Table 2 Overview of serious adverse events and adverse events of interest (E (E/100 PYs)) during more than 5 years of ADA treatment
| Â | Â | Time windows after the first injection of ADA in ReAct | ||||
|---|---|---|---|---|---|---|
|  |  | ≤0.5 Y | >0.5 to 1 Y | >1 to 3 Y | >3 to 5 Y | >5 Y |
| Â | Â | N = 6,610 | N = 5,922 | N = 4,283 | N = 2,623 | N = 2,000 |
Adverse event (AE) | Overall N = 6,610 (18,272 PYs) | (3,059 PYs) | (2,256 PYs) | (6,149 PYs) | (4,549 PYs) | (2,260 PYs) |
Serious AEs* | 2,529 (13.8) | 838 (27.4) | 419 (18.6) | 661 (10.7) | 417 (9.2) | 194 (8.6) |
Fatal AEs | 102 (0.6) | 29 (0.9) | 19 (0.8) | 27 (0.4) | 17 (0.4) | 10 (0.4) |
Serious infections* | 518 (2.8) | 162 (5.3) | 83 (3.7) | 154 (2.5) | 81 (1.8) | 38 (1.7) |
TB†| 35 (0.2) | 11 (0.4) | 11 (0.5) | 8 (0.1) | 4 (0.1) | 1 (<0.1) |
Sepsis | 35 (0.2) | 13 (0.4) | 4 (0.2) | 7 (0.1) | 7 (0.2) | 4 (0.2) |
Malignancies‡ | 121 (0.7) | 19 (0.6) | 16 (0.7) | 45 (0.7) | 25 (0.5) | 16 (0.7) |
Lymphoma | 15 (0.1) | 1 (<0.1) | 0 | 9 (0.1) | 4 (0.1) | 1 (<0.1) |
NMSC | 43 (0.2) | 8 (0.3) | 2 (0.1) | 17 (0.3) | 11 (0.2) | 5 (0.2) |
Serious CHF* | 47 (0.3) | 15 (0.5) | 6 (0.3) | 12 (0.2) | 13 (0.3) | 1 (<0.1) |
Cerebrovascular AEs§ | 56 (0.3) | 13 (0.4) | 5 (0.2) | 16 (0.3) | 15 (0.3) | 7 (0.3) |
Serious hepatic events* | 58 (0.3) | 10 (0.3) | 13 (0.6) | 16 (0.3) | 13 (0.3) | 6 (0.3) |