TABLE 18.

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 Extension Study)

Adverse Event*	Subjects (%) [N=55]	Infusions (%) [N=771]
Headache	18 (32.7)	56 (7.3)
Pain, all types†	14 (25.5)‡	31 (4.0)
Abdominal pain§	3 (5.5)	4 (0.5)
Chest pain	3 (5.5)	4 (0.5)
Pharyngolaryngeal pain	3 (5.5)	4 (0.5)
Nausea	6 (10.9)	10 (1.3)
Pyrexia	4 (7.3)	9 (1.2)
Chills	3 (5.5)	7 (0.9)
Influenza-like illness	3 (5.5)	4 (0.5)

Note: The AE rates in this study cannot be compared directly with the rates in other IVIg studies, including the original pivotal study of Privigen^®, because 1) the extension study used an enriched population, and 2) the selective use of higher infusion rates at the investigators’ discretion in a subset of subjects may have introduced bias.

^*Excluding infections.

^†Includes abdominal pain, abdominal pain upper, arthralgia, back pain, chest pain, fibromyalgia, injection-site pain, myalgia, pain, pain in extremity, painful respiration, pharyngolaryngeal pain, and toothache.

^§Also includes abdominal pain, upper.

^‡Some subjects experienced more than one type of pain.

Source: Adapted from Privigen^® Prescribing Information 2011.