Table 5.
Safety of rFVIIa
| Study identifier | Intervention | Number of patients treated | Any AE, n (%) | Any serious AE, n (%) | Any thromboembolic-associated event, n (%) | Any cardiovascular-related event, n (%) | Any death in patients receiving rFVIIa, n (%) | Mortality related to rFVIIa treatment, n (%) |
|---|---|---|---|---|---|---|---|---|
| Baudo 2004 [26] | rFVIIa | 15 | – | – | 0 (0) | – | 4 (26.7) | – |
| Baudo 2012 [7] | rFVIIa | 174 | – | – | 5 (2.9) | – | 29 (16.7) | – |
| Borg 2013 [2] | rFVIIa | 28 | – | – | – | – | 1 (3.57) | – |
| Hay 1997 [30] | rFVIIa | 38 | 5 (13.2) | – | 1 (2.6) | – | 4 (10.5) | – |
| Lentz 2014 [28] | rFVIIa | 65 | 0 (0) | – | – | – | 5 (7.7) | – |
| Luis 2010 [23] | rFVIIa | 11 | – | – | 0 (0) | – | 1 (9.1) | – |
| Ma 2012 [18] | rFVIIa | 68 | 3 (4.4) | 2 (2.9) | 1 (1.5) | 1 (1.5) | – | – |
| Scharf 2011a [31] | rFVIIa | 35 | – | – | – | – | 3 (8.6) | – |
| Seita 2013 [21] | rFVIIa | 132 | 19 (14.4) | 6 (4.5) | 3 (2.3) | – | 4 (3.03) | 2 (1.5)a |
| GTH Registry (data on file) [24] | rFVIIa | 61 | – | – | – | – | 6 (9.8) | 3 (4.9)a |
| Zhang 2015 [29] | Low-dose rFVIIa (25–55 μg/kg) | 12 | – | – | 0 (0) | – | 0 (0) | – |
| Zhang 2015 [29] | FVIII/low-dose rFVIIa (25–55 μg/kg) | 20 | – | – | 0 (0) | – | 0 (0) | – |
AE, adverse events; FVIII, factor VIII; N, number of evaluable patients; n, number of patients with outcome; rFVIIa, recombinant factor VIIa. Relationship of mortality to rFVIIa treatment as reported in the study; acausal relationship between rFVIIa therapy and the patient’s death could not be ruled out