Study of the Effectiveness of Intravenous Immune Globulin... | NCT00666263

ID	Type	Description	Link
2009-013841-27	EudraCT Number

Label	Type	Description	Intervention Names
IGIV, 10% Then Placebo	Experimental	STUDY PART 1: Open-label stabilization on IGIV, 10% (Stabilization Phase 1) all participants. STUDY PART 2: IGIV, 10% (double-blind treatment Cross-Over Period 1). STUDY PART 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 2). STUDY PART 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over period 2). STUDY PART 5: Participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 3). Each study part was 12 weeks in length. Participants received IGIV, 10% at the same equivalent dose per week administered prior to the study (0.4 to 2.0 g per kg body weight (BW) per infusion cycle).	Biological: Immune Globulin Intravenous (human), 10% Biological: 0.25% human albumin solution (Placebo)
Placebo Then IGIV, 10%	Experimental	STUDY PART 1: Open-label stabilization on IGIV, 10% (Stabilization Phase 1) all participants. STUDY PART 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human) (Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment Cross-Over Period 1). STUDY PART 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 2). STUDY PART 4: IGIV, 10% (double-blind treatment cross-over period 2). STUDY PART 5: Participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 3). Each study part was 12 weeks in length. Participants received IGIV, 10% at the same equivalent dose per week administered prior to the study (0.4 to 2.0 g per kg BW per infusion cycle)	Biological: Immune Globulin Intravenous (human), 10% Biological: 0.25% human albumin solution (Placebo)

Name	Type	Description	Arm Group Labels	Other Names
Immune Globulin Intravenous (human), 10%	Biological	Dose: Previous dose with 3, 4, or 6 cycles depending on previous schedule (patient specific)	IGIV, 10% Then Placebo

Measure	Description	Time Frame
Grip Strength in the More Affected Hand	The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. Each grip strength test consisted of 3 maximal repeated contractions (trials). Each participant will perform 2 sessions of grip strength testing. After a 10-minute break, the testing session will be repeated for a total of 6 grip repetitions per hand.	Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
Mean Relative Change in Grip Strength in the More Affected Hand	Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing.	Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
Co-Primary Endpoint: Guy's Neurologic Disability Scale (GNDS) for Upper Limbs	GNDS (based on Sharrack and Hughes, 1999) for the upper limbs were integers 0 to 5, with 0 indicating no impairment.	Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
Co-Primary Endpoint: Proportion of Participants With Deterioration in Guy's Neurological Disability Score (GNDS)	GNDS (based on Sharrack and Hughes, 1999) for the upper limbs were integers 0 to 5, with 0 indicating no impairment.

Measure	Description	Time Frame
Percentage of Participants With at Least a 30% Decline in Relative Grip Strength in the More Affected Hand (Measured Using a DynEx Digital Dynamometer)	Relative grip strength change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing.

Name	Affiliation	Role
Study Director	Takeda	Study Director

PubMed Identifier	Type	Citation	Retractions
11971045	Background	Merkies IS, Schmitz PI, van der Meche FG, Samijn JP, van Doorn PA; Inflammatory Neuropathy Cause and Treatment (INCAT) group. Clinimetric evaluation of a new overall disability scale in immune mediated polyneuropathies. J Neurol Neurosurg Psychiatry. 2002 May;72(5):596-601. doi: 10.1136/jnnp.72.5.596.
10467380	Background

ID	Title	Description
FG000	IGIV, 10% Then Placebo (During Cross-Over Periods)	Each of the following 5 study parts is 12 weeks. Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 3)

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

Grip Strength in the More Affected Hand

The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. Each grip strength test consisted of 3 maximal repeated contractions (trials). Each participant will perform 2 sessions of grip strength testing. After a 10-minute break, the testing session will be repeated for a total of 6 grip repetitions per hand.

Intent to treat

Posted

Median

Inter-Quartile Range

kilograms

Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit

ID	Title	Description
OG000	Before Stabilization 1	Baseline Measurements
OG001	End of Stabilization 1	IGIV, 10% (IGIV)
OG002	End of Cross-Over 1	Either IGIV, 10% or Placebo
OG003	End of Stabilization 2	IGIV, 10%
OG004	End of Cross-Over 2	Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
OG005	End of Stabilization 3	IGIV, 10%
OG006	End of the Study	Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.

Units	Counts
Participants	OG00044 OG00144 OG00242 OG003

Title

Denominators

Categories

IGIV then Placebo (N= 22, 22, 22, 22, 22, 17, 21)

Title	Measurements
	OG00018.14(9.30 to 30.43) OG00121.68(14.05 to 30.83) OG00219.54(10.15 to 29.15)

Primary

Mean Relative Change in Grip Strength in the More Affected Hand

Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing.

Intent to treat

Posted

Mean

95% Confidence Interval

Percent change in grip strength

Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)

ID	Title	Description
OG000	Arm 1: IGIV, 10% Then Placebo- Crossover Period 1	Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)

Secondary

Percentage of Participants With at Least a 30% Decline in Relative Grip Strength in the More Affected Hand (Measured Using a DynEx Digital Dynamometer)

Relative grip strength change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing.

Intent to treat

Posted

Number

Percentage of participants

Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)

ID	Title	Description
OG000	Decline Only During IGIV, 10%	Participants who experienced a relative decrease in grip strength of ≥30% in the more affected hand relative to baseline following IGIV, 10%, but not after the placebo
OG001	Decline Only During Placebo	Participants who experienced a relative decrease in grip strength of ≥30% in the more affected hand relative to baseline following the placebo, but not after IGIV, 10%

Secondary

Grip Strength in the Less Affected Hand

Intent to treat

Posted

Median

Inter-Quartile Range

kilograms

Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit

ID	Title	Description
OG000	Before Stabilization 1	Baseline Measurements
OG001	End of Stabilization 1	IGIV, 10% (IGIV)
OG002	End of Cross-Over 1	Either IGIV, 10% or Placebo
OG003	End of Stabilization 2	IGIV, 10%

Secondary

Mean Relative Change in Grip Strength in the Less Affected Hand

Relative Change is defined as 100 * (End of the Cross-Over Period - Baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing.

Intent to treat

Posted

Mean

95% Confidence Interval

Percent change in grip strength

Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)

ID	Title	Description
OG000	Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1	Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)

Secondary

Proportion of Participants That Were Accelerated Forward Into the Next Stabilization Phase (ie Switched to Open-Label IGIV, 10%)

Participants were permitted to switch from blinded treatment with placebo or IGIV, 10% to open label IGIV, 10% if they and investigator agreed that deterioration had occurred to the extent that the participant had unacceptable difficulty carrying out daily activities involving the affected muscles, or decline in grip strength of ≥50% in the more affected hand had occurred.

Intent to treat

Posted

Number

Proportion of participants

During the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)

ID	Title	Description
OG000	Accelerated Switch During IGIV, 10% and Placebo	Participants who required a switch to open label IGIV, 10% when receiving IGIV, 10%, and placebo
OG001	Accelerated Switch During Placebo, But Not IGIV, 10%	Participants who required a switch to open label IGIV, 10% when receiving the placebo, but not during IGIV, 10%
OG002	Accelerated Switch During IGIV, 10%, But Not Placebo	Participants who required a switch to open label IGIV, 10% when receiving IGIV, 10%, but not during placebo

Secondary

Patient Global Impression of Change

Patient Global Impression of Change was measured on an ordinal scale of 1-7, higher scores representing greater perceived deterioration since the previous efficacy assessment (ranging from (1) very much improved to very much worse (7)). 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse

Intent to treat

Posted

Median

Inter-Quartile Range

Scores on a scale

Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit

ID	Title	Description
OG000	End of Stabilization 1	(IGIV, 10%)
OG001	End of Cross-Over 1	Either IGIV, 10% or Placebo
OG002	End of Stabilization 2	(IGIV, 10%)
OG003	End of Cross-Over 2	Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.

Secondary

Overall Disability Sum Score

The overall disability sum scale (based on Merkies et al., 2002) is a patient questionnaire that measures disability. Overall disability sum score = arm disability scale (range 0-5) + leg disability scale (range 0-7); Overall Range: 0 (no signs of disability) to 12 (maximum disability).

Intent to treat

Posted

Median

Inter-Quartile Range

Scores on a scale

Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit

ID	Title	Description
OG000	Before Stabilization 1	Baseline Measurements
OG001	End of Stabilization 1	IGIV, 10% (IGIV)
OG002	End of Cross-Over 1	Either IGIV, 10% or Placebo
OG003	End of Stabilization 2	IGIV, 10%
OG004

Secondary

Overall Disability Sum Score - Standardized

Intent to treat

Posted

Median

Inter-Quartile Range

Scores on a scale

Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit

ID	Title	Description
OG000	Before Stabilization 1	Baseline Measurements
OG001	End of Stabilization 1	IGIV, 10% (IGIV)
OG002	End of Cross-Over 1	Either IGIV, 10% or Placebo
OG003	End of Stabilization 2	IGIV, 10%

Secondary

Mean Relative Change in Overall Disability Sum Score

Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The overall disability sum scale (based on Merkies et al., 2002) is a patient questionnaire that measures disability (from 0, "no signs of disability" to 12, "most severe disability"). This was standardized to a scale of 0 to 100 (the best score being 100) to allow calculation of relative changes.

Intent to treat

Posted

Mean

95% Confidence Interval

percent change in score

Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)

ID	Title	Description
OG000	Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1	Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
OG001

Secondary

Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Dominant Hand

The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Participants picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, participants removed the pegs one at a time and returned them to the container as quickly as possible. Each participant did this two times with their dominant hand. The 9-HCT objective is to see how fast participants could put all of the pegs in and take them out again.

Intent to treat

Posted

Median

Inter-Quartile Range

Seconds

Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit

ID	Title	Description
OG000	Before Stabilization 1	Baseline Measurements
OG001	End of Stabilization 1	IGIV, 10% (IGIV)
OG002	End of Cross-Over 1	Either IGIV, 10% or Placebo
OG003

Secondary

Mean Relative Change in Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Dominant Hand

Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Participants picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, participants removed the pegs one at a time and returned them to the container as quickly as possible. Each participant did this two times with their dominant hand. The 9-HCT objective is to see how fast participants could put all of the pegs in and take them out again.

Intent to treat

Posted

Mean

95% Confidence Interval

Percent change in time

Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)

ID	Title	Description
OG000	Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1	Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)

Secondary

Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Non-Dominant Hand

The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Participants picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, participants removed the pegs one at a time and returned them to the container as quickly as possible. Each participant did this two times with their non-dominant hand. The 9-HCT objective is to see how fast participants could put all of the pegs in and take them out again.

Intent to treat

Posted

Median

Inter-Quartile Range

Seconds

Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit

ID	Title	Description
OG000	Before Stabilization 1	Baseline Measurements
OG001	End of Stabilization 1	IGIV, 10% (IGIV)
OG002	End of Cross-Over 1	Either IGIV, 10% or Placebo

Secondary

Mean Relative Change in Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Non-Dominant Hand

Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Participants picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, participants removed the pegs one at a time and returned them to the container as quickly as possible. Each participant did this two times with their non-dominant hand. The 9-HCT objective is to see how fast participants could put all of the pegs in and take them out again.

Intent to treat

Posted

Mean

95% Confidence Interval

Percent change in time

Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)

ID	Title	Description
OG000	Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1	Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)

Secondary

Participants' Assessment of Physical Functioning on a Visual Analog Scale (VAS)

The VAS measured patients' assessment of physical functioning on a 10 centimeter scale of 0-10, on which 0 represents "no symptoms" and 10 "disabled, unable to use affected limbs".

Intent to treat

Posted

Median

Inter-Quartile Range

Scores on a scale

Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit

ID	Title	Description
OG000	Before Stabilization 1	Baseline Measurements
OG001	End of Stabilization 1	IGIV, 10% (IGIV)
OG002	End of Cross-Over 1	Either IGIV, 10% or Placebo
OG003	End of Stabilization 2	IGIV, 10%
OG004	End of Cross-Over 2

Secondary

Mean Relative Change in Participants' Assessment of Physical Functioning on a Visual Analog Scale (VAS)

Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The VAS measured patients' assessment of physical functioning on a 10 centimeter scale of 0-10, on which 0 represents "no symptoms" and 10 "disabled, unable to use affected limbs".

Intent to treat

Posted

Mean

95% Confidence Interval

Percent change in assessment

Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)

ID	Title	Description
OG000	Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1	Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
OG001	Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2

Primary

Co-Primary Endpoint: Guy's Neurologic Disability Scale (GNDS) for Upper Limbs

GNDS (based on Sharrack and Hughes, 1999) for the upper limbs were integers 0 to 5, with 0 indicating no impairment.

Intent to treat

Posted

Median

Inter-Quartile Range

Scores on a scale

Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit

ID	Title	Description
OG000	Before Stabilization 1	Baseline Measurements
OG001	End of Stabilization 1	IGIV, 10% (IGIV)
OG002	End of Cross-Over 1	Either IGIV, 10% or Placebo
OG003	End of Stabilization 2	IGIV, 10%
OG004	End of Cross-Over 2

Post-Hoc

Proportion of Participants With at Least a 30% Decline in Relative Grip Strength in the Less Affected Hand (Measured Using a DynEx Digital Dynamometer)

Intent to treat

Posted

Number

Proportion of participants

Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)

ID	Title	Description
OG000	Decline Only During IGIV, 10%	Participants who experienced a relative decrease in grip strength of ≥30% in the less affected hand relative to baseline following IGIV, 10%, but not after the placebo
OG001	Decline Only During Placebo	Participants who experienced a relative decrease in grip strength of ≥30% in the less affected hand relative to baseline following the placebo, but not after IGIV, 10%

Primary

Co-Primary Endpoint: Proportion of Participants With Deterioration in Guy's Neurological Disability Score (GNDS)

GNDS (based on Sharrack and Hughes, 1999) for the upper limbs were integers 0 to 5, with 0 indicating no impairment.

Intent to treat

Posted

Number

Proportion of participants

Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)

ID	Title	Description
OG000	Deterioration After IGIV, 10% and Placebo	Participants with deterioration in GNDS scores after IGIV, 10% and placebo
OG001	Deterioration After Placebo, But Not IGIV, 10%	Participants with deterioration in GNDS scores after Placebo, but not IGIV, 10%
OG002	Deterioration After IGIV, 10%, But Not Placebo	Participants with deterioration in GNDS scores after IGIV, 10%, but not Placebo
OG003	No Deterioration After IGIV, 10% or Placebo	Participants with no deterioration in GNDS scores after IGIV, 10% or Placebo

Primary

Rate of Temporally Associated Adverse Events (AEs) Per Infusion

The total number of all AEs which begin during or within 72 hours of completion of an infusion, irrespective of being related or not related to the study product (IGIV, 10% or Placebo), divided by the total number of infusions, and multiplied by 100.

Safety Dataset

Posted

Number

Percentage of AEs per infusion

Within 72 hours of completion of an infusion during the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)

Infusions

ID	Title	Description
OG000	Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period	Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
OG001	Arm 1: IGIV, 10% Then Placebo- Placebo Period	Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)

Primary

The Percentage of Participants for Whom the Infusion Rate of Any Infusion Was Reduced and/or the Infusion Was Interrupted or Stopped for Any Reason

Safety Dataset

Posted

Number

percentage of participants

Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)

ID	Title	Description
OG000	Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period	Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
OG001	Arm 1: IGIV, 10% Then Placebo- Placebo Period	Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)

Primary

The Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped for Any Reason

Safety Dataset

Posted

Number

percentage of infusions

Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)

Infusions

ID	Title	Description
OG000	Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period	Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
OG001	Arm 1: IGIV, 10% Then Placebo- Placebo Period	Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)

Secondary

Rate of Related AEs Per Infusion

The total number of AEs determined by the investigator to be related to the study product that occur at any time during the study divided by the total number of infusions, and multiplied by 100.

Safety Dataset

Posted

Number

AEs per infusion

Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)

Infusions

ID	Title	Description
OG000	Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period	Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
OG001	Arm 1: IGIV, 10% Then Placebo- Placebo Period	Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)

Secondary

Rate of Related SAEs Per Infusion

The total number of SAEs determined by the investigator to be related to the study product that occur at any time during the study divided by the total number of infusions, and multiplied by 100.

Safety Dataset

Posted

Number

SAEs per infusion

Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)

Infusions

ID	Title	Description
OG000	Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period	Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
OG001	Arm 1: IGIV, 10% Then Placebo- Placebo Period	Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)

Secondary

The Proportion of Participants for Whom the Infusion Rate of Any Infusion Was Reduced and/or the Infusion Was Interrupted or Stopped for Tolerability Concerns/AEs

Safety Dataset

Posted

Number

proportion of participants

Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)

ID	Title	Description
OG000	Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period	Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
OG001	Arm 1: IGIV, 10% Then Placebo- Placebo Period	Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)

Secondary

The Proportion of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped for Tolerability Concerns/AEs

Safety Dataset

Posted

Number

proportion of infusions

Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)

Infusions

ID	Title	Description
OG000	Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period	Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
OG001	Arm 1: IGIV, 10% Then Placebo- Placebo Period	Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)

Secondary

The Proportion of Infusions Associated With One or More AEs Related to the Study Product

Safety Dataset

Posted

Number

proportion of infusions

Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)

Infusions

ID	Title	Description
OG000	Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period	Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
OG001	Arm 1: IGIV, 10% Then Placebo- Placebo Period	Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)

Primary

The Percentage of Participants Reporting One or More Moderate or Severe AEs That Began During Infusion or Within 72 Hours of Completion of an Infusion

Safety Dataset

Posted

Number

percentage of participants

Within 72 hours of completion of an infusion during the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)

ID	Title	Description
OG000	Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period	Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
OG001	Arm 1: IGIV, 10% Then Placebo- Placebo Period	Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)

Facility	Status	City	State	ZIP	Country	Contacts
		Los Angeles	California		United States

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MeDRA			EG0001 events1 affected44 at risk EG0010 events0 affected43 at risk
Vision blurred	Eye disorders	MeDRA			EG0001 events1 affected44 at risk EG0010 events0 affected43 at risk

Term	Organ System	Source Vocabulary	Statistical Information
HEADACHE	Nervous system disorders	MeDRA	EG00034 events16 affected44 at risk EG0013 events2 affected43 at risk
NEUROLOGICAL DECOMPENSATION	Nervous system disorders	MeDRA	EG00010 events10 affected44 at risk EG00125 events25 affected43 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MeDRA	EG00015 events9 affected44 at risk EG0010 events0 affected43 at risk
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MeDRA	EG00012 events8 affected44 at risk EG0012 events2 affected43 at risk
INFLUENZA LIKE ILLNESS	General disorders	MeDRA	EG0009 events7 affected44 at risk EG0011 events1 affected43 at risk
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MeDRA	EG0008 events7 affected44 at risk EG0010 events0 affected43 at risk
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	MeDRA	EG0009 events6 affected44 at risk EG0013 events2 affected43 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MeDRA	EG0005 events5 affected44 at risk EG0012 events1 affected43 at risk
CONTUSION	Injury, poisoning and procedural complications	MeDRA	EG0009 events5 affected44 at risk EG0012 events2 affected43 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MeDRA	EG0006 events4 affected44 at risk EG0013 events3 affected43 at risk
CHEST DISCOMFORT	General disorders	MeDRA	EG0003 events3 affected44 at risk EG0010 events0 affected43 at risk
DIARRHOEA	Gastrointestinal disorders	MeDRA	EG0003 events3 affected44 at risk EG0010 events0 affected43 at risk
FATIGUE	General disorders	MeDRA	EG0005 events3 affected44 at risk EG0010 events0 affected43 at risk
NASOPHARYNGITIS	General disorders	MeDRA	EG0003 events3 affected44 at risk EG0012 events2 affected43 at risk
NAUSEA	Gastrointestinal disorders	MeDRA	EG00031 events3 affected44 at risk EG0013 events2 affected43 at risk
NECK PAIN	Musculoskeletal and connective tissue disorders	MeDRA	EG0003 events3 affected44 at risk EG0011 events1 affected43 at risk
NEUROLOGICAL SYMPTOM	Nervous system disorders	MeDRA	EG0003 events3 affected44 at risk EG0012 events2 affected43 at risk
PARAESTHESIA	Nervous system disorders	MeDRA	EG0004 events3 affected44 at risk EG0011 events1 affected43 at risk
SINUS CONGESTION	Respiratory, thoracic and mediastinal disorders	MeDRA	EG0003 events3 affected44 at risk EG0010 events0 affected43 at risk
SINUS HEADACHE	Nervous system disorders	MeDRA	EG0003 events3 affected44 at risk EG0010 events0 affected43 at risk
TOOTHACHE	Gastrointestinal disorders	MeDRA	EG0003 events3 affected44 at risk EG0010 events0 affected43 at risk
URINARY TRACT INFECTION	Infections and infestations	MeDRA	EG0003 events3 affected44 at risk EG0010 events0 affected43 at risk

ID	Term
D005719	gamma-Globulins
D000418	Albumins
D012996	Solutions
D000075462	Serum Albumin, Human

ID	Term
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D004364	Pharmaceutical Preparations
D012709	Serum Albumin

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	IGIV, 10%	Participants received IGIV, 10% at the same equivalent dose per week administered prior to the study (0.4 to 2.0 g per kg BW per infusion cycle)			2	44	35	44
EG001	Placebo	0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used)			0	43	33	43