切除不能な分化型甲状腺癌と診断され、ソラフェニブによる治療を受けたすべての患者を対象とした、承認後の前向き非介入安全性試験
基本情報
- NCT ID
- NCT02185560
- ステータス
- 実施中（募集終了）
- 試験のフェーズ
- -
- 試験タイプ
- 観察
- 目標被験者数
- 453
- 治験依頼者名
- Bayer
概要
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.