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The main goal of this study was to describe treatment patterns of patients with chronic myeloid leukemia (CML) who were treated with tyrosine kinase inhibitors (TKIs) in Japan.
This was a retrospective observational study with secondary use of data from the Medical Data Vision (MDV) hospital-based database. The index date was the date of the first prescription of any TKI of interest registered within the selection period (01 January 2011 to 31 December 2019). The follow-up period was from the index date until the end of the study period, end of continuous follow-up in the MDV database, or death, whichever came first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CML Cohort | Patients diagnosed with chronic phase CML who received treatment with a TKI in Japan between 01 January 2011 and 31 December 2019. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients by Line of Treatment (LoT) and TKI Received | TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib. | Up to approximately 9 years |
| Number of Patients who Switched TKI Treatment by LoT and TKI | TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib. | Up to approximately 9 years |
| Number of Patients who Discontinued TKI Treatment by Type of TKI | TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib. | Up to approximately 9 years |
| Number of Patients who Discontinued TKI Treatment for at Least One Year by Type of TKI | TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib. | Up to approximately 9 years |
| Number of Patients who Restarted any TKI Treatment After Discontinuing the TKI of Interest by Type of TKI | TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib. | Up to approximately 9 years |
| TKI Dose by LoT | TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib. | Baseline, up to approximately 9 years |
| TKI Persistence Rate by LoT | Months 6, 12, 18, and Year 5 | |
| Duration of TKI Treatment by LoT |
| Measure | Description | Time Frame |
|---|---|---|
| Annual Incidence of Inpatient and Outpatient Visits by LoT | Up to approximately 9 years | |
| Annual Mean Cost of All-cause Healthcare Resource Use by LoT | All-cause care included inpatient and outpatient visits. The following costs were calculated in Japanese yen (JPN):
|
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Patients who met all the below inclusion criteria and none of the exclusion criteria were included in the study.
Inclusion criteria:
Exclusion criteria:
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This was a retrospective, non-interventional cohort study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | East Hanover | New Jersey | 07936 | United States |
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| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Up to approximately 9 years |
| Up to approximately 9 years |
| Annual Incidence of CML-related Healthcare Resource Use by LoT | CML-related care included:
| Up to approximately 9 years |
| Annual Mean Cost of CML-related Healthcare Resource Use by LoT | CML-related care costs were calculated in Japanese Yen (JPY) and included the following:
| Up to approximately 9 years |
| Number of Patients With Adverse Events by TKI | TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib. | Up to approximately 9 years |
| D009196 |
| Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |