ASIS for GAMMAGARD in Primary Immunodeficiency (ASISinPI)
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ClinicalTrials.gov Identifier: NCT02123615 |
Recruitment Status : Unknown
Verified June 2015 by ASIS Corporation.
Recruitment status was: Not yet recruiting
First Posted : April 25, 2014
Last Update Posted : June 24, 2015
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Condition or disease | Intervention/treatment | Phase |
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Primary Immunodeficiency | Drug: Gadolinium For abdomen Drug: Gadolinium For lower back Drug: Efficacy of Gammagard subcutaneously at Week 12 Drug: Efficacy of Gammagard subcutaneously at Week 24 Drug: Efficacy of Gammagard subcutaneously at Week 36 Drug: Efficacy of Gammagard subdermally at Week 36 Drug: Efficacy of Gammagard subdermally at Week 12 Drug: Efficacy of Gammagard subdermally at Week 24 Drug: Adverse Reactions of Gammagard subcutaneously at Week 12 Drug: Adverse Reactions of Gammagard subcutaneously at Week 24 Drug: Adverse Reactions of Gammagard subcutaneously at Week 36 Drug: Adverse Reactions of Gammagard subdermally at Week 12 Drug: Adverse Reactions of Gammagard subdermally at Week 24 Drug: Adverse Reactions of Gammagard subdermally at Week 36 | Phase 1 Phase 2 |
Aim 1 would require 6 months, to demonstrate ASIS device's consistent performance on 60 subjects with Primary Immunodeficiency (PI), and the particular skin affected by this disease.
30 subjects will receive Gadolinium subcutaneously, and 30 subjects will receive Gadolinium subdermally with ASIS device. An MRI will be taken promptly after Gadolinium injection, as starting reference, to which subsequent MRI taken at 6 hrs, 12 hrs, and 24 hrs later will be compared for Persistent %. Since there isn't a way to measure level of Gadolinium within it, or any other (e.g.
GAMMAGARD) for that matter, at least the Prolongation of Gadolinium may be approximated by the greater or longer Persistent % on MRI. However, this approximation can only work if the variables are minimized to the same population with Primary Immunodeficiency (PI), and the particular skin affected by it. Case in point, Primary Immunodeficiency (PI) patients are prone to infection, and tend to have scared skin with less vascularity, so expectantly will have prolonged Gadolinium subcutaneously Persistent %, which will be very different from the skin of normal patients, while the Gadolinium subdermally Persistent % may or may not change. Therefore, the Relative Prolongation Ability Score or total Persistent % subdermally over that of total Persistent % subcutaneously, will be different and very specific for the particular skin affected by Primary Immunodeficiency. However, they are valuable indicators that will help us modify the GAMMAGARD dosage and duration to inject into that "unknown" subdermal space for Aim 2.
Aim 2 would require 12 months, using GAMMAGARD, instead of Gadolinium, to demonstrate the advantages of ASIS device subdermally over subcutaneously, for the same Primary Immunodeficiency subjects. Of course that Relative Prolongation Ability Score in Aim1 will be valuable, but it isn't absolutely required to start Aim 2, because GAMMAGARD's Pharmacokinetics will be studied anyway, by following Peak and Trough levels of immunoglobulin G.
However, the Pharmacokinetics of subdermally injected GAMMAGARD will be just dependent on GAMMAGARD's diffusion out of that subdermal bloodless space; therefore, if GAMMAGARD getting into the bloodstream becomes so severely inhibited, then we can just change the osmolality of GAMMAGARD in the end. The therapeutic advantages of GAMMAGARD with ASIS device subdermally over subcutaneously will also be studied by comparing the reduction of Validated Acute Serious Bacterial Infections, adverse reactions, and injection site pain.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | ASIS for GAMMAGARD in Primary Immunodeficiency |
Study Start Date : | January 2016 |
Estimated Primary Completion Date : | June 2016 |
Estimated Study Completion Date : | June 2016 |
Arm | Intervention/treatment |
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Experimental: Gadolinium For abdomen
Gadolinium For abdomen Total Persistent % subdermally, For abdomen Total Persistent % subcutaneously, and For abdomen Relative Prolongation Ability Score. Gadolinium Magnevist® (gadopentetate dimeglumine) 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg), subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients. |
Drug: Gadolinium For abdomen
Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subdermally with ASIS Device for 30 patients. Gadolinium For abdomen Total Persistent % subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs. Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine) Drug: Gadolinium For abdomen Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subcutaneously for 30 patients. Gadolinium For abdomen Total Persistent % subcutaneously on MRI at 6 hrs, 12 hrs, and 24 hrs. Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine) Drug: Gadolinium For abdomen Gadolinium For abdomen Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine) Drug: Gadolinium For lower back Gadolinium For lower back Total Persistent % subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs. Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subdermally with ASIS Device for 30 patients.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine) Drug: Gadolinium For lower back Gadolinium For lower back Total cumulative Persistent % of Gadolinium subcutaneously on MRI at 6 hrs, 12 hrs, and 24 hrs. Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subcutaneously for 30 patients.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine) Drug: Gadolinium For lower back Gadolinium For lower back Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI .
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine) |
Experimental: Gadolinium For lower back
1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg), subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients. Gadolinium For lower back Total Persistent % subdermally, For lower back Total Persistent % subcutaneously, and For lower back Relative Prolongation Ability Score. |
Drug: Gadolinium For abdomen
Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subdermally with ASIS Device for 30 patients. Gadolinium For abdomen Total Persistent % subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs. Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine) Drug: Gadolinium For abdomen Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subcutaneously for 30 patients. Gadolinium For abdomen Total Persistent % subcutaneously on MRI at 6 hrs, 12 hrs, and 24 hrs. Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine) Drug: Gadolinium For abdomen Gadolinium For abdomen Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine) Drug: Gadolinium For lower back Gadolinium For lower back Total Persistent % subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs. Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subdermally with ASIS Device for 30 patients.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine) Drug: Gadolinium For lower back Gadolinium For lower back Total cumulative Persistent % of Gadolinium subcutaneously on MRI at 6 hrs, 12 hrs, and 24 hrs. Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subcutaneously for 30 patients.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine) Drug: Gadolinium For lower back Gadolinium For lower back Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI .
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine) |
Experimental: subjects (%) of any infections
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.
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Drug: Efficacy of Gammagard subcutaneously at Week 12
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 (%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 (%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 (%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 (%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 (%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 (%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] |
Experimental: Annual rate of any infections
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.
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Drug: Efficacy of Gammagard subcutaneously at Week 12
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 (%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 (%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 (%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 (%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 (%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 (%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] |
Experimental: subjects (%) with Antibiotic use
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.
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Drug: Efficacy of Gammagard subcutaneously at Week 12
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 (%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 (%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 (%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 (%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 (%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 (%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] |
Experimental: Annual rate with Antibiotic use
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.
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Drug: Efficacy of Gammagard subcutaneously at Week 12
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 (%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 (%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 (%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 (%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 (%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 (%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] |
Experimental: subjects (%) with Days out of work
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.
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Drug: Efficacy of Gammagard subcutaneously at Week 12
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 (%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 (%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 (%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 (%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 (%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 (%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] |
Experimental: Annual rate with Days out of work
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.
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Drug: Efficacy of Gammagard subcutaneously at Week 12
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 (%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 (%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 (%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 (%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 (%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 (%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] |
Experimental: (%) with hospitalized infections
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.
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Drug: Efficacy of Gammagard subcutaneously at Week 12
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 (%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 (%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 (%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 (%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 (%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 (%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] |
Experimental: Annual rate hospitalized infections
Annual rate hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.
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Drug: Efficacy of Gammagard subcutaneously at Week 12
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 (%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 12 Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 (%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 24 Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subcutaneously at Week 36 subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 (%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 (%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 12 Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 (%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 24 Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 (%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Efficacy of Gammagard subdermally at Week 36 Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Other Name: Gammagard [Immune Globulin Infusion (Human)] |
Experimental: Adverse Injection Local Reactions
Adverse Injection Local Reactions as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.
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Drug: Adverse Reactions of Gammagard subcutaneously at Week 12
Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subcutaneously at Week 24 Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subcutaneously at Week 36 Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subdermally at Week 12 Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subdermally at Week 24 Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subdermally at Week 36 Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] |
Experimental: Adverse Reactions Headache
Headache as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.
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Drug: Adverse Reactions of Gammagard subcutaneously at Week 12
Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subcutaneously at Week 24 Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subcutaneously at Week 36 Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subdermally at Week 12 Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subdermally at Week 24 Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subdermally at Week 36 Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] |
Experimental: Adverse Reactions Fever
Fever as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.
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Drug: Adverse Reactions of Gammagard subcutaneously at Week 12
Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subcutaneously at Week 24 Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subcutaneously at Week 36 Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subdermally at Week 12 Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subdermally at Week 24 Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subdermally at Week 36 Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] |
Experimental: Adverse Reactions Nausea
Nausea as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.
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Drug: Adverse Reactions of Gammagard subcutaneously at Week 12
Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subcutaneously at Week 24 Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subcutaneously at Week 36 Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subdermally at Week 12 Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subdermally at Week 24 Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subdermally at Week 36 Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] |
Experimental: Adverse Reactions Vomiting
Vomiting as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.
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Drug: Adverse Reactions of Gammagard subcutaneously at Week 12
Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subcutaneously at Week 24 Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subcutaneously at Week 36 Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subdermally at Week 12 Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subdermally at Week 24 Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subdermally at Week 36 Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] |
Experimental: Adverse Reactions Fatigue
Fatigue as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.
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Drug: Adverse Reactions of Gammagard subcutaneously at Week 12
Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subcutaneously at Week 24 Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subcutaneously at Week 36 Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subdermally at Week 12 Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subdermally at Week 24 Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subdermally at Week 36 Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] |
Experimental: Adverse Reactions Diarrhea
Diarrhea as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.
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Drug: Adverse Reactions of Gammagard subcutaneously at Week 12
Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subcutaneously at Week 24 Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subcutaneously at Week 36 Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subdermally at Week 12 Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subdermally at Week 24 Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subdermally at Week 36 Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] |
Experimental: Adverse Reactions Asthma
Asthma as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.
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Drug: Adverse Reactions of Gammagard subcutaneously at Week 12
Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subcutaneously at Week 24 Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subcutaneously at Week 36 Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subdermally at Week 12 Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subdermally at Week 24 Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subdermally at Week 36 Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] |
Experimental: Adverse Reactions Oropharyngeal
Oropharyngeal as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.
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Drug: Adverse Reactions of Gammagard subcutaneously at Week 12
Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subcutaneously at Week 24 Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subcutaneously at Week 36 Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subdermally at Week 12 Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subdermally at Week 24 Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subdermally at Week 36 Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] |
Experimental: Adverse Reactions Abdominal Pain
Abdominal Pain as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.
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Drug: Adverse Reactions of Gammagard subcutaneously at Week 12
Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subcutaneously at Week 24 Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subcutaneously at Week 36 Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subdermally at Week 12 Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subdermally at Week 24 Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] Drug: Adverse Reactions of Gammagard subdermally at Week 36 Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Other Name: Gammagard [Immune Globulin Infusion (Human)] |
- Relative Prolongation Ability Score for Gadolinium subdermally injected [ Time Frame: 6 months ]Gadolinium will be injected with ASIS subdermally (30) or conventional subcutaneous (30) for 60 adult subjects with Primary Immunodeficiency. The first MRI taken promptly after Gadolinium injection for each patient would be his or her reference of 100% Persistent, to which his or her subsequent MRI taken @ 6 hr, @ 12 hr, and @24hr later will be compared for Persistent %. This approximation can only work if the variables are minimized to the same population with Primary Immunodeficiency. The Relative Prolongation Ability Score or total Persistent % subdermally over total Persistent % subcutaneously, in Primary Immunodeficiency will be very valuable indicators for us to modify the GAMMAGARD dosage and duration for testing with that "unknown" subdermal bloodless space in Aim 2.
- Efficacy of GAMMAGARD subcutaneously vs. subdermally in Primary Immunodeficiency [ Time Frame: 12 months ]The therapeutic efficacy of GAMMAGARD, in terms of reduction of Validated Acute Serious Bacterial Infections will be compared, eg. subjects (%) and Annual rate of any infections, subjects (%) and Annual rate of Antibiotic use, subjects (%) and Annual rate with Days out of work, subjects (%) and Annual rate of hospitalized infections, to demonstrate the advantages of ASIS device subdermally over subcutaneously for GAMMAGARD at Week 12, 24, and 36.
- Adverse Reactions of GAMMAGARD subcutaneously vs. subdermally in Primary Immunodeficiency [ Time Frame: 12 months ]Adverse Reactions of GAMMAGARD, in numbers of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain will be compared, to demonstrate the advantages of ASIS device subdermally over subcutaneously for GAMMAGARD at Week 12, 24, and 36.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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Inclusion Criteria in general and for Gadolinium:
- Main Criteria for Inclusion: Eligible Ages: 12 Years to 65
- Genders Eligible for Study: Both
- Accepts Healthy Volunteers: Yes
- Must be outpatient, male or female, of any race, between 18 and 65 years of age.
- Must be able to understand the requirements of the study including maintaining a diary, and sign informed consent.
- Must be in good general health as determined by investigator.
- If female of childbearing potential, must have negative pregnancy test result at screening visit and practice reliable method of contraception
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Inclusion Criteria for Primary Immunodeficiency in particular:
- Patients 12 years or older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies1,2.
Exclusion Criteria:
-
Exclusion Criteria for Primary Immunodeficiency in particular:
- Females who are pregnant, nursing, or planning a pregnancy during the study period or who are not using a reliable means of contraception.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02123615
Contact: Li Nguyen, MD | (714)-453-7857 | dr.li.nguyen@asis-inc.com | |
Contact: Thanh Phung, MD | 714-893-1915 | thanhphung@idit-inc.com |
United States, California | |
Automatic Subdermal Injector System, Inc | |
Westminster, California, United States, 92683 | |
Contact: Li Nguyen, MD 714-453-7857 dr.li.nguyen@asis-inc.com | |
Contact: Thanh Phung, MD (714)-893-1915 thanhphung@idit-inc.com | |
Principal Investigator: Li Nguyen, MD | |
Principal Investigator: Thanh Phung, MD | |
Principal Investigator: Hanh Nguyen, MD |
Principal Investigator: | Li Nguyen, MD | AUTOMATIC SUBDERMAL INJECTOR SYSTEM INC | |
Principal Investigator: | Thanh Phung, MD | AUTOMATIC SUBDERMAL INJECTOR SYSTEM, INC | |
Principal Investigator: | Hanh Nguyen, MD | AUTOMATIC SUBDERMAL INJECTOR SYSTEM,INC |
Responsible Party: | ASIS Corporation |
ClinicalTrials.gov Identifier: | NCT02123615 |
Other Study ID Numbers: |
NCTEB017805 1R01EB017805 ( Other Grant/Funding Number: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES ) |
First Posted: | April 25, 2014 Key Record Dates |
Last Update Posted: | June 24, 2015 |
Last Verified: | June 2015 |
Primary Immunodeficiency Subdermal bloodless space Subdermal injection Subcutaneous injection |
Injectable electromyography needle Electrical stimulation MRI with Gadolinium |
Primary Immunodeficiency Diseases Immunologic Deficiency Syndromes Immune System Diseases Genetic Diseases, Inborn Immunoglobulins Antibodies |
gamma-Globulins Immunoglobulins, Intravenous Rho(D) Immune Globulin Immunoglobulin G Immunologic Factors Physiological Effects of Drugs |