Renal Cell Carcinoma
Conditions
Brief summary
The primary objective of the study is to describe the real-life conditions of use and exposure of cabozantinib in France in two cohorts defined by their treatment initiation period.
Interventions
None listed
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Any subjects from the participating sites (dead or alive) who have received at least one dose of cabozantinib within the ATU program or between 10/12/2016 and 16/02/2018 and for whom the medical file is available
Exclusion criteria
* Patients alive at study initiation who have not received information notice * who have opposed to data collection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with permanent discontinuations | during the whole study period for a maximum of 28 to 31 months | — |
| Number of subjects with ≥1 temporary interruptions | during the whole study period for a maximum of 28 to 31 months | — |
| Number of interruptions per subject | during the whole study period for a maximum of 28 to 31 months | — |
| Number of subjects with ≥1 dose modification(s) | during the whole study period for a maximum of 28 to 31 months | — |
| Duration of treatment exposure | during the whole study period for a maximum of 28 to 31 months | — |
| Dose prescribed at initiation | during the whole study period for a maximum of 28 to 31 months | — |
| Average Daily Dose | during the whole study period for a maximum of 28 to 31 months | average daily dose received by subject during the treatment exposure |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival of subjects since RCC diagnosis. | during the whole study period for a maximum of 28 to 31 months |
| Overall survival of subjects since metastatic diagnosis | during the whole study period for a maximum of 28 to 31 months |
| Overall survival of subjects since cabozantinib initiation | during the whole study period for a maximum of 28 to 31 months |
Countries
France
Outcome results
None listed