Effectiveness of Early Intervention in Transfusion Independent Aplastic Anemia: a Retrospective Medical Claims Database Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1603 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-05

Study Completion Date

2023-11-03

Brief Summary

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This was a retrospective non-interventional cohort study with secondary use of data from the Medical Data Vision (MDV) hospital-based database to evaluate the effectiveness of early drug intervention in preventing transfusion compared to watchful observation among adult transfusion-independent aplastic anemia (AA) patients in Japan.

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Detailed Description

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Conditions

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Aplastic Anemia (AA)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Early drug intervention group

Patients who had at least one prescription record associated with any of the drug treatments of interest (cyclosporine A, eltrombopag, romiplostin, danazol, or methenolone) during each period of interest before the first transfusion record during the follow-up period.

No interventions assigned to this group

Watchful observation group

Patients with no prescription record associated with any of the drug treatments of interest (cyclosporine A, eltrombopag, romiplostin, danazol, or methenolone) during the follow-up period and before the first transfusion record, if any.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Having at least one confirmed diagnosis of AA within the selection period (1 inpatient or 2 outpatient claims per the International Statistical Classification of Diseases, 10th Revision \[ICD-10\] code, without any suspicion flag).
* Being aged 15 to 90 years at the index date.
* Having at least 3 months of continuous enrolment prior to the index date.

Exclusion Criteria

* Having a blood transfusion recorded any time before the index date.
* Having anti-thymocyte globulin (ATG) treatment recorded within 3 months after the index date.
* Having at least one prescription record for any of the drug treatments of interest any time before the index date.
* Having a diagnosis of acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML) or other leukemia any time before the index date.
* Having an AA diagnosis (without suspicious flag) date earlier than the start of patient's observation in the database.
* Having less than 6 months of continuous follow-up.

Safety Population - Additional Exclusion Criterion:

\- Having a diagnosis of hepatotoxicity, kidney dysfunction, hypertension, or diabetes mellitus any time before the index date.

Minimum Eligible Age

15 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No