Efficacy and Safety of Pazopanib Monotherapy After First-line Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Asian Women
2015年2月12日 更新者：GlaxoSmithKline
A Study to Evaluate Efficacy and Safety of Pazopanib Monotherapy in Asian Women Who Have Not Progressed After First-line Chemotherapy for Advanced Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma - An Extension Study to VEG110655
This is a study to determine whether therapy with pazopanib is effective and safe in Asian women with epithelial ovarian, fallopian tube or primary peritoneal cancer whose cancer has not progressed on first-line chemotherapy.
調査の概要
詳細な説明
This study is an extension study to the VEG110655 study.
The parent study, VEG110655, was designed to evaluate whether pazopanib 800 mg daily for 52 weeks will prolong progression free survival (PFS) in women diagnosed with ovarian, fallopian tube or primary peritoneal cancer.
These women will have obtained stable disease, a complete remission, or a partial remission after debulking surgery and at least five cycles of chemotherapy (taxane/platinum).
This extension study will evaluate safety and efficacy outcomes of pazopanib monotherapy and placebo in an Asian population with the same indication as the parent study.
研究の種類
介入
入学 (実際)
145
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Beijing、中国、100044
- GSK Investigational Site
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Beijing、中国、100021
- GSK Investigational Site
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Beijing、中国、100853
- GSK Investigational Site
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Shanghai、中国、200032
- GSK Investigational Site
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Guangdong
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Guangzhou、Guangdong、中国
- GSK Investigational Site
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Jiangsu
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Nanjing、Jiangsu、中国、210009
- GSK Investigational Site
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Liaoning
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Shenyang、Liaoning、中国、110022
- GSK Investigational Site
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Shandong
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Jinan、Shandong、中国、250012
- GSK Investigational Site
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Sichuan
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Chengdu、Sichuan、中国、610041
- GSK Investigational Site
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Zhejiang
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Hangzhou、Zhejiang、中国、310006
- GSK Investigational Site
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Hangzhou、Zhejiang、中国、310022
- GSK Investigational Site
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Taipei、台湾、104
- GSK Investigational Site
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Taipei、台湾、112
- GSK Investigational Site
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Seoul、大韓民国、135-710
- GSK Investigational Site
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Hong Kong、香港
- GSK Investigational Site
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
Inclusion Criteria:
- written informed consent
- At least 18 years old.
- Histologically confirmed, International Federation of Gynecology and Obstetrics (FIGO) stage II-IV epithelial ovarian, fallopian tube or primary peritoneal carcinoma that was treated with surgical debulking and at least five cycles of platinum-taxane doublet chemotherapy.
- Study randomization at least 3 weeks and not more than 12 weeks from the date of the last chemotherapy dose, and all major toxicities from the previous chemotherapy must have resolved.
- No evidence of disease progression
- Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
- Able to swallow and retain oral medication.
- Adequate hematologic, hepatic, and renal system function as follows:
Hematologic
- Absolute neutrophil count (ANC) at least 1.5 X 10^9/L
- Hemoglobin at least 9 g/dL (or 5.59 mmol/L)
- Platelets at least 100 X 10^9/L
- Prothrombin time (PT) or international normalized ratio (INR) up to 1.2 X ULN
- Activated partial thromboplastin time (aPTT) up to 1.2 X ULN Hepatic
- Total bilirubin up to 1.5 X ULN
- AST and ALT up to 2.5 X ULN Renal
- Serum creatinine up to 1.5 mg/dL
Or, if greater than 1.5 mg/dL:
Calculated creatinine clearance at least 50 mL/min Urine Protein
- Urine protein is 0, trace, or +1 determined by dipstick urinalysis, or < 1.0 gram determined by 24-hour urine protein analysis.
- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) OR childbearing potential, and agrees to use adequate contraception.
Exclusion Criteria:
- Either (a) bulky disease, or (b) any residual disease which in the opinion of the investigator will need imminent second-line therapy
- Synchronous primary endometrial carcinoma, or a past history of primary endometrial carcinoma, are excluded unless certain conditions are met.
- Clinically significant gastrointestinal abnormalities
- Prolongation of corrected QT interval (QTc) > 480 msecs
- History of any one or more cardiovascular conditions within the past 6 months prior to randomization
- Poorly controlled hypertension
- History of cerebrovascular accident (including transient ischemic attacks), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months prior to randomization
- Major surgery (including interval debulking) or trauma within 28 days, or minor surgical procedures within 7 days, prior to randomization, or has any non-healing wound, fracture, or ulcer.
- Evidence of active bleeding or bleeding diathesis.
- Hemoptysis within 6 weeks prior to randomization.
- Endobronchial metastases.
- Serious and/or unstable pre-existing medical (e.g., uncontrolled infection), psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
- Investigational or anti-VEGF anticancer therapy prior to study randomization.
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib.
- Prior or concurrent invasive malignancies that currently or within the last 5 years show/ed activity of disease (except ovarian, fallopian tube, or peritoneal cancer, or concurrent endometrial cancer FIGO stages IA/B)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター：プラセボ
プラセボコンパレータ
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Placebo 800 mg daily for 24 months
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実験的：pazopanib
experimental medication
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Pazopanib 800 mg daily for 24 months
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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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Progression-free Survival (PFS)
時間枠：From randomization until evidence of progressive disease or death, whichever occurred first (average of 15.2 months)
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PFS is defined as the time interval between randomization and evidence of progressive disease (PD), as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, or death, whichever occurred first.
A visit-based analysis approach to determine participants' dates of progression was applied in the analysis method.
PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Participants who were alive and had not progressed at the time of analysis were censored at the date associated with the last visit with adequate assessment.
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From randomization until evidence of progressive disease or death, whichever occurred first (average of 15.2 months)
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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 |
|---|---|---|
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Overall Survival
時間枠：From randomization until death due to any cause (average of 29.4 months)
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Overall survival is defined as the time interval from the date of randomization to the date of death due to any cause.
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From randomization until death due to any cause (average of 29.4 months)
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PFS by Gynaecologic Cancer Intergroup (GCIG) Criteria
時間枠：From randomization to the earliest date of disease progression per GCIG criteria or death due to any cause (average of 15.2 months)
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PFS by GCIG criteria is defined as the time from the randomization date to the earliest date of disease progression (PD) per GCIG criteria or death due to any cause.
Per GCIG criteria, an objective progression is defined as the earliest event of either tumor progression based on RECIST v1.0 or confirmed CA-125 progression.
A participant is counted as "Progressed per RECIST" if the radiological PD per RECIST occurred prior to or on the same day as CA-125 progression.
A participant is counted as "Progressed per CA-125" if the radiological PD occurred after CA-125 progression.
Per RECIST, PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Participants who were alive and had not progressed at the time of analysis were censored at the date associated with the last visit with adequate assessment.
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From randomization to the earliest date of disease progression per GCIG criteria or death due to any cause (average of 15.2 months)
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Number of Participants With Any Dose Reduction or Any Dose Interruption
時間枠：From Week 1 until the end of the treatment period (up to Study Week 108)
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Dose interruptions or reductions may have been required following potential drug-related toxicities.
As a general rule, if dose reduction of investigational product (IP) was necessary, the dose should have been reduced stepwise by 200 mg at each step, and the participant should have been monitored for 10 to 14 days.
If toxicity recurred or worsened during this monitoring time, the IP could have been interrupted and/or the dose of IP further decreased, with continued monitoring for an additional 10 to 14 days, and so on.
The cut off for these data was October 12, 2012.
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From Week 1 until the end of the treatment period (up to Study Week 108)
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Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)
時間枠：From Week 1 until the end of the treatment period (up to Study Week 108)
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An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalizaton or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect.
See the non-serious AE/SAE module for a list of specific events.
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From Week 1 until the end of the treatment period (up to Study Week 108)
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Number of Participants With Any On-therapy AE and Any AE Related to Study Treatment
時間枠：From Week 1 until the end of the treatment period (up to Study Week 108)
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An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
On-therapy AEs were those reported from the first day that randomized study drug was received to 28 days after the last dose of randomized study drug, and within 28 days of dose interruption.
Relatedness was assessed by the Investigator.
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From Week 1 until the end of the treatment period (up to Study Week 108)
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Number of Participants With Any Grade 3 or 4 AE
時間枠：From Week 1 until the end of the treatment period (up to Study Week 108)
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An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
The NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0 was used to grade AEs per the following scale to assess severity: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling AE; Grade 5, death related to AE.
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From Week 1 until the end of the treatment period (up to Study Week 108)
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Number of Participants With the Indicated On-therapy Grade 3-5 AEs
時間枠：From Week 1 until the end of the treatment period (up to Study Week 108)
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An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
On-therapy AEs were those reported from the first day that randomized study drug was received to 28 days after the last dose of randomized study drug, and within 28 days of dose interruption.
The NCI-CTCAE Version 3.0 was used to grade AEs per the following scale to assess severity: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling AE; Grade 5, death related to AE. ALT=alanine aminotransferase; AST=aspartate aminotransferase.
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From Week 1 until the end of the treatment period (up to Study Week 108)
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Number of Participants With AEs Leading to Permanent Discontinuation of Study Treatment, Dose Interruption, and Dose Reduction
時間枠：From Week 1 until the end of the treatment period (up to Study Week 108)
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An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Dose interruptions or reductions may have been required following potential drug-related toxicities.
As a general rule, if dose reduction of investigational product (IP) was necessary, the dose should have been reduced stepwise by 200 mg at each step, and the participant should have been monitored for 10 to 14 days.
If toxicity recurred or worsened during this monitoring time, the IP could have been interrupted and/or the dose of IP further decreased, with continued monitoring for an additional 10 to 14 days, and so on.
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From Week 1 until the end of the treatment period (up to Study Week 108)
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Number of Participants With Any SAE, Any SAE Related to Study Treatment, and Any Fatal SAE
時間枠：From Week 1 until the end of the treatment period (up to Study Week 108)
|
An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalizaton or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect.
See the non-serious AE/SAE module for a list of specific events.
Relatedness was assessed by the Investigator.
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From Week 1 until the end of the treatment period (up to Study Week 108)
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Number of Participants With the Indicated Worst-case On-therapy Blood Pressure Shifts From Baseline
時間枠：From Week 1 until the end of the treatment period (up to Study Week 108)
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Systolic blood pressure (SBP) and Diatolic blood pressure (DBP) are measured in millimeters of mercury (mmHg).
A participant could have been counted in more than one shift category.
Participants who experienced shifts in both SBP and DBP are represented under each individual parameter.
A worst-case on-therapy shift is defined as the worst shift that occurred at any time during the treatment period.
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From Week 1 until the end of the treatment period (up to Study Week 108)
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Number of Participants With the Indicated Worst-case On-therapy Shift From Baseline in Bazett's Corrected QT Interval (QTc)
時間枠：From Week 1 until the end of the treatment period (up to Study Week 108)
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12-lead ECGs were obtained at the scheduled visits.
A worst-case on-therapy shift is defined as the worst shift that occurred at any time during the treatment period.
The QTc is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle.
In general, the faster the heart rate the shorter the QTc.
If a QTc >=500 milliseconds (msec) was noted on a scheduled or unscheduled electrocardiogram (ECG), then two additional ECGs should have been obtained within 5 minutes to confirm the abnormality.
The average QTc was determined from the three ECG tracings by manual evaluation and was used to determine continued eligibility.
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From Week 1 until the end of the treatment period (up to Study Week 108)
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Number of Participants With the Indicated Worst-case On-therapy Hematology Parameter Grade Shifts From Baseline Grade
時間枠：From Week 1 until the end of the treatment period (up to Study Week 108)
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Grade shifts from Baseline were assessed as any grade increase (AGI), increase to Grade (G) 3 (ITG3), and increase to Grade 4 (ITG4).
Toxicities were graded according to the National Cancer Institute common toxicity criteria (NCI-Common Toxicity Criteria for Adverse Events), version 4.0.
Grade refers to the severity of the toxicity.
The CTCAE displays Grades (G) 1 through 5 with unique clinical descriptions of severity for each toxicity based on the following general guideline: G1, mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; G2, moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); G3, severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; G4, Life-threatening consequences; urgent intervention indicated.;
G5, death related to AE.
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From Week 1 until the end of the treatment period (up to Study Week 108)
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Number of Participants With the Indicated Worst-case On-therapy Chemistry Parameter Grade Shifts From Baseline Grade
時間枠：From Week 1 until the end of the treatment period (up to Study Week 108)
|
Grade shifts from Baseline were assessed as any grade increase (AGI), increase to Grade (G) 3 (ITG3), and increase to Grade 4 (ITG4).
Toxicities were graded according to the National Cancer Institute common toxicity criteria (NCI-Common Toxicity Criteria for Adverse Events), version 4.0.
Grade refers to the severity of the toxicity.
The CTCAE displays Grades (G) 1 through 5 with unique clinical descriptions of severity for each toxicity based on the following general guideline: G1, mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; G2, moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); G3, severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; G4, Life-threatening consequences; urgent intervention indicated.;
G5, death related to AE.
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From Week 1 until the end of the treatment period (up to Study Week 108)
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Number of Participants With the Indicated Worst-case Eastern Cooperative Oncology Group (ECOG) Performance Status Shifts From Baseline Grades of 0, 1, and 2
時間枠：From Week 1 until the end of the treatment period (up to Study Week 108)
|
The ECOG performance status scales and criteria are used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis.
Grade 0, fully active, able to carry on all pre-disease performance without restriction.
Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours.
Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours.
Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair.
Grade 5, dead.
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From Week 1 until the end of the treatment period (up to Study Week 108)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2010年9月1日
一次修了 (実際)
2012年10月1日
研究の完了 (実際)
2014年1月1日
試験登録日
最初に提出
2010年10月21日
QC基準を満たした最初の提出物
2010年10月21日
最初の投稿 (見積もり)
2010年10月25日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年3月3日
QC基準を満たした最後の更新が送信されました
2015年2月12日
最終確認日
2015年2月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。