GAMMAGARD LIQUID - IV Administration
Protecting life's moments with sustained protection against infection1,2
In the IV administration of GAMMAGARD LIQUID clinical study:
|validated acute serious bacterial infections|
Summary of Validated Acute Serious Bacterial Infections for the Per-Protocol Analysis
P valueb P < .0001 | 95% confidence interval (0.000, 0.064)
aSerious acute bacterial infections were defined by FDA and met specific diagnostic requirements.
bThe rate of validated infections was compared with a rate of <1 per subject per year, in accordance with recommendations by the FDA Blood Products Advisory Committee.
|hospitalizations secondary to validated bacterial infections|
|validated other bacterial infections|
Summary of Validated Other Bacterial Infections
cThe rate of validated infections was compared with a rate of <1 per subject per year, in accordance with recommendations by the FDA Blood Products Advisory Committee.
dOther bacterial infections that met specific diagnostic requirements.
References: 1. GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% [Prescribing Information]. Westlake Village, CA: Baxalta US Inc. 2. Church JA, Leibl H, Stein MR, et al, and the US-PID-IGIV 10%-Study Group. Efficacy, safety and tolerability of a new 10% liquid intravenous immune globulin [IVIG 10%] in patients with primary immunodeficiency. J Clin Immunol. 2006;26:388-395.
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