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| Name | Class |
|---|---|
| University of Aarhus | OTHER |
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This study aims to evaluate off-label XGEVA use in Denmark using data linked from registries and other sources in Northern Jutland Region and Copenhagen. This will allow for accurate assessment of prescriptions and diagnoses, especially those related to cancer patients during the first year post the initial market availability of XGEVA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Database assessment of off-label XGEVA use | Drug | No intervention is planned during this study as it involves analyses of patient electronic records from Northern Jutland Region and Copenhagen |
| Measure | Description | Time Frame |
|---|---|---|
| on or off label individual prescription type | Yes/no regarding whether an individual prescription was on (or off) label | 12 months |
| on or off label patient treatment | Yes/no regarding whether the patient was treated on (or off) label | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| type of off-label use | XGEVA prescription for each type of off-label use | 12 months |
| off-label use stratified by administering department | Prescriptions that are for off-label use stratified by department that administers treatment |
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Inclusion Criteria:
The study will include patients with a prescription for XGEVA® given in secondary care with a minimum of 108 XGEVA users, in the Northern Jutland Region and Copenhagen during the first 1-year post XGEVA market availability, defined as 12 months after RADS opinion on 24th January 2013 or after the minimum sample has been achieved.
Exclusion Criteria:
n/a
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The study population will include 108-200 patients who receive a prescription in secondary care of XGEVA during the first year after the initial market availability. These patients will be identified from the Danish National Registry of Patients and other sources in the Northern Jutland Region and Copenhagen.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| 12 months |