Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)

The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs).

AEs were considered temporally-associated AEs if they occurred during the infusion or in the period from the start of the infusion until either 48 or 72 hours after the end of the infusion.

Time frame: During each infusion, and within 48 or 72 hours after the end of each infusion.

Influence of Infusion Rate on Temporally-Associated AEs

The total and most frequent (1% or more) number of infusions for which subjects experienced temporally-associated AEs occurring within 72 hours of infusion, by infusion rate (≤ 4 mg/kg/min, ≤ 8 mg/kg/min, and \> 8 and ≤ 12 mg/kg/min). AEs were considered to be temporally-associated AEs if they occurred in the period from the start of the infusion until 72 hours after the end of the infusion.

Time frame: Within 72 hours after each infusion

Rate of AEs by Severity and Relationship

The AE rate was the number of AEs over the number of infusions administered. Mild AEs: Did not interfere with daily activities; Moderate AEs: Interfered with routine daily activities; Severe AEs: Impossible to perform routine daily activities. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.

Time frame: For the duration of the study, up to approximately 29 months

Number of Subjects With Clinically Significant Changes in Vital Signs.

Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.

Time frame: Before, during, and after each infusion.