Table 3.
Treatment regimens of rFVIIa across studies included in the systematic review
| Study identifier | Number of patients (Pt) or bleeds (B) treated | Initial dose (μg/kg) | Subsequent doses (μg/kg) | Dosing interval (hours) | Number of doses | Total dose per patient (mg/kg) | Total days of treatment | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dose | Min. | Max. | Doses | Min. | Max. | Dose | Min. | Max. | Mean | Min. | Max. | ||||
| Hay 1997 [30] | Pt = 38 | 90.4a | 45 | 181 | – | 2a | 28a | 1 | 541 | – | – | – | 3.9a | 0.0 | 43.0 |
| Baudo 2004 [26]b | Pt = 8 B = 10 |
90a (bolus) | 46 | 118 | 90a | 2 to 6 | 10a | 1 | 60 | – | – | – | 2.75a | 0 | 8 |
| Dehmel 2008 [25] | Pt = 10 | 105a | 88 | 150 | – | 2a | – | – | – | – | – | – | – | – | – |
| Luis 2010 [23] | Pt = 11 | 90 | – | – | 90c | 2 to 3 | 15c | 1 | 22 | – | – | – | – | – | – |
| Scharf 2011a [31] | Pt = 35 | – | – | – | 90–120 | 2 to 3 | – | – | – | – | – | – | – | – | – |
| Baudo 2012 [7]d | Pt = 159 (174 treated first line with rFVIIa) | 90a | – | – | – | 3a | 12a | 3 | 35 | 84a | 24 | 216 | – | – | – |
| Ma 2012 [18]e | Pt = 68 | 90a | 0.0 | – | – | – | 14.4c, f | 1 | 240 | – | – | – | 1a | – | – |
| Borg 2013 [2] | Pt = 28 | – | – | – | – | – | – | – | – | 0.8c | 0.01 | 3 | 4.7c | 2 | 33 |
| Seita 2013 [21]g | B = 302g | 99.5c | – | – | – | 4.6c | 11.6c | – | – | – | – | – | 2.9c | – | – |
| Lentz 2014 [28] | Pt = 65 | – | – | – | – | – | – | – | – | – | – | – | – | – | – |
| Zhang 2015 [29]h | Pt = 32 | 40c | 25 | 55 | – | 10c | 5.5c | 3 | 12 | 22c | 8 | 30 | – | – | – |
| GTH Registry (data on file) [24] | B = 51i | 90c | – | – | – | 3a | – | – | – | 250c | 5 | 1403 | – | – | – |
aMedian value; bContinuous infusion data were excluded; cMean value; dEfficacy and safety outcomes were reported for 159 and 174 patients, respectively; eData reported from CSR; fNumber of injections; gData for monotherapy included (302/372 bleeds) and supporting data taken from Amano (data on file); hData reported for monotherapy/combination therapy; iNumber of bleeds with known treatment dose, interval and outcome. B, number of bleeds; Max., maximum; Min., minimum; Pt, number of patients; rFVIIa, recombinant factor VIIa. Note: Borg 2013, Zhang 2015, and Lentz 2014 were included in the description of study characteristics; mean/median is not reported for Luis 2010 [23] initial dose