30 closest matches · ranked by relevance
Infections After Lung Transplant
Primary: The Primary Outcome Will be the Total Number of Days With Pneumonia. — 1714; 51 Number of days
Immunologic Deficiency Syndromes
Primary: The Incidence of Acute Serious Bacterial Infections (SBI) — 0.04; 0; 0.02 Number of events per patient per year
Primary Immunodeficiency Diseases
Primary: Number of Serious Bacterial Infections Per Person-year of Treatment — 0.080 Serious infections per person-year of tr
Common Variable Immunodeficiency · X-linked Agammaglobulinemia · Autosomal Recessive Agammaglobulinemia
Primary: Total Serum IgG Trough Levels — 8.10; 7.49 g/L
Primary Immune Deficiency
Primary: Annualized Rate of Serious Bacterial Infection (Intention-to-Treat Population) — 0.06 infections per subject year
Multiple Myeloma · Plasma Cell Neoplasm
Primary: Tolerance for Human Immune Globulin Intravenous (IGIV), as Reflected by the Number and Severity of Toxicity Incidents Occurring in Ten Patients Receiving at Least One…
Primary Immunodeficiency Diseases (PID)
Primary: Validated Acute Serious Bacterial Infection (VASBI) Rate — 0.025 Estimated infections/year — p=<0.0001
Primary Immunodeficiency · Common Variable Hypogammaglobulinemia · X-linked Hypogammaglobulinemia
Primary: Number of Serious, Acute, Bacterial Infections (SABIs) Per Subject Per Year in Subjects With Primary Immunodeficiency Disease. — 0 SABIs/subject/year — p=0.01
Primary Thrombocytopenia
Primary: Percentage of Responders — 80.6 Percentage of participants
Immunologic Deficiency Syndrome
Primary: Geometric Least Square Means of Area Under the Curve (AUC) for Plasma Total Immunoglobulin G (IgG) — 7549; 6706 mg*hr/ml
Primary Immune Deficiency
Primary: Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs) (MITT Population) — 0.00 SBIs per subject year
Common Variable Immunodeficiency · Agammaglobulinemia
Primary: Proportion of Patients Achieving Immunoglobulin G (IgG) Levels ≥ 5 g/L on Day 12 — 0.944 proportion of patients
Primary Immune Deficiency Disorders · Common Variable Immunodeficiency · X-linked Agammaglobulinaemia
Primary: Primary Bioequivalence Analysis - Area Under the Curve Within a 28-day Dosing Interval (AUC0-28) in Adult Subjects — 1.01; 1.01; 1.07; 1.07 ratio Gammaplex 10%/Gammaplex…
Primary Immunodeficiency
Primary: Annual Rate of Occurrence of Serious Bacterial Infections (SBI) — 0; 0.01; 0; 0.03 Rate of events per subject per year
Influenza · Multiple Myeloma · Waldenstrom's Macroglobulinemia
Primary: Number of Participants With Treatment Failure by Primary Endpoint — 26; 13 Participants
Primary Immune Deficiency Disorders (PIDD)
Primary: Rate of Serious Bacterial Infections (SBIs) Per Person-year on Treatment — 0.035 SBIs Per Total Person-Years
Gaucher Disease
Primary: Number of Patients With GD Diagnosis Confirmed by : Enzyme Testing of acidβ-glucosidase Activity Activity <15% in Blood Leucocytes Completed When Necsssary by GB1…
Hematologic Diseases · Secondary Immune Deficiency
Primary: Infusion Time of Multigam IV 5% and Multigam IV 10% — 4.92; 2.29 hour — p=<0.0001
Primary Immunodeficiency
Primary: Steady-state Area Under the Curve (AUC) for Serum Total Immunoglobulin (IgG) — 216873.7; 230830.0 h*mg/dL
Hypogammaglobulinemia · Lung Transplantation
Primary: Number of Clinically Diagnosed Bacterial Infections During the Treatment Period — 3; 1 Infections
Primary Immunodeficiency
Primary: AUC (0-7): Area Under the Concentration Time Curve Over a Dosing Interval of Either Every 3 Weeks [AUC0-21 Days] or Every 4 Weeks [AUC0-28 Days] for Total Immunoglobulin…
Primary Immune Deficiency Disorder
Primary: IgG Trough Levels From Baseline to End of Study (28 Weeks) — 0.144; 0.065; -0.593 g/L
Primary Immune Deficiency
Primary: IgG Trough Level — 1.09; 1.11 Ratio of Geometric Means
Primary Immunodeficiency
Primary: AUC in the IV Phase and SC Phases: Steady-state AUC of Total IgG Over a Regular Dosing Interval — 207921.5; 213141.4 h*mg/dL
Primary Immune Deficiency Disorders · Common Variable Immunodeficiency · X-linked Agammaglobulinemia
Primary: Adverse Events — 2 participants — p=0.01
Primary Immunodeficiency
Primary: Rate of Serious Bacterial Infection (SBI) Per Participant Per Year — 0; 0.023; 0.017 Rate of events per participant per year
Immune Thrombocytopenic Purpura
Primary: Set of Antibodies Most Frequently Bound to Red Blood Cells (RBCs) in Subjects Experiencing Clinically Significant Intravascular Hemolysis
Hypogammaglobulinemia · Congenital Heart Disease
Primary: Post-Operative Infections — 9; 6; 21; 14 subjects — p=1
Primary Immune Deficiency Disorder
Primary: Number of Serious Bacterial Infections Per Person-Year on Treatment — 0 SBI per patient year
Autoimmune Autonomic Ganglionopathy (AAG)
Primary: Change in Systolic Blood Pressure During 60° Tilt (ΔSBP) — 42.5; -12.3 mmHg