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.
Study Type
OBSERVATIONAL
Enrollment
6,086
RTI Health Solutions
Durham, North Carolina, United States
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).
Time frame: 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.
Time frame: 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.
Time frame: Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)
Number of Participants With Anaphylaxis
Anaphylaxis will be reported as adverse event (AE) and will include anaphylactic reaction or anaphylactic shock.
Time frame: 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)
Number of participants with TRALI will be reported.
Time frame: Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)
Number of Participants With Transfusion-associated Circulatory Overload (TACO)
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Number of participants with TACO will be reported.
Time frame: Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)