A Phase 3 Study Evaluating Safety and Effectiveness of Im... | NCT00818662

Name	Class
Alzheimer's Disease Cooperative Study (ADCS)	OTHER

Label	Type	Description	Intervention Names
IGIV, 10% 400mg/kg	Experimental	Immune Globulin Intravenous (Human), 10% (IGIV, 10%)	Biological: Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 400 mg/kg
IGIV, 10% 200mg/kg	Experimental	Immune Globulin Intravenous (Human), 10% (IGIV, 10%)	Biological: Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 200 mg/kg
Human Albumin 0.25% Solution - 4 mL/kg	Placebo Comparator	0.25% human albumin solution infused at 4 mL/kg/2weeks	Biological: Placebo solution: Human Albumin 0.25% - 4 mL/kg
Human Albumin 0.25% Solution - 2 mL/kg	Placebo Comparator	0.25% human albumin solution infused at 2 mL/kg/2weeks	Biological: Placebo solution: Human Albumin 0.25% - 2 mL/kg

Name	Type	Description	Arm Group Labels	Other Names
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 400 mg/kg	Biological	400 mg/kg bodyweight every 2 weeks for 70 weeks	IGIV, 10% 400mg/kg

Measure	Description	Time Frame
Change From Baseline at 18 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)	The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer's Disease Cooperative Study (ADCS) at each site. Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment; hence increases from baseline reflect potential cognitive deterioration.	Baseline & 18 months
Change From Baseline at 18 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)	The ADCS-ADL scale is a validated tool to assess instrumental and basic activities of daily living based on a 23 item structured interview of the caregiver or qualified study partner. Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; hence decreases from baseline reflect potential functional deterioration.	Baseline & 18 Months

Measure	Description	Time Frame
Change From Baseline at 9 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)	The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer's Disease Cooperative Study (ADCS) at each site. Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment; hence increases from baseline reflect potential cognitive deterioration.

Name	Affiliation	Role
Study Director	Takeda	Study Director

PubMed Identifier	Type	Citation
	Background	Relkin N, Gessert D, Stokes K, Adamiak B, Ngo LY, Thomas R, Gelmont D, Aisen P. The Gammaglobulin Alzheimer Partnership Study (GAP): Design, screening, enrollment and futility analysis results. Alzheimer's & Dementia: The Journal of the Alzheimer's Association 8[4 Suppl], P456. 2012.
	Background	Ngo L, Adamiak B, Gelmont D. A confirmatory phase 3 randomized, double-blind, placebo-controlled study of the safety and effectiveness of immune globulin intravenous (human), 10% solution (Gammagard Liquid/Kiovig) for the treatment of mild to moderate Alzheimer's Disease. Poster Presentation: Alzheimer's Association International Conference on Alzheimer's Disease (ICAD), Paris, France July 16-21 2011.
28381506	Derived	Relkin NR, Thomas RG, Rissman RA, Brewer JB, Rafii MS, van Dyck CH, Jack CR, Sano M, Knopman DS, Raman R, Szabo P, Gelmont DM, Fritsch S, Aisen PS; Alzheimer's Disease Cooperative Study. A phase 3 trial of IV immunoglobulin for Alzheimer disease. Neurology. 2017 May 2;88(18):1768-1775. doi: 10.1212/WNL.0000000000003904. Epub 2017 Apr 5.

ID	Title	Description
FG000	IGIV, 10% 400mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
FG001	IGIV, 10% 200mg/kg

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline at 18 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)

The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer's Disease Cooperative Study (ADCS) at each site. Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment; hence increases from baseline reflect potential cognitive deterioration.

Intent-to-Treat Analysis Set with both baseline and month 18 assessments.

Posted

Mean

Standard Deviation

Scores on a scale

Baseline & 18 months

ID	Title	Description
OG000	IGIV, 10% 400mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment
OG001	IGIV, 10% 200mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment
OG002	Placebo 2 mL/kg or 4 mL/kg	All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment

Units	Counts
Participants	OG000105 OG001100 OG00295

Title

Denominators

Categories

Title	Measurements
	OG0007.4± 7.95 OG0018.9± 8.20 OG0028.4± 9.37

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		ANCOVA		0.476		Difference in least-square means	-0.8				95	-3.1	1.5			Results combined from 100 imputations from estimates & standard errors from 100 ANCOVA results for fixed effect of treatment, E4 allele of apolipoprotein E carrier status, & continuous covariates age at baseline, baseline ADAS-Cog & education level		Superiority or Other (legacy)
OG001 OG002

Primary

Change From Baseline at 18 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)

The ADCS-ADL scale is a validated tool to assess instrumental and basic activities of daily living based on a 23 item structured interview of the caregiver or qualified study partner. Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; hence decreases from baseline reflect potential functional deterioration.

Intent-to-Treat Analysis Set with both baseline and month 18 assessments.

Posted

Mean

Standard Deviation

Scores on a scale

Baseline & 18 Months

ID	Title	Description
OG000	IGIV, 10% 400mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
OG001	IGIV, 10% 200mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks
OG002	Placebo 2 mL/kg or 4 mL/kg	All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks

Secondary

Change From Baseline at 9 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)

Intent-to-Treat Analysis Set with both baseline and month 9 assessments.

Posted

Mean

Standard Deviation

Scores on a scale

Baseline & 9 months

ID	Title	Description
OG000	IGIV, 10% 400mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment
OG001	IGIV, 10% 200mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment
OG002

Secondary

Change From Baseline at 9 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)

Intent-to-Treat Analysis Set with both baseline and month 9 assessments.

Posted

Mean

Standard Deviation

Scores on a scale

Baseline & 9 Months

ID	Title	Description
OG000	IGIV, 10% 400mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
OG001	IGIV, 10% 200mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks
OG002	Placebo 2 mL/kg or 4 mL/kg	All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks

Secondary

Change From Baseline at 9 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment

The ADCS-CGIC is a validated categorical measure of change in a participant's clinical condition between baseline and follow-up visits; it is used to assess global clinical status. The ADCS CGIC score is based on direct examination of the participant and an interview of the caregiver. The rater should refer to the baseline ADCS-CGIC worksheets in making a rating. A skilled and experienced clinician who is blinded to treatment assignment rates the participant on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening). 1= Very much better 2= Much better 3= A little better 4= Same 5= A little worse 6= Much worse 7= Very much worse

Intent-to-Treat Analysis Set with both baseline and month 9 assessments.

Posted

Number

participants

Baseline & 9 Months

ID	Title	Description
OG000	IGIV, 10% 400mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
OG001	IGIV, 10% 200mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks
OG002

Secondary

Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment

Intent-to-Treat Analysis Set with both baseline and month 18 assessments.

Posted

Number

participants

Baseline & 18 Months

ID	Title	Description
OG000	IGIV, 10% 400mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
OG001	IGIV, 10% 200mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks
OG002

Secondary

Change From Baseline at 18 Months in the Modified Mini-Mental State Examination (3MS) Examination

The 3MS is a comprehensive validated instrument that provides a 100 point composite rating for spatial and temporal orientation, verbal recall, simple attention, working memory, naming, repetition, comprehension, writing and constructional abilities. Scores range from 0 to 100 with lower values indicating greater impairment.

Intent-to-Treat Analysis Set with both baseline and month 18 assessments.

Posted

Mean

Standard Deviation

Scores on a scale

Baseline & 18 months

ID	Title	Description
OG000	IGIV, 10% 400mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
OG001	IGIV, 10% 200mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks
OG002	Placebo 2 mL/kg or 4 mL/kg	All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks

Secondary

Change From Baseline at 18 Months in the Neuropsychiatric Inventory (NPI) Assessment

The NPI is a validated instrument used to assess behavioral psychopathology in AD; it evaluates the frequency and severity of 12 neuropsychiatric features including delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, sleep and night-time behavior change, and appetite and eating change. The NPI total score ranged 0-144, with higher scores indicating greater impairment.

Intent-to-Treat Analysis Set with both baseline and month 18 assessments.

Posted

Mean

Standard Deviation

Scores on a scale

Baseline & 18 months

ID	Title	Description
OG000	IGIV, 10% 400mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
OG001	IGIV, 10% 200mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks
OG002	Placebo 2 mL/kg or 4 mL/kg	All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks

Secondary

Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Participant Response

The QOL AD is a validated, 13-item instrument developed specifically for individuals with dementia. The assessment rates the participant's quality of life for physical, emotional, interpersonal, and environmental domains. The QOL-AD total score ranged 13-52. Lower scores on the QOL AD are associated with a lower quality of life.

Intent-to-Treat Analysis Set with both baseline and month 18 assessments.

Posted

Mean

Standard Deviation

Scores on a scale

Baseline & 18 months

ID	Title	Description
OG000	IGIV, 10% 400mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
OG001	IGIV, 10% 200mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks
OG002	Placebo 2 mL/kg or 4 mL/kg	All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks

Secondary

Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Caregiver Response

Intent-to-Treat Analysis Set with both baseline and month 18 assessments.

Posted

Mean

Standard Deviation

Scores on a scale

Baseline & 18 months

ID	Title	Description
OG000	IGIV, 10% 400mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
OG001	IGIV, 10% 200mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks
OG002	Placebo 2 mL/kg or 4 mL/kg	All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks

Secondary

Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Forward

This test assesses working memory and attention, the rater asks the participant to repeat single-digit number sequences of increasing length, which are read aloud by the rater (in forward or backward order). Two trials are presented for each sequence length, and the test is ended when the participant misses both trials at a given sequence length. The WAIS-R score ranged from 0-14. Results are presented as total number correct; therefore, lower numbers represent greater impairment.

Per-Protocol Analysis Set with both baseline and month 18 assessments.

Posted

Mean

Standard Deviation

correct responses

Baseline & 18 months

ID	Title	Description
OG000	IGIV, 10% 400mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
OG001	IGIV, 10% 200mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks
OG002	Placebo 2 mL/kg or 4 mL/kg

Secondary

Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Backward

Per-Protocol Analysis Set with both baseline and month 18 assessments.

Posted

Mean

Standard Deviation

correct responses

Baseline & 18 months

ID	Title	Description
OG000	IGIV, 10% 400mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
OG001	IGIV, 10% 200mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks
OG002	Placebo 2 mL/kg or 4 mL/kg

Secondary

Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: FAS Verbal Fluency

In the FAS assessment of phenomic verbal fluency, participants are given 1 minute each to name as many words as they can that begin with a specified letter (F, A, S). To receive credit, words must be verifiable in a dictionary, cannot be proper nouns, and cannot be the same word or variations of the same word (e.g., the same word with a different ending, such as 'acts,' 'acted,' 'acting'). Results are presented as total number correct; therefore, lower numbers indicate greater impairment.

Per-Protocol Analysis Set with both baseline and month 18 assessments.

Posted

Mean

Standard Deviation

correct responses

Baseline & 18 months

ID	Title	Description
OG000	IGIV, 10% 400mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
OG001	IGIV, 10% 200mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks
OG002	Placebo 2 mL/kg or 4 mL/kg	All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks

Secondary

Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Symbol Substitution

WAIS-R digit symbol substitution test assesses attention, psychomotor speed, complex scanning, visual tracking, and immediate memory. This test consists of 4 rows each with 25 small blank squares; above each square is a number between 1 and 9. At the top is a 'key,' which pairs each number (1 through 9) with an unfamiliar symbol. The participant has 90 seconds to work as quickly as possible (left to right across the rows) to fill in each blank square with the appropriate symbol based on the number above the square. Results are presented as total number correct; therefore, lower numbers indicate greater impairment.

Per-Protocol Analysis Set with both baseline and month 18 assessments.

Posted

Mean

Standard Deviation

correct responses

Baseline & 18 months

ID	Title	Description
OG000	IGIV, 10% 400mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
OG001	IGIV, 10% 200mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks
OG002

Secondary

Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Animals Category Fluency

In this test, which assesses semantic verbal fluency, participants are given 1 minute to name as many items in the category "animals" as possible. To receive credit that word cannot be a mythical animal, but can be an animal species; breed; male, female, or infant name for a species (e.g., bull, cow, calf); in addition, names for birds, fish, reptiles, and insects receive credit. Results are presented as total number correct; therefore, lower numbers indicate greater impairment.

Per-Protocol Analysis Set with both baseline and month 18 assessments.

Posted

Mean

Standard Deviation

correct responses

Baseline & 18 months

ID	Title	Description
OG000	IGIV, 10% 400mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
OG001	IGIV, 10% 200mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks
OG002	Placebo 2 mL/kg or 4 mL/kg	All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks

Secondary

Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Trail-Making Test (TMT), Part A

This test, which has 2 parts, is used to assess processing speed, visuomotor and perceptual scanning skills, and executive function. In Part A, 25 circles each containing a number between 1 and 25 are randomly placed on a sheet of paper, and the participant is asked to draw a line as quickly as possible between each circle in ascending numerical order. In Part B, 25 circles are again randomly placed on a sheet of paper; however, in this test 13 of the circles contain the numbers 1 through 13, and the remaining 12 circles contain the letters A through L. In this test, the participant must draw a line as quickly as possible between the circles in alternating between numbers and letters in ascending order (e.g., 1 to A, A to 2, 2 to B,…). Total values for TMT Part A range between 0 and 150 seconds. Results are presented as time to complete; therefore, higher numbers indicate greater impairment.

Per-Protocol Analysis Set with both baseline and month 18 assessments.

Posted

Mean

Standard Deviation

seconds

Baseline & 18 months

ID	Title	Description
OG000	IGIV, 10% 400mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
OG001	IGIV, 10% 200mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks

Secondary

Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Trail-Making Test (TMT), Part B

This test, which has 2 parts, is used to assess processing speed, visuomotor and perceptual scanning skills, and executive function. In Part A, 25 circles each containing a number between 1 and 25 are randomly placed on a sheet of paper, and the participant is asked to draw a line as quickly as possible between each circle in ascending numerical order. In Part B, 25 circles are again randomly placed on a sheet of paper; however, in this test 13 of the circles contain the numbers 1 through 13, and the remaining 12 circles contain the letters A through L. In this test, the participant must draw a line as quickly as possible between the circles in alternating between numbers and letters in ascending order (e.g., 1 to A, A to 2, 2 to B,…). Total values for TMT Part B range between 0 and 300 seconds. Results are presented as time to complete; therefore, higher numbers indicate greater impairment.

Per-Protocol Analysis Set with both baseline and month 18 assessments.

Posted

Mean

Standard Deviation

seconds

Baseline & 18 months

ID	Title	Description
OG000	IGIV, 10% 400mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
OG001	IGIV, 10% 200mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks

Secondary

Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Clock Drawing Test

In this test, which assesses constructional ability, visuoperception, and executive functioning, the participant is given a blank sheet of paper and asked to draw the face of a clock showing the numbers and 2 hands set to 'ten after eleven.' Results are presented as score obtained (range 0 to 5, with 0 indicating the greatest impairment).

Per-Protocol Analysis Set with both baseline and month 18 assessments.

Posted

Mean

Standard Deviation

Scores on a scale

Baseline & 18 months

ID	Title	Description
OG000	IGIV, 10% 400mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
OG001	IGIV, 10% 200mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks
OG002	Placebo 2 mL/kg or 4 mL/kg	All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks

Secondary

Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class

Safety Analysis Set

Posted

Number

participants

Throughout the study period, approximately 4 years

ID	Title	Description
OG000	IGIV, 10% 400mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment
OG001	IGIV, 10% 200mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment
OG002	Placebo 2 mL/kg or 4 mL/kg	All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment

Units

Secondary

Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class

Safety Analysis Set

Posted

Number

participants

Throughout the study period, approximately 4 years

ID	Title	Description
OG000	IGIV, 10% 400mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment
OG001	IGIV, 10% 200mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment
OG002	Placebo 2 mL/kg or 4 mL/kg	All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment

Units	Counts

Secondary

Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class

Related and unrelated non-SAEs

Safety Analysis Set

Posted

Number

participants

Throughout the study period, approximately 4 years

ID	Title	Description
OG000	IGIV, 10% 400mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment
OG001	IGIV, 10% 200mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment
OG002	Placebo 2 mL/kg or 4 mL/kg	All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment

Secondary

Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class

Related and unrelated SAEs

Safety Analysis Set

Posted

Number

participants

Throughout the study period, approximately 4 years

ID	Title	Description
OG000	IGIV, 10% 400mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment
OG001	IGIV, 10% 200mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment
OG002	Placebo 2 mL/kg or 4 mL/kg	All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment

Secondary

Number of Infusions Temporally Associated With Non-serious Adverse Events (Non-SAEs) and/or Serious Adverse Events (SAEs)

Refers to non-SAEs and/or SAEs occurring during infusion or within 72 hours of completion of infusion (regardless of causality)

Safety Analysis Set

Posted

Number

Infusions

During or within 72 hours of completion of an infusion

Infusions

ID	Title	Description
OG000	IGIV, 10% 400mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment
OG001	IGIV, 10% 200mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment
OG002	Placebo 2 mL/kg or 4 mL/kg	All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment

Secondary

Number of Infusions With Causally Associated Non-serious Adverse Events (Non-SAEs) and/or Serious Adverse Events (SAEs)

Each adverse event (AE) that was considered related to investigational product (IP) was linked to the most recent infusion administered

Safety Analysis Set

Posted

Number

Infusions

Throughout the study period, approximately 4 years

Infusions

ID	Title	Description
OG000	IGIV, 10% 400mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment
OG001	IGIV, 10% 200mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment
OG002	Placebo 2 mL/kg or 4 mL/kg	All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment

Secondary

Number of Infusions Discontinued, Slowed, or Interrupted Due to an Adverse Event (AE)

Safety Analysis Set

Posted

Number

Adverse events

Throughout each infusion period

Infusions

ID	Title	Description
OG000	IGIV, 10% 400mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment
OG001	IGIV, 10% 200mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment
OG002	Placebo 2 mL/kg or 4 mL/kg	All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment

Units	Counts

Secondary

Number of Participants Experiencing a Clinically Significant Decrease in Hemoglobin (>1.5 g/dL) Between Consecutive Visits

Safety Analysis Set

Posted

Number

participants

Throughout the study period, approximately 4 years

ID	Title	Description
OG000	IGIV, 10% 400mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment
OG001	IGIV, 10% 200mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment
OG002	Placebo 2 mL/kg or 4 mL/kg	All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment

Units

Secondary

Number of Participants Experiencing a Clinically Significant Rash

Participants requiring systemic therapy or discontinuation from further treatment

Safety Analysis Set

Posted

Number

participants

Throughout the study period, approximately 4 years

ID	Title	Description
OG000	IGIV, 10% 400mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment
OG001	IGIV, 10% 200mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment
OG002	Placebo 2 mL/kg or 4 mL/kg	All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0010 events0 affected135 at risk EG0021 events1 affected121 at risk
Microcytic Anaemia	Blood and lymphatic system disorders	MedDRA (Unspecified)		EG0002 events2 affected127 at risk EG0010 events0 affected135 at risk EG0020 events0 affected121 at risk
Arrhythmia	Cardiac disorders	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0011 events1 affected135 at risk EG0020 events0 affected121 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA (Unspecified)		EG0001 events1 affected127 at risk EG0011 events1 affected135 at risk EG0022 events1 affected121 at risk
Bundle Branch Block Left	Cardiac disorders	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0011 events1 affected135 at risk EG0020 events0 affected121 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA (Unspecified)		EG0002 events1 affected127 at risk EG0010 events0 affected135 at risk EG0021 events1 affected121 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA (Unspecified)		EG0002 events2 affected127 at risk EG0010 events0 affected135 at risk EG0020 events0 affected121 at risk
Myocardial Infarction	Cardiac disorders	MedDRA (Unspecified)		EG0001 events1 affected127 at risk EG0010 events0 affected135 at risk EG0021 events1 affected121 at risk
Sinus Bradycardia	Cardiac disorders	MedDRA (Unspecified)		EG0001 events1 affected127 at risk EG0010 events0 affected135 at risk EG0020 events0 affected121 at risk
Sudden Hearing Loss	Ear and labyrinth disorders	MedDRA (Unspecified)		EG0001 events1 affected127 at risk EG0010 events0 affected135 at risk EG0020 events0 affected121 at risk
Colitis	Gastrointestinal disorders	MedDRA (Unspecified)		EG0001 events1 affected127 at risk EG0010 events0 affected135 at risk EG0020 events0 affected121 at risk
Diaphragmatic Hernia, Obstructive	Gastrointestinal disorders	MedDRA (Unspecified)		EG0001 events1 affected127 at risk EG0010 events0 affected135 at risk EG0020 events0 affected121 at risk
Ileus	Gastrointestinal disorders	MedDRA (Unspecified)		EG0001 events1 affected127 at risk EG0010 events0 affected135 at risk EG0020 events0 affected121 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0012 events1 affected135 at risk EG0020 events0 affected121 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0010 events0 affected135 at risk EG0021 events1 affected121 at risk
Upper Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA (Unspecified)		EG0001 events1 affected127 at risk EG0010 events0 affected135 at risk EG0020 events0 affected121 at risk
Vomiting	Gastrointestinal disorders	MedDRA (Unspecified)		EG0001 events1 affected127 at risk EG0010 events0 affected135 at risk EG0020 events0 affected121 at risk
Asthenia	General disorders	MedDRA (Unspecified)		EG0001 events1 affected127 at risk EG0010 events0 affected135 at risk EG0020 events0 affected121 at risk
Chest Pain	General disorders	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0013 events2 affected135 at risk EG0020 events0 affected121 at risk
Multi-Organ Failure	General disorders	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0012 events2 affected135 at risk EG0020 events0 affected121 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA (Unspecified)		EG0001 events1 affected127 at risk EG0010 events0 affected135 at risk EG0020 events0 affected121 at risk
Pyrexia	General disorders	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0010 events0 affected135 at risk EG0022 events2 affected121 at risk
Cholecystitis Chronic	Hepatobiliary disorders	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0010 events0 affected135 at risk EG0021 events1 affected121 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0011 events1 affected135 at risk EG0021 events1 affected121 at risk
Anaphylactic Reaction	Immune system disorders	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0011 events1 affected135 at risk EG0020 events0 affected121 at risk
Gallbladder Abscess	Infections and infestations	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0010 events0 affected135 at risk EG0021 events1 affected121 at risk
Gastroenteritis	Infections and infestations	MedDRA (Unspecified)		EG0001 events1 affected127 at risk EG0010 events0 affected135 at risk EG0020 events0 affected121 at risk
Gastroenteritis Viral	Infections and infestations	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0010 events0 affected135 at risk EG0021 events1 affected121 at risk
Joint Abscess	Infections and infestations	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0011 events1 affected135 at risk EG0020 events0 affected121 at risk
Pneumonia	Infections and infestations	MedDRA (Unspecified)		EG0001 events1 affected127 at risk EG0010 events0 affected135 at risk EG0021 events1 affected121 at risk
Urinary Tract Infection	Infections and infestations	MedDRA (Unspecified)		EG0001 events1 affected127 at risk EG0011 events1 affected135 at risk EG0023 events3 affected121 at risk
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0011 events1 affected135 at risk EG0020 events0 affected121 at risk
Muscle Rupture	Injury, poisoning and procedural complications	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0010 events0 affected135 at risk EG0021 events1 affected121 at risk
Pneumothorax Traumatic	Injury, poisoning and procedural complications	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0011 events1 affected135 at risk EG0020 events0 affected121 at risk
Spinal Fracture	Injury, poisoning and procedural complications	MedDRA (Unspecified)		EG0001 events1 affected127 at risk EG0010 events0 affected135 at risk EG0020 events0 affected121 at risk
Subdural Haematoma	Injury, poisoning and procedural complications	MedDRA (Unspecified)		EG0002 events2 affected127 at risk EG0010 events0 affected135 at risk EG0020 events0 affected121 at risk
Upper Limb Fracture	Injury, poisoning and procedural complications	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0010 events0 affected135 at risk EG0021 events1 affected121 at risk
Blood Pressure Increased	Investigations	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0011 events1 affected135 at risk EG0020 events0 affected121 at risk
Electrocardiogram Abnormal	Investigations	MedDRA (Unspecified)		EG0001 events1 affected127 at risk EG0010 events0 affected135 at risk EG0020 events0 affected121 at risk
Haemoglobin Decreased	Investigations	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0011 events1 affected135 at risk EG0020 events0 affected121 at risk
Weight Decreased	Investigations	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0010 events0 affected135 at risk EG0021 events1 affected121 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (Unspecified)		EG0001 events1 affected127 at risk EG0010 events0 affected135 at risk EG0022 events2 affected121 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0011 events1 affected135 at risk EG0020 events0 affected121 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)		EG0001 events1 affected127 at risk EG0010 events0 affected135 at risk EG0020 events0 affected121 at risk
Intervertebral Disc Compression	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0011 events1 affected135 at risk EG0020 events0 affected121 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0011 events1 affected135 at risk EG0020 events0 affected121 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)		EG0001 events1 affected127 at risk EG0010 events0 affected135 at risk EG0020 events0 affected121 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0011 events1 affected135 at risk EG0020 events0 affected121 at risk
B-Cell Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0011 events1 affected135 at risk EG0020 events0 affected121 at risk
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0011 events1 affected135 at risk EG0020 events0 affected121 at risk
Colon Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0010 events0 affected135 at risk EG0021 events1 affected121 at risk
Lung Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0011 events1 affected135 at risk EG0022 events2 affected121 at risk
Cerebral Haemorrhage	Nervous system disorders	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0011 events1 affected135 at risk EG0020 events0 affected121 at risk
Headache	Nervous system disorders	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0010 events0 affected135 at risk EG0021 events1 affected121 at risk
Normal Pressure Hydrocephalus	Nervous system disorders	MedDRA (Unspecified)		EG0001 events1 affected127 at risk EG0010 events0 affected135 at risk EG0020 events0 affected121 at risk
Partial Seizures	Nervous system disorders	MedDRA (Unspecified)		EG0001 events1 affected127 at risk EG0011 events1 affected135 at risk EG0020 events0 affected121 at risk
Radicular Pain	Nervous system disorders	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0010 events0 affected135 at risk EG0021 events1 affected121 at risk
Syncope	Nervous system disorders	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0013 events3 affected135 at risk EG0023 events2 affected121 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0010 events0 affected135 at risk EG0021 events1 affected121 at risk
Unresponsive To Stimuli	Nervous system disorders	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0011 events1 affected135 at risk EG0020 events0 affected121 at risk
Vasogenic Cerebral Oedema	Nervous system disorders	MedDRA (Unspecified)		EG0001 events1 affected127 at risk EG0010 events0 affected135 at risk EG0020 events0 affected121 at risk
Agitation	Psychiatric disorders	MedDRA (Unspecified)		EG0001 events1 affected127 at risk EG0010 events0 affected135 at risk EG0022 events2 affected121 at risk
Confusional State	Psychiatric disorders	MedDRA (Unspecified)		EG0001 events1 affected127 at risk EG0011 events1 affected135 at risk EG0020 events0 affected121 at risk
Mental Status Changes	Psychiatric disorders	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0011 events1 affected135 at risk EG0021 events1 affected121 at risk
Psychotic Disorder	Psychiatric disorders	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0011 events1 affected135 at risk EG0020 events0 affected121 at risk
Psychotic Disorder Due To A General Medical Condition	Psychiatric disorders	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0011 events1 affected135 at risk EG0020 events0 affected121 at risk
Calculus Ureteric	Renal and urinary disorders	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0011 events1 affected135 at risk EG0020 events0 affected121 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0010 events0 affected135 at risk EG0021 events1 affected121 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0011 events1 affected135 at risk EG0020 events0 affected121 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0010 events0 affected135 at risk EG0021 events1 affected121 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)		EG0001 events1 affected127 at risk EG0011 events1 affected135 at risk EG0022 events2 affected121 at risk
Inguinal Hernia Repair	Surgical and medical procedures	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0010 events0 affected135 at risk EG0021 events1 affected121 at risk
Knee Arthroplasty	Surgical and medical procedures	MedDRA (Unspecified)		EG0000 events0 affected127 at risk EG0011 events1 affected135 at risk EG0020 events0 affected121 at risk
Aortic Stenosis	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected127 at risk EG0010 events0 affected135 at risk EG0020 events0 affected121 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA (Unspecified)		EG0001 events1 affected127 at risk EG0010 events0 affected135 at risk EG0023 events3 affected121 at risk
Orthostatic Hypotension	Vascular disorders	MedDRA (Unspecified)		EG0002 events2 affected127 at risk EG0010 events0 affected135 at risk EG0022 events1 affected121 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (Unspecified)	EG0009 events7 affected127 at risk EG0013 events3 affected135 at risk EG0022 events2 affected121 at risk
Bradycardia	Cardiac disorders	MedDRA (Unspecified)	EG0001 events1 affected127 at risk EG0014 events4 affected135 at risk EG0029 events8 affected121 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (Unspecified)	EG00023 events18 affected127 at risk EG00124 events19 affected135 at risk EG00216 events15 affected121 at risk
Nausea	Gastrointestinal disorders	MedDRA (Unspecified)	EG00024 events16 affected127 at risk EG00123 events11 affected135 at risk EG00216 events10 affected121 at risk
Vomiting	Gastrointestinal disorders	MedDRA (Unspecified)	EG00016 events12 affected127 at risk EG00110 events6 affected135 at risk EG0026 events5 affected121 at risk
Chills	General disorders	MedDRA (Unspecified)	EG00012 events10 affected127 at risk EG00133 events15 affected135 at risk EG0023 events3 affected121 at risk
Fatigue	General disorders	MedDRA (Unspecified)	EG00011 events10 affected127 at risk EG00135 events13 affected135 at risk EG00228 events12 affected121 at risk
Gait Disturbance	General disorders	MedDRA (Unspecified)	EG0002 events2 affected127 at risk EG00112 events10 affected135 at risk EG0023 events3 affected121 at risk
Infusion Site Extravasation	General disorders	MedDRA (Unspecified)	EG00032 events23 affected127 at risk EG00118 events15 affected135 at risk EG00230 events21 affected121 at risk
Oedema Peripheral	General disorders	MedDRA (Unspecified)	EG0005 events5 affected127 at risk EG0019 events7 affected135 at risk EG0027 events6 affected121 at risk
Pyrexia	General disorders	MedDRA (Unspecified)	EG0008 events7 affected127 at risk EG00115 events7 affected135 at risk EG0024 events4 affected121 at risk
Nasopharyngitis	Infections and infestations	MedDRA (Unspecified)	EG0006 events6 affected127 at risk EG00110 events10 affected135 at risk EG00213 events9 affected121 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA (Unspecified)	EG0009 events8 affected127 at risk EG0019 events8 affected135 at risk EG00211 events10 affected121 at risk
Urinary Tract Infection	Infections and infestations	MedDRA (Unspecified)	EG00016 events12 affected127 at risk EG00110 events8 affected135 at risk EG00221 events15 affected121 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (Unspecified)	EG0009 events9 affected127 at risk EG00117 events13 affected135 at risk EG00220 events10 affected121 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (Unspecified)	EG00020 events14 affected127 at risk EG00120 events16 affected135 at risk EG00231 events23 affected121 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA (Unspecified)	EG0009 events7 affected127 at risk EG0015 events5 affected135 at risk EG00210 events9 affected121 at risk
Blood Pressure Increased	Investigations	MedDRA (Unspecified)	EG00065 events19 affected127 at risk EG00167 events12 affected135 at risk EG00249 events9 affected121 at risk
Weight Decreased	Investigations	MedDRA (Unspecified)	EG0002 events2 affected127 at risk EG0018 events7 affected135 at risk EG0022 events2 affected121 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	EG00012 events12 affected127 at risk EG0017 events7 affected135 at risk EG0024 events4 affected121 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	EG00013 events12 affected127 at risk EG00113 events11 affected135 at risk EG0028 events8 affected121 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	EG00011 events8 affected127 at risk EG0016 events4 affected135 at risk EG0025 events5 affected121 at risk
Cerebral Microhaemorrhage	Nervous system disorders	MedDRA (Unspecified)	EG0009 events8 affected127 at risk EG0011 events1 affected135 at risk EG0025 events4 affected121 at risk
Dizziness	Nervous system disorders	MedDRA (Unspecified)	EG00023 events16 affected127 at risk EG00116 events13 affected135 at risk EG00215 events12 affected121 at risk
Headache	Nervous system disorders	MedDRA (Unspecified)	EG000114 events29 affected127 at risk EG001101 events34 affected135 at risk EG00265 events22 affected121 at risk
Tremor	Nervous system disorders	MedDRA (Unspecified)	EG0001 events1 affected127 at risk EG00113 events12 affected135 at risk EG0025 events5 affected121 at risk
Agitation	Psychiatric disorders	MedDRA (Unspecified)	EG0009 events9 affected127 at risk EG00110 events10 affected135 at risk EG00212 events10 affected121 at risk
Anxiety	Psychiatric disorders	MedDRA (Unspecified)	EG00012 events9 affected127 at risk EG00116 events14 affected135 at risk EG00215 events10 affected121 at risk
Confusional State	Psychiatric disorders	MedDRA (Unspecified)	EG0005 events5 affected127 at risk EG00119 events13 affected135 at risk EG0026 events4 affected121 at risk
Depression	Psychiatric disorders	MedDRA (Unspecified)	EG00014 events14 affected127 at risk EG00118 events16 affected135 at risk EG00222 events19 affected121 at risk
Insomnia	Psychiatric disorders	MedDRA (Unspecified)	EG0001 events1 affected127 at risk EG00110 events9 affected135 at risk EG00211 events9 affected121 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	EG0008 events8 affected127 at risk EG00119 events13 affected135 at risk EG00213 events13 affected121 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	EG00015 events12 affected127 at risk EG0013 events3 affected135 at risk EG0025 events3 affected121 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	EG0009 events7 affected127 at risk EG0014 events3 affected135 at risk EG0021 events1 affected121 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	EG00027 events21 affected127 at risk EG00127 events19 affected135 at risk EG00210 events6 affected121 at risk
Hypertension	Vascular disorders	MedDRA (Unspecified)	EG00027 events14 affected127 at risk EG00127 events18 affected135 at risk EG00222 events11 affected121 at risk
Hypotension	Vascular disorders	MedDRA (Unspecified)	EG0003 events3 affected127 at risk EG0017 events6 affected135 at risk EG0029 events7 affected121 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama		United States

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D019965	Neurocognitive Disorders
D001523	Mental Disorders
D024801	Tauopathies
D019636	Neurodegenerative Diseases

ID	Term
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description
BG000	IGIV, 10% 400mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
BG001	IGIV, 10% 200mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks
BG002	Placebo 4 mL/kg	0.25% human albumin solution infused at 4 mL/kg/2weeks Placebo solution: 4 mL/kg : 0.25% human albumin solution infused at 4 mL/kg/2weeks for 70 weeks
BG003	Placebo 2 mL/kg	0.25% human albumin solution infused at 2 mL/kg/2weeks Placebo solution: 2 mL/kg : 0.25% human albumin solution infused at 2 mL/kg/2weeks for 70 weeks
BG004	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	IGIV, 10% 400mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment	21	127	112	127
EG001	IGIV, 10% 200mg/kg	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks Adverse Events That Occurred During or After Treatment	32	135	118	135
EG002	Placebo 2 mL/kg or 4 mL/kg	All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2weeks for 70 weeks Adverse Events That Occurred During or After Treatment	26	121	103	121