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| ID | Type | Description | Link |
|---|---|---|---|
| NX0802 | Other Identifier | company internal |
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In this international non-interventional study safety and clinical data concerning the treatment of patients suffering from Hepatocellular Carcinoma (HCC) will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Drug | Systemic oral therapy according to product information |
|
| Measure | Description | Time Frame |
|---|---|---|
| The safety of Nexavar in all patients with unresectable HCC who are candidates for systemic therapy and in whom a decision to treat with Nexavar has been made under real-life practice conditions | at each follow-up visit, every 2-4 months on average |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy [overall survival (OS), progression-free survival (PFS), time to progression (TTP), response rate (RR), stable disease(SD) rate] by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria of Nexavar | at every visit, roughly every 2-4 months | |
| The duration of therapy with Nexavar in a variety of settings according to patient characteristics and other variables |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with unresectable HCC who are candidates for systemic therapy and in whom a decision to treat with Nexavar has been made under real-life practice conditions and in a variety of patient subsets.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26735891 | Result | Ye SL, Chen X, Yang J, Bie P, Zhang S, Liu F, Liu L, Zhou J, Dou K, Hao C, Shao G, Xia Q, Chen Y, Yang J, Deng X, Liu Y, Yuan Y, Fu Z, Nakajima K, Yip CS, Lu Z. Safety and efficacy of sorafenib therapy in patients with hepatocellular carcinoma: final outcome from the Chinese patient subset of the GIDEON study. Oncotarget. 2016 Feb 9;7(6):6639-48. doi: 10.18632/oncotarget.6781. | |
| 29499662 |
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| at every visit, roughly every 2-4 months |
| To evaluate the methods of patient evaluation, diagnosis and follow up | at every visit, roughly every 2-4 months |
| To evaluate the co-morbidities in patients with unresectable HCC and their influence on treatment and outcome | at every visit, roughly every 2-4 months |
| To evaluate the practice patterns of the physicians involved in the care of patients with HCC under real-life conditions | at every visit, roughly every 2-4 months |
| Reports of adverse events | at every visit, roughly every 2-4 months |
| Many Locations |
| Arizona |
| United States |
| Many Locations | Arkansas | United States |
| Many Locations | California | United States |
| Many Locations | Colorado | United States |
| Many Locations | Connecticut | United States |
| Many Locations | Florida | United States |
| Many Locations | Georgia | United States |
| Many Locations | Hawaii | United States |
| Many Locations | Illinois | United States |
| Many Locations | Indiana | United States |
| Many Locations | Iowa | United States |
| Many Locations | Kansas | United States |
| Many Locations | Kentucky | United States |
| Many Locations | Louisiana | United States |
| Many Locations | Maryland | United States |
| Many Locations | Massachusetts | United States |
| Many Locations | Michigan | United States |
| Many Locations | Minnesota | United States |
| Many Locations | Missouri | United States |
| Many Locations | Nebraska | United States |
| Many Locations | Nevada | United States |
| Many Locations | New Hampshire | United States |
| Many Locations | New Jersey | United States |
| Many Locations | New York | United States |
| Many Locations | North Carolina | United States |
| Many Locations | Ohio | United States |
| Many Locations | Oklahoma | United States |
| Many Locations | Oregon | United States |
| Many Locations | Pennsylvania | United States |
| Many Locations | South Carolina | United States |
| Many Locations | Tennessee | United States |
| Many Locations | Texas | United States |
| Many Locations | Utah | United States |
| Many Locations | Virginia | United States |
| Many Locations | Washington | United States |
| Many Locations | Wisconsin | United States |
| Many Locations | Canada |
| Many Locations | China |
| Many Locations | Colombia |
| Many Locations | Croatia |
| Many Locations | Czechia |
| Many Locations | Finland |
| Many Locations | France |
| Many Locations | Greece |
| Many Locations | Hong Kong |
| Many Locations | Hungary |
| Many Locations | India |
| Many Locations | Indonesia |
| Many Locations | Israel |
| Many Locations | Italy |
| Many Locations | Japan |
| Many Locations | Kazakhstan |
| Many Locations | Libya |
| Many Locations | Malaysia |
| Many Locations | Mexico |
| Many Locations | Norway |
| Many Locations | Pakistan |
| Many Locations | Philippines |
| Many Locations | Portugal |
| Many Locations | Qatar |
| Many Locations | Romania |
| Many Locations | Russia |
| Many Locations | Singapore |
| Many Locations | Slovakia |
| Many Locations | South Korea |
| Many Locations | Spain |
| Many Locations | Sweden |
| Many Locations | Syria |
| Many Locations | Thailand |
| Many Locations | Ukraine |
| Many Locations | United Arab Emirates |
| Many Locations | Uruguay |
| Many Locations | Venezuela |
| Many Locations | Vietnam |
| Derived |
| Ye SL, Yang J, Bie P, Zhang S, Chen X, Liu F, Liu L, Zhou J, Dou K, Hao C, Shao G, Xia Q, Chen Y, Yang J, Deng X, Liu Y, Yuan Y, Fu Z, Nakajima K, Lv Z. Safety assessment of sorafenib in Chinese patients with unresectable hepatocellular carcinoma: subgroup analysis of the GIDEON study. BMC Cancer. 2018 Mar 2;18(1):247. doi: 10.1186/s12885-018-4144-9. |
| 26901163 | Derived | Kudo M, Lencioni R, Marrero JA, Venook AP, Bronowicki JP, Chen XP, Dagher L, Furuse J, Geschwind JF, Ladron de Guevara L, Papandreou C, Sanyal AJ, Takayama T, Yoon SK, Nakajima K, Lehr R, Heldner S, Ye SL. Regional differences in sorafenib-treated patients with hepatocellular carcinoma: GIDEON observational study. Liver Int. 2016 Aug;36(8):1196-205. doi: 10.1111/liv.13096. Epub 2016 Apr 1. |
| 20642705 | Derived | Lencioni R, Marrero J, Venook A, Ye SL, Kudo M. Design and rationale for the non-interventional Global Investigation of Therapeutic DEcisions in Hepatocellular Carcinoma and Of its Treatment with Sorafenib (GIDEON) study. Int J Clin Pract. 2010 Jul;64(8):1034-41. doi: 10.1111/j.1742-1241.2010.02414.x. |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver 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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