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Table 1 Efficacy of protection against infections

From: Efficacy, Safety, and Pharmacokinetics of a Novel Human Immune Globulin Subcutaneous, 20 % in Patients with Primary Immunodeficiency Diseases in North America

Parameter Annualized ratea per patient per treatment
IGIV 10 % (19.67 PY)b IGSC 20 % (83.70 PY)b
Point estimate 95 % CI Point estimate 95 % CI
Validated acute bacterial infections (VASBIs) [upper limit 99 % CI] 0.00 [0.234] 0.00 to 0.19 0.01c [0.024] 0.01 to 0.02
All infections d 3.86 2.77–5.22 2.41 1.89–3.03
Sinus infections 0.97 0.61–1.45 0.69 0.50–0.93
Fever episodes 0.61 0.34–0.99 0.13 0.08–0.21
Days off school or work due to illness or infection 3.20 1.88–5.03 1.16 0.70–1.79
Days on antibiotics 63.2 43.39–88.29 57.59 40.71–78.59
Days in hospital 0.20 0.08–0.42 0.11 0.05–0.20
Hospitalizations 0.05 0.02–0.10 0.02 0.01–0.04
Acute physician /emergency room visits 1.73 1.03–2.68 0.86 0.54–1.28
  1. NA not applicable, n number of treated patients, CI confidence interval
  2. aRate = number of infections divided by the total number of patient-years under treatment
  3. bPY: Patient-years = number of patient-years under treatment
  4. cFor the null hypothesis of one or more validated ASBI per year, p value < 0.0001
  5. dVASBIs and all other events clinically assessed as infections during the study