Table 1 (abstract A8). Safety Summary
| Â | pJIA | sJIA | ||||
|---|---|---|---|---|---|---|
TCZ SC Q3W (<30 kg) n = 24 | TCZ SC Q2W (≥30 kg) n = 20 | All TCZ SC N = 44 | TCZ SC Q10D or Q2W (<30 kg) n = 19 | TCZ SC QW (≥30 kg) n = 19 | All TCZ SC N = 38 | |
Duration in study, PY | 52.3 | 48.8 | 101.1 | 23.4 | 44.0 | 67.3 |
AEs | ||||||
 Pts, n (%) | 24 (100) | 20 (100) | 44 (100) | 17 (89.5) | 17 (89.5) | 34 (89.5) |
 n | 269 | 249 | 518 | 136 | 222 | 358 |
 rate/100 PY (95% CI) | 514.0 (454.5, 579.3) | 510.7 (449.2, 578.2) | 512.4 (469.2, 558.5) | 582.2 (488.5, 688.7) | 504.8 (440.6, 575.7) | 531.6 (478.0, 589.7) |
SAEs | ||||||
 Pts, n (%) | 2 (8.3) | 3 (15.0) | 5 (11.4) | 1 (5.3) | 1 (5.3) | 2 (5.3) |
 n | 2 | 4 | 6 | 1 | 1 | 2 |
 rate/100 PY (95% CI) | 3.8 (0.5, 13.8) | 8.2 (2.2, 21.0) | 5.9 (2.2, 12.9) | 4.3 (0.1, 23.9) | 2.3 (0.1, 12.7) | 3.0 (0.4, 10.7) |
AEs leading to withdrawal | ||||||
 Pts, n (%) | 2 (8.3) | 1 (5.0) | 3 (6.8) | 0 | 0 | 0 |
 n | 2 | 1 | 3 | 0 | 0 | 0 |
 rate/100 PY (95% CI) | 3.8 (0.5, 13.8) | 2.1 (0.1, 11.4) | 3.0 (0.6, 8.7) |  |  |  |
AEs leading to dose interruption | ||||||
 Pts, n (%) | 11 (45.8) | 2 (10.0) | 13 (29.5) | 4 (21.1) | 6 (31.6) | 10 (26.3) |
 n | 21 | 3 | 24 | 7 | 14 | 21 |
 rate/100 PY (95% CI) | 40.1 (24.8, 61.3) | 6.2 (1.3, 18.0) | 23.7 (15.2, 35.3) | 30.0 (12.0, 61.7) | 31.8 (17.4, 53.4) | 31.2 (19.3, 47.7) |