Table 2.
Distribution of serious adverse event reports for biologic response modifiers
| Drug |
Number of Serious Event Reports (%)
|
||
|---|---|---|---|
|
All Serious Events
(EB05 >0) n=12,151 |
All Signals
(EB05 >1) n=1,711 |
Significant Signals
(EBGM ≥ 2) n=199 |
|
| Antithymocyte immunoglobulin | 725 (5.9) | 172 (10.0) | 68 (34.1) |
| Azathioprine | 99 (0.8) | 36 (2.1) | 18 (9.0) |
| Cyclosporine | 1,067 (8.8) | 113 (6.6) | 58 (29.1) |
| Cyclophosphamide | 60 (0.5) | 9 (0.5) | 9 (4.5) |
| Daclizumab | 267 (2.2) | 22 (1.3) | 22 (11.0) |
| Everolimus | 5 (0.04) | 0 (0.0) | 0 (0.0) |
| Mycophenolic Acid | 2,317 (19.0) | 304 (18.0) | 0 (0.0) |
| Sirolimus | 6,749 (55.0) | 896 (52.0) | 0 (0.0) |
| Tacrolimus | 841 (6.9) | 159 (9.3) | 24 (12.0) |
| Tacrolimus and Sirolimus | 21 (0.2) | 0 (0.0) | 0 (0.0) |
EBGM: Empirical Bayes geometric mean
EB05: Lower limit of 95% confidence interval
n: Number of reports within the corresponding category