Ii Trials
ii 試練の紹介
アカデミックライティングで使える英語フレーズと例文集
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Ii Trials sentence examples within progression free survival
In phase III trials, ixabepilone has extended progression-free survival and increased overall response rates, with a manageable toxicity profile.
第III相試験では、イクサベピロンは無増悪生存期間を延長し、全体的な奏効率を高め、管理可能な毒性プロファイルを示しました。
In phase III trials, ixabepilone has extended progression-free survival and increased overall response rates, with a manageable toxicity profile.
第III相試験では、イクサベピロンは無増悪生存期間を延長し、全体的な奏効率を高め、管理可能な毒性プロファイルを示しました。
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Two small randomized phase II trials on synchronous disease showed an improvement in progression free survival, with the addition of LAT, and one also demonstrated an overall survival benefit.
同期疾患に関する2つの小規模なランダム化第II相試験では、LATの追加により無増悪生存期間の改善が示され、1つでも全体的な生存期間の改善が示されました。
Two small randomized phase II trials on synchronous disease showed an improvement in progression free survival, with the addition of LAT, and one also demonstrated an overall survival benefit.
同期疾患に関する2つの小規模なランダム化第II相試験では、LATの追加により無増悪生存期間の改善が示され、1つでも全体的な生存期間の改善が示されました。
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Ii Trials sentence examples within placebo controlled phase
Results from placebo-controlled phase III trials showed that IV amisulpride is efficacious both in the prevention of PONV (used either alone or in combination with an antiemetic of a different class) and in the treatment of PONV (irrespective of prior antiemetic prophylaxis status).
プラセボ対照第III相試験の結果は、IVアミスルプリドがPONVの予防（単独で、または異なるクラスの制吐剤と組み合わせて使用）とPONVの治療（以前の制吐剤の予防状態に関係なく）の両方で有効であることを示しました。
Results from placebo-controlled phase III trials showed that IV amisulpride is efficacious both in the prevention of PONV (used either alone or in combination with an antiemetic of a different class) and in the treatment of PONV (irrespective of prior antiemetic prophylaxis status).
プラセボ対照第III相試験の結果は、IVアミスルプリドがPONVの予防（単独で、または異なるクラスの制吐剤と組み合わせて使用）とPONVの治療（以前の制吐剤の予防状態に関係なく）の両方で有効であることを示しました。
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Messenger RNA (mRNA) BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) COVID-19 vaccines have been shown to be effective in preventing symptomatic COVID-19 in randomized placebo-controlled Phase III trials (1,2); however, the benefits of these vaccines for preventing asymptomatic and symptomatic SARS-CoV-2 (the virus that causes COVID-19) infection, particularly when administered in real-world conditions, is less well understood.
メッセンジャーRNA（mRNA）BNT162b2（Pfizer-BioNTech）およびmRNA-1273（Moderna）COVID-19ワクチンは、ランダム化されたプラセボ制御の第III相試験で症候性COVID-19の予防に効果的であることが示されています（1,2）。しかし、無症候性および症候性のSARS-CoV-2（COVID-19を引き起こすウイルス）感染を予防するためのこれらのワクチンの利点は、特に現実の条件で投与された場合、あまりよく理解されていません。
Messenger RNA (mRNA) BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) COVID-19 vaccines have been shown to be effective in preventing symptomatic COVID-19 in randomized placebo-controlled Phase III trials (1,2); however, the benefits of these vaccines for preventing asymptomatic and symptomatic SARS-CoV-2 (the virus that causes COVID-19) infection, particularly when administered in real-world conditions, is less well understood.
メッセンジャーRNA（mRNA）BNT162b2（Pfizer-BioNTech）およびmRNA-1273（Moderna）COVID-19ワクチンは、ランダム化されたプラセボ制御の第III相試験で症候性COVID-19の予防に効果的であることが示されています（1,2）。しかし、無症候性および症候性のSARS-CoV-2（COVID-19を引き起こすウイルス）感染を予防するためのこれらのワクチンの利点は、特に現実の条件で投与された場合、あまりよく理解されていません。
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Ii Trials sentence examples within two randomized phase
For patients with NSCLC, two randomized phase II trials also suggested that the addition of a radical local treatment results in encouraging survival data, with a good safety profile.
NSCLCの患者の場合、2つのランダム化第II相試験でも、根治的局所治療の追加により、良好な安全性プロファイルを備えた有望な生存データが得られることが示唆されました。
For patients with NSCLC, two randomized phase II trials also suggested that the addition of a radical local treatment results in encouraging survival data, with a good safety profile.
NSCLCの患者の場合、2つのランダム化第II相試験でも、根治的局所治療の追加により、良好な安全性プロファイルを備えた有望な生存データが得られることが示唆されました。
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A total of 486 mCRC patients treated with FOLFIRI/bevacizumab from two randomized phase III trials, TRIBE and FIRE-3, were included in the current study.
現在の研究には、2つのランダム化第III相試験であるTRIBEおよびFIRE-3からのFOLFIRI/ベバシズマブで治療された合計486人のmCRC患者が含まれていました。
A total of 486 mCRC patients treated with FOLFIRI/bevacizumab from two randomized phase III trials, TRIBE and FIRE-3, were included in the current study.
現在の研究には、2つのランダム化第III相試験であるTRIBEおよびFIRE-3からのFOLFIRI/ベバシズマブで治療された合計486人のmCRC患者が含まれていました。
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Ii Trials sentence examples within randomized double blind
Methods: In two 52-week, randomized, double-blind, placebo-controlled, phase III trials, ECZTRA 1 and ECZTRA 2, adults with moderate-to-severe AD were randomized (3 : 1) to subcutaneous tralokinumab 300 mg every 2 weeks (Q2W) or placebo.
方法：2つの52週間のランダム化二重盲検プラセボ対照第III相試験、ECZTRA1およびECZTRA2で、中等度から重度のADの成人を2回ごとに300 mgの皮下トラロキヌマブにランダム化（3：1）しました。週（Q2W）またはプラセボ。
Methods: In two 52-week, randomized, double-blind, placebo-controlled, phase III trials, ECZTRA 1 and ECZTRA 2, adults with moderate-to-severe AD were randomized (3 : 1) to subcutaneous tralokinumab 300 mg every 2 weeks (Q2W) or placebo.
方法：2つの52週間のランダム化二重盲検プラセボ対照第III相試験、ECZTRA1およびECZTRA2で、中等度から重度のADの成人を2回ごとに300 mgの皮下トラロキヌマブにランダム化（3：1）しました。週（Q2W）またはプラセボ。
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The efficacy and safety of guselkumab were demonstrated in four randomized, double-blind, Phase III trials (VOYAGE 1 and 2, NAVIGATE, and ECLIPSE), which demonstrated high levels of clinical response over three years of continuous treatment, regardless of sex, age, body weight, and race, maintaining a favourable safety profile and long-term tolerability.
グセルクマブの有効性と安全性は、4つのランダム化二重盲検第III相試験（VOYAGE 1および2、NAVIGATE、およびECLIPSE）で実証され、性別、年齢に関係なく、3年間の継続治療で高レベルの臨床反応が示されました。 、体重、および人種、良好な安全性プロファイルと長期的な忍容性を維持します。
The efficacy and safety of guselkumab were demonstrated in four randomized, double-blind, Phase III trials (VOYAGE 1 and 2, NAVIGATE, and ECLIPSE), which demonstrated high levels of clinical response over three years of continuous treatment, regardless of sex, age, body weight, and race, maintaining a favourable safety profile and long-term tolerability.
グセルクマブの有効性と安全性は、4つのランダム化二重盲検第III相試験（VOYAGE 1および2、NAVIGATE、およびECLIPSE）で実証され、性別、年齢に関係なく、3年間の継続治療で高レベルの臨床反応が示されました。 、体重、および人種、良好な安全性プロファイルと長期的な忍容性を維持します。
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Ii Trials sentence examples within randomized controlled phase
Methods: We conducted a meta-analysis of randomized controlled, phase II or III trials by searching of electronic databases from inception to September 1, 2020.
方法：開始から2020年9月1日までの電子データベースを検索することにより、ランダム化比較試験のメタアナリシスを実施しました。
Methods: We conducted a meta-analysis of randomized controlled, phase II or III trials by searching of electronic databases from inception to September 1, 2020.
方法：開始から2020年9月1日までの電子データベースを検索することにより、ランダム化比較試験のメタアナリシスを実施しました。
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All randomized controlled Phase III trials (RCTs) evaluating the administration of third-generation aromatase inhibitors (AIs) and CDK4/6 inhibitors in postmenopausal women in the metastatic setting were considered eligible for this review.
転移性設定の閉経後の女性における第3世代アロマターゼ阻害剤（AI）およびCDK4 / 6阻害剤の投与を評価するすべてのランダム化比較第III相試験（RCT）は、このレビューの対象と見なされました。
All randomized controlled Phase III trials (RCTs) evaluating the administration of third-generation aromatase inhibitors (AIs) and CDK4/6 inhibitors in postmenopausal women in the metastatic setting were considered eligible for this review.
転移性設定の閉経後の女性における第3世代アロマターゼ阻害剤（AI）およびCDK4 / 6阻害剤の投与を評価するすべてのランダム化比較第III相試験（RCT）は、このレビューの対象と見なされました。
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Ii Trials sentence examples within non small cell
Two such inhibitors, sotorasib (AMG 510) and adagrasib (MRTX849), were recently evaluated in phase I-III trials for the treatment of non-small cell lung cancer with KRAS-G12C mutations, heralding a new era of precision oncology.
このような2つの阻害剤、ソトラシブ（AMG 510）とアダグラシブ（MRTX849）は、KRAS-G12C変異を伴う非小細胞肺癌の治療を目的とした第I〜III相試験で最近評価され、精密腫瘍学の新時代を告げています。
Two such inhibitors, sotorasib (AMG 510) and adagrasib (MRTX849), were recently evaluated in phase I-III trials for the treatment of non-small cell lung cancer with KRAS-G12C mutations, heralding a new era of precision oncology.
このような2つの阻害剤、ソトラシブ（AMG 510）とアダグラシブ（MRTX849）は、KRAS-G12C変異を伴う非小細胞肺癌の治療を目的とした第I〜III相試験で最近評価され、精密腫瘍学の新時代を告げています。
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Results from phase II trials of two HER2-targeting agents, the antibody-drug conjugate trastuzumab deruxtecan and the HER2-targeting tyrosine kinase inhibitor poziotinib, indicate promising efficacy that could lead to new standards of care for HER2-mutant non-small cell lung cancer.
2つのHER2標的薬、抗体薬物複合体トラスツズマブデルクステカンとHER2標的チロシンキナーゼ阻害剤ポジオチニブの第II相試験の結果は、HER2変異非小細胞肺癌の新しい治療基準につながる可能性のある有望な有効性を示しています。
Results from phase II trials of two HER2-targeting agents, the antibody-drug conjugate trastuzumab deruxtecan and the HER2-targeting tyrosine kinase inhibitor poziotinib, indicate promising efficacy that could lead to new standards of care for HER2-mutant non-small cell lung cancer.
2つのHER2標的薬、抗体薬物複合体トラスツズマブデルクステカンとHER2標的チロシンキナーゼ阻害剤ポジオチニブの第II相試験の結果は、HER2変異非小細胞肺癌の新しい治療基準につながる可能性のある有望な有効性を示しています。
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Ii Trials sentence examples within improve overall survival
Phase II trials suggest that SBRT added to palliative therapy may improve overall survival and may delay the initiation of systemic therapy in OMD patients.
第II相試験では、緩和療法にSBRTを追加すると、全体的な生存率が向上し、OMD患者の全身療法の開始が遅れる可能性があることが示唆されています。
Phase II trials suggest that SBRT added to palliative therapy may improve overall survival and may delay the initiation of systemic therapy in OMD patients.
第II相試験では、緩和療法にSBRTを追加すると、全体的な生存率が向上し、OMD患者の全身療法の開始が遅れる可能性があることが示唆されています。
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RESULTS
The 113 EORTC TOSs examined in this analysis were mainly standard-sized, international, multicentre phase III trials using a relatively simple, randomised, open-label design and comparing pharmacological combination regimens against standard-of-care treatments in terms of their potential to improve overall survival of patients with cancer.
結果
この分析で検討された113のEORTCTOSは、主に、比較的単純でランダム化された非盲検デザインを使用し、改善の可能性の観点から標準治療と薬理学的併用レジメンを比較した、標準サイズの国際的な多施設第III相試験でした。がん患者の全体的な生存。
RESULTS
The 113 EORTC TOSs examined in this analysis were mainly standard-sized, international, multicentre phase III trials using a relatively simple, randomised, open-label design and comparing pharmacological combination regimens against standard-of-care treatments in terms of their potential to improve overall survival of patients with cancer.
結果 この分析で検討された113のEORTCTOSは、主に、比較的単純でランダム化された非盲検デザインを使用し、改善の可能性の観点から標準治療と薬理学的併用レジメンを比較した、標準サイズの国際的な多施設第III相試験でした。がん患者の全体的な生存。
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Ii Trials sentence examples within single arm phase
INTRODUCTION AND OBJECTIVE:Recently, bacillus Calmette Guerin (BCG) unresponsive criteria was established based on expert opinion to facilitate single arm Phase II/III trials for patients with NMIB.
はじめにと目的：最近、NMIB患者の単群第II / III相試験を容易にするために、専門家の意見に基づいてカルメットゲラン菌（BCG）の無反応基準が確立されました。
INTRODUCTION AND OBJECTIVE:Recently, bacillus Calmette Guerin (BCG) unresponsive criteria was established based on expert opinion to facilitate single arm Phase II/III trials for patients with NMIB.
はじめにと目的：最近、NMIB患者の単群第II / III相試験を容易にするために、専門家の意見に基づいてカルメットゲラン菌（BCG）の無反応基準が確立されました。
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Moreover, the proposed Bayesian designs using the exact posterior distributions accommodate the single-arm phase II trials with small sample sizes.
さらに、正確な後方分布を使用して提案されたベイズ計画は、小さなサンプルサイズでのシングルアームフェーズII試行に対応します。
Moreover, the proposed Bayesian designs using the exact posterior distributions accommodate the single-arm phase II trials with small sample sizes.
さらに、正確な後方分布を使用して提案されたベイズ計画は、小さなサンプルサイズでのシングルアームフェーズII試行に対応します。
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Ii Trials sentence examples within two pivotal phase
Based on the data from two pivotal phase III trials the drug was recently approved for marketing in the US as a topical treatment for actinic keratosis.
2つの重要な第III相試験のデータに基づいて、この薬は最近、光線性角化症の局所治療薬として米国での販売が承認されました。
Based on the data from two pivotal phase III trials the drug was recently approved for marketing in the US as a topical treatment for actinic keratosis.
2つの重要な第III相試験のデータに基づいて、この薬は最近、光線性角化症の局所治療薬として米国での販売が承認されました。
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Approval was based on two pivotal phase II trials in which romidepsin demonstrated an overall response rate (ORR) of 34% and a complete response (CR) rate of 6% with a duration of response of 13.
承認は、ロミデプシンが34％の全体的な奏効率（ORR）と13の奏効期間で6％の完全奏効（CR）率を示した2つの重要な第II相試験に基づいていました。
Approval was based on two pivotal phase II trials in which romidepsin demonstrated an overall response rate (ORR) of 34% and a complete response (CR) rate of 6% with a duration of response of 13.
承認は、ロミデプシンが34％の全体的な奏効率（ORR）と13の奏効期間で6％の完全奏効（CR）率を示した2つの重要な第II相試験に基づいていました。
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Ii Trials sentence examples within cell death protein
Its combination with the anti‐PD1 (programmed cell death protein 1) immune checkpoint inhibitor, pembrolizumab, has generated encouraging results in phase Ib and is currently being tested in phase III trials.
抗PD1（プログラム細胞死タンパク質1）免疫チェックポイント阻害剤であるペムブロリズマブとの組み合わせは、フェーズIbで有望な結果を生み出し、現在フェーズIII試験でテストされています。
Its combination with the anti‐PD1 (programmed cell death protein 1) immune checkpoint inhibitor, pembrolizumab, has generated encouraging results in phase Ib and is currently being tested in phase III trials.
抗PD1（プログラム細胞死タンパク質1）免疫チェックポイント阻害剤であるペムブロリズマブとの組み合わせは、フェーズIbで有望な結果を生み出し、現在フェーズIII試験でテストされています。
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Programmed cell death protein 1 (PD-1) inhibitors have demonstrated promising activity among patients with advanced soft tissue sarcomas (STS) in phase II trials.
プログラム細胞死タンパク質1（PD-1）阻害剤は、第II相試験で進行性軟部肉腫（STS）の患者さんの間で有望な活性を示しています。
Programmed cell death protein 1 (PD-1) inhibitors have demonstrated promising activity among patients with advanced soft tissue sarcomas (STS) in phase II trials.
プログラム細胞死タンパク質1（PD-1）阻害剤は、第II相試験で進行性軟部肉腫（STS）の患者さんの間で有望な活性を示しています。
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Ii Trials sentence examples within chronic kidney disease
Introduction Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that has demonstrated safety and efficacy versus placebo in phase III trials in patients with anemia of chronic kidney disease (CKD) who were not on dialysis (NDD).
はじめにロキサデュスタットは、透析を受けていない慢性腎臓病（CKD）の貧血患者を対象とした第III相試験で、プラセボと比較して安全性と有効性を示した経口低酸素誘導因子プロリルヒドロキシラーゼ阻害剤です。
Introduction Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that has demonstrated safety and efficacy versus placebo in phase III trials in patients with anemia of chronic kidney disease (CKD) who were not on dialysis (NDD).
はじめにロキサデュスタットは、透析を受けていない慢性腎臓病（CKD）の貧血患者を対象とした第III相試験で、プラセボと比較して安全性と有効性を示した経口低酸素誘導因子プロリルヒドロキシラーゼ阻害剤です。
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Addition of the nonsteroidal MRA finerenone to optimal RAS blockade recently reduced CV and kidney outcomes in two large phase III trials in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D).
非ステロイド性MRAフィネレノンを最適なRAS遮断薬に追加すると、最近、慢性腎臓病（CKD）と2型糖尿病（T2D）の患者を対象とした2つの大規模な第III相試験でCVと腎臓の転帰が減少しました。
Addition of the nonsteroidal MRA finerenone to optimal RAS blockade recently reduced CV and kidney outcomes in two large phase III trials in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D).
非ステロイド性MRAフィネレノンを最適なRAS遮断薬に追加すると、最近、慢性腎臓病（CKD）と2型糖尿病（T2D）の患者を対象とした2つの大規模な第III相試験でCVと腎臓の転帰が減少しました。
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Ii Trials sentence examples within large randomized phase
Preliminary early-phase human trial data support the proposition that NAICI in NSCLC may provide an feasible and potentially efficacious future treatment strategy and large, randomized phase III trials are currently recruiting to assess this approach.
予備的な初期段階のヒト試験データは、NSCLCのNAICIが実行可能で潜在的に有効な将来の治療戦略を提供する可能性があるという提案を支持し、大規模なランダム化第III相試験が現在このアプローチを評価するために募集しています。
Preliminary early-phase human trial data support the proposition that NAICI in NSCLC may provide an feasible and potentially efficacious future treatment strategy and large, randomized phase III trials are currently recruiting to assess this approach.
予備的な初期段階のヒト試験データは、NSCLCのNAICIが実行可能で潜在的に有効な将来の治療戦略を提供する可能性があるという提案を支持し、大規模なランダム化第III相試験が現在このアプローチを評価するために募集しています。
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Numerous attempts to combine R-CHOP with targeted agents failed in large randomized phase III trials.
R-CHOPと標的薬剤を組み合わせる多くの試みは、大規模なランダム化第III相試験で失敗しました。
Numerous attempts to combine R-CHOP with targeted agents failed in large randomized phase III trials.
R-CHOPと標的薬剤を組み合わせる多くの試みは、大規模なランダム化第III相試験で失敗しました。
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Ii Trials sentence examples within cell lung cancer
Two phase III trials in adult patients with non–small-cell lung cancers evaluating a platinum-based doublet with or without the programmed death 1 (PD-1) inhibitor pembrolizumab recommended that all patients receive dexamethasone as a component of the prophylactic antiemetic regimen.
プログラム死1（PD-1）阻害剤ペムブロリズマブの有無にかかわらずプラチナベースのダブレットを評価する非小細胞肺癌の成人患者を対象とした2つの第III相試験では、すべての患者に予防的制吐レジメンの構成要素としてデキサメタゾンを投与することが推奨されました。
Two phase III trials in adult patients with non–small-cell lung cancers evaluating a platinum-based doublet with or without the programmed death 1 (PD-1) inhibitor pembrolizumab recommended that all patients receive dexamethasone as a component of the prophylactic antiemetic regimen.
プログラム死1（PD-1）阻害剤ペムブロリズマブの有無にかかわらずプラチナベースのダブレットを評価する非小細胞肺癌の成人患者を対象とした2つの第III相試験では、すべての患者に予防的制吐レジメンの構成要素としてデキサメタゾンを投与することが推奨されました。
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In October 2015, based on the results of Phase II trials demonstrating the safety and efficacy of anti-PD-1 antibodies, the US Food and Drug Administration (FDA) expanded its approval of nivolumab to include the treatment of advanced, refractory metastatic nonsmall cell lung cancer (NSCLC) [2].
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In October 2015, based on the results of Phase II trials demonstrating the safety and efficacy of anti-PD-1 antibodies, the US Food and Drug Administration (FDA) expanded its approval of nivolumab to include the treatment of advanced, refractory metastatic nonsmall cell lung cancer (NSCLC) [2].
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Ii Trials sentence examples within overall survival benefit
The TRINITI-1 trial investigated ribociclib, a CDK4/6i that has recently demonstrated significant overall survival benefit in two phase III trials, in combination with everolimus and exemestane in patients with HR+, HER2− advanced breast cancer (ABC) after progression on a CDK4/6i.
TRINITI-1試験では、CDK4で進行した後のHR +、HER2-進行性乳がん（ABC）患者において、エベロリムスとエキセメスタンとの併用で、2つの第III相試験で有意な全体的な延命効果を最近示したCDK4/6iであるリボシクリブを調査しました。 /6i。
The TRINITI-1 trial investigated ribociclib, a CDK4/6i that has recently demonstrated significant overall survival benefit in two phase III trials, in combination with everolimus and exemestane in patients with HR+, HER2− advanced breast cancer (ABC) after progression on a CDK4/6i.
TRINITI-1試験では、CDK4で進行した後のHR +、HER2-進行性乳がん（ABC）患者において、エベロリムスとエキセメスタンとの併用で、2つの第III相試験で有意な全体的な延命効果を最近示したCDK4/6iであるリボシクリブを調査しました。 /6i。
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A patient-reported outcome (PRO) is a measurement of the patient’s condition, reported directly by the patient, without the interpretation by a clinician or anyone else [1] Recently, there has been a growing interest in the integration of PROs as part of data collection about toxicity and symptoms experienced by patients with cancer This integration could have relevant implications not only for a more accurate reporting of adverse events and definition of quality of life (QoL) within clinical trials [2], but also for a better patients’ management in routine clinical practice [3] Many tools and questionnaires have been validated to properly measure QoL and symptoms in patients with lung cancer The inclusion of these measures in clinical trials has several important advantages It allows providing a patient-focused assessment of the burden and the impact of disease Moreover, it allows completely assessing the clinical benefit of a therapy, by complementing the information provided by commonly used efficacy endpoints, including overall survival, and the traditional description of safety based on physicians’ assessment Furthermore, the availability of QoL data from trials could allow a more accurate patient-physician communication about the treatment strategies offered in clinical practice However, a systematic review that we performed in order to evaluate the adoption of QoL among endpoints in randomized phase III trials conducted in lung cancer, published between 2012 and 2018 in 11 major journals, showed quite disappointing findings [4] Beyond the importance in clinical trials, PROs can play an important role in clinical practice Several studies have demonstrated a clear benefit in terms of patients’ QoL [5,6] Our experience, focused on the adoption of PROs in patients receiving active anticancer treatment at Mauriziano Hospital in Turin, showed that the introduction of PROs, thanks to an active role of nurses, was feasible, produced high patients’ satisfaction and a significant QoL improvement compared to the traditional modality of visit [6] In details, we compared 2 groups: patients in the control group underwent “usual” visits, while patients in the “PRO” group received a paper questionnaire by a dedicated nurse before each visit, in order to provide information about symptoms and toxicities After 1 month, mean change from baseline of global QoL was significantly better in the PRO group, and significantly higher proportion of patients obtained a clinically significant improvement in global QoL score In addition to QoL benefit, several studies have shown a significant improvement in overall survival with the adoption of electronic PROs in patients with lung cancer [7-9] In a pivotal randomized trial involving US patients with different solid tumors (including lung cancer) undergoing chemotherapy, patients assigned to the control arm received usual care, while subjects assigned to experimental arm could report their symptoms remotely from home, using tablet computers or computer kiosks [5,7] Doctors received a report of symptoms referred by patients during visits, and nurses received email alerts when patients reported severe or worsening symptoms Beyond the QoL improvement (the primary endpoint of the trial), a significantly longer life expectancy in the experimental arm (median 31 2 months) compared to the usual care arm (26 0 months) was reported [7] A French randomized trial, conducted in lung cancer patients without evidence of disease progression after or during initial treatment, compared a web-mediated follow-up algorithm (experimental arm), based on weekly self-scored patient symptoms, with routine follow-up with CT scans scheduled every 3-6 months according to the disease stage (control arm) [8] In the experimental arm, the oncologist received automatically an alert email when self-scored symptoms matched predefined criteria Notably, a significant improvement in overall survival was found in patients assigned to experimental arm [9] The adoption of electronic PROs in clinical practice could have many advantages [10] Regular discussion of PROs questionnaires, filled out electronically by patients and received by nurses or doctors, could allow a systematic check of the clinical trend of symptoms and side-effects The early, proactive identification of worsening symptoms and toxicities could help prevent the occurrence of severe adverse events needing ER access and hospitalization Adoption and discussion of PROs would reasonably have a positive psychological impact on patients, increasing their satisfaction with healthcare services While the adoption of electronic PROs could initially appear as a challenging organizational effort, we believe that their benefits will definitely be evident in the long-term The use of PROs may allow a significant benefit in terms of patients’ QoL, and this should be more than enough to consider its adoption in clinical practice, which - overall survival benefit or not – is worth the trouble References: 1 Di Maio M, et al Patient-reported outcomes in the evaluation of toxicity of anticancer treatments Nat Rev Clin Oncol 2016;13(5):319-25 2 Marandino L, et al Deficiencies in health-related quality-of-life assessment and reporting: a systematic review of oncology randomized phase III trials published between 2012 and 2016 Ann Oncol 2018;29:2288-2295 3 Sperti E, Di Maio M Outcomes research: Integrating PROs into the clinic - overall survival benefit or not, it's worth the trouble Nat Rev Clin Oncol 2017;14(9):529-530 4 Reale ML, et al Quality of life analysis in lung cancer: A systematic review of phase III trials published between 2012 and 2018 Lung Cancer 2020 Jan;139:47-54 5 Basch E, et al Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial J Clin Oncol 2016;34(6):557-65 6 Baratelli C, et al The role of patient-reported outcomes in outpatients receiving active anti-cancer treatment: impact on patients' quality of life Support Care Cancer 2019;27(12):4697-4704 7 Basch E, et al Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment JAMA 2017;318(2):197-198 8 Denis F, et al Randomized Trial Comparing a Web-Mediated Follow-up With Routine Surveillance in Lung Cancer Patients J Natl Cancer Inst 2017 Sep 1;109(9) 9 Denis F, et al Two-Year Survival Comparing Web-Based Symptom Monitoring vs Routine Surveillance Following Treatment for Lung Cancer JAMA 2019;321(3):306-307 10 Marandino L, et al COVID-19 Emergency and the Need to Speed Up the Adoption of Electronic Patient-Reported Outcomes in Cancer Clinical Practice JCO Oncol Pract 2020;16(6):295-298 Keywords: patient-reported outcomes, health-related quality of life, ePROs.
nan
A patient-reported outcome (PRO) is a measurement of the patient’s condition, reported directly by the patient, without the interpretation by a clinician or anyone else [1] Recently, there has been a growing interest in the integration of PROs as part of data collection about toxicity and symptoms experienced by patients with cancer This integration could have relevant implications not only for a more accurate reporting of adverse events and definition of quality of life (QoL) within clinical trials [2], but also for a better patients’ management in routine clinical practice [3] Many tools and questionnaires have been validated to properly measure QoL and symptoms in patients with lung cancer The inclusion of these measures in clinical trials has several important advantages It allows providing a patient-focused assessment of the burden and the impact of disease Moreover, it allows completely assessing the clinical benefit of a therapy, by complementing the information provided by commonly used efficacy endpoints, including overall survival, and the traditional description of safety based on physicians’ assessment Furthermore, the availability of QoL data from trials could allow a more accurate patient-physician communication about the treatment strategies offered in clinical practice However, a systematic review that we performed in order to evaluate the adoption of QoL among endpoints in randomized phase III trials conducted in lung cancer, published between 2012 and 2018 in 11 major journals, showed quite disappointing findings [4] Beyond the importance in clinical trials, PROs can play an important role in clinical practice Several studies have demonstrated a clear benefit in terms of patients’ QoL [5,6] Our experience, focused on the adoption of PROs in patients receiving active anticancer treatment at Mauriziano Hospital in Turin, showed that the introduction of PROs, thanks to an active role of nurses, was feasible, produced high patients’ satisfaction and a significant QoL improvement compared to the traditional modality of visit [6] In details, we compared 2 groups: patients in the control group underwent “usual” visits, while patients in the “PRO” group received a paper questionnaire by a dedicated nurse before each visit, in order to provide information about symptoms and toxicities After 1 month, mean change from baseline of global QoL was significantly better in the PRO group, and significantly higher proportion of patients obtained a clinically significant improvement in global QoL score In addition to QoL benefit, several studies have shown a significant improvement in overall survival with the adoption of electronic PROs in patients with lung cancer [7-9] In a pivotal randomized trial involving US patients with different solid tumors (including lung cancer) undergoing chemotherapy, patients assigned to the control arm received usual care, while subjects assigned to experimental arm could report their symptoms remotely from home, using tablet computers or computer kiosks [5,7] Doctors received a report of symptoms referred by patients during visits, and nurses received email alerts when patients reported severe or worsening symptoms Beyond the QoL improvement (the primary endpoint of the trial), a significantly longer life expectancy in the experimental arm (median 31 2 months) compared to the usual care arm (26 0 months) was reported [7] A French randomized trial, conducted in lung cancer patients without evidence of disease progression after or during initial treatment, compared a web-mediated follow-up algorithm (experimental arm), based on weekly self-scored patient symptoms, with routine follow-up with CT scans scheduled every 3-6 months according to the disease stage (control arm) [8] In the experimental arm, the oncologist received automatically an alert email when self-scored symptoms matched predefined criteria Notably, a significant improvement in overall survival was found in patients assigned to experimental arm [9] The adoption of electronic PROs in clinical practice could have many advantages [10] Regular discussion of PROs questionnaires, filled out electronically by patients and received by nurses or doctors, could allow a systematic check of the clinical trend of symptoms and side-effects The early, proactive identification of worsening symptoms and toxicities could help prevent the occurrence of severe adverse events needing ER access and hospitalization Adoption and discussion of PROs would reasonably have a positive psychological impact on patients, increasing their satisfaction with healthcare services While the adoption of electronic PROs could initially appear as a challenging organizational effort, we believe that their benefits will definitely be evident in the long-term The use of PROs may allow a significant benefit in terms of patients’ QoL, and this should be more than enough to consider its adoption in clinical practice, which - overall survival benefit or not – is worth the trouble References: 1 Di Maio M, et al Patient-reported outcomes in the evaluation of toxicity of anticancer treatments Nat Rev Clin Oncol 2016;13(5):319-25 2 Marandino L, et al Deficiencies in health-related quality-of-life assessment and reporting: a systematic review of oncology randomized phase III trials published between 2012 and 2016 Ann Oncol 2018;29:2288-2295 3 Sperti E, Di Maio M Outcomes research: Integrating PROs into the clinic - overall survival benefit or not, it's worth the trouble Nat Rev Clin Oncol 2017;14(9):529-530 4 Reale ML, et al Quality of life analysis in lung cancer: A systematic review of phase III trials published between 2012 and 2018 Lung Cancer 2020 Jan;139:47-54 5 Basch E, et al Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial J Clin Oncol 2016;34(6):557-65 6 Baratelli C, et al The role of patient-reported outcomes in outpatients receiving active anti-cancer treatment: impact on patients' quality of life Support Care Cancer 2019;27(12):4697-4704 7 Basch E, et al Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment JAMA 2017;318(2):197-198 8 Denis F, et al Randomized Trial Comparing a Web-Mediated Follow-up With Routine Surveillance in Lung Cancer Patients J Natl Cancer Inst 2017 Sep 1;109(9) 9 Denis F, et al Two-Year Survival Comparing Web-Based Symptom Monitoring vs Routine Surveillance Following Treatment for Lung Cancer JAMA 2019;321(3):306-307 10 Marandino L, et al COVID-19 Emergency and the Need to Speed Up the Adoption of Electronic Patient-Reported Outcomes in Cancer Clinical Practice JCO Oncol Pract 2020;16(6):295-298 Keywords: patient-reported outcomes, health-related quality of life, ePROs.
nan
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Ii Trials sentence examples within advanced ovarian cancer
For improving the prognosis of PC, intraperitoneal (IP) chemotherapy has been introduced in the clinical setting, and phase III trials proved the superiority of IP chemotherapy to IV chemotherapy, in particular, in advanced ovarian cancer.
PCの予後を改善するために、腹腔内（IP）化学療法が臨床現場に導入され、第III相試験では、特に進行性卵巣癌において、IP化学療法がIV化学療法よりも優れていることが証明されました。
For improving the prognosis of PC, intraperitoneal (IP) chemotherapy has been introduced in the clinical setting, and phase III trials proved the superiority of IP chemotherapy to IV chemotherapy, in particular, in advanced ovarian cancer.
PCの予後を改善するために、腹腔内（IP）化学療法が臨床現場に導入され、第III相試験では、特に進行性卵巣癌において、IP化学療法がIV化学療法よりも優れていることが証明されました。
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OBJECTIVE
To evaluate the acceptability of early palliative care (EPC) among patients with advanced ovarian cancer and determine the feasibility of larger-scale phase III trials.
目的
進行性卵巣がん患者の早期緩和ケア（EPC）の受容性を評価し、大規模な第III相試験の実現可能性を判断すること。
OBJECTIVE
To evaluate the acceptability of early palliative care (EPC) among patients with advanced ovarian cancer and determine the feasibility of larger-scale phase III trials.
目的 進行性卵巣がん患者の早期緩和ケア（EPC）の受容性を評価し、大規模な第III相試験の実現可能性を判断すること。
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Ii Trials sentence examples within death protein 1
While phase III trials on therapies targeting KRAS, especially KRASG12C, are ongoing, the clinical efficacy of anti-programmed death protein-1 (PD-1) or its ligand (PD-L1) against KRAS-mutant NSCLCs remains a topic of debate.
KRAS、特にKRASG12Cを標的とした治療法に関する第III相試験が進行中ですが、KRAS変異型NSCLCに対する抗プログラム死タンパク質-1（PD-1）またはそのリガンド（PD-L1）の臨床的有効性は依然として議論の的となっています。
While phase III trials on therapies targeting KRAS, especially KRASG12C, are ongoing, the clinical efficacy of anti-programmed death protein-1 (PD-1) or its ligand (PD-L1) against KRAS-mutant NSCLCs remains a topic of debate.
KRAS、特にKRASG12Cを標的とした治療法に関する第III相試験が進行中ですが、KRAS変異型NSCLCに対する抗プログラム死タンパク質-1（PD-1）またはそのリガンド（PD-L1）の臨床的有効性は依然として議論の的となっています。
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Ii Trials sentence examples within neoadjuvant chemotherapy followed
Of the eight studies analysed, two were randomised controlled trials comparing neoadjuvant chemotherapy followed by oncological resection to upfront surgery and adjuvant chemotherapy, three were prospective single-arm phase II trials analysing neoadjuvant chemotherapy followed by surgery only, one was a retrospective study comparing neoadjuvant chemotherapy followed by surgery versus surgery first followed by adjuvant chemotherapy and the remaining two were single-arm retrospective studies of neoadjuvant chemotherapy followed by surgery.
分析された8件の研究のうち、2件はネオアジュバント化学療法とその後の腫瘍切除と先行手術およびアジュバント化学療法を比較したランダム化対照試験であり、3件はネオアジュバント化学療法とその後の手術のみを分析した前向きシングルアーム第II相試験であり、1件はネオアジュバント化学療法を比較した遡及的研究でした。続いて手術対手術、最初にアジュバント化学療法が続き、残りの2つはネオアジュバント化学療法とそれに続く手術の単群遡及的研究でした。
Of the eight studies analysed, two were randomised controlled trials comparing neoadjuvant chemotherapy followed by oncological resection to upfront surgery and adjuvant chemotherapy, three were prospective single-arm phase II trials analysing neoadjuvant chemotherapy followed by surgery only, one was a retrospective study comparing neoadjuvant chemotherapy followed by surgery versus surgery first followed by adjuvant chemotherapy and the remaining two were single-arm retrospective studies of neoadjuvant chemotherapy followed by surgery.
分析された8件の研究のうち、2件はネオアジュバント化学療法とその後の腫瘍切除と先行手術およびアジュバント化学療法を比較したランダム化対照試験であり、3件はネオアジュバント化学療法とその後の手術のみを分析した前向きシングルアーム第II相試験であり、1件はネオアジュバント化学療法を比較した遡及的研究でした。続いて手術対手術、最初にアジュバント化学療法が続き、残りの2つはネオアジュバント化学療法とそれに続く手術の単群遡及的研究でした。
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Ii Trials sentence examples within metastatic breast cancer
Several phase I and II trials have shown that PARP inhibitors are effective as monotherapy in patients with metastatic breast cancer and germline BRCA1/2 mutation.
いくつかの第I相および第II相試験では、PARP阻害剤が転移性乳がんおよび生殖細胞系BRCA1/2変異を有する患者の単剤療法として有効であることが示されています。
Several phase I and II trials have shown that PARP inhibitors are effective as monotherapy in patients with metastatic breast cancer and germline BRCA1/2 mutation.
いくつかの第I相および第II相試験では、PARP阻害剤が転移性乳がんおよび生殖細胞系BRCA1/2変異を有する患者の単剤療法として有効であることが示されています。
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Ii Trials sentence examples within Phase Ii Trials
For patients with NSCLC, two randomized phase II trials also suggested that the addition of a radical local treatment results in encouraging survival data, with a good safety profile.
NSCLCの患者の場合、2つのランダム化第II相試験でも、根治的局所治療の追加により、良好な安全性プロファイルを備えた有望な生存データが得られることが示唆されました。
For patients with NSCLC, two randomized phase II trials also suggested that the addition of a radical local treatment results in encouraging survival data, with a good safety profile.
NSCLCの患者の場合、2つのランダム化第II相試験でも、根治的局所治療の追加により、良好な安全性プロファイルを備えた有望な生存データが得られることが示唆されました。
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Ii Trials sentence examples within Freedom Ii Trials
OBJECTIVE AND METHODS
Post hoc analyses of data from the TRANSFORMS, FREEDOMS, and FREEDOMS II trials and their extensions assessed the effects of fingolimod (0.
目的と方法
TRANSFORMS、FREEDOMS、およびFREEDOMS II試験のデータの事後分析とそれらの拡張により、フィンゴリモドの効果が評価されました（0。
OBJECTIVE AND METHODS
Post hoc analyses of data from the TRANSFORMS, FREEDOMS, and FREEDOMS II trials and their extensions assessed the effects of fingolimod (0.
目的と方法 TRANSFORMS、FREEDOMS、およびFREEDOMS II試験のデータの事後分析とそれらの拡張により、フィンゴリモドの効果が評価されました（0。
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METHODS
This post-hoc analysis pooled data from the phase 3 FREEDOMS and FREEDOMS II trials (N=1556).
方法
この事後分析では、フェーズ3のFREEDOMSおよびFREEDOMS II試験（N = 1556）のデータがプールされました。
METHODS
This post-hoc analysis pooled data from the phase 3 FREEDOMS and FREEDOMS II trials (N=1556).
方法 この事後分析では、フェーズ3のFREEDOMSおよびFREEDOMS II試験（N = 1556）のデータがプールされました。
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Ii Trials sentence examples within ii trials evaluating
Methods We analyzed ORR alone or in combination with DOR (RMTR) in available phase I, II, and III trials evaluating nivolumab monotherapy or in combination with ipilimumab across solid tumor types.
方法我々は、固形腫瘍タイプ全体でニボルマブ単剤療法またはイピリムマブとの併用を評価する利用可能な第I、II、およびIII相試験において、ORRを単独またはDOR（RMTR）と組み合わせて分析しました。
Methods We analyzed ORR alone or in combination with DOR (RMTR) in available phase I, II, and III trials evaluating nivolumab monotherapy or in combination with ipilimumab across solid tumor types.
方法我々は、固形腫瘍タイプ全体でニボルマブ単剤療法またはイピリムマブとの併用を評価する利用可能な第I、II、およびIII相試験において、ORRを単独またはDOR（RMTR）と組み合わせて分析しました。
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Ii Trials sentence examples within ii trials showed
Tosedostat is a selective oral aminopeptidase inhibitor, which in phase I/II trials showed acceptable toxicity and encouraging efficacy.
トセドスタットは選択的経口アミノペプチダーゼ阻害剤であり、第I/II相試験で許容できる毒性と有望な有効性を示しました。
Tosedostat is a selective oral aminopeptidase inhibitor, which in phase I/II trials showed acceptable toxicity and encouraging efficacy.
トセドスタットは選択的経口アミノペプチダーゼ阻害剤であり、第I/II相試験で許容できる毒性と有望な有効性を示しました。
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Results from placebo-controlled phase III trials showed that IV amisulpride is efficacious both in the prevention of PONV (used either alone or in combination with an antiemetic of a different class) and in the treatment of PONV (irrespective of prior antiemetic prophylaxis status).
プラセボ対照第III相試験の結果は、IVアミスルプリドがPONVの予防（単独で、または異なるクラスの制吐剤と組み合わせて使用）とPONVの治療（以前の制吐剤の予防状態に関係なく）の両方で有効であることを示しました。
Results from placebo-controlled phase III trials showed that IV amisulpride is efficacious both in the prevention of PONV (used either alone or in combination with an antiemetic of a different class) and in the treatment of PONV (irrespective of prior antiemetic prophylaxis status).
プラセボ対照第III相試験の結果は、IVアミスルプリドがPONVの予防（単独で、または異なるクラスの制吐剤と組み合わせて使用）とPONVの治療（以前の制吐剤の予防状態に関係なく）の両方で有効であることを示しました。
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Ii Trials sentence examples within ii trials comparing
Overall response rates appear comparable to published phase III trials comparing the combination of Pd with or without an anti-CD38 monoclonal antibody (Table 1).
全体的な反応率は、抗CD38モノクローナル抗体の有無にかかわらずPdの組み合わせを比較した公開された第III相試験に匹敵するようです（表1）。
Overall response rates appear comparable to published phase III trials comparing the combination of Pd with or without an anti-CD38 monoclonal antibody (Table 1).
全体的な反応率は、抗CD38モノクローナル抗体の有無にかかわらずPdの組み合わせを比較した公開された第III相試験に匹敵するようです（表1）。
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Two European phase III trials comparing D1 and D2 demonstrated that D2 did not improve the overall survival and was associated with a high mortality related to splenectomy.
D1とD2を比較した2つのヨーロッパの第III相試験は、D2が全体的な生存率を改善せず、脾臓摘出術に関連する高い死亡率と関連していることを示しました。
Two European phase III trials comparing D1 and D2 demonstrated that D2 did not improve the overall survival and was associated with a high mortality related to splenectomy.
D1とD2を比較した2つのヨーロッパの第III相試験は、D2が全体的な生存率を改善せず、脾臓摘出術に関連する高い死亡率と関連していることを示しました。
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Ii Trials sentence examples within ii trials testing
Little is known about the risk/benefit ratio for pediatric cancer phase II trials testing targeted therapies.
標的療法をテストする小児がんの第II相試験のリスク/ベネフィット比についてはほとんど知られていません。
Little is known about the risk/benefit ratio for pediatric cancer phase II trials testing targeted therapies.
標的療法をテストする小児がんの第II相試験のリスク/ベネフィット比についてはほとんど知られていません。
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Our objectives were to describe the incidence of MPEs in recently published phase III trials testing systemic treatments in patients with advanced cancer; the main characteristics of trials adopting MPEs; the presence of mature results for all endpoints in the primary publication; consistency between results of each endpoint and authors' conclusions.
私たちの目的は、進行がん患者の全身治療をテストする最近公開された第III相試験におけるMPEの発生率を説明することでした。 MPEを採用した試験の主な特徴。一次刊行物のすべてのエンドポイントの成熟した結果の存在。各エンドポイントの結果と著者の結論の間の一貫性。
Our objectives were to describe the incidence of MPEs in recently published phase III trials testing systemic treatments in patients with advanced cancer; the main characteristics of trials adopting MPEs; the presence of mature results for all endpoints in the primary publication; consistency between results of each endpoint and authors' conclusions.
私たちの目的は、進行がん患者の全身治療をテストする最近公開された第III相試験におけるMPEの発生率を説明することでした。 MPEを採用した試験の主な特徴。一次刊行物のすべてのエンドポイントの成熟した結果の存在。各エンドポイントの結果と著者の結論の間の一貫性。
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Ii Trials sentence examples within ii trials investigating
Therefore, we provide a complete overview of all phase II and phase III trials investigating targeted therapies in AML and their primary endpoints over the past two decades in perspective of their clinical benefit.
したがって、我々は、AMLの標的療法と、それらの臨床的利益の観点から過去20年間にわたるそれらの主要エンドポイントを調査する、すべての第II相および第III相試験の完全な概要を提供します。
Therefore, we provide a complete overview of all phase II and phase III trials investigating targeted therapies in AML and their primary endpoints over the past two decades in perspective of their clinical benefit.
したがって、我々は、AMLの標的療法と、それらの臨床的利益の観点から過去20年間にわたるそれらの主要エンドポイントを調査する、すべての第II相および第III相試験の完全な概要を提供します。
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PubMed, Embase, and Cochrane Library were systematically searched for phase I and phase II trials investigating an experimental compound as a single agent or in combination with dexamethasone, published from January 1, 2010 to July 1, 2020.
PubMed、Embase、およびCochrane Libraryは、2010年1月1日から2020年7月1日まで公開された、単剤またはデキサメタゾンとの組み合わせとしての実験化合物を調査する第I相および第II相試験を体系的に検索しました。
PubMed, Embase, and Cochrane Library were systematically searched for phase I and phase II trials investigating an experimental compound as a single agent or in combination with dexamethasone, published from January 1, 2010 to July 1, 2020.
PubMed、Embase、およびCochrane Libraryは、2010年1月1日から2020年7月1日まで公開された、単剤またはデキサメタゾンとの組み合わせとしての実験化合物を調査する第I相および第II相試験を体系的に検索しました。
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Ii Trials sentence examples within ii trials demonstrating
Both agents were approved based on phase III trials demonstrating that they were associated with improved progression-free survival compared with treatment of physician’s choice in patients receiving second-third line therapy for locally advanced, inoperable, or metastatic breast cancer in patients with germline pathogenic BRCA 1 or BRCA2 variants.
両方の薬剤は、生殖細胞系病原性BRCA患者の局所進行性、手術不能、または転移性乳がんの2番目から3番目のライン治療を受けている患者の医師の選択による治療と比較して無増悪生存期間の改善に関連していることを示す第III相試験に基づいて承認されました1またはBRCA2バリアント。
Both agents were approved based on phase III trials demonstrating that they were associated with improved progression-free survival compared with treatment of physician’s choice in patients receiving second-third line therapy for locally advanced, inoperable, or metastatic breast cancer in patients with germline pathogenic BRCA 1 or BRCA2 variants.
両方の薬剤は、生殖細胞系病原性BRCA患者の局所進行性、手術不能、または転移性乳がんの2番目から3番目のライン治療を受けている患者の医師の選択による治療と比較して無増悪生存期間の改善に関連していることを示す第III相試験に基づいて承認されました1またはBRCA2バリアント。
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Purpose of review The pivotal phase III trials demonstrating efficacy and safety of direct oral anticoagulants (DOACs) in the treatment of venous thromboembolism (VTE) or nonvalvular atrial fibrillation (NVAF) excluded patients with important and common comorbidities, including obesity, advanced chronic kidney disease, cirrhosis, cancer and antiphospholipid antibody syndrome.
レビューの目的静脈血栓塞栓症（VTE）または非弁膜症性心房細動（NVAF）の治療における直接経口抗凝固薬（DOAC）の有効性と安全性を実証する極めて重要な第III相試験では、肥満、進行性慢性腎臓病などの重要かつ一般的な併存疾患のある患者を除外しました、肝硬変、癌および抗リン脂質抗体症候群。
Purpose of review The pivotal phase III trials demonstrating efficacy and safety of direct oral anticoagulants (DOACs) in the treatment of venous thromboembolism (VTE) or nonvalvular atrial fibrillation (NVAF) excluded patients with important and common comorbidities, including obesity, advanced chronic kidney disease, cirrhosis, cancer and antiphospholipid antibody syndrome.
レビューの目的静脈血栓塞栓症（VTE）または非弁膜症性心房細動（NVAF）の治療における直接経口抗凝固薬（DOAC）の有効性と安全性を実証する極めて重要な第III相試験では、肥満、進行性慢性腎臓病などの重要かつ一般的な併存疾患のある患者を除外しました、肝硬変、癌および抗リン脂質抗体症候群。
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Ii Trials sentence examples within ii trials suggest
Phase II trials suggest that SBRT added to palliative therapy may improve overall survival and may delay the initiation of systemic therapy in OMD patients.
第II相試験では、緩和療法にSBRTを追加すると、全体的な生存率が向上し、OMD患者の全身療法の開始が遅れる可能性があることが示唆されています。
Phase II trials suggest that SBRT added to palliative therapy may improve overall survival and may delay the initiation of systemic therapy in OMD patients.
第II相試験では、緩和療法にSBRTを追加すると、全体的な生存率が向上し、OMD患者の全身療法の開始が遅れる可能性があることが示唆されています。
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On the contrary, latest evidence of some phase II trials suggests efficacy of consolidating WBRT is comparable to ASCT.
それどころか、いくつかの第II相試験の最新の証拠は、WBRTを統合することの有効性がASCTに匹敵することを示唆しています。
On the contrary, latest evidence of some phase II trials suggests efficacy of consolidating WBRT is comparable to ASCT.
それどころか、いくつかの第II相試験の最新の証拠は、WBRTを統合することの有効性がASCTに匹敵することを示唆しています。
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Ii Trials sentence examples within ii trials currently
This review describes preclinical studies of omidenepag, published results of phase I–III clinical trials, and preliminary results of phase III trials currently in progress.
このレビューでは、オミデネパグの前臨床試験、公開されている第I〜III相臨床試験の結果、および現在進行中の第III相試験の予備結果について説明します。
This review describes preclinical studies of omidenepag, published results of phase I–III clinical trials, and preliminary results of phase III trials currently in progress.
このレビューでは、オミデネパグの前臨床試験、公開されている第I〜III相臨床試験の結果、および現在進行中の第III相試験の予備結果について説明します。
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Two phase III trials currently underway—the “Randomized Trial of IMPT versus IMRT for the Treatment of Oropharyngeal Cancer of the Head and Neck” and the “TOxicity Reduction using Proton bEam therapy for Oropharyngeal cancer (TORPEdO)” trial—are expected to provide prospective, level I evidence regarding the effectiveness of IMPT for such patients.
現在進行中の2つの第III相試験、「頭頸部中咽頭がんの治療のためのIMPTとIMRTのランダム化試験」および「中咽頭がんに対する陽子線治療を使用した毒性低減（TORPEdO）」試験は、前向きな結果をもたらすと期待されています。 、そのような患者に対するIMPTの有効性に関するレベルIの証拠。
Two phase III trials currently underway—the “Randomized Trial of IMPT versus IMRT for the Treatment of Oropharyngeal Cancer of the Head and Neck” and the “TOxicity Reduction using Proton bEam therapy for Oropharyngeal cancer (TORPEdO)” trial—are expected to provide prospective, level I evidence regarding the effectiveness of IMPT for such patients.
現在進行中の2つの第III相試験、「頭頸部中咽頭がんの治療のためのIMPTとIMRTのランダム化試験」および「中咽頭がんに対する陽子線治療を使用した毒性低減（TORPEdO）」試験は、前向きな結果をもたらすと期待されています。 、そのような患者に対するIMPTの有効性に関するレベルIの証拠。
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Ii Trials sentence examples within ii trials showing
EXPERT OPINION
Bortezomib-lenalidomide-dexamethasone (VRd), daratumumab-bortezomib-melphalan-prednisone (DaraVMP) and daratumumab-lenalidomide-dexamethasone (DaraRd) represent new standard of care (SOC) treatments for NDTIMM patients, based on phase III trials showing their superior efficacy as compared with previous SOCs.
専門家の意見
ボルテゾミブ-レナリドミド-デキサメタゾン（VRd）、ダラツムマブ-ボルテゾミブ-メルファラン-プレドニゾン（DaraVMP）、およびダラツムマブ-レナリドミド-デキサメタゾン（DaraRd）は、NDTIMM患者の新しい標準治療（SOC）治療であり、その優れた有効性を示しています。以前のSOCと比較して。
EXPERT OPINION
Bortezomib-lenalidomide-dexamethasone (VRd), daratumumab-bortezomib-melphalan-prednisone (DaraVMP) and daratumumab-lenalidomide-dexamethasone (DaraRd) represent new standard of care (SOC) treatments for NDTIMM patients, based on phase III trials showing their superior efficacy as compared with previous SOCs.
専門家の意見 ボルテゾミブ-レナリドミド-デキサメタゾン（VRd）、ダラツムマブ-ボルテゾミブ-メルファラン-プレドニゾン（DaraVMP）、およびダラツムマブ-レナリドミド-デキサメタゾン（DaraRd）は、NDTIMM患者の新しい標準治療（SOC）治療であり、その優れた有効性を示しています。以前のSOCと比較して。
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This was evident with the Ebola vaccine (Johnson & Johnson) wherein a mixeddose approach was specifically adopted in phase I and phase II trials showing safety and longlasting immunity.
これは、安全性と長期的な免疫を示す第I相および第II相試験で混合用量アプローチが特に採用されたエボラワクチン（Johnson＆Johnson）で明らかでした。
This was evident with the Ebola vaccine (Johnson & Johnson) wherein a mixeddose approach was specifically adopted in phase I and phase II trials showing safety and longlasting immunity.
これは、安全性と長期的な免疫を示す第I相および第II相試験で混合用量アプローチが特に採用されたエボラワクチン（Johnson＆Johnson）で明らかでした。
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Ii Trials sentence examples within ii trials conducted
A patient-reported outcome (PRO) is a measurement of the patient’s condition, reported directly by the patient, without the interpretation by a clinician or anyone else [1] Recently, there has been a growing interest in the integration of PROs as part of data collection about toxicity and symptoms experienced by patients with cancer This integration could have relevant implications not only for a more accurate reporting of adverse events and definition of quality of life (QoL) within clinical trials [2], but also for a better patients’ management in routine clinical practice [3] Many tools and questionnaires have been validated to properly measure QoL and symptoms in patients with lung cancer The inclusion of these measures in clinical trials has several important advantages It allows providing a patient-focused assessment of the burden and the impact of disease Moreover, it allows completely assessing the clinical benefit of a therapy, by complementing the information provided by commonly used efficacy endpoints, including overall survival, and the traditional description of safety based on physicians’ assessment Furthermore, the availability of QoL data from trials could allow a more accurate patient-physician communication about the treatment strategies offered in clinical practice However, a systematic review that we performed in order to evaluate the adoption of QoL among endpoints in randomized phase III trials conducted in lung cancer, published between 2012 and 2018 in 11 major journals, showed quite disappointing findings [4] Beyond the importance in clinical trials, PROs can play an important role in clinical practice Several studies have demonstrated a clear benefit in terms of patients’ QoL [5,6] Our experience, focused on the adoption of PROs in patients receiving active anticancer treatment at Mauriziano Hospital in Turin, showed that the introduction of PROs, thanks to an active role of nurses, was feasible, produced high patients’ satisfaction and a significant QoL improvement compared to the traditional modality of visit [6] In details, we compared 2 groups: patients in the control group underwent “usual” visits, while patients in the “PRO” group received a paper questionnaire by a dedicated nurse before each visit, in order to provide information about symptoms and toxicities After 1 month, mean change from baseline of global QoL was significantly better in the PRO group, and significantly higher proportion of patients obtained a clinically significant improvement in global QoL score In addition to QoL benefit, several studies have shown a significant improvement in overall survival with the adoption of electronic PROs in patients with lung cancer [7-9] In a pivotal randomized trial involving US patients with different solid tumors (including lung cancer) undergoing chemotherapy, patients assigned to the control arm received usual care, while subjects assigned to experimental arm could report their symptoms remotely from home, using tablet computers or computer kiosks [5,7] Doctors received a report of symptoms referred by patients during visits, and nurses received email alerts when patients reported severe or worsening symptoms Beyond the QoL improvement (the primary endpoint of the trial), a significantly longer life expectancy in the experimental arm (median 31 2 months) compared to the usual care arm (26 0 months) was reported [7] A French randomized trial, conducted in lung cancer patients without evidence of disease progression after or during initial treatment, compared a web-mediated follow-up algorithm (experimental arm), based on weekly self-scored patient symptoms, with routine follow-up with CT scans scheduled every 3-6 months according to the disease stage (control arm) [8] In the experimental arm, the oncologist received automatically an alert email when self-scored symptoms matched predefined criteria Notably, a significant improvement in overall survival was found in patients assigned to experimental arm [9] The adoption of electronic PROs in clinical practice could have many advantages [10] Regular discussion of PROs questionnaires, filled out electronically by patients and received by nurses or doctors, could allow a systematic check of the clinical trend of symptoms and side-effects The early, proactive identification of worsening symptoms and toxicities could help prevent the occurrence of severe adverse events needing ER access and hospitalization Adoption and discussion of PROs would reasonably have a positive psychological impact on patients, increasing their satisfaction with healthcare services While the adoption of electronic PROs could initially appear as a challenging organizational effort, we believe that their benefits will definitely be evident in the long-term The use of PROs may allow a significant benefit in terms of patients’ QoL, and this should be more than enough to consider its adoption in clinical practice, which - overall survival benefit or not – is worth the trouble References: 1 Di Maio M, et al Patient-reported outcomes in the evaluation of toxicity of anticancer treatments Nat Rev Clin Oncol 2016;13(5):319-25 2 Marandino L, et al Deficiencies in health-related quality-of-life assessment and reporting: a systematic review of oncology randomized phase III trials published between 2012 and 2016 Ann Oncol 2018;29:2288-2295 3 Sperti E, Di Maio M Outcomes research: Integrating PROs into the clinic - overall survival benefit or not, it's worth the trouble Nat Rev Clin Oncol 2017;14(9):529-530 4 Reale ML, et al Quality of life analysis in lung cancer: A systematic review of phase III trials published between 2012 and 2018 Lung Cancer 2020 Jan;139:47-54 5 Basch E, et al Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial J Clin Oncol 2016;34(6):557-65 6 Baratelli C, et al The role of patient-reported outcomes in outpatients receiving active anti-cancer treatment: impact on patients' quality of life Support Care Cancer 2019;27(12):4697-4704 7 Basch E, et al Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment JAMA 2017;318(2):197-198 8 Denis F, et al Randomized Trial Comparing a Web-Mediated Follow-up With Routine Surveillance in Lung Cancer Patients J Natl Cancer Inst 2017 Sep 1;109(9) 9 Denis F, et al Two-Year Survival Comparing Web-Based Symptom Monitoring vs Routine Surveillance Following Treatment for Lung Cancer JAMA 2019;321(3):306-307 10 Marandino L, et al COVID-19 Emergency and the Need to Speed Up the Adoption of Electronic Patient-Reported Outcomes in Cancer Clinical Practice JCO Oncol Pract 2020;16(6):295-298 Keywords: patient-reported outcomes, health-related quality of life, ePROs.
nan
A patient-reported outcome (PRO) is a measurement of the patient’s condition, reported directly by the patient, without the interpretation by a clinician or anyone else [1] Recently, there has been a growing interest in the integration of PROs as part of data collection about toxicity and symptoms experienced by patients with cancer This integration could have relevant implications not only for a more accurate reporting of adverse events and definition of quality of life (QoL) within clinical trials [2], but also for a better patients’ management in routine clinical practice [3] Many tools and questionnaires have been validated to properly measure QoL and symptoms in patients with lung cancer The inclusion of these measures in clinical trials has several important advantages It allows providing a patient-focused assessment of the burden and the impact of disease Moreover, it allows completely assessing the clinical benefit of a therapy, by complementing the information provided by commonly used efficacy endpoints, including overall survival, and the traditional description of safety based on physicians’ assessment Furthermore, the availability of QoL data from trials could allow a more accurate patient-physician communication about the treatment strategies offered in clinical practice However, a systematic review that we performed in order to evaluate the adoption of QoL among endpoints in randomized phase III trials conducted in lung cancer, published between 2012 and 2018 in 11 major journals, showed quite disappointing findings [4] Beyond the importance in clinical trials, PROs can play an important role in clinical practice Several studies have demonstrated a clear benefit in terms of patients’ QoL [5,6] Our experience, focused on the adoption of PROs in patients receiving active anticancer treatment at Mauriziano Hospital in Turin, showed that the introduction of PROs, thanks to an active role of nurses, was feasible, produced high patients’ satisfaction and a significant QoL improvement compared to the traditional modality of visit [6] In details, we compared 2 groups: patients in the control group underwent “usual” visits, while patients in the “PRO” group received a paper questionnaire by a dedicated nurse before each visit, in order to provide information about symptoms and toxicities After 1 month, mean change from baseline of global QoL was significantly better in the PRO group, and significantly higher proportion of patients obtained a clinically significant improvement in global QoL score In addition to QoL benefit, several studies have shown a significant improvement in overall survival with the adoption of electronic PROs in patients with lung cancer [7-9] In a pivotal randomized trial involving US patients with different solid tumors (including lung cancer) undergoing chemotherapy, patients assigned to the control arm received usual care, while subjects assigned to experimental arm could report their symptoms remotely from home, using tablet computers or computer kiosks [5,7] Doctors received a report of symptoms referred by patients during visits, and nurses received email alerts when patients reported severe or worsening symptoms Beyond the QoL improvement (the primary endpoint of the trial), a significantly longer life expectancy in the experimental arm (median 31 2 months) compared to the usual care arm (26 0 months) was reported [7] A French randomized trial, conducted in lung cancer patients without evidence of disease progression after or during initial treatment, compared a web-mediated follow-up algorithm (experimental arm), based on weekly self-scored patient symptoms, with routine follow-up with CT scans scheduled every 3-6 months according to the disease stage (control arm) [8] In the experimental arm, the oncologist received automatically an alert email when self-scored symptoms matched predefined criteria Notably, a significant improvement in overall survival was found in patients assigned to experimental arm [9] The adoption of electronic PROs in clinical practice could have many advantages [10] Regular discussion of PROs questionnaires, filled out electronically by patients and received by nurses or doctors, could allow a systematic check of the clinical trend of symptoms and side-effects The early, proactive identification of worsening symptoms and toxicities could help prevent the occurrence of severe adverse events needing ER access and hospitalization Adoption and discussion of PROs would reasonably have a positive psychological impact on patients, increasing their satisfaction with healthcare services While the adoption of electronic PROs could initially appear as a challenging organizational effort, we believe that their benefits will definitely be evident in the long-term The use of PROs may allow a significant benefit in terms of patients’ QoL, and this should be more than enough to consider its adoption in clinical practice, which - overall survival benefit or not – is worth the trouble References: 1 Di Maio M, et al Patient-reported outcomes in the evaluation of toxicity of anticancer treatments Nat Rev Clin Oncol 2016;13(5):319-25 2 Marandino L, et al Deficiencies in health-related quality-of-life assessment and reporting: a systematic review of oncology randomized phase III trials published between 2012 and 2016 Ann Oncol 2018;29:2288-2295 3 Sperti E, Di Maio M Outcomes research: Integrating PROs into the clinic - overall survival benefit or not, it's worth the trouble Nat Rev Clin Oncol 2017;14(9):529-530 4 Reale ML, et al Quality of life analysis in lung cancer: A systematic review of phase III trials published between 2012 and 2018 Lung Cancer 2020 Jan;139:47-54 5 Basch E, et al Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial J Clin Oncol 2016;34(6):557-65 6 Baratelli C, et al The role of patient-reported outcomes in outpatients receiving active anti-cancer treatment: impact on patients' quality of life Support Care Cancer 2019;27(12):4697-4704 7 Basch E, et al Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment JAMA 2017;318(2):197-198 8 Denis F, et al Randomized Trial Comparing a Web-Mediated Follow-up With Routine Surveillance in Lung Cancer Patients J Natl Cancer Inst 2017 Sep 1;109(9) 9 Denis F, et al Two-Year Survival Comparing Web-Based Symptom Monitoring vs Routine Surveillance Following Treatment for Lung Cancer JAMA 2019;321(3):306-307 10 Marandino L, et al COVID-19 Emergency and the Need to Speed Up the Adoption of Electronic Patient-Reported Outcomes in Cancer Clinical Practice JCO Oncol Pract 2020;16(6):295-298 Keywords: patient-reported outcomes, health-related quality of life, ePROs.
nan
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Accurate estimation of response and early progression rates based on the data from the phase II trials conducted according to the optimal two-stage designs would be very useful for further testing of the agents in phase II trials.
最適な2段階の設計に従って実施された第II相試験のデータに基づく応答と早期進行率の正確な推定は、第II相試験での薬剤のさらなる試験に非常に役立ちます。
Accurate estimation of response and early progression rates based on the data from the phase II trials conducted according to the optimal two-stage designs would be very useful for further testing of the agents in phase II trials.
最適な2段階の設計に従って実施された第II相試験のデータに基づく応答と早期進行率の正確な推定は、第II相試験での薬剤のさらなる試験に非常に役立ちます。
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Ii Trials sentence examples within ii trials designed
3559 Background: The MORPHEUS platform consists of multiple, global, open-label, randomized Phase Ib/II trials designed to identify early efficacy and safety signals of treatment (tx) combinations across cancers.
3559背景：MORPHEUSプラットフォームは、複数のグローバルな非盲検ランダム化第Ib / II相試験で構成されており、がん全体の治療（tx）の組み合わせの早期の有効性と安全性のシグナルを特定するように設計されています。
3559 Background: The MORPHEUS platform consists of multiple, global, open-label, randomized Phase Ib/II trials designed to identify early efficacy and safety signals of treatment (tx) combinations across cancers.
3559背景：MORPHEUSプラットフォームは、複数のグローバルな非盲検ランダム化第Ib / II相試験で構成されており、がん全体の治療（tx）の組み合わせの早期の有効性と安全性のシグナルを特定するように設計されています。
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82Background: The MORPHEUS platform consists of multiple, global, open-label, randomized Phase Ib/II trials designed to identify early efficacy signals and safety of treatment (tx) combinations acr.
82背景：MORPHEUSプラットフォームは、初期の有効性シグナルと治療の安全性（tx）の組み合わせを特定するために設計された、複数のグローバルな非盲検ランダム化第Ib/II相試験で構成されています。
82Background: The MORPHEUS platform consists of multiple, global, open-label, randomized Phase Ib/II trials designed to identify early efficacy signals and safety of treatment (tx) combinations acr.
82背景：MORPHEUSプラットフォームは、初期の有効性シグナルと治療の安全性（tx）の組み合わせを特定するために設計された、複数のグローバルな非盲検ランダム化第Ib/II相試験で構成されています。
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Ii Trials sentence examples within ii trials involving
Anti‐angiogenic drugs targeting the VEGF pathway are most effective in advanced metastatic disease settings of certain types of cancers, whereas they have been unsuccessful as adjuvant therapies of micrometastatic disease in numerous phase III trials involving early‐stage (resectable) cancers.
VEGF経路を標的とする抗血管新生薬は、特定の種類の癌の進行した転移性疾患の設定で最も効果的ですが、初期（切除可能な）癌を含む多くの第III相試験で微小転移性疾患の補助療法としては成功していません。
Anti‐angiogenic drugs targeting the VEGF pathway are most effective in advanced metastatic disease settings of certain types of cancers, whereas they have been unsuccessful as adjuvant therapies of micrometastatic disease in numerous phase III trials involving early‐stage (resectable) cancers.
VEGF経路を標的とする抗血管新生薬は、特定の種類の癌の進行した転移性疾患の設定で最も効果的ですが、初期（切除可能な）癌を含む多くの第III相試験で微小転移性疾患の補助療法としては成功していません。
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these findings compare favourably with the outcomes of vemurafenib monotherapy in two multicentre phase ii trials involving a total of 54 patients with r/r HCL.
これらの所見は、r /rHCLの合計54人の患者を対象とした2つの多施設第II相試験におけるベムラフェニブ単剤療法の結果と比べて遜色ありません。
these findings compare favourably with the outcomes of vemurafenib monotherapy in two multicentre phase ii trials involving a total of 54 patients with r/r HCL.
これらの所見は、r /rHCLの合計54人の患者を対象とした2つの多施設第II相試験におけるベムラフェニブ単剤療法の結果と比べて遜色ありません。
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Ii Trials sentence examples within ii trials tested
Even fewer phase III and randomized phase II trials tested an RT-specific hypothesis (11.
さらに少数の第III相およびランダム化第II相試験で、RT固有の仮説が検証されました（11。
Even fewer phase III and randomized phase II trials tested an RT-specific hypothesis (11.
さらに少数の第III相およびランダム化第II相試験で、RT固有の仮説が検証されました（11。
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Six phase III trials tested the hypothesis that 3 months is noninferior in efficacy to 6 months and reduces long-term side effects for patients.
6つの第III相試験では、3か月は6か月まで有効性が劣らず、患者の長期的な副作用を軽減するという仮説を検証しました。
Six phase III trials tested the hypothesis that 3 months is noninferior in efficacy to 6 months and reduces long-term side effects for patients.
6つの第III相試験では、3か月は6か月まで有効性が劣らず、患者の長期的な副作用を軽減するという仮説を検証しました。
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Ii Trials sentence examples within ii trials enrolling
In this review, we study two decades of efforts to improve upon the gemcitabine backbone - 67 phase II and III trials enrolling 16,446 patients - that culminated in the approvals of gemcitabine/nab-paclitaxel (Gem/NabP) and FOLFIRINOX.
このレビューでは、ゲムシタビンバックボーン（16,446人の患者を登録する67の第II相および第III相試験）を改善するための20年間の取り組みを研究し、ゲムシタビン/ nab-パクリタキセル（Gem / NabP）およびFOLFIRINOXの承認に至りました。
In this review, we study two decades of efforts to improve upon the gemcitabine backbone - 67 phase II and III trials enrolling 16,446 patients - that culminated in the approvals of gemcitabine/nab-paclitaxel (Gem/NabP) and FOLFIRINOX.
このレビューでは、ゲムシタビンバックボーン（16,446人の患者を登録する67の第II相および第III相試験）を改善するための20年間の取り組みを研究し、ゲムシタビン/ nab-パクリタキセル（Gem / NabP）およびFOLFIRINOXの承認に至りました。
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Randomized phase III, and for tyrosine kinase inhibitors (TKIs) also randomized phase II trials enrolling advanced/metastatic NSCLC patients were included.
無作為化第III相、およびチロシンキナーゼ阻害剤（TKI）については、進行/転移性NSCLC患者を登録する無作為化第II相試験も含まれていました。
Randomized phase III, and for tyrosine kinase inhibitors (TKIs) also randomized phase II trials enrolling advanced/metastatic NSCLC patients were included.
無作為化第III相、およびチロシンキナーゼ阻害剤（TKI）については、進行/転移性NSCLC患者を登録する無作為化第II相試験も含まれていました。
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10.1007/s40262-021-01019-9
Population pharmacokinetic (PK) and PK/pharmacodynamic (PD) models were developed using data from phase I, II, and III trials, and the impact of clinically relevant covariates on PK and PD parameters was assessed.
集団薬物動態（PK）およびPK /薬力学（PD）モデルは、フェーズI、II、およびIII試験のデータを使用して開発され、PKおよびPDパラメーターに対する臨床的に関連する共変量の影響が評価されました。
Population pharmacokinetic (PK) and PK/pharmacodynamic (PD) models were developed using data from phase I, II, and III trials, and the impact of clinically relevant covariates on PK and PD parameters was assessed.
集団薬物動態（PK）およびPK /薬力学（PD）モデルは、フェーズI、II、およびIII試験のデータを使用して開発され、PKおよびPDパラメーターに対する臨床的に関連する共変量の影響が評価されました。
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10.3390/cancers13174438
Results: 20 studies were identified, of which 16 were phase I or II and 4 phase III trials.
結果：20件の研究が特定され、そのうち16件はフェーズIまたはII、4件はフェーズIIIの試験でした。
Results: 20 studies were identified, of which 16 were phase I or II and 4 phase III trials.
結果：20件の研究が特定され、そのうち16件はフェーズIまたはII、4件はフェーズIIIの試験でした。
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10.1200/JCO.20.01605
In two phase III trials (CheckMate 017 and CheckMate 057), nivolumab showed an improvement in overall survival (OS) and favorable safety versus docetaxel in patients with previously treated, advanced squamous and nonsquamous NSCLC, respectively.
2つの第III相試験（CheckMate017およびCheckMate057）で、ニボルマブは、以前に治療を受けた、進行した扁平上皮および非扁平上皮NSCLCの患者において、ドセタキセルと比較して、それぞれ全生存期間（OS）および良好な安全性の改善を示しました。
In two phase III trials (CheckMate 017 and CheckMate 057), nivolumab showed an improvement in overall survival (OS) and favorable safety versus docetaxel in patients with previously treated, advanced squamous and nonsquamous NSCLC, respectively.
2つの第III相試験（CheckMate017およびCheckMate057）で、ニボルマブは、以前に治療を受けた、進行した扁平上皮および非扁平上皮NSCLCの患者において、ドセタキセルと比較して、それぞれ全生存期間（OS）および良好な安全性の改善を示しました。
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10.1007/s00277-021-04404-3
We searched PubMed and Cochrane databases for phase III trials in previously treated MM that had lenalidomide or bortezomib in the control arm.
PubMedおよびCochraneデータベースで、コントロールアームにレナリドマイドまたはボルテゾミブを含む以前に治療されたMMでの第III相試験を検索しました。
We searched PubMed and Cochrane databases for phase III trials in previously treated MM that had lenalidomide or bortezomib in the control arm.
PubMedおよびCochraneデータベースで、コントロールアームにレナリドマイドまたはボルテゾミブを含む以前に治療されたMMでの第III相試験を検索しました。
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10.1177/1756286420982134
Background: In the 2-year CARE-MS I and II trials, alemtuzumab 12 mg administered on 5 consecutive days at core study baseline and on 3 consecutive days 12 months later significantly improved outcomes versus subcutaneous interferon beta-1a (SC IFNB-1a) in relapsing–remitting multiple sclerosis patients.
背景：2年間のCARE-MS IおよびII試験では、アレムツズマブ12 mgをコア試験ベースラインで連続5日間投与し、12か月後に連続3日間投与すると、皮下インターフェロンベータ-1a（SC IFNB-1a）と比較して転帰が有意に改善しました。再発寛解型多発性硬化症患者。
Background: In the 2-year CARE-MS I and II trials, alemtuzumab 12 mg administered on 5 consecutive days at core study baseline and on 3 consecutive days 12 months later significantly improved outcomes versus subcutaneous interferon beta-1a (SC IFNB-1a) in relapsing–remitting multiple sclerosis patients.
背景：2年間のCARE-MS IおよびII試験では、アレムツズマブ12 mgをコア試験ベースラインで連続5日間投与し、12か月後に連続3日間投与すると、皮下インターフェロンベータ-1a（SC IFNB-1a）と比較して転帰が有意に改善しました。再発寛解型多発性硬化症患者。
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10.3390/cancers13071683
We want to promote randomised phase-II trials in osteosarcoma relapses, with broad inclusion criteria at study entry in terms of age and disease status, and PFS as primary endpoint.
骨肉腫の再発におけるランダム化された第II相試験を促進したいと考えており、年齢と病状の観点から研究開始時に幅広い選択基準を使用し、主要エンドポイントとしてPFSを使用しています。
We want to promote randomised phase-II trials in osteosarcoma relapses, with broad inclusion criteria at study entry in terms of age and disease status, and PFS as primary endpoint.
骨肉腫の再発におけるランダム化された第II相試験を促進したいと考えており、年齢と病状の観点から研究開始時に幅広い選択基準を使用し、主要エンドポイントとしてPFSを使用しています。
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10.1007/s40274-021-7555-9
A short-term acute-care decision tree followed by a post-discharge Markov model, populated with data on inpatient care, use of mechanical ventialtion and post-discharge ventilator-related morbidity from phase III trials, was used to evaluate the cost effectiveness of a potential treatment in patients hospitalised with COVID-19, compared with best supportive care (BSC), from US health payer, societal and fee-for-service (FFS) payment perspectives over a lifetime time horizon.
短期の急性期治療決定木とそれに続く退院後のマルコフモデルは、入院治療、機械的換気の使用、および第III相試験からの退院後の人工呼吸器関連の罹患率に関するデータで構成され、 COVID-19で入院した患者の潜在的な治療法は、米国の医療費支払者、社会的およびサービス料金（FFS）の支払いの観点から、生涯にわたる最善の支援的ケア（BSC）と比較されます。
A short-term acute-care decision tree followed by a post-discharge Markov model, populated with data on inpatient care, use of mechanical ventialtion and post-discharge ventilator-related morbidity from phase III trials, was used to evaluate the cost effectiveness of a potential treatment in patients hospitalised with COVID-19, compared with best supportive care (BSC), from US health payer, societal and fee-for-service (FFS) payment perspectives over a lifetime time horizon.
短期の急性期治療決定木とそれに続く退院後のマルコフモデルは、入院治療、機械的換気の使用、および第III相試験からの退院後の人工呼吸器関連の罹患率に関するデータで構成され、 COVID-19で入院した患者の潜在的な治療法は、米国の医療費支払者、社会的およびサービス料金（FFS）の支払いの観点から、生涯にわたる最善の支援的ケア（BSC）と比較されます。
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10.1080/21678707.2021.1882299
Currently, novel putative agents for the treatment of IPF are being tested in phase III trials, possibly marking a new breakthrough in IPF management.
現在、IPFの治療のための新規の推定薬剤が第III相試験でテストされており、IPF管理における新たな突破口となる可能性があります。
Currently, novel putative agents for the treatment of IPF are being tested in phase III trials, possibly marking a new breakthrough in IPF management.
現在、IPFの治療のための新規の推定薬剤が第III相試験でテストされており、IPF管理における新たな突破口となる可能性があります。
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10.36401/JIPO-20-33
However, grade ≥ III pneumonitis was not reported in phase III trials (PRIMA or NOVA).
ただし、グレードIII以上の非感染性肺炎は第III相試験（PRIMAまたはNOVA）では報告されていません。
However, grade ≥ III pneumonitis was not reported in phase III trials (PRIMA or NOVA).
ただし、グレードIII以上の非感染性肺炎は第III相試験（PRIMAまたはNOVA）では報告されていません。
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10.1111/bjd.19938
Monotherapy of abrocitinib, an oral, once-daily, Janus kinase 1 selective inhibitor, was shown to be effective and safe for moderate-to-severe AD in two phase III trials [JADE MONO-1 (NCT03349060) and JADE MONO-2 (NCT03575871)].
経口の1日1回のヤヌスキナーゼ1選択的阻害剤であるアブロシチニブの単剤療法は、2つの第III相試験[JADE MONO-1（NCT03349060）およびJADE MONO-2（ NCT03575871）]。
Monotherapy of abrocitinib, an oral, once-daily, Janus kinase 1 selective inhibitor, was shown to be effective and safe for moderate-to-severe AD in two phase III trials [JADE MONO-1 (NCT03349060) and JADE MONO-2 (NCT03575871)].
経口の1日1回のヤヌスキナーゼ1選択的阻害剤であるアブロシチニブの単剤療法は、2つの第III相試験[JADE MONO-1（NCT03349060）およびJADE MONO-2（ NCT03575871）]。
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10.1101/2021.06.23.21259415
Phase III trials of COVID-19 vaccines have shown that protection from vaccination does not occur immediately, meaning that COVID-19 risk should be similar in recently vaccinated and unvaccinated individuals, in the absence of confounding or other bias.
COVID-19ワクチンの第III相試験では、ワクチン接種からの保護がすぐには起こらないことが示されています。つまり、交絡やその他のバイアスがない限り、COVID-19のリスクは最近ワクチン接種を受けた人とワクチン接種を受けていない人で同じになるはずです。
Phase III trials of COVID-19 vaccines have shown that protection from vaccination does not occur immediately, meaning that COVID-19 risk should be similar in recently vaccinated and unvaccinated individuals, in the absence of confounding or other bias.
COVID-19ワクチンの第III相試験では、ワクチン接種からの保護がすぐには起こらないことが示されています。つまり、交絡やその他のバイアスがない限り、COVID-19のリスクは最近ワクチン接種を受けた人とワクチン接種を受けていない人で同じになるはずです。
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10.1016/j.lungcan.2021.07.005
While KRAS was long considered 'undruggable', several novel direct KRASG12C inhibitors have shown encouraging signs of efficacy in phase I/II trials and one of these (sotorasib) has recently been approved by the US Food and Drug Administration.
KRASは長い間「耐久性がない」と考えられていましたが、いくつかの新規直接KRASG12C阻害剤は、第I / II相試験で有効性の有望な兆候を示しており、これらの1つ（ソトラシブ）は最近米国食品医薬品局によって承認されました。
While KRAS was long considered 'undruggable', several novel direct KRASG12C inhibitors have shown encouraging signs of efficacy in phase I/II trials and one of these (sotorasib) has recently been approved by the US Food and Drug Administration.
KRASは長い間「耐久性がない」と考えられていましたが、いくつかの新規直接KRASG12C阻害剤は、第I / II相試験で有効性の有望な兆候を示しており、これらの1つ（ソトラシブ）は最近米国食品医薬品局によって承認されました。
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10.1136/jitc-2021-002876
Phase I and II trials with intratumoral IMO-2125 demonstrated its safety and antitumoral activity.
腫瘍内IMO-2125を用いた第I相および第II相試験では、その安全性と抗腫瘍活性が実証されました。
Phase I and II trials with intratumoral IMO-2125 demonstrated its safety and antitumoral activity.
腫瘍内IMO-2125を用いた第I相および第II相試験では、その安全性と抗腫瘍活性が実証されました。
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10.1002/biof.1797
High grade liver redox imbalance occurring in severe iron overload is adequately handled by iron chelation, however, that underlying NAFLD/NASH is currently under study in several Phase II and Phase III trials.
重度の鉄過剰症で発生する高悪性度の肝臓の酸化還元不均衡は、鉄キレート化によって適切に処理されますが、基礎となるNAFLD/NASHは現在いくつかの第II相および第III相試験で研究されています。
High grade liver redox imbalance occurring in severe iron overload is adequately handled by iron chelation, however, that underlying NAFLD/NASH is currently under study in several Phase II and Phase III trials.
重度の鉄過剰症で発生する高悪性度の肝臓の酸化還元不均衡は、鉄キレート化によって適切に処理されますが、基礎となるNAFLD/NASHは現在いくつかの第II相および第III相試験で研究されています。
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10.1080/14760584.2021.1889094
Nearly 80 years later, only one malaria vaccine (MosquirixTM), albeit one with moderate efficacy, has progressed into Phase III trials and has subsequently been licensed.
ほぼ80年後、中程度の有効性を備えたマラリアワクチン（MosquirixTM）が1つだけ、第III相試験に進み、その後認可されました。
Nearly 80 years later, only one malaria vaccine (MosquirixTM), albeit one with moderate efficacy, has progressed into Phase III trials and has subsequently been licensed.
ほぼ80年後、中程度の有効性を備えたマラリアワクチン（MosquirixTM）が1つだけ、第III相試験に進み、その後認可されました。
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10.1158/1538-7445.SABCS20-PD13-06
Given evolving CNS-directed treatments, including focal radiation (RT), we compared the proportion of pts diagnosed with asymptomatic CNS mets before and after 2012 as data from Phase III trials in the preceding years (yr) increasingly supported the use of stereotactic radiosurgery (SRS).
焦点放射線（RT）を含むCNSに向けられた治療法の進化を踏まえ、過去数年間（yr）の第III相試験のデータが定位放射線手術の使用をますます支持するように、2012年前後に無症候性CNSと診断されたptsの割合を比較しました（ SRS）。
Given evolving CNS-directed treatments, including focal radiation (RT), we compared the proportion of pts diagnosed with asymptomatic CNS mets before and after 2012 as data from Phase III trials in the preceding years (yr) increasingly supported the use of stereotactic radiosurgery (SRS).
焦点放射線（RT）を含むCNSに向けられた治療法の進化を踏まえ、過去数年間（yr）の第III相試験のデータが定位放射線手術の使用をますます支持するように、2012年前後に無症候性CNSと診断されたptsの割合を比較しました（ SRS）。
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10.1158/2159-8290.CD-21-0697
These results formed the basis for ongoing futibatinib phase II/III trials and demonstrate the potential of genomically selected early-phase trials to help identify molecular subsets likely to benefit from targeted therapy.
これらの結果は、進行中のフチバチニブ第II / III相試験の基礎を形成し、標的療法の恩恵を受ける可能性のある分子サブセットを特定するのに役立つ、ゲノム的に選択された初期段階試験の可能性を示しています。
These results formed the basis for ongoing futibatinib phase II/III trials and demonstrate the potential of genomically selected early-phase trials to help identify molecular subsets likely to benefit from targeted therapy.
これらの結果は、進行中のフチバチニブ第II / III相試験の基礎を形成し、標的療法の恩恵を受ける可能性のある分子サブセットを特定するのに役立つ、ゲノム的に選択された初期段階試験の可能性を示しています。
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10.1002/cpt.2183
In this paper, we discuss several possible designs, illustrate them via simulations, and also discuss challenges, such as the heterogeneity of the target population, time‐varying standard of care, and the potentially high number of false hypothesis rejections in phase II and phase III trials.
この論文では、いくつかの可能な設計について説明し、シミュレーションによってそれらを説明します。また、ターゲット母集団の不均一性、時間とともに変化する標準治療、フェーズIIおよびフェーズでの潜在的に多数の誤った仮説の拒否などの課題についても説明します。 III試験。
In this paper, we discuss several possible designs, illustrate them via simulations, and also discuss challenges, such as the heterogeneity of the target population, time‐varying standard of care, and the potentially high number of false hypothesis rejections in phase II and phase III trials.
この論文では、いくつかの可能な設計について説明し、シミュレーションによってそれらを説明します。また、ターゲット母集団の不均一性、時間とともに変化する標準治療、フェーズIIおよびフェーズでの潜在的に多数の誤った仮説の拒否などの課題についても説明します。 III試験。
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10.20944/preprints202108.0037.v1
Results: 20 studies were selected, of which 16 were phase I or II and 4 phase III trials.
結果：20の研究が選択され、そのうち16はフェーズIまたはII、4つのフェーズIII試験でした。
Results: 20 studies were selected, of which 16 were phase I or II and 4 phase III trials.
結果：20の研究が選択され、そのうち16はフェーズIまたはII、4つのフェーズIII試験でした。
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10.2147/CMAR.S330710
While first-line Phase III trials are currently underway to test these targeted approach against standard-of-care chemotherapy, translational studies are trying to better understand primary and secondary resistance mechanisms in order to optimize FGFR2 blockade in iCCA.
現在、標準治療化学療法に対するこれらの標的アプローチをテストするための第一線の第III相試験が進行中ですが、翻訳研究では、iCCAでのFGFR2遮断を最適化するために、一次および二次耐性メカニズムをよりよく理解しようとしています。
While first-line Phase III trials are currently underway to test these targeted approach against standard-of-care chemotherapy, translational studies are trying to better understand primary and secondary resistance mechanisms in order to optimize FGFR2 blockade in iCCA.
現在、標準治療化学療法に対するこれらの標的アプローチをテストするための第一線の第III相試験が進行中ですが、翻訳研究では、iCCAでのFGFR2遮断を最適化するために、一次および二次耐性メカニズムをよりよく理解しようとしています。
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10.4254/wjh.v13.i5.522
The phase III trials of recently approved vaccines for SARS-CoV-2 did not include enough patients with pre-existing liver diseases and excluded immunocompromised patients or those on immunomodulators.
最近承認されたSARS-CoV-2ワクチンの第III相試験には、既存の肝疾患の患者が十分に含まれず、免疫不全の患者または免疫調節剤を使用している患者は除外されました。
The phase III trials of recently approved vaccines for SARS-CoV-2 did not include enough patients with pre-existing liver diseases and excluded immunocompromised patients or those on immunomodulators.
最近承認されたSARS-CoV-2ワクチンの第III相試験には、既存の肝疾患の患者が十分に含まれず、免疫不全の患者または免疫調節剤を使用している患者は除外されました。
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10.1080/17512433.2021.1901574
Suboptimal clinical response rate with ceftazidime-avibactam and ceftolozane-tazobactam was reported in phase II–III trials in patients with moderate kidney injury; data on patients undergoing renal replacement therapy are limited to some case reports; dose adjustment in augmented renal clearance is provided only for cefiderocol.
セフタジジム-アビバクタムおよびセフトロザン-タゾバクタムによる次善の臨床反応率は、中等度の腎障害のある患者を対象とした第II〜III相試験で報告されました。腎代替療法を受けている患者に関するデータは、一部の症例報告に限定されています。増強された腎クリアランスの用量調整は、セフィデロコールに対してのみ提供されます。
Suboptimal clinical response rate with ceftazidime-avibactam and ceftolozane-tazobactam was reported in phase II–III trials in patients with moderate kidney injury; data on patients undergoing renal replacement therapy are limited to some case reports; dose adjustment in augmented renal clearance is provided only for cefiderocol.
セフタジジム-アビバクタムおよびセフトロザン-タゾバクタムによる次善の臨床反応率は、中等度の腎障害のある患者を対象とした第II〜III相試験で報告されました。腎代替療法を受けている患者に関するデータは、一部の症例報告に限定されています。増強された腎クリアランスの用量調整は、セフィデロコールに対してのみ提供されます。
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10.1101/2021.07.30.21260912
Background Phase III trials have estimated COVID-19 vaccine efficacy (VE) against symptomatic and asymptomatic infection.
背景第III相試験では、症候性および無症候性感染に対するCOVID-19ワクチン有効性（VE）が推定されています。
Background Phase III trials have estimated COVID-19 vaccine efficacy (VE) against symptomatic and asymptomatic infection.
背景第III相試験では、症候性および無症候性感染に対するCOVID-19ワクチン有効性（VE）が推定されています。
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10.1038/s41536-021-00161-z
While these outcomes are significant, additional phase II/III trials are required to validate the efficacy of MSCs to improve the survival of COVID-19 patients with ARDS.
これらの結果は重要ですが、ARDSのCOVID-19患者の生存率を改善するためのMSCの有効性を検証するには、追加の第II/III相試験が必要です。
While these outcomes are significant, additional phase II/III trials are required to validate the efficacy of MSCs to improve the survival of COVID-19 patients with ARDS.
これらの結果は重要ですが、ARDSのCOVID-19患者の生存率を改善するためのMSCの有効性を検証するには、追加の第II/III相試験が必要です。
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10.3390/cancers13174421
Following three pivotal first-line phase III trials in HER2-negative metastatic BC (MBC), this drug was finally approved in combination with cyclophosphamide in this specific setting.
HER2陰性転移性BC（MBC）での3つの重要な第一選択第III相試験の後、この薬剤はこの特定の設定でシクロホスファミドとの併用で最終的に承認されました。
Following three pivotal first-line phase III trials in HER2-negative metastatic BC (MBC), this drug was finally approved in combination with cyclophosphamide in this specific setting.
HER2陰性転移性BC（MBC）での3つの重要な第一選択第III相試験の後、この薬剤はこの特定の設定でシクロホスファミドとの併用で最終的に承認されました。
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10.1007/s40274-021-7432-6
The model was based on pooled individual patient survival data generated from two recently published, large, randomised phase III trials (SARAH* and SIRveNIB**).
このモデルは、最近公開された2つの大規模なランダム化第III相試験（SARAH*およびSIRveNIB**）から生成されたプールされた個々の患者の生存データに基づいていました。
The model was based on pooled individual patient survival data generated from two recently published, large, randomised phase III trials (SARAH* and SIRveNIB**).
このモデルは、最近公開された2つの大規模なランダム化第III相試験（SARAH*およびSIRveNIB**）から生成されたプールされた個々の患者の生存データに基づいていました。
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10.3390/cancers13174453
After several years of negative phase III trials in gastric and esophageal cancer, a significant breakthrough in the treatment of metastatic adenocarcinomas of the gastroesophageal junction (GEJ) and stomach (GC) is now becoming evident with the emerging of precision oncology and implementation of molecular targets in tumor treatment.
胃癌および食道癌における数年間の陰性第III相試験の後、胃食道接合部（GEJ）および胃（GC）の転移性腺癌の治療における重要な進歩が、精密腫瘍学および分子標的の実施の出現により明らかになりつつあります。腫瘍治療において。
After several years of negative phase III trials in gastric and esophageal cancer, a significant breakthrough in the treatment of metastatic adenocarcinomas of the gastroesophageal junction (GEJ) and stomach (GC) is now becoming evident with the emerging of precision oncology and implementation of molecular targets in tumor treatment.
胃癌および食道癌における数年間の陰性第III相試験の後、胃食道接合部（GEJ）および胃（GC）の転移性腺癌の治療における重要な進歩が、精密腫瘍学および分子標的の実施の出現により明らかになりつつあります。腫瘍治療において。
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10.12998/wjcc.v9.i5.1148
Studies proving the safety and efficacy of the magnesium-based resorbable scaffolds (MgBRSs) include the BIOSOLVE-I and BIOSOLVE-II trials and the latest BIOSOLVE-IV registry.
マグネシウムベースの吸収性足場（MgBRS）の安全性と有効性を証明する研究には、BIOSOLVE-IおよびBIOSOLVE-II試験と最新のBIOSOLVE-IVレジストリが含まれます。
Studies proving the safety and efficacy of the magnesium-based resorbable scaffolds (MgBRSs) include the BIOSOLVE-I and BIOSOLVE-II trials and the latest BIOSOLVE-IV registry.
マグネシウムベースの吸収性足場（MgBRS）の安全性と有効性を証明する研究には、BIOSOLVE-IおよびBIOSOLVE-II試験と最新のBIOSOLVE-IVレジストリが含まれます。
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10.1007/s13311-021-01055-0
According to recent phase II-III trials, biologics significantly reduced the risk of relapses in aquaporin-4-seropositive patients, whereas results were less striking in the small cohorts of aquaporin-4-seronegative patients.
最近の第II-III相試験によると、生物学的製剤はアクアポリン4血清陽性患者の再発リスクを有意に低下させましたが、アクアポリン4血清陰性患者の小規模コホートでは結果はそれほど顕著ではありませんでした。
According to recent phase II-III trials, biologics significantly reduced the risk of relapses in aquaporin-4-seropositive patients, whereas results were less striking in the small cohorts of aquaporin-4-seronegative patients.
最近の第II-III相試験によると、生物学的製剤はアクアポリン4血清陽性患者の再発リスクを有意に低下させましたが、アクアポリン4血清陰性患者の小規模コホートでは結果はそれほど顕著ではありませんでした。
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10.1016/j.critrevonc.2021.103505
A total of 20 randomized phase III trials were selected.
合計20のランダム化された第III相試験が選択されました。
A total of 20 randomized phase III trials were selected.
合計20のランダム化された第III相試験が選択されました。
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10.1089/jayao.2021.0014
We sought to explore where phase II and phase III trials are available for an AYA cohort.
私たちは、AYAコホートでフェーズIIおよびフェーズIIIの試験が利用できる場所を調査しようとしました。
We sought to explore where phase II and phase III trials are available for an AYA cohort.
私たちは、AYAコホートでフェーズIIおよびフェーズIIIの試験が利用できる場所を調査しようとしました。
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10.3389/fonc.2021.636561
Despite high-level endorsement, the number of adaptive Phase II/III trials in rare cancers needs to be improved, with better understanding of their value for clinical decisions in daily practice.
高いレベルの支持にもかかわらず、まれな癌における適応フェーズII / III試験の数は、日常診療における臨床的決定に対するそれらの価値をよりよく理解することで、改善される必要があります。
Despite high-level endorsement, the number of adaptive Phase II/III trials in rare cancers needs to be improved, with better understanding of their value for clinical decisions in daily practice.
高いレベルの支持にもかかわらず、まれな癌における適応フェーズII / III試験の数は、日常診療における臨床的決定に対するそれらの価値をよりよく理解することで、改善される必要があります。
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