An Observational Post Authorisation Study to Evaluate Safety and Efficacy in Patients Receiving Azacitidine in Daily Clinical Practice in the Netherlands (OCEAN)
A Non-interventional Observational Post Authorization Study to Evaluate Safety and Efficacy in Patients Receiving Azacitidine in Daily Clinical Practice in the Netherlands (OCEAN)
The study design is a prospective, non-interventional, observational single arm study.
A minimum of 150 patients will be recruited from approximately 30 haematology/oncology sites in the Netherlands. In all cases, the decision to treat the patient with azacitidine was already made prior to the decision to enter the subject into the study.
Recruitment will continue until end of June 2015, provided a minimum of 150 patients have been included in the study. When this date is reached, all patients on azacitidine will continue to be followed until the last patient enrolled has been followed for 12 months.
調査の概要
状態
研究の種類
入学 (実際)
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Patients over 18 years of age who understand and voluntarily sign an informed consent form.
- Patients who are treated with azacitidine in accordance with registered indication and clinical practice.
Exclusion Criteria:
- Refusal to participate in the study.
- Participation in an interventional clinical study.
- Patients previously treated with azacitidine except when given as induction therapy for a maximum of three courses.
- Women who are pregnant or breast-feeding.
- Hypersensitivity to the active substance or to any of the excipients.
- Advanced malignant hepatic tumors.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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Patients receiving Azacitidine per daily clinical practice
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Adverse Events (AEs)
時間枠：Up to approximately 4 years
|
Adverse events will be classified using the Medical Drug Regulatory Activities (MedDRA) classification system.
The severity of the toxicities will be graded according to the NCI CTCAE VERSION 4.03 whenever possible
|
Up to approximately 4 years
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Fact-Anemia Quality of life questionnaire
時間枠：Up to approximately 4 years
|
The Functional Assessment of Cancer Therapy-Anemia (FACT-An) questionnaire was used to assess health-related quality of life (HRQoL).
In addition to general HRQoL, the FACT-An measures the impact of fatigue and other anemia-related symptoms on patient functioning.
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Up to approximately 4 years
|
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Percentage of patients with a Haematological Response in daily clinical practice using the International Work Group Criteria in Myelodysplastic Syndrome Assessed by the Investigator
時間枠：Up to approximately 4 years
|
Hematologic Response according to the 2000 International Working Group (IWG) response criteria for Myelodysplastic Syndrome (MDS)
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Up to approximately 4 years
|
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Percentage of patients with a Hematologic Improvement Using International Working Group (IWG Criteria for Hematologic Improvement Cheson 2000) Criteria for Myelodysplastic Syndrome (MDS) and Assessed by the investigator in daily clinical practice
時間枠：Up to approximately 4 years
|
Overall hematological improvement (HI) was defined as any type (major or minor) of improvement of HI-E, HI-P, or HI-N. Criteria: Pretreatment=hemoglobin <100g/L or RBC transfusion-dependent, platelet count <100x10^9/L or platelet transfusion dependent, absolute neutrophil count <1.5x10^9/L. Sponsor's determination was derived using clinically relevant data. Denominator for progression/relapse after HI included participants who had achieved HI. |
Up to approximately 4 years
|
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Time to treatment Failure daily clinical practice
時間枠：Up to approximately 4 years
|
Time to Treatment Failure is defined as the time from randomization to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death.
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Up to approximately 4 years
|
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Overall Survival in daily clinical practice
時間枠：Up to approximately 4 years
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Overall survival (OS) was assessed using the time between randomization and the date of death
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Up to approximately 4 years
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Jan Koedam, MSc、Celgene
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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