Treatment-emergent AEs in Phase 3 Studies
| Wk 0–18 | Long-term analysis (Wk 0-safety cutoff) | ||||
|---|---|---|---|---|---|
| Pbo (N=850) | SIR 50mg q4w (N=848) | SIR 100mg q2w (N=850) | SIR 50mg q4w (N=1461) | SIR 100mg q2w (N=1465) | |
| AEs, n (%) | 444 (52.2) | 515 (60.7) | 548 (64.5) | 1207 (82.6) | 1237 (84.4) |
| AEs leading to discontinuation, n (%) | 22 (2.6) | 34 (4.0) | 45 (5.3) | 174 (11.9) | 196 (13.4) |
| SAEs, n (%) | 27 (3.2) | 41 (4.8) | 46 (5.4) | 265 (18.1) | 268 (18.3) |
| Incidence* | 9.36 (6.17–13.61) | 14.36 (10.30–19.48) | 16.14 (11.82–21.53) | 13.12 (11.58–14.79) | 13.12 (11.60–14.79) |
| Serious infection, n (%) | 7 (0.8) | 16 (1.9) | 14 (1.6) | 102 (7.0) | 101 (6.9) |
| Incidence* | 2.40 (0.97–4.95) | 5.52 (3.15–8.96) | 4.81 (2.63–8.07) | 4.76 (3.88–5.77) | 4.67 (3.81–5.68) |
| GI perforation, n (%) | 0 | 1 (0.1) | 3 (0.4) | 5 (0.3) | 9 (0.6) |
| Incidence* | 0 (0–1.02) | 0.34 (0.01–1.91) | 1.02 (0.21–2.99) | 0.23 (0.07–0.53) | 0.41 (0.19–0.77) |
| MACE, n (%) | 2 (0.2) | 3 (0.4) | 2 (0.2) | 20 (1.4) | 9 (0.6) |
| Incidence* | 0.68 (0.08–2.47) | 1.03 (0.21–3.00) | 0.68 (0.08–2.46) | 0.92 (0.56–1.42) | 0.41 (0.19–0.77) |
| Malignancy, n (%) | 2 (0.2) | 1 (0.1) | 1 (0.1) | 23 (1.6) | 19 (1.3) |
| Incidence* | 0.68 (0.08–2.47) | 0.34 (0.01–1.91) | 0.34 (0.01–1.91) | 1.05 (0.67–1.58) | 0.86 (0.52–1.35) |
| Death, n (%) | 1 (0.1) | 1 (0.1) | 1 (0.1) | 15 (1.0) | 14 (1.0) |
| Incidence* | 0.34 (0.01–1.91) | 0.34 (0.01–1.91) | 0.34 (0.01–1.90) | 0.68 (0.38–1.13) | r 0.63 (0.35–1.06) |
*Incidence per 100 pt-years (95% CI).