XGEVA Off-label Use
Conditions
Brief summary
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.
Interventions
DRUGDatabase assessment of off-label XGEVA use
No intervention is planned during this study as it involves analyses of patient electronic records from Northern Jutland Region and Copenhagen
Sponsors
University of Aarhus
Amgen
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| on or off label individual prescription type | 12 months | Yes/no regarding whether an individual prescription was on (or off) label |
| on or off label patient treatment | 12 months | Yes/no regarding whether the patient was treated on (or off) label |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| type of off-label use | 12 months | XGEVA prescription for each type of off-label use |
| off-label use stratified by administering department | 12 months | Prescriptions that are for off-label use stratified by department that administers treatment |
Outcome results
None listed