The incidence of inhibitor formation dependent on period of study
| . | All patients . | Non-RODIN . | RODIN . | ||||||
|---|---|---|---|---|---|---|---|---|---|
| . | No. of inhibitors . | No. of patients . | % . | No. of inhibitors . | No. of patients . | % . | No. of inhibitors . | No. of patients . | % . |
| 2000-2004 | |||||||||
| Advate | 3 | 12 | 25 | 1 | 7 | 14.3 | 2 | 5 | 40 |
| Kogenate Bayer/Helixate NexGen | 24 | 65 | 37 | 20 | 55 | 36.4 | 4 | 10 | 40 |
| 2005-2008 | |||||||||
| Advate | 26 | 117 | 22 | 20 | 87 | 23 | 6 | 30 | 20 |
| Kogenate Bayer/Helixate NexGen | 16 | 31 | 52 | 11 | 25 | 44 | 5 | 6 | 83.3 |
| 2009-2013 | |||||||||
| Advate | 13 | 43 | 30 | 8 | 30 | 26.7 | 5 | 13 | 38.5 |
| Kogenate Bayer/Helixate NexGen | 5 | 32 | 16 | 4 | 27 | 14.8 | 1 | 5 | 20 |
| . | All patients . | Non-RODIN . | RODIN . | ||||||
|---|---|---|---|---|---|---|---|---|---|
| . | No. of inhibitors . | No. of patients . | % . | No. of inhibitors . | No. of patients . | % . | No. of inhibitors . | No. of patients . | % . |
| 2000-2004 | |||||||||
| Advate | 3 | 12 | 25 | 1 | 7 | 14.3 | 2 | 5 | 40 |
| Kogenate Bayer/Helixate NexGen | 24 | 65 | 37 | 20 | 55 | 36.4 | 4 | 10 | 40 |
| 2005-2008 | |||||||||
| Advate | 26 | 117 | 22 | 20 | 87 | 23 | 6 | 30 | 20 |
| Kogenate Bayer/Helixate NexGen | 16 | 31 | 52 | 11 | 25 | 44 | 5 | 6 | 83.3 |
| 2009-2013 | |||||||||
| Advate | 13 | 43 | 30 | 8 | 30 | 26.7 | 5 | 13 | 38.5 |
| Kogenate Bayer/Helixate NexGen | 5 | 32 | 16 | 4 | 27 | 14.8 | 1 | 5 | 20 |
The incidence of inhibitor formation dependent on study time period shows that the increased incidence associated with Kogenate Bayer/Helixate NexGen was seen in the first 2 time periods and not the third. The number of patients exposed to Kogenate Bayer/Helixate NexGen in the final time period is lower than earlier in the study.