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| ID | Type | Description | Link |
|---|---|---|---|
| EUPAS46101 | Other Identifier | EUPAS |
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| Name | Class |
|---|---|
| Baxalta Innovations GmbH, now part of Shire | INDUSTRY |
| RTI Health Solutions | OTHER |
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The main aim of this study is to evaluate the rates of adverse events of special interest (AESIs) (thrombotic events, acute kidney injury [AKI], and hemolytic events) among participants with CIDP initiating GGL compared with rates among participants with CIDP initiating comparator intravenous immunoglobulin (IVIG) products.
No study medicines will be provided to participants in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ig-naive (New-to-class) Cohort | Participants who initiate GGL or one of the comparator IVIG products who have no record of previous use of any Ig product (Ig naive) for at least 6 months before study initiation will be include in this cohort. | ||
| Ig-experienced (New-to-drug) Cohort | Participants who initiate either GGL or a comparator IVIG product with no record of previous use of that specific IVIG product but with previous use of any other Ig product (Ig experienced) in all available study data will be included in this cohort. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Thrombotic Events (TEs) | Thrombotic events will be reported as adverse events of special interest (AESI) and will include: acute ischemic stroke, acute myocardial infarction (AMI), and acute venous thromboembolism (VTE) events including (deep vein thrombosis (DVT), cerebral venous thrombosis (CVT), pulmonary embolism (PE). | Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years) |
| Number of Participants With Acute kidney injury (AKI) | AKI will be reported as AESI and will include acute renal failure. | Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years) |
| Number of Participants With Hemolytic Events (HEs) | HEs will be reported as AESI and will include nonautoimmune hemolytic anemia, acquired hemolytic anemia, ABO incompatibility reaction, or hemolytic transfusion reaction. | Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Anaphylaxis | Anaphylaxis will be reported as adverse event (AE) and will include anaphylactic reaction or anaphylactic shock. | Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years) |
| Number of Participants With Transfusion-related Acute Lung Injury (TRALI) |
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Inclusion Criteria:
Exclusion Criteria:
Having claims for greater than or equal to (>=) 2 different IVIG products on the index date.
Recorded diagnosis of any of the following conditions where Ig products are used for treatment on or before the index date
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Participants with CIDP on treatment with GGL and other IVIG products will be observed in this retrospective study.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RTI Health Solutions | Durham | North Carolina | 12194 | United States |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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De-identified individual participant data from this particular study will not be shared as the data are subject to contractual (or consent) provisions that prohibit transfer to third parties.
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| ID | Term |
|---|---|
| D020277 | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
| ID | Term |
|---|---|
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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Number of participants with TRALI will be reported. |
| Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years) |
| Number of Participants With Transfusion-associated Circulatory Overload (TACO) | Number of participants with TACO will be reported. | Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years) |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |