Trial Outcomes & Findings for Phase 3 IGIV, 10% in Alzheimer´s Disease (NCT NCT01524887)
NCT ID: NCT01524887
Last Updated: 2021-05-19
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
508 participants
Primary outcome timeframe
Baseline to 9 Months (actual time frame)
Results posted on
2021-05-19
Participant Flow
Enrollment was conducted at 58 clinical sites worldwide.
Of 508 enrolled subjects, 303 met entry criteria. 42 subjects discontinued before randomization due to study termination. Of 261 randomized subjects, 10 subjects discontinued before receiving treatment (7 study termination, 2 withdrawal by subject, 1 withdrawal by caregiver). Number of subjects who received treatment (IVIG,10% or placebo) = 251.
Participant milestones
| Measure |
IGIV, 10% at High Dose (0.4 g/kg)
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
IGIV, 10% at Low Dose (0.2 g/kg)
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
Placebo Control
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
|
|---|---|---|---|
|
Overall Study
STARTED
|
85
|
90
|
86
|
|
Overall Study
Received Treatment
|
83
|
85
|
83
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
85
|
90
|
86
|
Reasons for withdrawal
| Measure |
IGIV, 10% at High Dose (0.4 g/kg)
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
IGIV, 10% at Low Dose (0.2 g/kg)
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
Placebo Control
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
2
|
3
|
|
Overall Study
Adverse Event
|
5
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
|
Overall Study
Study termination
|
73
|
87
|
79
|
|
Overall Study
Withdrawal by Caregiver
|
0
|
0
|
2
|
|
Overall Study
Use of prohibited medication
|
1
|
0
|
0
|
Baseline Characteristics
Phase 3 IGIV, 10% in Alzheimer´s Disease
Baseline characteristics by cohort
| Measure |
IGIV, 10% at High Dose (0.4 g/kg)
n=83 Participants
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
IGIV, 10% at Low Dose (0.2 g/kg)
n=85 Participants
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
Placebo Control
n=83 Participants
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
|
Total
n=251 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
72.0 years
STANDARD_DEVIATION 8.36 • n=5 Participants
|
69.9 years
STANDARD_DEVIATION 8.59 • n=7 Participants
|
70.6 years
STANDARD_DEVIATION 9.98 • n=5 Participants
|
70.8 years
STANDARD_DEVIATION 9.01 • n=4 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
132 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
119 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
81 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
238 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
66 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
199 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Region of Enrollment
Belgium
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to 9 Months (actual time frame)Population: Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.
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.
Outcome measures
| Measure |
IGIV, 10% at High Dose (0.4 g/kg)
n=21 Participants
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
IGIV, 10% at Low Dose (0.2 g/kg)
n=28 Participants
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
Placebo Control
n=36 Participants
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
|
|---|---|---|---|
|
Change From Baseline to Month 18 in Cognitive Subscale of the Alzheimer´s Disease Assessment Scale (ADAS-Cog)
|
4.0 Scores on a scale
Standard Deviation 6.44
|
4.4 Scores on a scale
Standard Deviation 8.56
|
3.1 Scores on a scale
Standard Deviation 4.28
|
PRIMARY outcome
Timeframe: Baseline to 9 Months (actual time frame)Population: Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.
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.
Outcome measures
| Measure |
IGIV, 10% at High Dose (0.4 g/kg)
n=21 Participants
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
IGIV, 10% at Low Dose (0.2 g/kg)
n=29 Participants
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
Placebo Control
n=36 Participants
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
|
|---|---|---|---|
|
Change From Baseline to Month 18 in Alzheimer´s Disease Cooperative Study (ADCS)-Activities of Daily Living (ADL) Inventory
|
-8.1 Scores on a scale
Standard Deviation 7.36
|
-5.0 Scores on a scale
Standard Deviation 11.64
|
-3.8 Scores on a scale
Standard Deviation 9.26
|
SECONDARY outcome
Timeframe: Baseline to 9 Months (actual time frame)Population: Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.
The ADCS-CGIC is a validated categorical measure of change in a participant's global clinical status between baseline and follow-up visits, based on interview of the participant and the caregiver by a skilled and experienced clinician who was blinded to treatment assignment. The ADCS-CGIC score is based on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening).
Outcome measures
| Measure |
IGIV, 10% at High Dose (0.4 g/kg)
n=10 Participants
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
IGIV, 10% at Low Dose (0.2 g/kg)
n=16 Participants
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
Placebo Control
n=16 Participants
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
|
|---|---|---|---|
|
ADCS-Clinical Global Impression of Change (CGIC) at 18 Months
|
4.3 Scores on a scale
Interval 3.7 to 4.8
|
4.4 Scores on a scale
Interval 4.0 to 4.9
|
4.5 Scores on a scale
Interval 4.1 to 5.0
|
SECONDARY outcome
Timeframe: Baseline to 9 Months (actual time frame)Population: Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.
The NPI is a validated instrument used to assess behavioral psychopathology in AD; it evaluates the frequency and severity of 10 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.
Outcome measures
| Measure |
IGIV, 10% at High Dose (0.4 g/kg)
n=21 Participants
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
IGIV, 10% at Low Dose (0.2 g/kg)
n=29 Participants
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
Placebo Control
n=36 Participants
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
|
|---|---|---|---|
|
Change From Baseline to Month 18 in Neuropsychiatric Inventory (NPI)
|
2.3 Scores on a scale
Standard Deviation 5.76
|
3.8 Scores on a scale
Standard Deviation 12.44
|
0.6 Scores on a scale
Standard Deviation 5.68
|
SECONDARY outcome
Timeframe: Baseline to 9 Months (actual time frame)Population: Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.
Outcome measures
| Measure |
IGIV, 10% at High Dose (0.4 g/kg)
n=9 Participants
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
IGIV, 10% at Low Dose (0.2 g/kg)
n=15 Participants
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
Placebo Control
n=17 Participants
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
|
|---|---|---|---|
|
Change From Baseline to Month 18 in Volumetric Magnetic Resonance Imaging (MRI) Parameters: Rate of Whole Brain Atrophy and Ventricular Enlargement
|
0.00065 mm^3
Standard Deviation 0.00059
|
0.00057 mm^3
Standard Deviation 0.00070
|
0.00067 mm^3
Standard Deviation 0.00163
|
SECONDARY outcome
Timeframe: Baseline to 9 Months (actual time frame)Population: Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.
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, with lower scores associated with a lower quality of life.
Outcome measures
| Measure |
IGIV, 10% at High Dose (0.4 g/kg)
n=16 Participants
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
IGIV, 10% at Low Dose (0.2 g/kg)
n=26 Participants
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
Placebo Control
n=30 Participants
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
|
|---|---|---|---|
|
Change From Baseline to Month 18 in Logsdon Quality of Life in Alzheimer´s Disease (QOL-AD)
|
-0.1 Scores on a scale
Standard Deviation 4.43
|
0.4 Scores on a scale
Standard Deviation 3.68
|
0.1 Scores on a scale
Standard Deviation 4.56
|
SECONDARY outcome
Timeframe: Baseline to 9 Months (actual time frame)Population: Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.
The IADCQ is a 12-item validated questionnaire that has been developed to measure the emotional, physical, and social impact of care giving on AD caregivers. Higher scores on the IADCQ are associated with a higher impact. IADCQ total score range: 0 (no impact) - 48 (greatest impact). Each item can be scored either 0 (Not at all), 1 (A little), 2 (Somewhat), 3 (A lot), or 4 (Extremely). As this is a 12-item scale, the minimum possible score is 0 and the maximum possible score is 4x12 = 48.
Outcome measures
| Measure |
IGIV, 10% at High Dose (0.4 g/kg)
n=19 Participants
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
IGIV, 10% at Low Dose (0.2 g/kg)
n=27 Participants
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
Placebo Control
n=30 Participants
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
|
|---|---|---|---|
|
Change From Baseline to Month 18 in Impact of Alzheimer´s Disease on Caregiver Questionnaire (IADCQ)
|
5.8 Scores on a scale
Standard Deviation 4.13
|
1.9 Scores on a scale
Standard Deviation 6.66
|
1.4 Scores on a scale
Standard Deviation 5.97
|
SECONDARY outcome
Timeframe: Throughout the study period: 18 MonthsPopulation: The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product.
Outcome measures
| Measure |
IGIV, 10% at High Dose (0.4 g/kg)
n=83 Participants
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
IGIV, 10% at Low Dose (0.2 g/kg)
n=85 Participants
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
Placebo Control
n=83 Participants
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
|
|---|---|---|---|
|
Number of Participants Experiencing Study Product-related Adverse Events (AEs) and/or Serious Adverse Events (SAEs)
Participants with product-related SAEs
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants Experiencing Study Product-related Adverse Events (AEs) and/or Serious Adverse Events (SAEs)
Participants with product-related AEs (incl SAEs)
|
31 participants
|
25 participants
|
16 participants
|
|
Number of Participants Experiencing Study Product-related Adverse Events (AEs) and/or Serious Adverse Events (SAEs)
Participants with product-related non-serious AEs
|
30 participants
|
25 participants
|
16 participants
|
SECONDARY outcome
Timeframe: Throughout the study period: 18 MonthsPopulation: The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product.
Outcome measures
| Measure |
IGIV, 10% at High Dose (0.4 g/kg)
n=83 Participants
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
IGIV, 10% at Low Dose (0.2 g/kg)
n=85 Participants
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
Placebo Control
n=83 Participants
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
|
|---|---|---|---|
|
Number of Participants Experiencing Any AEs and/or SAEs
Participants with AEs (incl SAEs)
|
57 participants
|
54 participants
|
49 participants
|
|
Number of Participants Experiencing Any AEs and/or SAEs
Participants with non-serious AEs
|
55 participants
|
53 participants
|
48 participants
|
|
Number of Participants Experiencing Any AEs and/or SAEs
Participants with serious AEs (SAEs)
|
5 participants
|
7 participants
|
7 participants
|
SECONDARY outcome
Timeframe: During or within 72 hours of completion of an infusionPopulation: The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product.
A temporal association was defined as an AE and/or SAE occurring during or within 72 hours of completion of an infusion, regardless of causality.
Outcome measures
| Measure |
IGIV, 10% at High Dose (0.4 g/kg)
n=817 Total number of infusions administered
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
IGIV, 10% at Low Dose (0.2 g/kg)
n=935 Total number of infusions administered
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
Placebo Control
n=1023 Total number of infusions administered
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
|
|---|---|---|---|
|
Number of Infusions Temporally Associated With AEs and/or SAEs
|
72 infusions
|
80 infusions
|
47 infusions
|
SECONDARY outcome
Timeframe: During or within 7 days of completion of an infusionOutcome measures
| Measure |
IGIV, 10% at High Dose (0.4 g/kg)
n=817 Total number of infusions administered
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
IGIV, 10% at Low Dose (0.2 g/kg)
n=935 Total number of infusions administered
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
Placebo Control
n=1023 Total number of infusions administered
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
|
|---|---|---|---|
|
Number of Infusions Associated With AEs and/or SAEs Occurring During or Within 7 Days of Completion of an Infusion
|
97 infusions
|
107 infusions
|
72 infusions
|
SECONDARY outcome
Timeframe: Throughout the study period: 18 MonthsPopulation: The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product.
Outcome measures
| Measure |
IGIV, 10% at High Dose (0.4 g/kg)
n=817 Total number of infusions administered
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
IGIV, 10% at Low Dose (0.2 g/kg)
n=935 Total number of infusions administered
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
Placebo Control
n=1023 Total number of infusions administered
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
|
|---|---|---|---|
|
Number of Infusions Causally Associated With AEs and/or SAEs
|
46 infusions
|
48 infusions
|
30 infusions
|
SECONDARY outcome
Timeframe: Throughout infusions, approximately 2-5 hoursPopulation: The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product.
Outcome measures
| Measure |
IGIV, 10% at High Dose (0.4 g/kg)
n=817 Total number of infusions administered
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
IGIV, 10% at Low Dose (0.2 g/kg)
n=935 Total number of infusions administered
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
Placebo Control
n=1023 Total number of infusions administered
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
|
|---|---|---|---|
|
Number of Infusions Discontinued, Slowed, or Interrupted Due to an AE
|
7 infusions
|
2 infusions
|
1 infusions
|
Adverse Events
IGIV, 10% at High Dose (0.4 g/kg)
Serious events: 5 serious events
Other events: 30 other events
Deaths: 0 deaths
IGIV, 10% at Low Dose (0.2 g/kg)
Serious events: 7 serious events
Other events: 33 other events
Deaths: 0 deaths
Placebo Control
Serious events: 7 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IGIV, 10% at High Dose (0.4 g/kg)
n=83 participants at risk
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
IGIV, 10% at Low Dose (0.2 g/kg)
n=85 participants at risk
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
Placebo Control
n=83 participants at risk
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
|
|---|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
1.2%
1/83 • Number of events 1 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/85 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
1.2%
1/83 • Number of events 1 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
1.2%
1/85 • Number of events 1 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/85 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
1.2%
1/83 • Number of events 1 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/85 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
1.2%
1/83 • Number of events 1 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
Infections and infestations
Human Ehrlichiosis
|
1.2%
1/83 • Number of events 1 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/85 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
Infections and infestations
Pneumonia
|
1.2%
1/83 • Number of events 1 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/85 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
Infections and infestations
Urinary Tract Infection
|
1.2%
1/83 • Number of events 1 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/85 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
Injury, poisoning and procedural complications
Alcohol Poisoning
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
1.2%
1/85 • Number of events 1 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
1.2%
1/85 • Number of events 1 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/85 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
2.4%
2/83 • Number of events 2 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/85 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
2.4%
2/83 • Number of events 2 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
Nervous system disorders
Encephalopathy
|
1.2%
1/83 • Number of events 1 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/85 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
Nervous system disorders
Headache
|
1.2%
1/83 • Number of events 1 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/85 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
Nervous system disorders
Hemiparesis
|
1.2%
1/83 • Number of events 1 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/85 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
Nervous system disorders
Spinal Cord Disorder
|
1.2%
1/83 • Number of events 1 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/85 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
Nervous system disorders
Syncope
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/85 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
1.2%
1/83 • Number of events 1 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/85 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
1.2%
1/83 • Number of events 1 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
Psychiatric disorders
Abnormal Behaviour
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
1.2%
1/85 • Number of events 1 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
Psychiatric disorders
Mental Status Changes
|
1.2%
1/83 • Number of events 1 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/85 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
Renal and urinary disorders
Calculus Ureteric
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
1.2%
1/85 • Number of events 1 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
1.2%
1/85 • Number of events 1 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
1.2%
1/85 • Number of events 1 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
Vascular disorders
Thrombophlebitis Superficial
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
1.2%
1/85 • Number of events 1 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
Other adverse events
| Measure |
IGIV, 10% at High Dose (0.4 g/kg)
n=83 participants at risk
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
IGIV, 10% at Low Dose (0.2 g/kg)
n=85 participants at risk
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
|
Placebo Control
n=83 participants at risk
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
12.0%
10/83 • Number of events 14 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
12.9%
11/85 • Number of events 19 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
6.0%
5/83 • Number of events 6 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
General disorders
Fatigue
|
6.0%
5/83 • Number of events 11 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
11.8%
10/85 • Number of events 15 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
7.2%
6/83 • Number of events 12 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.4%
7/83 • Number of events 8 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
9.4%
8/85 • Number of events 9 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
1.2%
1/83 • Number of events 1 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
General disorders
Infusion Site Extravasation
|
6.0%
5/83 • Number of events 10 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
7.1%
6/85 • Number of events 6 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
4.8%
4/83 • Number of events 4 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.0%
5/83 • Number of events 7 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
5.9%
5/85 • Number of events 8 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
3.6%
3/83 • Number of events 3 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
Gastrointestinal disorders
Nausea
|
6.0%
5/83 • Number of events 7 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
5.9%
5/85 • Number of events 7 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
3.6%
3/83 • Number of events 5 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
3.6%
3/83 • Number of events 4 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
5.9%
5/85 • Number of events 6 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
6.0%
5/83 • Number of events 5 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
1/83 • Number of events 1 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/85 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
12.0%
10/83 • Number of events 15 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
3.5%
3/85 • Number of events 3 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
6.0%
5/83 • Number of events 5 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
6.0%
5/83 • Number of events 5 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
1.2%
1/85 • Number of events 1 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
0.00%
0/83 • Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee For this study, PIs are restricted from independently publishing results before completion of a single multicenter publication or one year after study completion, whichever occurs first. Baxter requires a review of results communications (e.g., for confidential information) ≥90 days prior to submission or communication. Baxter may request an additional delay of ≤60 days (eg, for intellectual property protection).
- Publication restrictions are in place
Restriction type: OTHER