8 (12, 5.7) | 26.7 (52, 6.1) | 20.6 (21, 11.4) | 13.0 (56, 7.3) |
Serious infections, incidence/100 pt-yrs (n, %) | 8.3 (4, 1.9) | 11.1 (22, 2.6) | 5.7 (6, 3.3) | 4.1 (18, 2.3) |
Deaths, n (%) | 0 | 2 (0.2) | 1 (0.5) | 1 (0.1) |