NCT06669221已完成不适用
Effectiveness of Early Intervention in Transfusion Independent Aplastic Anemia: a Retrospective Medical Claims Database Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,603
- 试验地点
- 1
- 主要终点
- Probability of Having Blood Transfusion in the Matched Effectiveness Population
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 15 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Probability of Having Blood Transfusion in the Matched Effectiveness Population
时间窗: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
The Kaplan-Meier survival analysis technique was used to estimate probability.
Crude Hazard Ratios of Having Blood Transfusion After 6 Months of Follow-up in the Matched Effectiveness Population
时间窗: Baseline, 6 months
Adjusted Hazard Ratios of Having Blood Transfusion After 6 Months of Follow-up in the Matched Effectiveness Population
时间窗: 6 months
次要结局
- Neutrophil Count(Baseline)
- Hemoglobin Level(Baseline)
- Sex(Baseline)
- Age(Baseline)
- Weight(Baseline)
- Body Mass Index (BMI)(Baseline)
- Number of Patients With Aplastic Anemia, per Severity Level(Baseline)
- Number of Patients With Immune Thrombocytopenia (ITP) Diagnosis Before Index Date(Baseline)
- Number of Patients With Myelodysplastic Syndrome (MDS) Diagnosis Before Index Date(Baseline)
- Number of Patients With Pre-index Comorbidities(Baseline)
- Number of Patients With Pre-index Use of Chloramphenicol(Baseline)
- Platelet Count(Baseline)
- Number of Patients Per Treatment Therapy in the Matched Effectiveness Population(Baseline)
- Number of Patients With Aplastic Anemia in the Matched Effectiveness Population, per Severity Level(Baseline)
- Number of Patients in the Matched Effectiveness Population Who Discontinued(Baseline, at 6 and 9 months, and at 1 and 2 years)
- Probability of Having Blood Transfusion in Early Drug Intervention and Watchful Observation Matched Patients From the Effectiveness Population(Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years)
- Probability of Having Stem-Cell Transplantation (SCT) in Early Drug Intervention and Watchful Observation Matched Patients From the Effectiveness Population(Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years)
- Probability of Having Anti-Thymocyte Globulin (ATG) in Early Drug Intervention and Watchful Observation Matched Patients From the Effectiveness Population(Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years)
- Probability of Having Blood Transfusion at Different Timepoints by Drug Categories in the Matched Effectiveness Population(Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years)
- Probability of Having SCT at Different Timepoints by Drug Categories in the Matched Effectiveness Population(Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years)
- Probability of Having ATG at Different Timepoints by Drug Categories in the Matched Effectiveness Population(Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years)
- Probability of Having a Bleeding Event in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population(Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years)
- Probability of Having Cataract in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population(Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years)
- Probability of Having Diabetes in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population(Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years)
- Probability of Having Hepatotoxicity in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population(Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years)
- Probability of Having Hypertension in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population(Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years)
- Probability of Having an Infection in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population(Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years)
- Probability of Having Kidney Dysfunction in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population(Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years)
- Probability of Having Diabetes by Drug Categories in the Matched Safety Population(Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years)
- Probability of Having Acute Myeloid Leukemia (AML), Chronic Myelomonocytic Leukemia (CMML) or Another Leukemia in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population(Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years)
- Probability of Having MDS in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population(Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years)
- Probability of Having Paroxysmal Nocturnal Hemoglobinuria (PNH) in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population(Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years)
- Probability of Having a Thromboembolic Event in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population(Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years)
- Probability of Having Myelofibrosis in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population(Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years)
- Probability of Having a Bleeding Event by Drug Categories in the Matched Safety Population(Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years)
- Probability of Having Cataract by Drug Categories in the Matched Safety Population(Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years)
- Probability of Having Hepatotoxicity by Drug Categories in the Matched Safety Population(Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years)
- Probability of Having an Infection by Drug Categories in the Matched Safety Population(Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years)
- Probability of Having Kidney Dysfunction by Drug Categories in the Matched Safety Population(Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years)
- Probability of Having AML, CMML or Another Leukemia by Drug Categories in the Matched Safety Population(Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years)
- Probability of Having MDS by Drug Categories in the Matched Safety Population(Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years)
- Probability of Having PNH by Drug Categories in the Matched Safety Population(Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years)
- Probability of Having a Thromboembolic Event by Drug Categories in the Matched Safety Population(Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years)
- Probability of Having Myelofibrosis by Drug Categories in the Matched Safety Population(Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years)
研究者
研究点 (1)
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