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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003149-41 | EudraCT Number |
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This is a prospective, multicenter, randomized, open-label, crossover study to investigate the safety, tolerability, and pharmacokinetics of IgPro20 in participants with diffuse cutaneous systemic sclerosis (dcSSc). The pharmacokinetic study aims to evaluate the relative bioavailability of IgPro20, and characterize pharmacokinetics of IgPro20 and IgPro10, respectively, in participants with dcSSc. Safety, tolerability, and pharmacokinetics of IgPro10 will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A (IgPro20/IgPro10) | Experimental | Participants received IgPro20 of a total dose of 0.5 grams per kilogram (g/kg) over 2 sessions per week as a subcutaneous (SC) injection for up to 16 weeks in Treatment Period 1 followed by IgPro10 of a total dose of 2 g/kg over 2 to 5 sessions on consecutive days every 4 weeks as an intravenous (IV) infusion for up to 16 weeks in Treatment Period 2. |
|
| Sequence B (IgPro10/IgPro20) | Experimental | Participants received IgPro10 of a total dose of 2 g/kg over 2 to 5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 1 followed by IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IgPro20 | Biological | Human normal immunoglobulin for subcutaneous administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least One Adverse Event (AE) for IgPro20 | AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. | From first dose of study drug through last follow-up visit (up to 36 weeks) |
| Percentage of Participants With at Least One AE for IgPro20 | AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. | From first dose of study drug through last follow-up visit (up to 36 weeks) |
| Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) for IgPro20 | AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product that does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. TEAEs are defined as AEs reported at or after the start of the first infusion in the study. | From first dose of study drug through last follow-up visit (up to 36 weeks) |
| Percentage of Participants With at Least One TEAE for IgPro20 |
| Measure | Description | Time Frame |
|---|---|---|
| Relative Bioavailability (%F) of IgPro20 | Relative bioavailability was calculated using Mixed Model Repeated Measures on Log-transformed Dose-normalized area under the curve to the end of the dosing period [AUC0-tau] following administration of the first dose of IgPro20 in the last week of dosing for Sequence A and / or Sequence B. Relative Bioavailability= (AUCtau IgPro20 (SC)/dose of IgPro20 (SC) / (AUCtau of IgPro10 (IV)/dose of IgPro10 (IV)). |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of ISRs Per Participant for IgPro20 | From first dose of study drug through last follow up visit (up to 36 weeks) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | CSL Behring | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia | ||
| Charité Universitätsmedizin Berlin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39909490 | Derived | Denton CP, Kowal-Bielecka O, Proudman SM, Olesinska M, Worm M, Del Papa N, Matucci-Cerinic M, Radewonuk J, Jochems J, Panaite A, Shebl A, Krupa A, Allanore Y, Hofmann JH, Gasior MJ. A phase 2 randomized trial of safety and pharmacokinetics of IgPro20 and IgPro10 in patients with diffuse cutaneous systemic sclerosis. Rheumatology (Oxford). 2025 Jun 1;64(6):3657-3666. doi: 10.1093/rheumatology/keaf066. |
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CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.
If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.
Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.
An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.
The requesting party must execute an appropriate data sharing agreement before IPD will be made available.
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A total of 30 participants were screened, of which 27 participants were enrolled and randomized to Sequence A or Sequence B in this study.
Participants were enrolled at study centers in Australia, Germany, Italy, Poland, and the United Kingdom from 19 September 2019 to 17 May 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence A (IgPro20/IgPro10) | Participants received IgPro20 of a total dose of 0.5 grams per kilogram (g/kg) over 2 sessions per week as a subcutaneous (SC) injection for up to 16 weeks in Treatment Period 1 followed by IgPro10 of a total dose of 2 g/kg over 2 to 5 sessions on consecutive days every 4 weeks as an intravenous (IV) infusion for up to 16 weeks in Treatment Period 2. |
| FG001 | Sequence B (IgPro10/IgPro20) | Participants received IgPro10 of a total dose of 2 g/kg over 2 to 5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 1 followed by IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 (Week 1 to Week 16) |
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| Treatment Period 2 (Week 17 to Week 32) |
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Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence A (IgPro20/IgPro10) | Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as an SC injection for up to 16 weeks in Treatment Period 1 followed by IgPro10 of a total dose of 2 g/kg over 2 to 5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 2. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With at Least One Adverse Event (AE) for IgPro20 | AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed. | Posted | Count of Participants | Participants | From first dose of study drug through last follow-up visit (up to 36 weeks) |
|
From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sequence A: IgPro20 | Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral Infection | Infections and infestations | MedDRA version 25.0. | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 25.0. | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | CSL Behring | 610-878-4000 | clinicaltrials@cslbehring.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 22, 2021 | May 18, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 9, 2021 | May 18, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D045743 | Scleroderma, Diffuse |
| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C558471 | Hizentra |
| D016756 | Immunoglobulins, Intravenous |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| IgPro10 | Biological | Human normal immunoglobulin for intravenous administration |
|
|
AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. TEAEs are defined as AEs reported at or after the start of the first infusion in the study. |
| From first dose of study drug through last follow-up visit (up to 36 weeks) |
| Number of Participants With at Least One Serious Adverse Event (SAE) for IgPro20 | An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, or is a medically significant event. | From first dose of study drug through last follow-up visit (up to 36 weeks) |
| Percentage of Participants With at Least One SAE for IgPro20 | An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, or is a medically significant event. | From first dose of study drug through last follow-up visit (up to 36 weeks) |
| Number of Participants With at Least One Adverse Event of Special Interest (AESI) for IgPro20 | AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An AESI is an AE of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor is appropriate. | From first dose of study drug through last follow-up visit (up to 36 weeks) |
| Percentage of Participants With at Least One AESI for IgPro20 | AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An AESI is an AE of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor is appropriate. | From first dose of study drug through last follow up visit (up to 36 weeks) |
| Number of Participants With AEs Categorized as Infusion Site Reactions (ISRs) for IgPro20 | ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'. | From first dose of study drug through last follow up visit (up to 36 weeks) |
| Percentage of Participants With AEs Categorized as ISRs for IgPro20 | ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'. | From first dose of study drug through last follow up visit (up to 36 weeks) |
| Rate of ISRs Per Infusion for IgPro20 | ISR rate per infusion = total number of ISRs across all participants while on IgPro20 / total number of IgPro20 Infusions across all participants. ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions NEC', 'Infusion site reactions', or 'Injection site reactions' | From first dose of study drug through last follow up visit (up to 36 weeks) |
| Time to Onset of ISRs for IgPro20 | ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'. Time to onset of ISR since the start of the treatment period was reported. | From first dose of study drug through last follow up visit (up to 36 weeks) |
| Duration of ISRs for IgPro20 | ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'. | From first dose of study drug through last follow up visit (up to 36 weeks) |
| Number of Participants With Clinically Significant Abnormalities in Laboratory Tests for IgPro20 | Abnormality criteria:Hematology-Hemoglobin:<10 g/dL;Platelet count:<75x10^9/L or >500x10^9/L;White Blood Cell Count:<3x10^9/L or >16x10^9/L;Neutrophils:absolute <1.5x10^9/L,differential <40%;Lymphocytes:absolute <0.8x10^9/L,differential <10 or >50%; Biochemistry-Bilirubin:>1.5xupper limit of normal (ULN);Alkaline phosphatase:>2.5xULN;Serum Glutamic-oxalacetic transaminase(SGOT), Aspartate transaminase(AST):>3xULN;Serum glutamic-pyruvic transaminase(SGPT), Alanine transaminase(ALT):>3xULN;Screening:AST/ALT >3xULN and Total Bilirubin >2xULN;Urea nitrogen:>2.5xULN; Creatinine, serum>1.5xbaseline assessment or change >0.3mg/dL since last visit;Glucose,blood (non-fasting):<55/>160mg/dL;Calcium:<7/>11.5mg/dL;Total protein: <5/>9g/dL; Albumin:<3g/dL;Sodium:<130/>150mmol/L;Potassium:<3/>5.5mmol/L; Uric acid,serum:>10mg/dL Males,>8mg/dL Females;Gamma Glutamyl Transpeptidase:>2.5xULN; Phosphorus,inorganic:<2.5/>5mg/dL;Lactate dehydrogenase:>3xULN;Urinalysis-Protein:>20mg/dL. | From first dose of study drug through last follow up visit (up to 36 weeks) |
| Number of Participants With Clinically Significant Changes in Vital Signs for IgPro20 | Clinically significant abnormality criteria for vital signs included Systolic blood pressure (BP): <100 millimeters of mercury (mmHg) or ≥140 mmHg or ≥140 mmHg and increase >10 from reference visit; Diastolic BP: <50 mmHg or ≥90 mmHg or ≥90 mmHg and increase >10 from reference visit; Pulse rate: <50 beats/minute or ≥120 beats/minute or ≥120 beats/minute and increase >15 from reference visit; Weight (kilograms) ≥10% change (increase and decrease) from baseline assessment; Body temperature: > 39-degree Celsius (°C ) or <35°C (oral, tympanic, axilla or forehead). | From first dose of study drug through last follow up visit (up to 36 weeks) |
| Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Parameters for IgPro20 | Clinically significant abnormality criteria for ECG parameters included Heart rate: ≤50 or ≥100 beats/minute; PR Interval: ≥200 millisecond (msec); QRS Interval: ≥120 msec; QT: ≥480 msec; QT interval corrected using Bazett' s formula (QTcB): ≤ 500 msec; QT interval corrected using Fridericia's formula (QTcF): >500 msec; QT: increase from baseline ≥ 30; QTcB: increase from baseline < 60 msec; QTcF: increase from baseline ≥ 60. | From first dose of study drug through last follow up visit (up to 36 weeks) |
| Number of Participants With Clinically Significant Abnormalities in Pulmonary Function Tests (PFTs) for IgPro20 | PFTs include Spirometry which included forced vital capacity (FVC) % Predicted, considered as clinically significant abnormality when decrease is greater than10 percentage points from the reference visit. | From first dose of study drug through last follow up visit (up to 36 weeks) |
| Seq A-(Pre-injection [inj] at Weeks [Wks] 1,5,9,13,14; 24,48,72,96,168 hours [hrs] post 1st inj at Wk 14; 240 hrs post 1st inj at Wk 15), Seq B-(Pre-inj at Wks 17,21,25,29,30; 24,48,72,96,168 hrs post 1st inj at Wk 30; 240 hrs post 1st inj at Wk 31) |
| Area Under the Concentration Curve to the End of the Dosing Period (AUC0-tau) for IgPro20 | Seq A-(Pre-injection [inj] at Weeks [Wks] 1,5,9,13,14; 24,48,72,96,168 hours [hrs] post 1st inj at Wk 14; 240 hrs post 1st inj at Wk 15), Seq B-(Pre-inj at Wks 17,21,25,29,30; 24,48,72,96,168 hrs post 1st inj at Wk 30; 240 hrs post 1st inj at Wk 31) |
| Area Under the Concentration Curve up to the Last Measurable Concentration (AUC0-last) for IgPro20 | Seq A-(Pre-injection [inj] at Weeks [Wks] 1,5,9,13,14; 24,48,72,96,168 hours [hrs] post 1st inj at Wk 14; 240 hrs post 1st inj at Wk 15), Seq B-(Pre-inj at Wks 17,21,25,29,30; 24,48,72,96,168 hrs post 1st inj at Wk 30; 240 hrs post 1st inj at Wk 31) |
| Maximum Plasma Drug Concentration (Cmax) for IgPro20 | Seq A-(Pre-injection [inj] at Weeks [Wks] 1,5,9,13,14; 24,48,72,96,168 hours [hrs] post 1st inj at Wk 14; 240 hrs post 1st inj at Wk 15), Seq B-(Pre-inj at Wks 17,21,25,29,30; 24,48,72,96,168 hrs post 1st inj at Wk 30; 240 hrs post 1st inj at Wk 31) |
| Minimum Plasma Drug Concentration (Ctrough) for IgPro20 in Sequence A | Pre-injection at Weeks 5, 9, 13, and 14 |
| Minimum Plasma Drug Concentration (Ctrough) for IgPro20 in Sequence B | Pre-injection at Weeks 21, 25, 29, and 30 |
| Area Under the Concentration Curve to the End of the Dosing Period (AUC0-tau) for IgPro10 | Seq A and B respectively-Pre-infusion (inf) at Wks 17,21,25,29 and 1,5,9,13; 1 hour (hr) post 1st and 2nd inf, 168 hr post 1st inf at Wk 29,13; 264 and 336 hr post 1st inf at Wk 30, 14; 504 hr post 1st inf at Wk 31,15; 672 hr post 1st inf at Wk 32,16 |
| Area Under the Concentration Curve up to the Last Measurable Concentration (AUC0-last) for IgPro10 | Seq A and B respectively-Pre-infusion (inf) at Wks 17,21,25,29 and 1,5,9,13; 1 hour (hr) post 1st and 2nd inf, 168 hr post 1st inf at Wk 29,13; 264 and 336 hr post 1st inf at Wk 30, 14; 504 hr post 1st inf at Wk 31,15; 672 hr post 1st inf at Wk 32,16 |
| Maximum Plasma Drug Concentration (Cmax) for IgPro10 | Seq A and B respectively-Pre-infusion (inf) at Wks 17,21,25,29 and 1,5,9,13; 1 hour (hr) post 1st and 2nd inf, 168 hr post 1st inf at Wk 29,13; 264 and 336 hr post 1st inf at Wk 30, 14; 504 hr post 1st inf at Wk 31,15; 672 hr post 1st inf at Wk 32,16 |
| Minimum Plasma Drug Concentration (Ctrough) for IgPro10 in Sequence A | Pre-infusion at Weeks 21, 25 and 29 |
| Minimum Plasma Drug Concentration (Ctrough) for IgPro10 in Sequence B | Pre-infusion at Weeks 5, 9 and 13 |
| Number of Participants With at Least One AE for IgPro10 | AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. | From first dose of study drug through last follow up visit (up to 36 weeks) |
| Percentage of Participants With at Least One AE for IgPro10 | AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. | From first dose of study drug through last follow up visit (up to 36 weeks) |
| Number of Participants With at Least One TEAE for IgPro10 | AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product that does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. TEAEs are defined as AEs reported at or after the start of the first infusion in the study. | From first dose of study drug through last follow up visit (up to 36 weeks) |
| Percentage of Participants With at Least One TEAE for IgPro10 | AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. TEAEs are defined as AEs reported at or after the start of the first infusion in the study. | From first dose of study drug through last follow up visit (up to 36 weeks) |
| Number of Participants With at Least One SAE for IgPro10 | An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, or is a medically significant event. | From first dose of study drug through last follow up visit (up to 36 weeks) |
| Percentage of Participants With at Least One SAE for IgPro10 | An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, or is a medically significant event. | From first dose of study drug through last follow up visit (up to 36 weeks) |
| Number of Participants With at Least One AESI for IgPro10 | AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An AESI is an AE of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor is appropriate. | From first dose of study drug through last follow up visit (up to 36 weeks) |
| Percentage of Participants With at Least One AESI for IgPro10 | AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An AESI is an AE of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor is appropriate. | From first dose of study drug through last follow up visit (up to 36 weeks) |
| Number of Participants With AEs Categorized as ISRs for IgPro10 | ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'. | From first dose of study drug through last follow up visit (up to 36 weeks) |
| Percentage of Participants With AEs Categorized as ISRs for IgPro10 | ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'. | From first dose of study drug through last follow up visit (up to 36 weeks) |
| Number of Participants With Clinically Significant Abnormalities in Laboratory Tests for IgPro10 | Abnormality criteria:Hematology-Hemoglobin:<10 g/dL;Platelet count:<75x10^9/L or >500x10^9/L;White Blood Cell Count:<3x10^9/L or >16x10^9/L;Neutrophils:absolute <1.5x10^9/L,differential <40%;Lymphocytes:absolute <0.8x10^9/L,differential <10 or >50%; Biochemistry-Bilirubin:>1.5xupper limit of normal (ULN);Alkaline phosphatase:>2.5xULN;Serum Glutamic-oxalacetic transaminase(SGOT), Aspartate transaminase(AST):>3xULN;Serum glutamic-pyruvic transaminase(SGPT), Alanine transaminase(ALT):>3xULN;Screening:AST/ALT >3xULN and Total Bilirubin >2xULN;Urea nitrogen:>2.5xULN; Creatinine, serum>1.5xbaseline assessment or change >0.3mg/dL since last visit;Glucose,blood (non-fasting):<55/>160mg/dL;Calcium:<7/>11.5mg/dL;Total protein: <5/>9g/dL; Albumin:<3g/dL;Sodium:<130/>150mmol/L;Potassium:<3/>5.5mmol/L; Uric acid,serum:>10mg/dL Males,>8mg/dL Females;Gamma Glutamyl Transpeptidase:>2.5xULN; Phosphorus,inorganic:<2.5/>5mg/dL;Lactate dehydrogenase:>3xULN;Urinalysis-Protein:>20mg/dL. | From first dose of study drug through last follow up visit (up to 36 weeks) |
| Number of Participants With Clinically Significant Changes in Vital Signs for IgPro10 | Clinically significant abnormality criteria for vital signs included Systolic blood pressure (BP): <100 millimeters of mercury (mmHg) or ≥140 mmHg or ≥140 mmHg and increase >10 from reference visit; Diastolic BP: <50 mmHg or ≥90 mmHg or ≥90 mmHg and increase >10 from reference visit; Pulse rate: <50 beats/minute or ≥120 beats/minute or ≥120 beats/minute and increase >15 from reference visit; Weight (kilograms) ≥10% change (increase and decrease) from baseline assessment; Body temperature: > 39-degree Celsius (°C ) or <35°C (oral, tympanic, axilla or forehead). | From first dose of study drug through last follow up visit (up to 36 weeks) |
| Number of Participants With Clinically Significant Abnormalities in ECG Parameters for IgPro10 | Clinically significant abnormality criteria for ECG parameters included Heart rate: ≤50 or ≥100 beats/minute; PR Interval: ≥200 millisecond (msec); QRS Interval: ≥120 msec; QT: ≥480 msec; QT interval corrected using Bazett' s formula (QTcB): ≤ 500 msec; QT interval corrected using Fridericia's formula (QTcF): >500 msec; QT: increase from baseline ≥ 30; QTcB: increase from baseline < 60 msec; QTcF: increase from baseline ≥ 60. | From first dose of study drug through last follow up visit (up to 36 weeks) |
| Number of Participants With Clinically Significant Abnormalities in PFTs for IgPro10 | PFTs include Spirometry which included forced vital capacity (FVC) % Predicted, considered as clinically significant abnormality when decrease is greater than10 percentage points from the reference visit. | From first dose of study drug through last follow up visit (up to 36 weeks) |
| Berlin |
| 10117 |
| Germany |
| Uniklinik Köln, innere Medizin | Cologne | 50937 | Germany |
| ASST Spedali Civili di Brescia | Brescia | 25123 | Italy |
| Azienda Ospedaliera Gaetano Pini | Milan | 20122 | Italy |
| Uniwersytecki Szpital Kliniczny W Bialymstoku | Bialystok | 15-276 | Poland |
| Szpital Kliniczny Jezus | Warsaw | 02-008 | Poland |
| Narodowy Instytut Geriatrii | Warsaw | 02-637 | Poland |
| The Royal Free Hospital | London | NW3 2QG | United Kingdom |
| NOT COMPLETED |
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| Sequence B (IgPro10/IgPro20) |
Participants received IgPro10 of a total dose of 2 g/kg over 2 to 5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 1 followed by IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Sequence B: IgPro20 | Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2. |
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| Primary | Percentage of Participants With at Least One AE for IgPro20 | AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed. The percentage of participants are rounded off to the single decimal point. | Posted | Number | percentage of participants | From first dose of study drug through last follow-up visit (up to 36 weeks) |
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| Primary | Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) for IgPro20 | AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product that does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. TEAEs are defined as AEs reported at or after the start of the first infusion in the study. | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed. | Posted | Count of Participants | Participants | From first dose of study drug through last follow-up visit (up to 36 weeks) |
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| Primary | Percentage of Participants With at Least One TEAE for IgPro20 | AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. TEAEs are defined as AEs reported at or after the start of the first infusion in the study. | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed. The percentage of participants are rounded off to the single decimal point. | Posted | Number | percentage of participants | From first dose of study drug through last follow-up visit (up to 36 weeks) |
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| Primary | Number of Participants With at Least One Serious Adverse Event (SAE) for IgPro20 | An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, or is a medically significant event. | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed. | Posted | Count of Participants | Participants | From first dose of study drug through last follow-up visit (up to 36 weeks) |
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| Primary | Percentage of Participants With at Least One SAE for IgPro20 | An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, or is a medically significant event. | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed. The percentage of participants are rounded off to the single decimal point. | Posted | Number | percentage of participants | From first dose of study drug through last follow-up visit (up to 36 weeks) |
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| Primary | Number of Participants With at Least One Adverse Event of Special Interest (AESI) for IgPro20 | AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An AESI is an AE of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor is appropriate. | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed. | Posted | Count of Participants | Participants | From first dose of study drug through last follow-up visit (up to 36 weeks) |
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| Primary | Percentage of Participants With at Least One AESI for IgPro20 | AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An AESI is an AE of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor is appropriate. | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed. The percentage of participants are rounded off to the single decimal point. | Posted | Number | percentage of participants | From first dose of study drug through last follow up visit (up to 36 weeks) |
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| Primary | Number of Participants With AEs Categorized as Infusion Site Reactions (ISRs) for IgPro20 | ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'. | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed. | Posted | Count of Participants | Participants | From first dose of study drug through last follow up visit (up to 36 weeks) |
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| Primary | Percentage of Participants With AEs Categorized as ISRs for IgPro20 | ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'. | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed. The percentage of participants are rounded off to the single decimal point. | Posted | Number | percentage of participants | From first dose of study drug through last follow up visit (up to 36 weeks) |
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| Primary | Rate of ISRs Per Infusion for IgPro20 | ISR rate per infusion = total number of ISRs across all participants while on IgPro20 / total number of IgPro20 Infusions across all participants. ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions NEC', 'Infusion site reactions', or 'Injection site reactions' | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed. | Posted | Number | ISRs per infusion | From first dose of study drug through last follow up visit (up to 36 weeks) | Infusions | Infusions |
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| Primary | Time to Onset of ISRs for IgPro20 | ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'. Time to onset of ISR since the start of the treatment period was reported. | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 and with ISRs were analyzed. | Posted | Median | Full Range | days | From first dose of study drug through last follow up visit (up to 36 weeks) | ISRs | ISRs |
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| Primary | Duration of ISRs for IgPro20 | ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'. | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 and with ISRs were analyzed. | Posted | Median | Full Range | minutes | From first dose of study drug through last follow up visit (up to 36 weeks) | ISRs | ISRs |
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| Primary | Number of Participants With Clinically Significant Abnormalities in Laboratory Tests for IgPro20 | Abnormality criteria:Hematology-Hemoglobin:<10 g/dL;Platelet count:<75x10^9/L or >500x10^9/L;White Blood Cell Count:<3x10^9/L or >16x10^9/L;Neutrophils:absolute <1.5x10^9/L,differential <40%;Lymphocytes:absolute <0.8x10^9/L,differential <10 or >50%; Biochemistry-Bilirubin:>1.5xupper limit of normal (ULN);Alkaline phosphatase:>2.5xULN;Serum Glutamic-oxalacetic transaminase(SGOT), Aspartate transaminase(AST):>3xULN;Serum glutamic-pyruvic transaminase(SGPT), Alanine transaminase(ALT):>3xULN;Screening:AST/ALT >3xULN and Total Bilirubin >2xULN;Urea nitrogen:>2.5xULN; Creatinine, serum>1.5xbaseline assessment or change >0.3mg/dL since last visit;Glucose,blood (non-fasting):<55/>160mg/dL;Calcium:<7/>11.5mg/dL;Total protein: <5/>9g/dL; Albumin:<3g/dL;Sodium:<130/>150mmol/L;Potassium:<3/>5.5mmol/L; Uric acid,serum:>10mg/dL Males,>8mg/dL Females;Gamma Glutamyl Transpeptidase:>2.5xULN; Phosphorus,inorganic:<2.5/>5mg/dL;Lactate dehydrogenase:>3xULN;Urinalysis-Protein:>20mg/dL. | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed. | Posted | Count of Participants | Participants | From first dose of study drug through last follow up visit (up to 36 weeks) |
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| Primary | Number of Participants With Clinically Significant Changes in Vital Signs for IgPro20 | Clinically significant abnormality criteria for vital signs included Systolic blood pressure (BP): <100 millimeters of mercury (mmHg) or ≥140 mmHg or ≥140 mmHg and increase >10 from reference visit; Diastolic BP: <50 mmHg or ≥90 mmHg or ≥90 mmHg and increase >10 from reference visit; Pulse rate: <50 beats/minute or ≥120 beats/minute or ≥120 beats/minute and increase >15 from reference visit; Weight (kilograms) ≥10% change (increase and decrease) from baseline assessment; Body temperature: > 39-degree Celsius (°C ) or <35°C (oral, tympanic, axilla or forehead). | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed. | Posted | Count of Participants | Participants | From first dose of study drug through last follow up visit (up to 36 weeks) |
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| Primary | Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Parameters for IgPro20 | Clinically significant abnormality criteria for ECG parameters included Heart rate: ≤50 or ≥100 beats/minute; PR Interval: ≥200 millisecond (msec); QRS Interval: ≥120 msec; QT: ≥480 msec; QT interval corrected using Bazett' s formula (QTcB): ≤ 500 msec; QT interval corrected using Fridericia's formula (QTcF): >500 msec; QT: increase from baseline ≥ 30; QTcB: increase from baseline < 60 msec; QTcF: increase from baseline ≥ 60. | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed. | Posted | Count of Participants | Participants | From first dose of study drug through last follow up visit (up to 36 weeks) |
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| Primary | Number of Participants With Clinically Significant Abnormalities in Pulmonary Function Tests (PFTs) for IgPro20 | PFTs include Spirometry which included forced vital capacity (FVC) % Predicted, considered as clinically significant abnormality when decrease is greater than10 percentage points from the reference visit. | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed. | Posted | Count of Participants | Participants | From first dose of study drug through last follow up visit (up to 36 weeks) |
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| Secondary | Relative Bioavailability (%F) of IgPro20 | Relative bioavailability was calculated using Mixed Model Repeated Measures on Log-transformed Dose-normalized area under the curve to the end of the dosing period [AUC0-tau] following administration of the first dose of IgPro20 in the last week of dosing for Sequence A and / or Sequence B. Relative Bioavailability= (AUCtau IgPro20 (SC)/dose of IgPro20 (SC) / (AUCtau of IgPro10 (IV)/dose of IgPro10 (IV)). | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. 'Overall number of participants analyzed' indicates the number of participants who received IgPro20 and with data available for outcome measure analysis. | Posted | Geometric Mean | 95% Confidence Interval | percentage bioavailability | Seq A-(Pre-injection [inj] at Weeks [Wks] 1,5,9,13,14; 24,48,72,96,168 hours [hrs] post 1st inj at Wk 14; 240 hrs post 1st inj at Wk 15), Seq B-(Pre-inj at Wks 17,21,25,29,30; 24,48,72,96,168 hrs post 1st inj at Wk 30; 240 hrs post 1st inj at Wk 31) |
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| Secondary | Area Under the Concentration Curve to the End of the Dosing Period (AUC0-tau) for IgPro20 | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. 'Overall number of participants analyzed' indicates the number of participants who received IgPro20 and with data available for outcome measure analysis. | Posted | Geometric Mean | 95% Confidence Interval | hours*grams per liter (h*g/L) | Seq A-(Pre-injection [inj] at Weeks [Wks] 1,5,9,13,14; 24,48,72,96,168 hours [hrs] post 1st inj at Wk 14; 240 hrs post 1st inj at Wk 15), Seq B-(Pre-inj at Wks 17,21,25,29,30; 24,48,72,96,168 hrs post 1st inj at Wk 30; 240 hrs post 1st inj at Wk 31) |
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| Secondary | Area Under the Concentration Curve up to the Last Measurable Concentration (AUC0-last) for IgPro20 | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. 'Overall number of participants analyzed' indicates the number of participants who received IgPro20 and with data available for outcome measure analysis. | Posted | Geometric Mean | 95% Confidence Interval | h*g/L | Seq A-(Pre-injection [inj] at Weeks [Wks] 1,5,9,13,14; 24,48,72,96,168 hours [hrs] post 1st inj at Wk 14; 240 hrs post 1st inj at Wk 15), Seq B-(Pre-inj at Wks 17,21,25,29,30; 24,48,72,96,168 hrs post 1st inj at Wk 30; 240 hrs post 1st inj at Wk 31) |
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| Secondary | Maximum Plasma Drug Concentration (Cmax) for IgPro20 | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. 'Overall number of participants analyzed' indicates the number of participants who received IgPro20 and with data available for outcome measure analysis. | Posted | Geometric Mean | 95% Confidence Interval | g/L | Seq A-(Pre-injection [inj] at Weeks [Wks] 1,5,9,13,14; 24,48,72,96,168 hours [hrs] post 1st inj at Wk 14; 240 hrs post 1st inj at Wk 15), Seq B-(Pre-inj at Wks 17,21,25,29,30; 24,48,72,96,168 hrs post 1st inj at Wk 30; 240 hrs post 1st inj at Wk 31) |
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| Secondary | Minimum Plasma Drug Concentration (Ctrough) for IgPro20 in Sequence A | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed. 'Number analyzed' indicates the number of participants with data available for analysis at the specified time point. | Posted | Geometric Mean | Full Range | g/L | Pre-injection at Weeks 5, 9, 13, and 14 |
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| Secondary | Minimum Plasma Drug Concentration (Ctrough) for IgPro20 in Sequence B | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. 'Overall number of participants analyzed' indicates the number of participants who received IgPro20 and with data available for outcome measure analysis. | Posted | Geometric Mean | Full Range | g/L | Pre-injection at Weeks 21, 25, 29, and 30 |
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| Secondary | Area Under the Concentration Curve to the End of the Dosing Period (AUC0-tau) for IgPro10 | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. 'Overall number of participants analyzed' indicates the number of participants who received IgPro10 and with data available for outcome measure analysis. | Posted | Geometric Mean | 95% Confidence Interval | h*g/L | Seq A and B respectively-Pre-infusion (inf) at Wks 17,21,25,29 and 1,5,9,13; 1 hour (hr) post 1st and 2nd inf, 168 hr post 1st inf at Wk 29,13; 264 and 336 hr post 1st inf at Wk 30, 14; 504 hr post 1st inf at Wk 31,15; 672 hr post 1st inf at Wk 32,16 |
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| Secondary | Area Under the Concentration Curve up to the Last Measurable Concentration (AUC0-last) for IgPro10 | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. 'Overall number of participants analyzed' indicates the number of participants who received IgPro10 and with data available for outcome measure analysis. | Posted | Geometric Mean | 95% Confidence Interval | h*g/L | Seq A and B respectively-Pre-infusion (inf) at Wks 17,21,25,29 and 1,5,9,13; 1 hour (hr) post 1st and 2nd inf, 168 hr post 1st inf at Wk 29,13; 264 and 336 hr post 1st inf at Wk 30, 14; 504 hr post 1st inf at Wk 31,15; 672 hr post 1st inf at Wk 32,16 |
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| Secondary | Maximum Plasma Drug Concentration (Cmax) for IgPro10 | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. 'Overall number of participants analyzed' indicates the number of participants who received IgPro10 and with data available for outcome measure analysis. | Posted | Geometric Mean | 95% Confidence Interval | g/L | Seq A and B respectively-Pre-infusion (inf) at Wks 17,21,25,29 and 1,5,9,13; 1 hour (hr) post 1st and 2nd inf, 168 hr post 1st inf at Wk 29,13; 264 and 336 hr post 1st inf at Wk 30, 14; 504 hr post 1st inf at Wk 31,15; 672 hr post 1st inf at Wk 32,16 |
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| Secondary | Minimum Plasma Drug Concentration (Ctrough) for IgPro10 in Sequence A | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro10 were analyzed. 'Number analyzed' indicates the number of participants with data available for analysis at the specified time point. | Posted | Geometric Mean | Full Range | g/L | Pre-infusion at Weeks 21, 25 and 29 |
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| Secondary | Minimum Plasma Drug Concentration (Ctrough) for IgPro10 in Sequence B | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. 'Overall number of participants analyzed' indicates the number of participants who received IgPro10 and with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at the specified time point. | Posted | Geometric Mean | Full Range | g/L | Pre-infusion at Weeks 5, 9 and 13 |
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| Secondary | Number of Participants With at Least One AE for IgPro10 | AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro10 were analyzed. | Posted | Count of Participants | Participants | From first dose of study drug through last follow up visit (up to 36 weeks) |
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| Secondary | Percentage of Participants With at Least One AE for IgPro10 | AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro10 were analyzed. The percentage of participants are rounded off to the single decimal point. | Posted | Number | percentage of participants | From first dose of study drug through last follow up visit (up to 36 weeks) |
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| Secondary | Number of Participants With at Least One TEAE for IgPro10 | AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product that does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. TEAEs are defined as AEs reported at or after the start of the first infusion in the study. | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro10 were analyzed. | Posted | Count of Participants | Participants | From first dose of study drug through last follow up visit (up to 36 weeks) |
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| Secondary | Percentage of Participants With at Least One TEAE for IgPro10 | AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. TEAEs are defined as AEs reported at or after the start of the first infusion in the study. | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro10 were analyzed. The percentage of participants are rounded off to the single decimal point. | Posted | Number | percentage of participants | From first dose of study drug through last follow up visit (up to 36 weeks) |
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| Secondary | Number of Participants With at Least One SAE for IgPro10 | An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, or is a medically significant event. | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro10 were analyzed. | Posted | Count of Participants | Participants | From first dose of study drug through last follow up visit (up to 36 weeks) |
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| Secondary | Percentage of Participants With at Least One SAE for IgPro10 | An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, or is a medically significant event. | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro10 were analyzed. The percentage of participants are rounded off to the single decimal point. | Posted | Number | percentage of participants | From first dose of study drug through last follow up visit (up to 36 weeks) |
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| Secondary | Number of Participants With at Least One AESI for IgPro10 | AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An AESI is an AE of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor is appropriate. | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro10 were analyzed. | Posted | Count of Participants | Participants | From first dose of study drug through last follow up visit (up to 36 weeks) |
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| Secondary | Percentage of Participants With at Least One AESI for IgPro10 | AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An AESI is an AE of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor is appropriate. | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro10 were analyzed. The percentage of participants are rounded off to the single decimal point. | Posted | Number | percentage of participants | From first dose of study drug through last follow up visit (up to 36 weeks) |
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| Secondary | Number of Participants With AEs Categorized as ISRs for IgPro10 | ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'. | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro10 were analyzed. | Posted | Count of Participants | Participants | From first dose of study drug through last follow up visit (up to 36 weeks) |
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| Secondary | Percentage of Participants With AEs Categorized as ISRs for IgPro10 | ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'. | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro10 were analyzed. | Posted | Number | percentage of participants | From first dose of study drug through last follow up visit (up to 36 weeks) |
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| Secondary | Number of Participants With Clinically Significant Abnormalities in Laboratory Tests for IgPro10 | Abnormality criteria:Hematology-Hemoglobin:<10 g/dL;Platelet count:<75x10^9/L or >500x10^9/L;White Blood Cell Count:<3x10^9/L or >16x10^9/L;Neutrophils:absolute <1.5x10^9/L,differential <40%;Lymphocytes:absolute <0.8x10^9/L,differential <10 or >50%; Biochemistry-Bilirubin:>1.5xupper limit of normal (ULN);Alkaline phosphatase:>2.5xULN;Serum Glutamic-oxalacetic transaminase(SGOT), Aspartate transaminase(AST):>3xULN;Serum glutamic-pyruvic transaminase(SGPT), Alanine transaminase(ALT):>3xULN;Screening:AST/ALT >3xULN and Total Bilirubin >2xULN;Urea nitrogen:>2.5xULN; Creatinine, serum>1.5xbaseline assessment or change >0.3mg/dL since last visit;Glucose,blood (non-fasting):<55/>160mg/dL;Calcium:<7/>11.5mg/dL;Total protein: <5/>9g/dL; Albumin:<3g/dL;Sodium:<130/>150mmol/L;Potassium:<3/>5.5mmol/L; Uric acid,serum:>10mg/dL Males,>8mg/dL Females;Gamma Glutamyl Transpeptidase:>2.5xULN; Phosphorus,inorganic:<2.5/>5mg/dL;Lactate dehydrogenase:>3xULN;Urinalysis-Protein:>20mg/dL. | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro10 were analyzed. | Posted | Count of Participants | Participants | From first dose of study drug through last follow up visit (up to 36 weeks) |
|
|
|
| Secondary | Number of Participants With Clinically Significant Changes in Vital Signs for IgPro10 | Clinically significant abnormality criteria for vital signs included Systolic blood pressure (BP): <100 millimeters of mercury (mmHg) or ≥140 mmHg or ≥140 mmHg and increase >10 from reference visit; Diastolic BP: <50 mmHg or ≥90 mmHg or ≥90 mmHg and increase >10 from reference visit; Pulse rate: <50 beats/minute or ≥120 beats/minute or ≥120 beats/minute and increase >15 from reference visit; Weight (kilograms) ≥10% change (increase and decrease) from baseline assessment; Body temperature: > 39-degree Celsius (°C ) or <35°C (oral, tympanic, axilla or forehead). | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro10 were analyzed. | Posted | Count of Participants | Participants | From first dose of study drug through last follow up visit (up to 36 weeks) |
|
|
|
| Secondary | Number of Participants With Clinically Significant Abnormalities in ECG Parameters for IgPro10 | Clinically significant abnormality criteria for ECG parameters included Heart rate: ≤50 or ≥100 beats/minute; PR Interval: ≥200 millisecond (msec); QRS Interval: ≥120 msec; QT: ≥480 msec; QT interval corrected using Bazett' s formula (QTcB): ≤ 500 msec; QT interval corrected using Fridericia's formula (QTcF): >500 msec; QT: increase from baseline ≥ 30; QTcB: increase from baseline < 60 msec; QTcF: increase from baseline ≥ 60. | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro10 were analyzed. | Posted | Count of Participants | Participants | From first dose of study drug through last follow up visit (up to 36 weeks) |
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| Secondary | Number of Participants With Clinically Significant Abnormalities in PFTs for IgPro10 | PFTs include Spirometry which included forced vital capacity (FVC) % Predicted, considered as clinically significant abnormality when decrease is greater than10 percentage points from the reference visit. | Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro10 were analyzed. | Posted | Count of Participants | Participants | From first dose of study drug through last follow up visit (up to 36 weeks) |
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| Other Pre-specified | Rate of ISRs Per Participant for IgPro20 | Not Posted | From first dose of study drug through last follow up visit (up to 36 weeks) | Participants |
| 0 |
| 13 |
| 2 |
| 13 |
| 8 |
| 13 |
| EG001 | Sequence A: IgPro10 | Participants received IgPro10 of a total dose of 2 g/kg over 2 to 5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 2. | 0 | 13 | 1 | 13 | 5 | 13 |
| EG002 | Sequence B: IgPro10 | Participants received IgPro10 of a total dose of 2 g/kg over 2 to 5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 1. | 0 | 14 | 1 | 14 | 8 | 14 |
| EG003 | Sequence B: IgPro20 | Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2. | 0 | 13 | 3 | 13 | 6 | 13 |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Chronic gastritis | Gastrointestinal disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0. | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Saliva altered | Gastrointestinal disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Anosmia | Nervous system disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Dermatitis psoriasiform | Skin and subcutaneous tissue disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Lichenoid keratosis | Skin and subcutaneous tissue disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Scleroderma associated digital ulcer | Skin and subcutaneous tissue disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Umbilical erythema | Skin and subcutaneous tissue disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Infusion site pain | General disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Infusion site swelling | General disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Infusion site discharge | General disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Infusion site erosion | General disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Infusion site erythema | General disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Infusion site haemorrhage | General disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Infusion site reaction | General disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Infusion site vesicles | General disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Injection site hypersensitivity | General disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Injection site mass | General disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 25.0. | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA version 25.0. | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA version 25.0. | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA version 25.0. | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 25.0. | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA version 25.0. | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA version 25.0. | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA version 25.0. | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA version 25.0. | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0. | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA version 25.0. | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA version 25.0. | Systematic Assessment |
|
Not provided
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
|
| Week 13 |
|
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| Week 14 |
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| Title | Measurements |
|---|---|
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| Week 30 |
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| Week 29 |
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| Week 13 |
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