Adverse events reported during the study
Adverse event by patient and dose cohort . | Severity . | Day of onset . | Duration, d . |
|---|---|---|---|
| Patient 4; 6 U/kg | |||
| Headache | Mild | 2 | Ongoing |
| Pharyngolaryngeal pain | Mild | 2 | 2 |
| Throat tightness | Mild | 2 | 2 |
| Arthralgia | Mild | 3 | Ongoing |
| Contusion | Mild | 7 | 5 |
| Arthralgia | Mild | 7 | 5 |
| Patient 6; 20 U/kg | |||
| Headache | Mild | 1 | 1 |
| Patient 7; 50 U/kg | |||
| Headache | Mild | 1 | 1 |
| Pain in limb | Mild | 2 | 1 |
| Body aches | Moderate | 8 | 8 |
| Patient 9; 50 U/kg | |||
| Arthralgia | Mild | 2 | 1 |
Adverse event by patient and dose cohort . | Severity . | Day of onset . | Duration, d . |
|---|---|---|---|
| Patient 4; 6 U/kg | |||
| Headache | Mild | 2 | Ongoing |
| Pharyngolaryngeal pain | Mild | 2 | 2 |
| Throat tightness | Mild | 2 | 2 |
| Arthralgia | Mild | 3 | Ongoing |
| Contusion | Mild | 7 | 5 |
| Arthralgia | Mild | 7 | 5 |
| Patient 6; 20 U/kg | |||
| Headache | Mild | 1 | 1 |
| Patient 7; 50 U/kg | |||
| Headache | Mild | 1 | 1 |
| Pain in limb | Mild | 2 | 1 |
| Body aches | Moderate | 8 | 8 |
| Patient 9; 50 U/kg | |||
| Arthralgia | Mild | 2 | 1 |
No serious adverse events were reported during the study. Eleven adverse events were reported among 4 patients; patient 4 reported 6 of these events. Patient 4 had a history of headaches and arthralgia before the start of the study. Adverse events did not appear related to the dose of rFXIII administered or to the timing of dose in relation to the reported adverse event. No bleeding or thrombotic complications were noted during the study period.