| Study-related SAEs, n =38 (12.7%) |
| Catheter-related events (n = 36) |
| 15 infections in 7 subjects |
| 13 insertions/removals |
| 5 malfunctioning catheters |
| 2 catheter site wound dehiscences |
| FVIII reaction (n = 1) |
| Trauma (n = 1) |
| Non-study–related SAEs, n = 262 (87.3%) |
| 11 traumas* |
| 69 spontaneous bleeds |
| 140 catheter-related problems |
| 75 catheter infections in 23 subjects |
| 43 catheter insertion/removals |
| 1 subclavian thrombosis |
| 3 hematomas at injection site |
| 21 other catheter-related problems |
| 10 infections unrelated to catheters |
| 12 fever of unknown origin |
| 9 surgeries (including 2 dental extractions) |
| 2 bronchospasm |
| 1 possible FVIII reaction |
| 5 unspecified |
| AEs (n = 209) |
| 64 catheter-related AEs |
| 80 minor infections |
| 29 fevers |
| 30 traumas |
| 6 unspecified |
| Study-related SAEs, n =38 (12.7%) |
| Catheter-related events (n = 36) |
| 15 infections in 7 subjects |
| 13 insertions/removals |
| 5 malfunctioning catheters |
| 2 catheter site wound dehiscences |
| FVIII reaction (n = 1) |
| Trauma (n = 1) |
| Non-study–related SAEs, n = 262 (87.3%) |
| 11 traumas* |
| 69 spontaneous bleeds |
| 140 catheter-related problems |
| 75 catheter infections in 23 subjects |
| 43 catheter insertion/removals |
| 1 subclavian thrombosis |
| 3 hematomas at injection site |
| 21 other catheter-related problems |
| 10 infections unrelated to catheters |
| 12 fever of unknown origin |
| 9 surgeries (including 2 dental extractions) |
| 2 bronchospasm |
| 1 possible FVIII reaction |
| 5 unspecified |
| AEs (n = 209) |
| 64 catheter-related AEs |
| 80 minor infections |
| 29 fevers |
| 30 traumas |
| 6 unspecified |
Includes 1 death from traumatic intracranial hemorrhage, prerandomization.
AE indicates nonserious adverse event.