Alzheimer´s Disease
Conditions
Keywords
Alzheimer´s, Dementia, Dementia of Alzheimer Type, Immunoglobulins, Gammaglobulins, Immune Globulin Intravenous (IGIV), Intravenous Immune Globulin (IVIG), Antibodies, Amyloid, Immunotherapy
Brief summary
The purpose of this study was to evaluate the efficacy and safety of 2 doses of Immune Globulin Intravenous (IGIV), 10% administered every 2 weeks as an intravenous (IV) infusion compared with placebo in participants with mild to moderate Alzheimer's disease (AD).
Detailed description
Study visits: Each participant will be tested at the investigational site, and if qualified, will be treated intravenously (through a vein) every two weeks for 70 weeks (approximately 18 months). The first three infusions must be done at the site, but if the infusions are well tolerated, subsequent infusions may be done by a qualified healthcare provider in the home or other suitable location. Each participant must return to the site every 3 months for evaluation of cognition as well as blood tests and scans of the brain.
Interventions
BIOLOGICALImmune Globulin Intravenous (Human), 10% (IGIV, 10%) 400 mg/kg
400 mg/kg bodyweight every 2 weeks for 70 weeks
BIOLOGICALImmune Globulin Intravenous (Human), 10% (IGIV, 10%) 200 mg/kg
200 mg/kg bodyweight every 2 weeks for 70 weeks
BIOLOGICALPlacebo solution: Human Albumin 0.25% - 4 mL/kg
Placebo solution: 0.25% human albumin solution infused at 4 mL/kg/2weeks for 70 weeks
BIOLOGICALPlacebo solution: Human Albumin 0.25% - 2 mL/kg
Placebo solution: 0.25% human albumin solution infused at 2 mL/kg/2weeks for 70 weeks
Sponsors
Alzheimer's Disease Cooperative Study (ADCS)
Baxalta now part of Shire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Written informed consent - participant (or participant´s legally acceptable representative) and caregiver who are willing and able to participate for the duration of the study * Diagnosis of probable Alzheimer´s Disease (AD) * Dementia of mild to moderate severity defined as mini-mental state examination (MMSE) 16-26 inclusive at the time of screening * Neuroimaging (computed tomography \[CT\] or MRI) performed after symptom onset consistent with AD diagnosis * Ability to comply with testing and infusion regimen, including fluency in English or Spanish, adequate corrected visual acuity and hearing ability * On stable doses of regulatory authority approved AD medication(s) for at least 3 months prior to screening. These medications must be continued throughout this study. * If receiving psychoactive medications (e.g. antidepressants other than monoamine oxidase inhibitors (MAOIs) and most tricyclics, antipsychotics, anxiolytics, anticonvulsants, mood stabilizers, etc), must be on stable doses for at least 6 weeks prior to screening Main
Exclusion criteria
(Reasons why it might not be appropriate to participate): * Any other forms of dementia * Medical issues that might increase the risk of treatment with IGIV, 10%, such as: 1. Significant problems with blood pressure, heart disease, clotting disorders, strokes or recent heart attacks 2. Evidence of current bleeding in the brain by MRI 3. Serious problems with the liver or kidneys 4. Allergies to blood products * Medical issues that might interfere with the evaluation of the treatment of dementia or might make dementia worse, such as: 1. Diabetes 2. Recent treatment with chemotherapy or immune suppression 3. The recent use of other investigational drugs, especially antibody therapy for AD 4. Severe headaches or psychiatric problems
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline at 18 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) | Baseline & 18 months | 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. |
| Change From Baseline at 18 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) | Baseline & 18 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline at 9 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Baseline & 9 Months | 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 |
| Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Baseline & 18 Months | 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 |
| Change From Baseline at 18 Months in the Modified Mini-Mental State Examination (3MS) Examination | Baseline & 18 months | 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. |
| Change From Baseline at 18 Months in the Neuropsychiatric Inventory (NPI) Assessment | Baseline & 18 months | 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. |
| Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Participant Response | Baseline & 18 months | 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. |
| Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Caregiver Response | Baseline & 18 months | 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. |
| Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Forward | Baseline & 18 months | 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. |
| Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Backward | Baseline & 18 months | 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. |
| Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: FAS Verbal Fluency | Baseline & 18 months | 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. |
| Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Symbol Substitution | Baseline & 18 months | 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. |
| Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Animals Category Fluency | Baseline & 18 months | 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. |
| Change From Baseline at 9 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) | Baseline & 9 months | 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. |
| Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Trail-Making Test (TMT), Part B | Baseline & 18 months | 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. |
| Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Clock Drawing Test | Baseline & 18 months | 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). |
| Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Throughout the study period, approximately 4 years | — |
| Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class | Throughout the study period, approximately 4 years | — |
| Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Throughout the study period, approximately 4 years | Related and unrelated non-SAEs |
| Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Throughout the study period, approximately 4 years | Related and unrelated SAEs |
| Number of Infusions Temporally Associated With Non-serious Adverse Events (Non-SAEs) and/or Serious Adverse Events (SAEs) | During or within 72 hours of completion of an infusion | Refers to non-SAEs and/or SAEs occurring during infusion or within 72 hours of completion of infusion (regardless of causality) |
| Number of Infusions With Causally Associated Non-serious Adverse Events (Non-SAEs) and/or Serious Adverse Events (SAEs) | Throughout the study period, approximately 4 years | Each adverse event (AE) that was considered related to investigational product (IP) was linked to the most recent infusion administered |
| Number of Infusions Discontinued, Slowed, or Interrupted Due to an Adverse Event (AE) | Throughout each infusion period | — |
| Number of Participants Experiencing a Clinically Significant Decrease in Hemoglobin (>1.5 g/dL) Between Consecutive Visits | Throughout the study period, approximately 4 years | — |
| Number of Participants Experiencing a Clinically Significant Rash | Throughout the study period, approximately 4 years | Participants requiring systemic therapy or discontinuation from further treatment |
| Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Trail-Making Test (TMT), Part A | Baseline & 18 months | 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. |
| Change From Baseline at 9 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) | Baseline & 9 Months | 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. |
Countries
Canada, United States
Participant flow
Recruitment details
Recruitment was conducted in the U.S., and Canada, at 45 study sites. The first participant was enrolled in December 2008.
Pre-assignment details
702 participants were enrolled; 308 were screen failures; 4 were discontinued before randomization; and 7 were withdrawn after randomization, but prior to receiving investigational product. Therefore 383 participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 127 |
| 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 | 135 |
| 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 | 58 |
| 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 | 63 |
| Total | 383 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Admitted to long term nursing care | 0 | 1 | 0 | 0 |
| Overall Study | Adverse Event | 5 | 14 | 4 | 3 |
| Overall Study | Caregiver to pursue other treatment | 0 | 1 | 0 | 0 |
| Overall Study | Change in living situation | 0 | 0 | 0 | 1 |
| Overall Study | Death | 1 | 3 | 0 | 0 |
| Overall Study | Declined move to another study site | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 |
| Overall Study | Moving out of state | 0 | 0 | 0 | 1 |
| Overall Study | Participant's health declined | 0 | 0 | 0 | 1 |
| Overall Study | Physician Decision | 1 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 1 | 0 | 0 |
| Overall Study | Requires a Prohibited Medication | 1 | 0 | 0 | 0 |
| Overall Study | Safety Risk | 1 | 1 | 0 | 1 |
| Overall Study | Study partner decision | 0 | 0 | 0 | 1 |
| Overall Study | Study Partner Unwilling or Unable | 3 | 2 | 1 | 1 |
| Overall Study | Unwilling or Unable to Participate | 4 | 6 | 2 | 4 |
| Overall Study | Withdrawal by Subject | 5 | 4 | 2 | 2 |
Baseline characteristics
| Characteristic | IGIV, 10% 400mg/kg | IGIV, 10% 200mg/kg | Placebo 4 mL/kg | Placebo 2 mL/kg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 70.5 years STANDARD_DEVIATION 9.6 | 70.1 years STANDARD_DEVIATION 8.3 | 70.3 years STANDARD_DEVIATION 9.7 | 70.1 years STANDARD_DEVIATION 10.3 | 70.3 years STANDARD_DEVIATION 9.3 |
| Region of Enrollment Canada | 10 Participants | 8 Participants | 2 Participants | 5 Participants | 25 Participants |
| Region of Enrollment United States | 117 Participants | 127 Participants | 56 Participants | 58 Participants | 358 Participants |
| Sex: Female, Male Female | 69 Participants | 74 Participants | 33 Participants | 33 Participants | 209 Participants |
| Sex: Female, Male Male | 58 Participants | 61 Participants | 25 Participants | 30 Participants | 174 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 112 / 127 | 118 / 135 | 103 / 121 |
| serious Total, serious adverse events | 21 / 127 | 32 / 135 | 26 / 121 |
Outcome results
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.
Time frame: Baseline & 18 Months
Population: Intent-to-Treat Analysis Set with both baseline and month 18 assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IGIV, 10% 400mg/kg | Change From Baseline at 18 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) | -11.4 Scores on a scale | Standard Deviation 10.49 |
| IGIV, 10% 200mg/kg | Change From Baseline at 18 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) | -12.4 Scores on a scale | Standard Deviation 11.41 |
| Placebo 2 mL/kg or 4 mL/kg | Change From Baseline at 18 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) | -11.4 Scores on a scale | Standard Deviation 12.19 |
p-value: 0.81295% CI: [-2.9, 3.7]ANCOVA
p-value: 0.60295% CI: [-4.3, 2.5]ANCOVA
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.
Time frame: Baseline & 18 months
Population: Intent-to-Treat Analysis Set with both baseline and month 18 assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IGIV, 10% 400mg/kg | Change From Baseline at 18 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) | 7.4 Scores on a scale | Standard Deviation 7.95 |
| IGIV, 10% 200mg/kg | Change From Baseline at 18 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) | 8.9 Scores on a scale | Standard Deviation 8.2 |
| Placebo 2 mL/kg or 4 mL/kg | Change From Baseline at 18 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) | 8.4 Scores on a scale | Standard Deviation 9.37 |
p-value: 0.47695% CI: [-3.1, 1.5]ANCOVA
p-value: 0.5395% CI: [-1.6, 3]ANCOVA
Secondary
Change From Baseline at 18 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
Time frame: Baseline & 18 Months
Population: Intent-to-Treat Analysis Set with both baseline and month 18 assessments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IGIV, 10% 400mg/kg | Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 18: Much better (2) | 1 participants |
| IGIV, 10% 400mg/kg | Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 18: A little worse (5) | 44 participants |
| IGIV, 10% 400mg/kg | Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 18: Same (4) | 15 participants |
| IGIV, 10% 400mg/kg | Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 18: Very much better (1) | 0 participants |
| IGIV, 10% 400mg/kg | Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 18: Very much worse (7) | 7 participants |
| IGIV, 10% 400mg/kg | Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 18: Much worse (6) | 32 participants |
| IGIV, 10% 400mg/kg | Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 18: A little better (3) | 6 participants |
| IGIV, 10% 200mg/kg | Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 18: Same (4) | 15 participants |
| IGIV, 10% 200mg/kg | Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 18: Very much better (1) | 0 participants |
| IGIV, 10% 200mg/kg | Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 18: Much better (2) | 2 participants |
| IGIV, 10% 200mg/kg | Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 18: A little better (3) | 1 participants |
| IGIV, 10% 200mg/kg | Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 18: A little worse (5) | 43 participants |
| IGIV, 10% 200mg/kg | Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 18: Much worse (6) | 33 participants |
| IGIV, 10% 200mg/kg | Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 18: Very much worse (7) | 7 participants |
| Placebo 2 mL/kg or 4 mL/kg | Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 18: A little worse (5) | 36 participants |
| Placebo 2 mL/kg or 4 mL/kg | Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 18: Much better (2) | 1 participants |
| Placebo 2 mL/kg or 4 mL/kg | Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 18: Very much worse (7) | 4 participants |
| Placebo 2 mL/kg or 4 mL/kg | Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 18: Much worse (6) | 32 participants |
| Placebo 2 mL/kg or 4 mL/kg | Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 18: Same (4) | 16 participants |
| Placebo 2 mL/kg or 4 mL/kg | Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 18: A little better (3) | 3 participants |
| Placebo 2 mL/kg or 4 mL/kg | Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 18: Very much better (1) | 0 participants |
p-value: 0.6695% CI: [-0.3, 0.2]Mixed Models Analysis
p-value: 0.76695% CI: [-0.2, 0.3]Mixed Models Analysis
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.
Time frame: Baseline & 18 months
Population: Per-Protocol Analysis Set with both baseline and month 18 assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IGIV, 10% 400mg/kg | Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Animals Category Fluency | -2.8 correct responses | Standard Deviation 4.06 |
| IGIV, 10% 200mg/kg | Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Animals Category Fluency | -2.2 correct responses | Standard Deviation 6.84 |
| Placebo 2 mL/kg or 4 mL/kg | Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Animals Category Fluency | -2.7 correct responses | Standard Deviation 3.82 |
p-value: 0.98895% CI: [-1.5, 1.5]ANCOVA
p-value: 0.55595% CI: [-1, 1.9]ANCOVA
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).
Time frame: Baseline & 18 months
Population: Per-Protocol Analysis Set with both baseline and month 18 assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IGIV, 10% 400mg/kg | Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Clock Drawing Test | -0.7 Scores on a scale | Standard Deviation 1.27 |
| IGIV, 10% 200mg/kg | Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Clock Drawing Test | -0.7 Scores on a scale | Standard Deviation 1.15 |
| Placebo 2 mL/kg or 4 mL/kg | Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Clock Drawing Test | -0.6 Scores on a scale | Standard Deviation 1.17 |
p-value: 0.58895% CI: [-0.4, 0.2]ANCOVA
p-value: 0.35195% CI: [-0.5, 0.2]ANCOVA
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.
Time frame: Baseline & 18 months
Population: Per-Protocol Analysis Set with both baseline and month 18 assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IGIV, 10% 400mg/kg | Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: FAS Verbal Fluency | -4.7 correct responses | Standard Deviation 8.6 |
| IGIV, 10% 200mg/kg | Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: FAS Verbal Fluency | -7.4 correct responses | Standard Deviation 9 |
| Placebo 2 mL/kg or 4 mL/kg | Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: FAS Verbal Fluency | -6.3 correct responses | Standard Deviation 8.17 |
p-value: 0.23895% CI: [-1, 4]ANCOVA
p-value: 0.495% CI: [-3.6, 1.4]ANCOVA
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.
Time frame: Baseline & 18 months
Population: Per-Protocol Analysis Set with both baseline and month 18 assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IGIV, 10% 400mg/kg | Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Trail-Making Test (TMT), Part A | 21.6 seconds | Standard Deviation 36.93 |
| IGIV, 10% 200mg/kg | Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Trail-Making Test (TMT), Part A | 20.5 seconds | Standard Deviation 30.61 |
| Placebo 2 mL/kg or 4 mL/kg | Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Trail-Making Test (TMT), Part A | 21.3 seconds | Standard Deviation 35.5 |
p-value: 0.78395% CI: [-12.2, 9.2]ANCOVA
p-value: 0.795% CI: [-13.1, 8.8]ANCOVA
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.
Time frame: Baseline & 18 months
Population: Per-Protocol Analysis Set with both baseline and month 18 assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IGIV, 10% 400mg/kg | Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Trail-Making Test (TMT), Part B | 13.0 seconds | Standard Deviation 60.49 |
| IGIV, 10% 200mg/kg | Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Trail-Making Test (TMT), Part B | 28.4 seconds | Standard Deviation 65.01 |
| Placebo 2 mL/kg or 4 mL/kg | Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Trail-Making Test (TMT), Part B | 31.9 seconds | Standard Deviation 66.32 |
p-value: 0.19195% CI: [-38, 7.7]ANCOVA
p-value: 0.89295% CI: [-25.4, 22.1]ANCOVA
Secondary
Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Backward
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.
Time frame: Baseline & 18 months
Population: Per-Protocol Analysis Set with both baseline and month 18 assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IGIV, 10% 400mg/kg | Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Backward | -0.8 correct responses | Standard Deviation 1.95 |
| IGIV, 10% 200mg/kg | Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Backward | -1.2 correct responses | Standard Deviation 1.88 |
| Placebo 2 mL/kg or 4 mL/kg | Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Backward | -1.2 correct responses | Standard Deviation 1.79 |
p-value: 0.17395% CI: [-0.2, 0.9]ANCOVA
p-value: 0.74495% CI: [-0.4, 0.6]ANCOVA
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.
Time frame: Baseline & 18 months
Population: Per-Protocol Analysis Set with both baseline and month 18 assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IGIV, 10% 400mg/kg | Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Forward | -0.8 correct responses | Standard Deviation 2 |
| IGIV, 10% 200mg/kg | Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Forward | -1.2 correct responses | Standard Deviation 2.21 |
| Placebo 2 mL/kg or 4 mL/kg | Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Forward | -1.1 correct responses | Standard Deviation 1.81 |
p-value: 0.16795% CI: [-0.2, 1]ANCOVA
p-value: 0.99895% CI: [-0.6, 0.6]ANCOVA
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.
Time frame: Baseline & 18 months
Population: Per-Protocol Analysis Set with both baseline and month 18 assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IGIV, 10% 400mg/kg | Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Symbol Substitution | -6.8 correct responses | Standard Deviation 10.61 |
| IGIV, 10% 200mg/kg | Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Symbol Substitution | -7.7 correct responses | Standard Deviation 9.67 |
| Placebo 2 mL/kg or 4 mL/kg | Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Symbol Substitution | -6.2 correct responses | Standard Deviation 7.34 |
p-value: 0.69595% CI: [-3.6, 2.4]ANCOVA
p-value: 0.4195% CI: [-4.5, 1.9]ANCOVA
Secondary
Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Caregiver 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.
Time frame: Baseline & 18 months
Population: Intent-to-Treat Analysis Set with both baseline and month 18 assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IGIV, 10% 400mg/kg | Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Caregiver Response | -3.0 Scores on a scale | Standard Deviation 4.97 |
| IGIV, 10% 200mg/kg | Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Caregiver Response | -2.5 Scores on a scale | Standard Deviation 5.17 |
| Placebo 2 mL/kg or 4 mL/kg | Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Caregiver Response | -1.6 Scores on a scale | Standard Deviation 5.12 |
p-value: 0.09695% CI: [-2.3, 0.2]ANCOVA
p-value: 0.12395% CI: [-2.2, 0.3]ANCOVA
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.
Time frame: Baseline & 18 months
Population: Intent-to-Treat Analysis Set with both baseline and month 18 assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IGIV, 10% 400mg/kg | Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Participant Response | -0.5 Scores on a scale | Standard Deviation 5.34 |
| IGIV, 10% 200mg/kg | Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Participant Response | -0.7 Scores on a scale | Standard Deviation 4.4 |
| Placebo 2 mL/kg or 4 mL/kg | Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Participant Response | -1.5 Scores on a scale | Standard Deviation 5.2 |
p-value: 0.09395% CI: [-0.2, 2.3]ANCOVA
p-value: 0.09495% CI: [-0.2, 2.3]ANCOVA
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.
Time frame: Baseline & 18 months
Population: Intent-to-Treat Analysis Set with both baseline and month 18 assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IGIV, 10% 400mg/kg | Change From Baseline at 18 Months in the Modified Mini-Mental State Examination (3MS) Examination | -12.1 Scores on a scale | Standard Deviation 13.12 |
| IGIV, 10% 200mg/kg | Change From Baseline at 18 Months in the Modified Mini-Mental State Examination (3MS) Examination | -15.3 Scores on a scale | Standard Deviation 12.76 |
| Placebo 2 mL/kg or 4 mL/kg | Change From Baseline at 18 Months in the Modified Mini-Mental State Examination (3MS) Examination | -13.5 Scores on a scale | Standard Deviation 10.95 |
p-value: 0.20695% CI: [-1, 4.8]ANCOVA
p-value: 0.33195% CI: [-4.3, 1.5]ANCOVA
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.
Time frame: Baseline & 18 months
Population: Intent-to-Treat Analysis Set with both baseline and month 18 assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IGIV, 10% 400mg/kg | Change From Baseline at 18 Months in the Neuropsychiatric Inventory (NPI) Assessment | 3.7 Scores on a scale | Standard Deviation 12.93 |
| IGIV, 10% 200mg/kg | Change From Baseline at 18 Months in the Neuropsychiatric Inventory (NPI) Assessment | 4.9 Scores on a scale | Standard Deviation 13.3 |
| Placebo 2 mL/kg or 4 mL/kg | Change From Baseline at 18 Months in the Neuropsychiatric Inventory (NPI) Assessment | 2.4 Scores on a scale | Standard Deviation 10.77 |
p-value: 0.6495% CI: [-2.1, 3.4]ANCOVA
p-value: 0.07595% CI: [-0.3, 5.3]ANCOVA
Secondary
Change From Baseline at 9 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.
Time frame: Baseline & 9 Months
Population: Intent-to-Treat Analysis Set with both baseline and month 9 assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IGIV, 10% 400mg/kg | Change From Baseline at 9 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) | -5.4 Scores on a scale | Standard Deviation 7.03 |
| IGIV, 10% 200mg/kg | Change From Baseline at 9 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) | -6.1 Scores on a scale | Standard Deviation 8.13 |
| Placebo 2 mL/kg or 4 mL/kg | Change From Baseline at 9 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) | -5.8 Scores on a scale | Standard Deviation 8.32 |
p-value: 0.77895% CI: [-1.8, 2.4]ANCOVA
p-value: 0.85195% CI: [-2.3, 1.9]ANCOVA
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
Time frame: Baseline & 9 Months
Population: Intent-to-Treat Analysis Set with both baseline and month 9 assessments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IGIV, 10% 400mg/kg | Change From Baseline at 9 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 9: Much better (2) | 2 participants |
| IGIV, 10% 400mg/kg | Change From Baseline at 9 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 9: A little worse (5) | 52 participants |
| IGIV, 10% 400mg/kg | Change From Baseline at 9 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 9: Same (4) | 33 participants |
| IGIV, 10% 400mg/kg | Change From Baseline at 9 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 9: Very much better (1) | 0 participants |
| IGIV, 10% 400mg/kg | Change From Baseline at 9 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 9: Very much worse (7) | 1 participants |
| IGIV, 10% 400mg/kg | Change From Baseline at 9 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 9: Much worse (6) | 19 participants |
| IGIV, 10% 400mg/kg | Change From Baseline at 9 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 9: A little better (3) | 7 participants |
| IGIV, 10% 200mg/kg | Change From Baseline at 9 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 9: Same (4) | 33 participants |
| IGIV, 10% 200mg/kg | Change From Baseline at 9 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 9: Very much better (1) | 0 participants |
| IGIV, 10% 200mg/kg | Change From Baseline at 9 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 9: Much better (2) | 1 participants |
| IGIV, 10% 200mg/kg | Change From Baseline at 9 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 9: A little better (3) | 3 participants |
| IGIV, 10% 200mg/kg | Change From Baseline at 9 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 9: A little worse (5) | 56 participants |
| IGIV, 10% 200mg/kg | Change From Baseline at 9 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 9: Much worse (6) | 18 participants |
| IGIV, 10% 200mg/kg | Change From Baseline at 9 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 9: Very much worse (7) | 3 participants |
| Placebo 2 mL/kg or 4 mL/kg | Change From Baseline at 9 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 9: A little worse (5) | 48 participants |
| Placebo 2 mL/kg or 4 mL/kg | Change From Baseline at 9 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 9: Much better (2) | 1 participants |
| Placebo 2 mL/kg or 4 mL/kg | Change From Baseline at 9 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 9: Very much worse (7) | 0 participants |
| Placebo 2 mL/kg or 4 mL/kg | Change From Baseline at 9 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 9: Much worse (6) | 12 participants |
| Placebo 2 mL/kg or 4 mL/kg | Change From Baseline at 9 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 9: Same (4) | 36 participants |
| Placebo 2 mL/kg or 4 mL/kg | Change From Baseline at 9 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 9: A little better (3) | 7 participants |
| Placebo 2 mL/kg or 4 mL/kg | Change From Baseline at 9 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment | Month 9: Very much better (1) | 0 participants |
p-value: 0.30695% CI: [-0.1, 0.3]Mixed Models Analysis
p-value: 0.02895% CI: [0, 0.5]Mixed Models Analysis
Secondary
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.
Time frame: Baseline & 9 months
Population: Intent-to-Treat Analysis Set with both baseline and month 9 assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IGIV, 10% 400mg/kg | Change From Baseline at 9 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) | 2.7 Scores on a scale | Standard Deviation 5.2 |
| IGIV, 10% 200mg/kg | Change From Baseline at 9 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) | 4.5 Scores on a scale | Standard Deviation 6.16 |
| Placebo 2 mL/kg or 4 mL/kg | Change From Baseline at 9 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) | 3.5 Scores on a scale | Standard Deviation 6.44 |
p-value: 0.36895% CI: [-2.3, 0.8]ANCOVA
p-value: 0.31995% CI: [-0.8, 2.4]ANCOVA
Secondary
Number of Infusions Discontinued, Slowed, or Interrupted Due to an Adverse Event (AE)
Time frame: Throughout each infusion period
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IGIV, 10% 400mg/kg | Number of Infusions Discontinued, Slowed, or Interrupted Due to an Adverse Event (AE) | 48 Adverse events |
| IGIV, 10% 200mg/kg | Number of Infusions Discontinued, Slowed, or Interrupted Due to an Adverse Event (AE) | 28 Adverse events |
| Placebo 2 mL/kg or 4 mL/kg | Number of Infusions Discontinued, Slowed, or Interrupted Due to an Adverse Event (AE) | 36 Adverse events |
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)
Time frame: During or within 72 hours of completion of an infusion
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IGIV, 10% 400mg/kg | Number of Infusions Temporally Associated With Non-serious Adverse Events (Non-SAEs) and/or Serious Adverse Events (SAEs) | 396 Infusions |
| IGIV, 10% 200mg/kg | Number of Infusions Temporally Associated With Non-serious Adverse Events (Non-SAEs) and/or Serious Adverse Events (SAEs) | 467 Infusions |
| Placebo 2 mL/kg or 4 mL/kg | Number of Infusions Temporally Associated With Non-serious Adverse Events (Non-SAEs) and/or Serious Adverse Events (SAEs) | 349 Infusions |
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
Time frame: Throughout the study period, approximately 4 years
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IGIV, 10% 400mg/kg | Number of Infusions With Causally Associated Non-serious Adverse Events (Non-SAEs) and/or Serious Adverse Events (SAEs) | 225 Infusions |
| IGIV, 10% 200mg/kg | Number of Infusions With Causally Associated Non-serious Adverse Events (Non-SAEs) and/or Serious Adverse Events (SAEs) | 265 Infusions |
| Placebo 2 mL/kg or 4 mL/kg | Number of Infusions With Causally Associated Non-serious Adverse Events (Non-SAEs) and/or Serious Adverse Events (SAEs) | 172 Infusions |
Secondary
Number of Participants Experiencing a Clinically Significant Decrease in Hemoglobin (>1.5 g/dL) Between Consecutive Visits
Time frame: Throughout the study period, approximately 4 years
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IGIV, 10% 400mg/kg | Number of Participants Experiencing a Clinically Significant Decrease in Hemoglobin (>1.5 g/dL) Between Consecutive Visits | 31 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing a Clinically Significant Decrease in Hemoglobin (>1.5 g/dL) Between Consecutive Visits | 24 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing a Clinically Significant Decrease in Hemoglobin (>1.5 g/dL) Between Consecutive Visits | 16 participants |
Secondary
Number of Participants Experiencing a Clinically Significant Rash
Participants requiring systemic therapy or discontinuation from further treatment
Time frame: Throughout the study period, approximately 4 years
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IGIV, 10% 400mg/kg | Number of Participants Experiencing a Clinically Significant Rash | Rash requiring discontinuation from treatment | 3 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing a Clinically Significant Rash | Rash requiring systemic therapy | 19 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing a Clinically Significant Rash | Rash requiring discontinuation from treatment | 2 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing a Clinically Significant Rash | Rash requiring systemic therapy | 16 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing a Clinically Significant Rash | Rash requiring discontinuation from treatment | 0 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing a Clinically Significant Rash | Rash requiring systemic therapy | 8 participants |
Secondary
Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class
Related and unrelated non-SAEs
Time frame: Throughout the study period, approximately 4 years
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Renal and Urinary Disorders | 13 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Infections and Infestations | 40 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Endocrine Disorders | 1 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Psychiatric Disorders | 41 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Injury, Poisoning, and Procedural Complications | 36 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Vascular Disorders | 22 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Nervous System Disorders | 63 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Investigations | 37 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Skin and Subcutaneous Tissue Disorders | 49 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Neoplasms, Benign, Malignant and Unspecified | 8 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Metabolism and Nutrition Disorders | 14 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Eye Disorders | 14 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Musculoskeletal and Connective Tissue Disorders | 40 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Surgical and Medical Procedures | 8 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Respiratory, Thoracic and Mediastinal Disorders | 23 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Gastrointestinal Disorders | 47 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Ear and Labyrinth Disorders | 4 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Blood and Lymphatic System Disorders | 13 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | General Disorders & Administration Site Conditions | 57 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Cardiac Disorders | 3 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Reproductive System and Breast Disorders | 5 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Immune System Disorders | 1 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Social Circumstances | 0 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Reproductive System and Breast Disorders | 4 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Blood and Lymphatic System Disorders | 7 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Cardiac Disorders | 11 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Ear and Labyrinth Disorders | 3 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Endocrine Disorders | 0 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Eye Disorders | 5 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Gastrointestinal Disorders | 51 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | General Disorders & Administration Site Conditions | 66 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Immune System Disorders | 7 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Infections and Infestations | 46 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Injury, Poisoning, and Procedural Complications | 37 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Investigations | 48 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Metabolism and Nutrition Disorders | 15 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Musculoskeletal and Connective Tissue Disorders | 44 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Neoplasms, Benign, Malignant and Unspecified | 8 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Nervous System Disorders | 73 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Psychiatric Disorders | 49 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Renal and Urinary Disorders | 16 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Respiratory, Thoracic and Mediastinal Disorders | 35 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Skin and Subcutaneous Tissue Disorders | 52 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Social Circumstances | 1 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Surgical and Medical Procedures | 6 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Vascular Disorders | 30 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Social Circumstances | 0 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Psychiatric Disorders | 49 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Immune System Disorders | 3 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Cardiac Disorders | 15 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Renal and Urinary Disorders | 12 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | General Disorders & Administration Site Conditions | 52 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Gastrointestinal Disorders | 36 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Reproductive System and Breast Disorders | 3 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Eye Disorders | 9 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Vascular Disorders | 31 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Respiratory, Thoracic and Mediastinal Disorders | 23 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Endocrine Disorders | 1 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Surgical and Medical Procedures | 8 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Metabolism and Nutrition Disorders | 16 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Skin and Subcutaneous Tissue Disorders | 31 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Musculoskeletal and Connective Tissue Disorders | 27 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Investigations | 30 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Ear and Labyrinth Disorders | 5 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Neoplasms, Benign, Malignant and Unspecified | 13 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Injury, Poisoning, and Procedural Complications | 50 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Blood and Lymphatic System Disorders | 5 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Nervous System Disorders | 53 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class | Infections and Infestations | 57 participants |
Secondary
Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class
Related and unrelated SAEs
Time frame: Throughout the study period, approximately 4 years
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Psychiatric Disorders | 2 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Injury, Poisoning, and Procedural Complications | 3 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Blood and Lymphatic System Disorders | 2 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Nervous System Disorders | 3 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Investigations | 1 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | General Disorders & Administration Site Conditions | 2 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Neoplasms, Benign, Malignant and Unspecified | 0 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Metabolism and Nutrition Disorders | 1 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Cardiac Disorders | 5 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Musculoskeletal and Connective Tissue Disorders | 2 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Surgical and Medical Procedures | 0 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Hepatobiliary Disorders | 0 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Gastrointestinal Disorders | 5 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Respiratory, Thoracic and Mediastinal Disorders | 1 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Immune System Disorders | 0 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Ear and Labyrinth Disorders | 1 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Renal and Urinary Disorders | 0 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Infections and Infestations | 2 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Vascular Disorders | 4 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Injury, Poisoning, and Procedural Complications | 2 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Blood and Lymphatic System Disorders | 0 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Ear and Labyrinth Disorders | 0 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Gastrointestinal Disorders | 1 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | General Disorders & Administration Site Conditions | 4 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Hepatobiliary Disorders | 1 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Immune System Disorders | 1 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Infections and Infestations | 2 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Investigations | 2 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Metabolism and Nutrition Disorders | 1 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Musculoskeletal and Connective Tissue Disorders | 3 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Neoplasms, Benign, Malignant and Unspecified | 3 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Nervous System Disorders | 6 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Psychiatric Disorders | 4 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Renal and Urinary Disorders | 1 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Respiratory, Thoracic and Mediastinal Disorders | 2 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Surgical and Medical Procedures | 1 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Vascular Disorders | 0 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Cardiac Disorders | 3 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Infections and Infestations | 4 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Cardiac Disorders | 3 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Psychiatric Disorders | 3 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Immune System Disorders | 0 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Vascular Disorders | 4 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Renal and Urinary Disorders | 1 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Hepatobiliary Disorders | 1 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Blood and Lymphatic System Disorders | 1 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Respiratory, Thoracic and Mediastinal Disorders | 3 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | General Disorders & Administration Site Conditions | 2 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Metabolism and Nutrition Disorders | 2 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Ear and Labyrinth Disorders | 0 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Musculoskeletal and Connective Tissue Disorders | 0 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Investigations | 1 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Surgical and Medical Procedures | 1 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Neoplasms, Benign, Malignant and Unspecified | 3 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Injury, Poisoning, and Procedural Complications | 2 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Gastrointestinal Disorders | 1 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class | Nervous System Disorders | 5 participants |
Secondary
Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class
Time frame: Throughout the study period, approximately 4 years
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Nervous System Disorders | 33 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Infections and Infestations | 1 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Cardiac Disorders | 1 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Blood and Lymphatic System Disorders | 7 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Injury, Poisoning, and Procedural Complications | 5 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Respiratory, Thoracic and Mediastinal Disorders | 3 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Musculoskeletal and Connective Tissue Disorders | 7 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Investigations | 15 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Gastrointestinal Disorders | 10 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Metabolism and Nutrition Disorders | 0 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Vascular Disorders | 10 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Reproductive System and Breast Disorders | 0 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | General Disorders & Administration Site Conditions | 22 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Skin and Subcutaneous Tissue Disorders | 26 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Psychiatric Disorders | 5 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Immune System Disorders | 0 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Eye Disorders | 1 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Musculoskeletal and Connective Tissue Disorders | 5 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Blood and Lymphatic System Disorders | 2 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Cardiac Disorders | 0 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Eye Disorders | 1 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Gastrointestinal Disorders | 13 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | General Disorders & Administration Site Conditions | 32 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Immune System Disorders | 1 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Infections and Infestations | 1 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Injury, Poisoning, and Procedural Complications | 1 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Investigations | 16 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Metabolism and Nutrition Disorders | 1 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Nervous System Disorders | 34 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Psychiatric Disorders | 6 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Reproductive System and Breast Disorders | 1 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Respiratory, Thoracic and Mediastinal Disorders | 4 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Skin and Subcutaneous Tissue Disorders | 20 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Vascular Disorders | 18 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Cardiac Disorders | 4 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Nervous System Disorders | 24 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | General Disorders & Administration Site Conditions | 13 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Vascular Disorders | 17 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Psychiatric Disorders | 2 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Gastrointestinal Disorders | 7 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Skin and Subcutaneous Tissue Disorders | 9 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Reproductive System and Breast Disorders | 0 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Eye Disorders | 0 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Blood and Lymphatic System Disorders | 1 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Investigations | 13 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Respiratory, Thoracic and Mediastinal Disorders | 4 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Metabolism and Nutrition Disorders | 0 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Injury, Poisoning, and Procedural Complications | 0 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Infections and Infestations | 1 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Musculoskeletal and Connective Tissue Disorders | 0 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class | Immune System Disorders | 0 participants |
Secondary
Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class
Time frame: Throughout the study period, approximately 4 years
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class | Psychiatric Disorders | 0 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class | Investigations | 0 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class | Vascular Disorders | 0 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class | Nervous System Disorders | 1 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class | Cardiac Disorders | 1 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class | Respiratory, Thoracic and Mediastinal Disorders | 0 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class | Immune System Disorders | 0 participants |
| IGIV, 10% 400mg/kg | Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class | General Disorders & Administration Site Conditions | 0 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class | Nervous System Disorders | 2 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class | Cardiac Disorders | 0 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class | General Disorders & Administration Site Conditions | 0 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class | Immune System Disorders | 1 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class | Investigations | 2 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class | Psychiatric Disorders | 1 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class | Respiratory, Thoracic and Mediastinal Disorders | 1 participants |
| IGIV, 10% 200mg/kg | Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class | Vascular Disorders | 0 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class | Psychiatric Disorders | 0 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class | General Disorders & Administration Site Conditions | 1 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class | Vascular Disorders | 2 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class | Respiratory, Thoracic and Mediastinal Disorders | 1 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class | Cardiac Disorders | 1 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class | Nervous System Disorders | 0 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class | Immune System Disorders | 0 participants |
| Placebo 2 mL/kg or 4 mL/kg | Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class | Investigations | 0 participants |