Chronic Inflammatory Demyelinating Polyneuropathy
Conditions
Keywords
Chronic inflammatory demyelinating polyneuropathy, CIDP
Brief summary
The objective of this study is to demonstrate the efficacy and safety of Privigen in subjects with CIDP.
Interventions
BIOLOGICAL10% liquid formulation of human immunoglobulin
Sponsors
CSL Behring
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
IVIG-untreated subjects: * Either subjects with newly diagnosed CIDP (developing over at least 2 months) or subjects with an IVIG treatment interruption for at least 1 year with a progressive disease (deteriorating in the last 2 months) prior to enrolment. * Actual diagnosis (including electrophysiology) of CIDP with progressive or relapsing dysfunction from motor and sensory or symmetric motor nerve only in at least 1 limb resulting from neuropathy. Criteria for definite or probable CIDP according to EFNS/PNS guideline. * Age ≥18 years. * Male or female. * Written informed consent for study participation obtained before undergoing any study specific procedures. IVIG-pretreated subjects: * Being treated regularly with IVIG on a fixed cycle length of 2 to 6 weeks ± 5 days in the last 6 months, on a fixed dosage of ± 20 % in the last 6 months and deteriorating by at least 1 INCAT score point during the Washout Period of up to 10 weeks (except for an increase from 0 to 1 solely due to upper limb score). * Historic diagnosis of CIDP with progressive or relapsing dysfunction from motor and sensory or symmetric motor nerve only in at least 1 limb resulting from neuropathy. Criteria for definite or probable CIDP according to EFNS/PNS guideline. * Age ≥18 years. * Male or female. * Written informed consent for study participation obtained before undergoing any study specific procedures.
Exclusion criteria
* A motor syndrome that fulfils criteria for multifocal motor neuropathy (MMN) with conduction block (i.e., upper limb motor weakness without sensory deficit and with a 50% decrease in action potential amplitude or area on proximal compared with distal stimulation in motor nerves). * CIDP with monoclonal gammopathy of uncertain significance (CIDP-MGUS) with anti-MGUS antibodies and patients with distal acquired demyelinating symmetric (DADS)neuropathy. * Any disease (mainly neurological or chronic orthopedic) that may cause symptoms or may interfere with treatment or outcome assessments with the INCAT (e.g., diphtheria, drug or toxin exposure and diabetes mellitus likely to have caused the neuropathy, IgM paraproteinemia, familial neuropathy, borreliosis with radiculopathy, post-polio-syndrome,M. Parkinson, stroke). * Current malignancy. * History of cardiac insufficiency (New York Heart Association \[NYHA\] III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease, congestive heart failure or severe hypertension. * History of thrombotic episodes (deep vein thrombosis, myocardial infarction, cerebrovascular accident). * Migraine associated with IVIG infusion in the last 3 months prior to enrolment. * Known allergic or other severe reactions to blood products including intolerability to previous IVIG (i.e. severe headache, hypersensitivity, intravascular hemolysis). * Subjects with serum IgA level less than 50% of the lower normal limit. * Known hyperprolinemia. * Any condition (including alcohol, drug or medication abuse) that is likely to interfere with evaluation of the study product or satisfactory conduct of the study. * Plasma exchange 3 months prior to enrolment. * Treatment with immunomodulatory agents others than steroids, methotrexate or azathioprine (e.g. interferon, TNF-α inhibitors) within 6 months before enrolment. * Treatment with rituximab in the 12 months before enrolment. * Abnormal laboratory parameters: creatinine \> 1.5 times the upper normal limit (UNL), lactate dehydrogenase (LDH) \> 1.5 times the UNL, C-reactive protein (CRP) \> 1.5 times the UNL, hemoglobin (Hb) \< 10 g/dL. * Ongoing HIV, hepatitis C and hepatitis B infection. * Participation in another clinical study (or use of another investigational medicinal product \[IMP\]) within 3 months prior to enrolment * Not able to comply with study procedures and treatment regimen. * Employee at the study site, or spouse/partner or relative of any study staff (e.g., investigator, sub-investigators, or study nurse). * Pregnancy or nursing mother. * Intention to become pregnant during the course of the study. * Female subjects of childbearing potential either not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study, or not sexually abstinent for the entire duration of the study, or not surgically sterile.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate | 25 weeks | Percentage of responders based on the adjusted Inflammatory Neuropathy Cause and Treatment Scale (INCAT) score. Responders were defined as those subjects who: 1) demonstrated a clinically meaningful improvement between baseline and Week 25, or 2) who were discontinued from the study for any reason after the start of IgPro10 treatment but with clinically meaningful improvement at the last study visit. Clinically meaningful improvement was a decrease of at least 1 adjusted INCAT score point excluding an improvement of one point in the total score if this improvement was only due to a decrease in the upper limb score of 1 to 0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Maximum Grip Strength | Up to 34 weeks | Change in maximum grip strength of the dominant hand. A non-parametric analysis was used to calculate the Hodges-Lehmann point estimate and the corresponding Tukey confidence interval on an exploratory basis. Positive values for change in maximum grip strength indicate improvement. |
| Change in Medical Research Council Sum Scale (MRC) | Up to 34 weeks | The change in MRC sum score was determined at the completion visit compared to baseline and to the last measurement under the previous IVIG treatment using a non-parametric analysis to calculate the Hodges-Lehmann point estimate and the corresponding Tukey confidence interval on an exploratory basis. The 80-point MRC sum score is the sum of scores for eight bilateral (left and right side) muscle groups, each rated between 0 (no visible contraction) to 5 (normal movement). A higher MRC sum score indicates greater muscle contraction/limb movement. Positive values for change in MRC sum score indicate improvement, with a more positive value indicating greater muscle contraction/ limb movement compared with the value at baseline. |
| Immunoglobulin G (IgG) Level | At baseline and at Weeks 7, 13 and 19 (levels determined immediately before and after IVIG infusion), and at completion visit (Week 25) | — |
| Frequency of Adverse Events (AEs) | For the duration of the study, up to 34 weeks | Overall rate of AEs per infusion. |
| Severity of AEs Per Infusion | For the duration of the study, up to 34 weeks | The severity of each AE was to be graded by the investigator as follows: * Mild: Symptoms were easily tolerated and there was no interference with daily activities. * Moderate: Discomfort enough to cause some interference with daily activities. * Severe: Incapacitating with inability to work or do usual activity. |
| Severity of AEs Per Subject | 34 weeks | The severity of each AE was to be graded by the investigator as follows: * Mild: Symptoms were easily tolerated and there was no interference with daily activities. * Moderate: Discomfort enough to cause some interference with daily activities. * Severe: Incapacitating with inability to work or do usual activity. |
| Change in Adjusted INCAT Score | Up to 34 weeks | The change in INCAT score was determined at the completion visit compared to baseline and to the last measurement under the previous IVIG treatment using a non-parametric analysis to calculate the Hodges-Lehmann point estimate and the corresponding Tukey confidence interval on an exploratory basis. The INCAT disability score ranges from 0 to 10 and is the sum of arm and leg disability each rated between 0 and 5 (where arm = 0 indicates 'no upper limb problems' and arm = 5 indicates 'inability to use either arm for any purposeful movement', and leg = 0 indicates 'walking not affected', and leg = 5 indicates 'restricted to wheelchair, unable to stand and walk a few steps with help'). Thus, a higher INCAT disability score indicates greater disability. Negative values for change in INCAT score indicate improvement, with a more negative value indicating greater improvement compared with the value at baseline. |
| Relatedness of AEs Per Subject | For the duration of the study, up to 34 weeks | The causal relationship of an AE to the study drug was to be assessed and assigned by the investigator. |
| Mean Change in Systolic and Diastolic Blood Pressure During Infusion | At Days 1 to 5 and at Weeks 4, 7, 10, 13, 16, 19 and 22. | Systolic and diastolic blood pressure (BP) were measured before the start of IgPro10 infusion, at 30 minutes and 1 hour after the start of infusion, then every hour until the end of infusion and at 1 hour after the end of infusion. Mean changes from the pre-infusion value to each of the post-infusion values were calculated for each infusion, and the mean value and standard deviation (SD) of these individual mean changes is reported. |
| Mean Change in Pulse Rate During Infusion | At Days 1 to 5 and at Weeks 4, 7, 10, 13, 16, 19 and 22. | Pulse rate was measured before the start of IgPro10 infusion, at 30 minutes and 1 hour after the start of infusion, then every hour until the end of infusion and at 1 hour after the end of infusion. Mean changes from the pre-infusion value to each of the post-infusion values were calculated for each infusion, and the mean value and SD of these individual mean changes is reported. |
| Mean Change in Body Temperature During Infusion | At Days 1 to 5 and at Weeks 4, 7, 10, 13, 16, 19 and 22. | Body temperature was measured before the start of IgPro10 infusion, at 30 minutes and 1 hour after the start of infusion, then every hour until the end of infusion and at 1 hour after the end of infusion. Mean changes from the pre-infusion value to each of the post-infusion values were calculated for each infusion, and the mean value and SD of these individual mean changes is reported. |
| Number of Subjects With Normal/Abnormal Not Clinically Significant (ANCS) Value at Baseline Changing to Abnormal Clinically Significant (ACS) Value at Completion Visit in Routine Laboratory Parameters. | At Day 1 (baseline) and at Completion Visit (Week 25 or early discontinuation) | Number of subjects with changes from normal/ANCS values at baseline to ACS values at Completion Visit in routine laboratory parameters including hematology and serum chemistry analytes. Investigators flagged each laboratory value as normal, ANCS or ACS at each assessment timepoint. |
| Relatedness of AEs Per Infusion | For the duration of the study, up to 34 weeks | The causal relationship of an AE to the study drug was to be assessed and assigned by the investigator. |
Countries
Belgium, Finland, France, Germany, Poland
Participant flow
Recruitment details
This multicenter study enrolled subjects at 13 participating study centers in 5 countries in Europe.
Pre-assignment details
A total of 31 subjects were screened and 28 were eligible. * Intravenous immunoglobulin (IVIG)-untreated subjects: screening took place up to 3 weeks prior to the first IgPro10 infusion * IVIG-pretreated subjects: Screening took place at any time at or after the last dose of pre-study IVIG (up to 10 weeks prior to the first IgPro10 infusion)
Participants by arm
| Arm | Count |
|---|---|
| IgPro10 10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw. | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Insufficient response | 1 |
Baseline characteristics
| Characteristic | IgPro10 |
|---|---|
| Age, Continuous | 58.7 years STANDARD_DEVIATION 14.34 |
| Previous IVIG treatment IVIG-pretreated subjects | 13 participants |
| Previous IVIG treatment IVIG-untreated subjects | 15 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 22 / 28 |
| serious Total, serious adverse events | 4 / 28 |
Outcome results
Primary
Responder Rate
Percentage of responders based on the adjusted Inflammatory Neuropathy Cause and Treatment Scale (INCAT) score. Responders were defined as those subjects who: 1) demonstrated a clinically meaningful improvement between baseline and Week 25, or 2) who were discontinued from the study for any reason after the start of IgPro10 treatment but with clinically meaningful improvement at the last study visit. Clinically meaningful improvement was a decrease of at least 1 adjusted INCAT score point excluding an improvement of one point in the total score if this improvement was only due to a decrease in the upper limb score of 1 to 0.
Time frame: 25 weeks
Population: The full analysis set (FAS) includes all subjects who received at least one dose of IgPro10, regardless of whether or not the subject recorded an efficacy variable measurement. The valid cases set (VCS) consists of all FAS subjects without any major protocol deviation (ie, the subjects who participated in the study as intended).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IgPro10 | Responder Rate | FAS (n = 28) | 60.7 percentage of responders |
| IgPro10 | Responder Rate | VCS (n = 22) | 63.6 percentage of responders |
Secondary
Change in Adjusted INCAT Score
The change in INCAT score was determined at the completion visit compared to baseline and to the last measurement under the previous IVIG treatment using a non-parametric analysis to calculate the Hodges-Lehmann point estimate and the corresponding Tukey confidence interval on an exploratory basis. The INCAT disability score ranges from 0 to 10 and is the sum of arm and leg disability each rated between 0 and 5 (where arm = 0 indicates 'no upper limb problems' and arm = 5 indicates 'inability to use either arm for any purposeful movement', and leg = 0 indicates 'walking not affected', and leg = 5 indicates 'restricted to wheelchair, unable to stand and walk a few steps with help'). Thus, a higher INCAT disability score indicates greater disability. Negative values for change in INCAT score indicate improvement, with a more negative value indicating greater improvement compared with the value at baseline.
Time frame: Up to 34 weeks
Population: The FAS includes all subjects who received at least one dose of IgPro10, regardless of whether or not the subject recorded an efficacy variable measurement. Analysed subgroups include all subjects and IVIG-pretreated and IVIG-untreated subjects from baseline to completion, and IVIG-pretreated subjects from last IVIG treatment to completion.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| IgPro10 | Change in Adjusted INCAT Score | All subjects; n = 28 | -1.3 score on a scale |
| IgPro10 | Change in Adjusted INCAT Score | IVIG-pretreated; n = 13 | -2.0 score on a scale |
| IgPro10 | Change in Adjusted INCAT Score | IVIG-untreated; n = 15 | -1.0 score on a scale |
| IgPro10 | Change in Adjusted INCAT Score | IVIG-pretreated (last IVIG to completion); n = 13 | -2.0 score on a scale |
Secondary
Change in Maximum Grip Strength
Change in maximum grip strength of the dominant hand. A non-parametric analysis was used to calculate the Hodges-Lehmann point estimate and the corresponding Tukey confidence interval on an exploratory basis. Positive values for change in maximum grip strength indicate improvement.
Time frame: Up to 34 weeks
Population: The FAS includes all subjects who received at least one dose of IgPro10, regardless of whether or not the subject recorded an efficacy variable measurement. Analysed subgroups include all subjects and IVIG-pretreated and IVIG-untreated subjects from baseline to completion, and IVIG-pretreated subjects from last IVIG treatment to completion.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| IgPro10 | Change in Maximum Grip Strength | IVIG-pretreated; n = 13 | 8.0 kPa |
| IgPro10 | Change in Maximum Grip Strength | IVIG-untreated; n = 15 | 9.0 kPa |
| IgPro10 | Change in Maximum Grip Strength | All subjects; n = 28 | 9.0 kPa |
| IgPro10 | Change in Maximum Grip Strength | IVIG-pretreated (last IVIG to completion); n = 13 | -1.5 kPa |
Secondary
Change in Medical Research Council Sum Scale (MRC)
The change in MRC sum score was determined at the completion visit compared to baseline and to the last measurement under the previous IVIG treatment using a non-parametric analysis to calculate the Hodges-Lehmann point estimate and the corresponding Tukey confidence interval on an exploratory basis. The 80-point MRC sum score is the sum of scores for eight bilateral (left and right side) muscle groups, each rated between 0 (no visible contraction) to 5 (normal movement). A higher MRC sum score indicates greater muscle contraction/limb movement. Positive values for change in MRC sum score indicate improvement, with a more positive value indicating greater muscle contraction/ limb movement compared with the value at baseline.
Time frame: Up to 34 weeks
Population: The FAS includes all subjects who received at least one dose of IgPro10, regardless of whether or not the subject recorded an efficacy variable measurement. Analysed subgroups include all subjects and IVIG-pretreated and IVIG-untreated subjects from baseline to completion, and IVIG-pretreated subjects from last IVIG treatment to completion.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| IgPro10 | Change in Medical Research Council Sum Scale (MRC) | All subjects; n = 28 | 6.5 score on a scale |
| IgPro10 | Change in Medical Research Council Sum Scale (MRC) | IVIG-pretreated; n = 13 | 6.0 score on a scale |
| IgPro10 | Change in Medical Research Council Sum Scale (MRC) | IVIG-untreated; n = 15 | 7.0 score on a scale |
| IgPro10 | Change in Medical Research Council Sum Scale (MRC) | IVIG-pretreated (last IVIG to completion); n = 13 | 1.0 score on a scale |
Secondary
Frequency of Adverse Events (AEs)
Overall rate of AEs per infusion.
Time frame: For the duration of the study, up to 34 weeks
Population: The safety data set (SDS) comprised all subjects treated with the study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IgPro10 | Frequency of Adverse Events (AEs) | 0.417 AE rate per infusion |
Secondary
Immunoglobulin G (IgG) Level
Time frame: At baseline and at Weeks 7, 13 and 19 (levels determined immediately before and after IVIG infusion), and at completion visit (Week 25)
Population: The FAS includes all subjects who received at least one dose of IgPro10, regardless of whether or not the subject recorded an efficacy variable measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IgPro10 | Immunoglobulin G (IgG) Level | At Week 7 (n = 26) | 1750.0 mg/dL | Standard Deviation 313.73 |
| IgPro10 | Immunoglobulin G (IgG) Level | At Week 19 (n = 25 and 24, respectively) | 1684.6 mg/dL | Standard Deviation 306.62 |
| IgPro10 | Immunoglobulin G (IgG) Level | At Week 13 (n = 25) | 1733.2 mg/dL | Standard Deviation 353 |
| IgPro10 | Immunoglobulin G (IgG) Level | At Completion (n = 0 and 28 respectively) | NA mg/dL | — |
| IgPro10 | Immunoglobulin G (IgG) Level | At baseline (n = 28 and 27, respectively) | 1259.5 mg/dL | Standard Deviation 377.47 |
| IgPro10 - After Infusion | Immunoglobulin G (IgG) Level | At Completion (n = 0 and 28 respectively) | 1943.6 mg/dL | Standard Deviation 465.85 |
| IgPro10 - After Infusion | Immunoglobulin G (IgG) Level | At baseline (n = 28 and 27, respectively) | 2859.2 mg/dL | Standard Deviation 846.83 |
| IgPro10 - After Infusion | Immunoglobulin G (IgG) Level | At Week 7 (n = 26) | 3228.8 mg/dL | Standard Deviation 803.22 |
| IgPro10 - After Infusion | Immunoglobulin G (IgG) Level | At Week 13 (n = 25) | 3496.7 mg/dL | Standard Deviation 575.11 |
| IgPro10 - After Infusion | Immunoglobulin G (IgG) Level | At Week 19 (n = 25 and 24, respectively) | 3386.1 mg/dL | Standard Deviation 567.05 |
Secondary
Mean Change in Body Temperature During Infusion
Body temperature was measured before the start of IgPro10 infusion, at 30 minutes and 1 hour after the start of infusion, then every hour until the end of infusion and at 1 hour after the end of infusion. Mean changes from the pre-infusion value to each of the post-infusion values were calculated for each infusion, and the mean value and SD of these individual mean changes is reported.
Time frame: At Days 1 to 5 and at Weeks 4, 7, 10, 13, 16, 19 and 22.
Population: The SDS comprised all subjects treated with the study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IgPro10 | Mean Change in Body Temperature During Infusion | 0.06 °C | Standard Deviation 0.17 |
Secondary
Mean Change in Pulse Rate During Infusion
Pulse rate was measured before the start of IgPro10 infusion, at 30 minutes and 1 hour after the start of infusion, then every hour until the end of infusion and at 1 hour after the end of infusion. Mean changes from the pre-infusion value to each of the post-infusion values were calculated for each infusion, and the mean value and SD of these individual mean changes is reported.
Time frame: At Days 1 to 5 and at Weeks 4, 7, 10, 13, 16, 19 and 22.
Population: The SDS comprised all subjects treated with the study drug
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IgPro10 | Mean Change in Pulse Rate During Infusion | -1.14 beats per minute | Standard Deviation 3.58 |
Secondary
Mean Change in Systolic and Diastolic Blood Pressure During Infusion
Systolic and diastolic blood pressure (BP) were measured before the start of IgPro10 infusion, at 30 minutes and 1 hour after the start of infusion, then every hour until the end of infusion and at 1 hour after the end of infusion. Mean changes from the pre-infusion value to each of the post-infusion values were calculated for each infusion, and the mean value and standard deviation (SD) of these individual mean changes is reported.
Time frame: At Days 1 to 5 and at Weeks 4, 7, 10, 13, 16, 19 and 22.
Population: The SDS comprised all subjects treated with the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IgPro10 | Mean Change in Systolic and Diastolic Blood Pressure During Infusion | Systolic BP mean value of mean change | 1.03 mm Hg | Standard Deviation 7.62 |
| IgPro10 | Mean Change in Systolic and Diastolic Blood Pressure During Infusion | Diastolic BP mean value of mean change | 0.99 mm Hg | Standard Deviation 7.46 |
Secondary
Number of Subjects With Normal/Abnormal Not Clinically Significant (ANCS) Value at Baseline Changing to Abnormal Clinically Significant (ACS) Value at Completion Visit in Routine Laboratory Parameters.
Number of subjects with changes from normal/ANCS values at baseline to ACS values at Completion Visit in routine laboratory parameters including hematology and serum chemistry analytes. Investigators flagged each laboratory value as normal, ANCS or ACS at each assessment timepoint.
Time frame: At Day 1 (baseline) and at Completion Visit (Week 25 or early discontinuation)
Population: The SDS comprised all subjects treated with the study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IgPro10 | Number of Subjects With Normal/Abnormal Not Clinically Significant (ANCS) Value at Baseline Changing to Abnormal Clinically Significant (ACS) Value at Completion Visit in Routine Laboratory Parameters. | 4 participants |
Secondary
Relatedness of AEs Per Infusion
The causal relationship of an AE to the study drug was to be assessed and assigned by the investigator.
Time frame: For the duration of the study, up to 34 weeks
Population: The SDS comprised all subjects treated with the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IgPro10 | Relatedness of AEs Per Infusion | Not Related | 0.201 AE rate per infusion |
| IgPro10 | Relatedness of AEs Per Infusion | Unlikely Related | 0.027 AE rate per infusion |
| IgPro10 | Relatedness of AEs Per Infusion | Possibly Related | 0.081 AE rate per infusion |
| IgPro10 | Relatedness of AEs Per Infusion | Probably Related | 0.042 AE rate per infusion |
| IgPro10 | Relatedness of AEs Per Infusion | Related | 0.066 AE rate per infusion |
Secondary
Relatedness of AEs Per Subject
The causal relationship of an AE to the study drug was to be assessed and assigned by the investigator.
Time frame: For the duration of the study, up to 34 weeks
Population: The SDS comprised all subjects treated with the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IgPro10 | Relatedness of AEs Per Subject | Not Related | 60.7 percentage of subjects |
| IgPro10 | Relatedness of AEs Per Subject | Unlikely Related | 14.3 percentage of subjects |
| IgPro10 | Relatedness of AEs Per Subject | Possibly Related | 39.3 percentage of subjects |
| IgPro10 | Relatedness of AEs Per Subject | Probably Related | 25.0 percentage of subjects |
| IgPro10 | Relatedness of AEs Per Subject | Related | 25.0 percentage of subjects |
Secondary
Severity of AEs Per Infusion
The severity of each AE was to be graded by the investigator as follows: * Mild: Symptoms were easily tolerated and there was no interference with daily activities. * Moderate: Discomfort enough to cause some interference with daily activities. * Severe: Incapacitating with inability to work or do usual activity.
Time frame: For the duration of the study, up to 34 weeks
Population: The SDS comprised all subjects treated with the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IgPro10 | Severity of AEs Per Infusion | Mild AE | 0.266 AE rate per infusion |
| IgPro10 | Severity of AEs Per Infusion | Moderate AE | 0.143 AE rate per infusion |
| IgPro10 | Severity of AEs Per Infusion | Severe AE | 0.008 AE rate per infusion |
Secondary
Severity of AEs Per Subject
The severity of each AE was to be graded by the investigator as follows: * Mild: Symptoms were easily tolerated and there was no interference with daily activities. * Moderate: Discomfort enough to cause some interference with daily activities. * Severe: Incapacitating with inability to work or do usual activity.
Time frame: 34 weeks
Population: The SDS comprised all subjects treated with the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IgPro10 | Severity of AEs Per Subject | Mild AE | 67.9 percentage of subjects |
| IgPro10 | Severity of AEs Per Subject | Moderate AE | 46.4 percentage of subjects |
| IgPro10 | Severity of AEs Per Subject | Severe AE | 7.1 percentage of subjects |