TABLE 16.
Adverse Events Occurring in >5% of Subjects With Primary Immunodeficiency During a Privigen® Infusion or Within 72 Hours After the End of an Infusion, Irrespective of Causality (PIDD Pivotal Study)
| Adverse Event* | Subjects (%) [N=80] | Infusions (%) [N=1,038] |
|---|---|---|
| Headache | 35 (43.8) | 82 (7.9) |
| Pain | 20 (25.0) | 44 (4.2) |
| Fatigue | 13 (16.3) | 27 (2.6) |
| Nausea | 10 (12.5) | 19 (1.8) |
| Chills | 9 (11.3) | 15 (1.4) |
| Vomiting | 7 (8.8) | 13 (1.3) |
| Pyrexia | 6 (7.5) | 10 (1.0) |
| Cough | 5 (6.3) | 5 (0.5) |
| Diarrhea | 5 (6.3) | 5 (0.5) |
| Stomach discomfort | 5 (6.3) | 5 (0.5) |
*
Excluding infections.
Source: Adapted from Privigen® Prescribing Information 2011.