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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-006522-25 | EudraCT Number | ||
| 1461 | Other Identifier | CSL Behring |
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The objective of this study is to assess the efficacy and safety of Vivaglobin in previously untreated patients (PUPs) with primary immunodeficiency (PID) over a 25-week observation period. The purpose is to investigate whether PUPs will respond to subcutaneous immunoglobulin (SCIG) treatment with adequate trough levels without first receiving immunoglobulins by the intravenous route by demonstrating that 100 mg immunoglobulin G/kg body weight (IgG/kg bw) administered on 5 consecutive days (i.e. resulting in a total dose of 500 mg IgG/kg bw) results in an IgG increase to ≥ 5 g/L on Day 12 after initiation of SCIG therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vivaglobin | Experimental | Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivaglobin | Drug | Human normal immunoglobulin G (IgG) for subcutaneous (SC) use. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Achieving Immunoglobulin G (IgG) Levels ≥ 5 g/L on Day 12 | On Day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Achieving IgG Levels ≥ 5 g/L on Day 19 | On Day 19 | |
| Proportion of Patients Achieving IgG Levels ≥ 5 g/L on Day 26 | On Day 26 | |
| IgG Increase (Change From Baseline) on Day 12 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Borte, MD | Klinik für Kinder-und Jugendmedizin am Städtischen Klinikum St. Georg, Leipzig, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact CSL Behring for facility details | Edmonton | Alberta | T6G 2B7 | Canada | ||
| Contact CSL Behring for facility details |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21932110 | Result | Borte M, Quinti I, Soresina A, Fernandez-Cruz E, Ritchie B, Schmidt DS, McCusker C. Efficacy and safety of subcutaneous vivaglobin(R) replacement therapy in previously untreated patients with primary immunodeficiency: a prospective, multicenter study. J Clin Immunol. 2011 Dec;31(6):952-61. doi: 10.1007/s10875-011-9588-5. Epub 2011 Sep 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vivaglobin | Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vivaglobin | Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Proportion of Patients Achieving IgG Levels ≥ 5 g/L on Day 19 | The ITT data set comprised all patients who were treated with the study drug and completed Day 12. | Posted | Number | 95% Confidence Interval | proportion of participants | On Day 19 |
|
|
For the duration of the study, up to approximately 25 weeks
The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vivaglobin | Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA V11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA V11.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure Manager | CSL Behring | Use email contact | clinicaltrials@cslbehring.com |
| ID | Term |
|---|---|
| D017074 | Common Variable Immunodeficiency |
| D000361 | Agammaglobulinemia |
| D000081207 | Primary Immunodeficiency Diseases |
| C537409 | Bruton type agammaglobulinemia |
| ID | Term |
|---|---|
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| C510539 | Vivaglobin |
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| Baseline to Day 12 |
| Overall Rate of Infections | Annualized rate of any infection. The annualized rate was based on the total number of infections and the total number of patient study days for all patients in the specified analysis population and adjusted to 365 days. Infections were classified as all AEs with the system organ class "infections and infestations". | For the duration of the study, up to approximately 25 weeks |
| Total Serum IgG Trough Levels on Day 12 | On Day 12 |
| Total Serum IgG Trough Levels at Week 25 | At Week 25 |
| Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles on Day 12 | On Day 12 |
| Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles at Week 25 | At Week 25 |
| Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae On Day 12 | On Day 12 |
| Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae at Week 25 | At Week 25 |
| Use of Antibiotics for Infection Prophylaxis and Treatment | Number of patients. Medications were classified as antibiotics according to the anatomic therapeutic chemical code. | For the duration of the study, up to approximately 25 weeks |
| Quality of Life as Measured by the Adapted Short Form-36 Health Survey (SF-36; Age ≥ 14 Years) | The SF-36 is a 36-item questionnaire that measures generic health concepts that are relevant across age, disease, and treatment groups. The questions are grouped into eight domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100, with higher scores indicating a better health state. | At study completion, approximately Week 25 |
| Quality of Life as Measured by the Child Health Questionnaire Parent Form-50 (CHQ-PF50; Age ≤ 13 Years) | The CHQ-PF50 is a 50-item questionnaire that measures generic health concepts and is suitable for patients younger than 14 years of age. The questions are grouped into 15 domains: global health, physical functioning, role/social limitations - emotional/behavioral, role/social limitations - physical, bodily pain, behavior, global behavior, mental health, self esteem, general health perceptions, change in health, parental impact - emotional, parental impact - time, family activities, and family cohesion. Scores range from 0 to 100, with higher scores indicating a better health state. | At study completion, approximately Week 25 |
| Number of Patients With Adverse Events (AEs) by Severity and Relatedness | Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping. | For the duration of the study, up to approximately 25 weeks |
| Rate of AEs by Severity and Relatedness | The rate was the number of AEs over the number of infusions administered. Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping. | For the duration of the study, up to approximately 25 weeks |
| Number of Patients With Local Reactions by Severity and Relatedness | Local reactions included: infusion site erythema, infusion site pain, infusion site pruritus, infusion site rash, infusion site reaction, infusion site swelling, injection site bruising, injection site erythema, injection site irritation, injection site pruritus, injection site swelling, edema peripheral, tenderness, erythema, pruritus, and skin swelling. Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping. | For the duration of the study, up to approximately 25 weeks |
| Rate of Local Reactions by Severity and Relatedness | The rate was the number of local reactions over the number of infusions administered. Local reactions included:
Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping. | For the duration of the study, up to approximately 25 weeks |
| Number of Patients With Clinically Relevant Changes in Routine Laboratory Parameters | Laboratory parameters included hematology, serum chemistry, and urinalysis parameters, and were assessed at screening, Week 12 (hematology and serum chemistry) and at the completion visit (approximately Week 25). | At Weeks 12 and 25 |
| Number of Patients With Clinically Relevant Changes in Vital Signs | Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature. | At the screening visit, before and after infusions (Days 1 to 5), and at the completion visit (Week 25) |
| Montreal |
| Quebec |
| H3H 1P3 |
| Canada |
| Contact CSL Behring for facility details | Leipzig | 04129 | Germany |
| Contact CSL Behring for facility details | Brescia | 25123 | Italy |
| Contact CSL Behring for facility details | Roma | 00186 | Italy |
| Contact CSL Behring for facility details | Madrid | 28007 | Spain |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Proportion of Patients Achieving IgG Levels ≥ 5 g/L on Day 26 | The ITT data set comprised all patients who were treated with the study drug and completed Day 12. | Posted | Number | 95% Confidence Interval | proportion of participants | On Day 26 |
|
|
|
| Secondary | IgG Increase (Change From Baseline) on Day 12 | The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which IgG results, as required for the analysis, were available. | Posted | Mean | Standard Deviation | g/L | Baseline to Day 12 |
|
|
|
| Secondary | Overall Rate of Infections | Annualized rate of any infection. The annualized rate was based on the total number of infections and the total number of patient study days for all patients in the specified analysis population and adjusted to 365 days. Infections were classified as all AEs with the system organ class "infections and infestations". | The ITT data set comprised all patients who were treated with the study drug and completed Day 12. | Posted | Number | 95% Confidence Interval | infections per patient year | For the duration of the study, up to approximately 25 weeks | Infections | Participants |
|
|
|
| Secondary | Total Serum IgG Trough Levels on Day 12 | The ITT data set comprised all patients who were treated with the study drug and completed Day 12. | Posted | Mean | Standard Deviation | g/L | On Day 12 |
|
|
|
| Secondary | Total Serum IgG Trough Levels at Week 25 | The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which Week 25 total serum IgG results were available. | Posted | Mean | Standard Deviation | g/L | At Week 25 |
|
|
|
| Secondary | Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles on Day 12 | The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which Day 12 specific IgG results were available. | Posted | Mean | Standard Deviation | IU/mL | On Day 12 |
|
|
|
| Primary | Proportion of Patients Achieving Immunoglobulin G (IgG) Levels ≥ 5 g/L on Day 12 | The intention-to-treat (ITT) data set comprised all patients who were treated with the study drug and completed Day 12. | Posted | Number | 95% Confidence Interval | proportion of patients | On Day 12 |
|
|
|
| Secondary | Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles at Week 25 | The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which Week 25 specific IgG results were available. | Posted | Mean | Standard Deviation | IU/mL | At Week 25 |
|
|
|
| Secondary | Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae On Day 12 | The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which Day 12 specific IgG results were available. | Posted | Mean | Standard Deviation | mg/L | On Day 12 |
|
|
|
| Secondary | Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae at Week 25 | The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which Week 25 specific IgG results were available. | Posted | Mean | Standard Deviation | mg/L | At Week 25 |
|
|
|
| Secondary | Use of Antibiotics for Infection Prophylaxis and Treatment | Number of patients. Medications were classified as antibiotics according to the anatomic therapeutic chemical code. | The ITT data set comprised all patients who were treated with the study drug and completed Day 12. | Posted | Number | participants | For the duration of the study, up to approximately 25 weeks |
|
|
|
| Secondary | Quality of Life as Measured by the Adapted Short Form-36 Health Survey (SF-36; Age ≥ 14 Years) | The SF-36 is a 36-item questionnaire that measures generic health concepts that are relevant across age, disease, and treatment groups. The questions are grouped into eight domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100, with higher scores indicating a better health state. | The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set), and for which responses to the SF-36 questionnaire were available. | Posted | Mean | Standard Deviation | units on a scale | At study completion, approximately Week 25 |
|
|
|
| Secondary | Quality of Life as Measured by the Child Health Questionnaire Parent Form-50 (CHQ-PF50; Age ≤ 13 Years) | The CHQ-PF50 is a 50-item questionnaire that measures generic health concepts and is suitable for patients younger than 14 years of age. The questions are grouped into 15 domains: global health, physical functioning, role/social limitations - emotional/behavioral, role/social limitations - physical, bodily pain, behavior, global behavior, mental health, self esteem, general health perceptions, change in health, parental impact - emotional, parental impact - time, family activities, and family cohesion. Scores range from 0 to 100, with higher scores indicating a better health state. | The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set), and for which responses to the CHQ-PF50 questionnaire were available. | Posted | Mean | Standard Deviation | units on a scale | At study completion, approximately Week 25 |
|
|
|
| Secondary | Number of Patients With Adverse Events (AEs) by Severity and Relatedness | Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping. | The Safety data set (SDS) comprised all treated patients. | Posted | Number | participants | For the duration of the study, up to approximately 25 weeks |
|
|
|
| Secondary | Rate of AEs by Severity and Relatedness | The rate was the number of AEs over the number of infusions administered. Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping. | The SDS comprised all treated patients. | Posted | Number | AEs per infusion | For the duration of the study, up to approximately 25 weeks | Infusions | Participants |
|
|
|
| Secondary | Number of Patients With Local Reactions by Severity and Relatedness | Local reactions included: infusion site erythema, infusion site pain, infusion site pruritus, infusion site rash, infusion site reaction, infusion site swelling, injection site bruising, injection site erythema, injection site irritation, injection site pruritus, injection site swelling, edema peripheral, tenderness, erythema, pruritus, and skin swelling. Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping. | The SDS comprised all treated patients. | Posted | Number | participants | For the duration of the study, up to approximately 25 weeks |
|
|
|
| Secondary | Rate of Local Reactions by Severity and Relatedness | The rate was the number of local reactions over the number of infusions administered. Local reactions included:
Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping. | The SDS comprised all treated patients. | Posted | Number | local reactions per infusion | For the duration of the study, up to approximately 25 weeks | infusions | Participants |
|
|
|
| Secondary | Number of Patients With Clinically Relevant Changes in Routine Laboratory Parameters | Laboratory parameters included hematology, serum chemistry, and urinalysis parameters, and were assessed at screening, Week 12 (hematology and serum chemistry) and at the completion visit (approximately Week 25). | The SDS comprised all treated patients. | Posted | Number | participants | At Weeks 12 and 25 |
|
|
|
| Secondary | Number of Patients With Clinically Relevant Changes in Vital Signs | Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature. | The SDS comprised all treated patients. | Posted | Number | participants | At the screening visit, before and after infusions (Days 1 to 5), and at the completion visit (Week 25) |
|
|
|
| 2 |
| 18 |
| 14 |
| 18 |
| Meningitis | Infections and infestations | MedDRA V11.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA V11.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA V11.1 | Systematic Assessment |
|
| Pseudomonal bacteraemia | Infections and infestations | MedDRA V11.1 | Systematic Assessment |
|
| Haemophilus infection | Infections and infestations | MedDRA V11.1 | Systematic Assessment |
|
| Pseudomonas bronchitis | Infections and infestations | MedDRA V11.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA V11.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA V11.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA V11.1 | Systematic Assessment |
|
| Infusion site erythema | General disorders | MedDRA V11.1 | Systematic Assessment |
|
| Infusion site pain | General disorders | MedDRA V11.1 | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA V11.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA V11.1 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA V11.1 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA V11.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA V11.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA V11.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA V11.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA V11.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA V11.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA V11.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA V11.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA V11.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA V11.1 | Systematic Assessment |
|
| Haemolysis | Blood and lymphatic system disorders | MedDRA V11.1 | Systematic Assessment |
|
| Eye swelling | Eye disorders | MedDRA V11.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA V11.1 | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA V11.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA V11.1 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA V11.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA V11.1 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA V11.1 | Systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA V11.1 | Systematic Assessment |
|
| Swollen tongue | Gastrointestinal disorders | MedDRA V11.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA V11.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA V11.1 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA V11.1 | Systematic Assessment |
|
| Infusion site pruritus | General disorders | MedDRA V11.1 | Systematic Assessment |
|
| Infusion site rash | General disorders | MedDRA V11.1 | Systematic Assessment |
|
| Infusion site reaction | General disorders | MedDRA V11.1 | Systematic Assessment |
|
| Infusion site swelling | General disorders | MedDRA V11.1 | Systematic Assessment |
|
| Injection site irritation | General disorders | MedDRA V11.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA V11.1 | Systematic Assessment |
|
| Tenderness | General disorders | MedDRA V11.1 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA V11.1 | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA V11.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA V11.1 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA V11.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA V11.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA V11.1 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA V11.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA V11.1 | Systematic Assessment |
|
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA V11.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA V11.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA V11.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA V11.1 | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA V11.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA V11.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA V11.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA V11.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA V11.1 | Systematic Assessment |
|
| Nervousness | Psychiatric disorders | MedDRA V11.1 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA V11.1 | Systematic Assessment |
|
| Renal pain | Renal and urinary disorders | MedDRA V11.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA V11.1 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA V11.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA V11.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA V11.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA V11.1 | Systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA V11.1 | Systematic Assessment |
|
| Pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA V11.1 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA V11.1 | Systematic Assessment |
|
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA V11.1 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA V11.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA V11.1 | Systematic Assessment |
|
| Pruritus generalized | Skin and subcutaneous tissue disorders | MedDRA V11.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA V11.1 | Systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA V11.1 | Systematic Assessment |
|
| Skin swelling | Skin and subcutaneous tissue disorders | MedDRA V11.1 | Systematic Assessment |
|
CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
|
| General health |
|
| Vitality |
|
| Social functioning |
|
| Role-emotional |
|
| Mental health |
|
| Title | Measurements |
|---|---|
|
| Role/social limitations - physical |
|
| Bodily pain |
|
| Behavior |
|
| Global behavior |
|
| Mental health |
|
| Self esteem |
|
| General health perceptions |
|
| Change in health |
|
| Parental impact - emotional |
|
| Parental impact - time |
|
| Family activities |
|
| Family cohesion |
|
| Title | Measurements |
|---|---|
|
| Severe AEs |
|
| Not related AEs |
|
| Possibly related AEs |
|
| Probably related AEs |
|
| Related AEs |
|
| Title | Measurements |
|---|---|
|
| Severe AEs |
|
| Not related AEs |
|
| Possibly related AEs |
|
| Probably related AEs |
|
| Related AEs |
|
| Title | Measurements |
|---|---|
|
| Severe local reactions |
|
| Not related local reactions |
|
| Possibly related local reactions |
|
| Probably related local reactions |
|
| Related local reactions |
|
| Title | Measurements |
|---|---|
|
| Severe local reactions |
|
| Not related local reactions |
|
| Possibly related local reactions |
|
| Probably related local reactions |
|
| Related local reactions |
|