rFVIIIFc consumption on study and bypassing agent use during the ITI period
| . | Total∗, † (N = 16) . | ITI period∗ (N = 16) . | Tapering period‡ (N = 10) . | Follow-up period§ (N = 10) . |
|---|---|---|---|---|
| Annualized rFVIIIFc consumption‖,¶,# n | ||||
| 16 | 13 | 10 | 10 | |
| Median (IQR), IU/kg per y | 36 717 (25 646-62 841) | 70 677 (59 996-72 466) | 22 342 (19 106-27 220) | 9 210 (8 205-12 544) |
| Patients receiving bypassing agents,∗∗ n (%) | ||||
| aPCC | 4 (25.0) | 4 (25.0) | 0 | 0 |
| rFVIIa | 5 (31.3) | 5 (31.3) | 0 | 0 |
| Median (IQR) annualized bypassing agent consumption¶,†† | ||||
| aPCC, U/kg per y | 4 866 (211-26 437) | 9 463 (154-43 411) | N/A | N/A |
| rFVIIa, μg/kg per y | 2 345 (229-23 642) | 5 691 (714-23 642) | N/A | N/A |
| . | Total∗, † (N = 16) . | ITI period∗ (N = 16) . | Tapering period‡ (N = 10) . | Follow-up period§ (N = 10) . |
|---|---|---|---|---|
| Annualized rFVIIIFc consumption‖,¶,# n | ||||
| 16 | 13 | 10 | 10 | |
| Median (IQR), IU/kg per y | 36 717 (25 646-62 841) | 70 677 (59 996-72 466) | 22 342 (19 106-27 220) | 9 210 (8 205-12 544) |
| Patients receiving bypassing agents,∗∗ n (%) | ||||
| aPCC | 4 (25.0) | 4 (25.0) | 0 | 0 |
| rFVIIa | 5 (31.3) | 5 (31.3) | 0 | 0 |
| Median (IQR) annualized bypassing agent consumption¶,†† | ||||
| aPCC, U/kg per y | 4 866 (211-26 437) | 9 463 (154-43 411) | N/A | N/A |
| rFVIIa, μg/kg per y | 2 345 (229-23 642) | 5 691 (714-23 642) | N/A | N/A |
aPCC, activated prothrombin complex concentrate; N/A, not applicable.
Total study and ITI period based on the ITI full analysis set.
The total column includes a patient’s entire study period for annualized consumption calculations.
Tapering period is based on the tapering period full analysis set.
Follow-up period is based on the follow-up period full analysis set.
Annualized rFVIIIFc consumption for a treatment period is the (total nominal rFVIIIFc [IU/kg] per length of period in days) × 365.25.
Annualized analysis excludes patients who were observed for <90 days in the period.
Surgical-related consumption was not included.
Bypassing agents were used only during the ITI period.
Annualized bypassing agent consumption is the (total consumption/length of period in days) × 365.25.