Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Treatment line |
Treatment line will be assessed at baseline. It is a percentage of patients receiving cabozantinib as 1st, 2nd or later lines of treatment or cabozantinib in monotherapy or in combination with nivolumab as 1st line of treatment. |
Baseline |
|
| Primary |
Dose reductions and reasons |
Number of dose reductions and reason |
From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop |
|
| Primary |
Treatment interruptions and reason |
Number of treatment interruptions and reason |
From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop |
|
| Primary |
Treatment discontinuations and reason |
Number of patients with permanent discontinuation and reason |
From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop |
|
| Primary |
Alternative dose schedule |
Number of patients with schedules other than 1 pill at fixed dose/day for the total treatment period |
From baseline until the end of study up to 9 months |
|
| Primary |
Mean number of any dose modification |
|
From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop |
|
| Primary |
Median number of any dose modification |
|
From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop |
|
| Primary |
Median time to any first dose modification |
|
From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop |
|
| Primary |
Median time to end of treatment |
|
From baseline until the end of study up to 9 months |
|
| Primary |
Duration of treatment exposure |
|
From baseline until the end of study up to 9 months |
|
| Primary |
Dose prescribed at initiation |
Number of patients with dose of 60 mg/day, 40 mg/day or 20 mg/day at baseline |
Baseline |
|
| Primary |
Average daily dose |
Estimation of average daily dose received by subject during the treatment exposure |
From baseline until the end of study up to 9 months |
|
| Secondary |
Change in Quality of Life score |
Changes in quality of life data by comparing changes in scores on Using the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (NFKSI-19). It describes the severity, interference, and frequency rates. |
From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop |
|
| Secondary |
Progression Free Survival (PFS) |
Radiological progression using RECIST 1.1 or investigator assessed or according to local standard of care or death; PFS evaluated at least every 12 weeks under treatment with cabozantinib |
From baseline until the end of study up to 9 months |
|
| Secondary |
Objective Response Rate |
Percent of patients with partial and complete response during the treatment with cabozantinib |
From baseline until the end of study up to 9 months |
|
| Secondary |
Disease Control Rate |
Percent of patients with stable disease, partial and complete response during the treatment with cabozantinib |
From baseline until the end of study up to 9 months |
|
