30 closest matches · ranked by relevance
Primary Immunodeficiency Diseases
Primary: Number of Serious Bacterial Infections Per Person-year of Treatment — 0.080 Serious infections per person-year of tr
Primary Immunodeficiency Diseases (PID)
Primary: Validated Acute Serious Bacterial Infection (VASBI) Rate — 0.025 Estimated infections/year — p=<0.0001
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 · 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
Celiac Disease
Primary: Number of Participants for Which Treatment Was Concluded to be Safe — 6; 18; 4; 5 participants
Primary Immune Deficiency Disorders · Common Variable Immunodeficiency · X-linked Agammaglobulinemia
Primary: Adverse Events — 2 participants — p=0.01
Primary Immune Deficiency
Primary: Annualized Rate of Serious Bacterial Infection (Intention-to-Treat Population) — 0.06 infections per subject year
Common Variable Immunodeficiency · X-linked Agammaglobulinemia · Autosomal Recessive Agammaglobulinemia
Primary: Total Serum IgG Trough Levels — 8.10; 7.49 g/L
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…
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…
Primary Immune Deficiency
Primary: Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs) (MITT Population) — 0.00 SBIs per subject year
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 Disorders (PIDD)
Primary: Rate of Serious Bacterial Infections (SBIs) Per Person-year on Treatment — 0.035 SBIs Per Total Person-Years
Complete DiGeorge Anomaly · DiGeorge Syndrome · DiGeorge Anomaly
Primary: Survival Rate at End of 1 Year — 79.3 percentage of participants
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
Infections After Lung Transplant
Primary: The Primary Outcome Will be the Total Number of Days With Pneumonia. — 1714; 51 Number of days
Primary Immune Deficiency
Primary: IgG Trough Level — 1.09; 1.11 Ratio of Geometric Means
Primary Thrombocytopenia
Primary: Percentage of Responders — 80.6 Percentage of participants
Autoimmune Autonomic Ganglionopathy (AAG)
Primary: Change in Systolic Blood Pressure During 60° Tilt (ΔSBP) — 42.5; -12.3 mmHg
Primary Immunodeficiency
Primary: Steady-state Area Under the Curve (AUC) for Serum Total Immunoglobulin (IgG) — 216873.7; 230830.0 h*mg/dL
Lymphoma
Primary: Overall Response — 3 participants
Hemophagocytic Lymphohistiocytosis · Chronic Active Epstein-Barr Virus Infection · Chronic Granulomatous Disease
Primary: Percentage of Participants With Overall Survival (OS) — 80.4; 66.7 percentage of participants
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…
Short Stature
Primary: Height Standard Deviation Score — -2.52; -1.57; -1.19; -1.09 standard deviation score
Agammaglobulinemia · IgG Deficiency · Common Variable Immunodeficiency
Primary: The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs). — 0.073; 0.141; 0.150 Proportion of infusions
Primary Immunodeficiency (PID)
Primary: Total Serum IgG Trough Levels — 7.97 g/L
Severe Combined Immunodeficiency
Primary: Number of Participants With Adverse Events — 10; 9; 0; 10 participants
Immunologic Deficiency Syndromes
Primary: Survival — 12 Participants
Inherited Immune Deficiencies
Primary: Stem Cell Transplant Engraftment — 7; 31; 3; 0 Participants