hypogammaglobulinemia
Conditions
Interventions
None listed
Sponsors
CSL Behring K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Diagnosed with hematologic malignancies (ICD-10 codes: C81x-96x) during the study period (from May 2010 to March 2021). (2) Diagnosed with hypogammaglobulinemia (disease code: 2790006) during the study period. (3) Received immunoglobulins (IVIGs and SCIG [drug codes: J06C0 and J06E0, respectively]) after both the first diagnosis date of hematologic malignancy and that of hypogammaglobulinemia. The first prescription date after the first diagnosis date of hypogammaglobulinemia will be defined as the index date. (4) Have 2 or more medical records in the 12 months before the index date (baseline period). (5) Have 2 or more medical records in the subsequent 12 months after the index date (follow-up period). (6) Received 2 or more courses of immunoglobulins (drug codes: J06C0 and J06E0) during the follow-up period. One course will be defined as a continuous prescription period with an interval of less than 7 days. (7) Aged >= 16 years at the index date.
Exclusion criteria
Exclusion criteria: (1) Diagnosed with immunodeficiency (primary immunodeficiency [PID; disease code: 2793012] or human immunodeficiency virus [HIV; ICD-10 code: B20x-B24x]) during the study period. (2) Diagnosed with any other diseases* for which immunoglobulins can be used according to regulations in Japan (ICD-10 code: D693, G360, G610, G618, G700, H46x, L10x, L12x, L511, L512, M301, M303, M33x) during the study period. (3) Have a record of immunoglobulin treatment before the initial diagnosis of hypogammaglobulinemia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence rate of SBIs per person-year in the 12 months after the index date, which is defined as the date of initiation of IgRT, will be compared with that in the 12 months before the index date in patients on an adequate dosage of IgRT. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) The number of days of administration of intravenous antibiotics during hospitalization in the 12 months after the index date will be compared with that in the 12 months before the index date in patients on an adequate dosage of IgRT. (2) The incidence rate of SBIs per person-year in the 3 months after the index date will be compared with that in the 3 months before the index date in patients on an adequate dosage of IgRT. (3) The incidence rate of SBIs per person-year during the period from the initiation of anti-cancer drugs until the index date will be compared with that during the period of administration of IgRT in patients on an adequate dosage of IgRT, without any experience of HSCT. (4) Subgroup analysis of the primary endpoint by the type of hematologic malignancy (i.e., CLL, NHL, MM), the type of B-cell targeted agents received, and whether or not HSCT was performed before the index date in patients on an adequate dosage of IgRT. | — |
Countries
Japan
Contacts
Public ContactAyako Shoji
Medilead Inc. Data Science Dept.
Outcome results
None listed