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| Name | Class |
|---|---|
| DocCheck Medical Services GmbH | UNKNOWN |
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Documentation of data concerning tolerability and efficacy of the intravenous treatment with vinflunine performed under daily routine conditions in Germany. The trial focusses on tolerability including the assessment of the usage of anti-emetic and anti-obstipative concomitant treatment as well as on the efficacy of the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with advanced / metastatic TCCU after CDDP-failure |
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| Measure | Description | Time Frame |
|---|---|---|
| Side effects according to NCI-CTCAE v3.0 and treatment conditions in daily routine | 9 months after LPI |
| Measure | Description | Time Frame |
|---|---|---|
| Explorative assessment of Overall Response Rate (ORR) | 9 months after LPI | |
| Anti-emetic comedication | 9 months after LPI | |
| Anti-obstipative diet / comedication |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with advanced or metastatic transitional cell carcinoma of the urothelium after failure of a Cisplatinum-containing therapy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pierre Fabre Pharma GmbH | Freiburg im Breisgau | Germany |
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| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 9 months after LPI |
| General well-being / quality of life of the patients (patient questionnaire) | 9 months after LPI |
| Patients' satisfaction with the treatment (patient questionnaire) | 9 months after LPI |
| Physicians' satisfaction with the treatment | 9 months after LPI |
| Patients' compliance with regards to the cotreatments (patient questionnaire) | 9 months after LPI |
| D010342 |
| Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |