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.
Patients with primary immunodeficiency (PID) enrolled in the PID patient registry.
Participant for whom study drug is entered in the therapeutic drug field on the data set.
Participant who is entered the intractable disease diagnosis corresponding to PID in the intractable disease information field.
Participant for whom the presence or absence of adverse events has been entered in the column of adverse events.
Participant for whom study drug has not been entered in the drug name in the medical history field during the period from January 24, 2024 to January 23, 2029.
Participant who is not entered the intractable disease diagnosis corresponding to PID in the intractable disease information field.
Participant for whom the presence or absence of adverse events has not been entered in the column of adverse events.
The population of this survey are all participants who meet the inclusion/exclusion criteria.
Cohort
Retrospective
Immune Globulin Subcutaneous (Human), 20% Solution
DrugCUVITRU 20% Solution
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.
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.
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.
