TABLE 11.
Incidence of Subjects With Adverse Reactions (ARs) (Experienced by 2 or More Subjects) to Hizentra™ and Rate per Infusion (ITT Population)
| Adverse reaction (≥2 Subjects) | Number (%) of subjects (n=49) | Number (rate*) of adverse reactions (n=2264 infusions) |
|---|---|---|
| Local reactions† | 49 (100) | 1338 (0.591) |
| Other ARs: | ||
| Headache | 12 (24.5) | 36 (0.016) |
| Vomiting | 3 (6.1) | 3 (0.001) |
| Pain | 3 (6.1) | 4 (0.002) |
| Fatigue | 3 (6.1) | 3 (0.001) |
| Contusion | 2 (4.1) | 3 (0.001) |
| Back pain | 2 (4.1) | 3 (0.001) |
| Migraine | 2 (4.1) | 3 (0.001) |
| Diarrhea | 2 (4.1) | 2 (<0.001) |
| Abdominal pain, upper | 2 (4.1) | 2 (<0.001) |
| Nausea | 2 (4.1) | 2 (<0.001) |
| Rash | 2 (4.1) | 2 (<0.001) |
| Arthralgia | 2 (4.1) | 2 (<0.001) |
*
Rate of ARs per infusion.
†
Includes injection-site reactions as well as bruising, scabbing, pain, irritation, cysts, eczema, and nodules at the injection site.