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| ID | Type | Description | Link |
|---|---|---|---|
| NEXAVAR-TC-01 | Other Identifier | Company Internal |
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This is a non-interventional, multi center post-authorization safety study that includes all patients diagnosed as Unresectable Differentiated Thyroid Carcinoma (DTC) and treated with Sorafenib within a certain period. The investigator should have made the choice of treatment (NEXAVAR) according with the Japanese Package Insert prior to enrolling the patient in this study.
The enrollment period is of 9 months. The observation period for each patient starts when the therapy with NEXAVAR is initiated. Patients will be followed for 9 months or until it is no longer possible (e.g. lost to follow-up); this will be considered the standard observation period. Those patients, to whom a total of 24 month follow up is possible, information on effectiveness including treatment duration and survival status of the patient and of keratoacanthoma and/or squamous cell cancer development will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY43-9006 | NEXAVAR treatment group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Drug | Patients treated by Physician with Nexavar under approved local prescriptions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse drug reaction as a measure of safety and tolerability. | Up to 9 months | |
| Number of participants with Serious adverse events as a measure of safety and tolerability. | Up to 9 months | |
| Number of participants with Serious adverse drug reaction as a measure of safety and tolerability | Up to 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year survival | Percentage of participants who survived 2 years from start of treatment | At 24 months |
| Time of treatment failure (TTF) | Time to treatment failure is defined as the time interval from start of Nexavar therapy to the date of permanent discontinuation for any reason including disease progression, adverse event, patient preference or death. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with Sorafenib for Unresectable Differentiated Thyroid Carcinoma (DTC)
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Japan |
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| Up to 24 months |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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