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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2031240293 | Registry Identifier | jRCT |
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This study is a retrospective database study in Japan to evaluate the safety of Immune Globulin Subcutaneous (Human), 20% Solution in participants with primary immunodeficiency disease (PID). This survey will conduct in use of medical database called PIDJ2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immune Globulin Subcutaneous (Human), 20% Solution | Participants with primary immunodeficiency disease who received Immune Globulin Subcutaneous (Human) 20% infusion in accordance with package insert. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immune Globulin Subcutaneous (Human), 20% Solution | Drug | CUVITRU 20% Solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience Anaphylactic Reaction as an Adverse Event (AE) | An AE is defined as any untoward event that occurred in a participant after the first dose of study drug, which does not necessarily have a causal relationship with primary immunodeficiency disease. Number of participants who experience anaphylactic reaction as an AE will be reported. | From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years) |
| Number of Participants Who Experience Thromboembolism as an AE | An AE is defined as any untoward event that occurred in a participant after the first dose of study drug, which does not necessarily have a causal relationship with primary immunodeficiency disease. Number of participants who experience thromboembolism as an AE will be reported. | From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years) |
| Number of Participants Who Experience Aseptic Meningitis as an AE | An AE is defined as any untoward event that occurred in a participant after the first dose of study drug, which does not necessarily have a causal relationship with primary immunodeficiency disease. Number of participants who experience aseptic meningitis as an AE will be reported. | From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years) |
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Inclusion Criteria:
Exclusion Criteria:
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The population of this survey are all participants who meet the inclusion/exclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Takeda Contact | Contact | +1-877-825-3327 | medinfoUS@takeda.com | |
| Study Director | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takeda selected site | Recruiting | Tokyo | Tokyo | Japan |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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| ID | Term |
|---|---|
| D000081207 | Primary Immunodeficiency Diseases |
| ID | Term |
|---|---|
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D005719 | gamma-Globulins |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D004364 | Pharmaceutical Preparations |
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