Summary of AEs that are related or of unknown relationship to rFIX
Adverse event . | No. of patients (%) . | No. of events . |
|---|---|---|
| Infection* | 2 (3) | 2 |
| Rigors (chills) | 1 (2) | 1 |
| Injection site reaction | 1 (2) | 1 |
| Photosensitivity reaction | 1 (2) | 1 |
| Diarrhea | 1 (2) | 5 |
| FIX inhibitor | 2 (3) | 2 |
| Elevated alkaline phosphatase | 1 (2) | 1 |
| Elevated AST | 1 (2) | 1 |
| Elevated ALT | 1 (2) | 1 |
| Dyspnea | 2 (3) | 2 |
| Asthma | 1 (2) | 1 |
| Urticaria | 3 (5) | 3 |
| Rash | 1 (2) | 1 |
Adverse event . | No. of patients (%) . | No. of events . |
|---|---|---|
| Infection* | 2 (3) | 2 |
| Rigors (chills) | 1 (2) | 1 |
| Injection site reaction | 1 (2) | 1 |
| Photosensitivity reaction | 1 (2) | 1 |
| Diarrhea | 1 (2) | 5 |
| FIX inhibitor | 2 (3) | 2 |
| Elevated alkaline phosphatase | 1 (2) | 1 |
| Elevated AST | 1 (2) | 1 |
| Elevated ALT | 1 (2) | 1 |
| Dyspnea | 2 (3) | 2 |
| Asthma | 1 (2) | 1 |
| Urticaria | 3 (5) | 3 |
| Rash | 1 (2) | 1 |
Eleven patients had a total of 22 AEs. These patients may appear in more than one AE category and may have had more than one occurrence of a specific AE. Table includes AEs that were of definite, probable, possible, or unknown relationship to rFIX and excludes all AEs that occurred before study drug dosing.
Includes one event of hepatitis A seroconversion and one event of parvovirus B19 seroconversion, each in one patient; the relationship of both events to rFIX was unknown.