Administered Daily for 5 Days in Adult Patients with Refractory Solid Tumors
5.3.5.3 複数の試験成績を合わせて解析した報告書
5.3.5.4 その他の臨床試験報告書 11 -18 ／ 25
5.3.5.4.1 CLO34100405 11 -18 ／ 25
Final Clinical Study Report – CLO34100405
A Phase III Randomized, Double-Blind, Controlled Study Comparing Clofarabine and Cytarabine vs Cytarabine Alone in Adult Patients 55 Years and Older with Acute Myelogenous Leukemia (AML) who have Relapsed or are Refractory after Receiving up to Two Prior Induction Regimens
5.3.6 市販後の使用経験に関する報告書 19 -21 ／ 25
5.3.6.1 PSUR 1 19 ／ 25
Evoltra® PERIODIC SAFETY UPDATE REPORT
5.3.6.2 PSUR 2 19 ／ 25
Evoltra® (clofarabine) PERIODIC SAFETY UPDATE REPORT
5.3.6.3 PSUR 3 19 ／ 25
Evoltra@ (Clofarabine) EU/1/06/334/001-004 Periodic Safety Update Report 3
5.3.6.4 PSUR 4 19 ／ 25
PSUR 4: PERIODIC SAFETY UPDATE REPORT for ACTIVE SUBSTANCE(S): Clofarabine
5.3.6.5 PSUR 5 19 ／ 25
Evoltra@, 1mg/m1 concentrate for solution for infusion EU/1/06/334/001-004
Periodic Safety Report 5
5.3.6.6 PSUR 6 20 ／ 25
6th PERIODIC SAFETY UPDATE REPORT for Evoltra® / Clolar® (clofarabine) 1 mg/ml concentrate for solution for infusion
5.3.6.7 PSUR 7 20 ／ 25
7th PERIODIC SAFETY UPDATE REPORT for Evoltra® / Clolar®
エボルトラ点滴静注20mg モジュール2.1 CTDの目次（第2部から第5部）
2.1 - 37
巻／巻数 (clofarabine) 1 mg/ml concentrate for solution for infusion
5.3.6.8 PSUR 8 21 ／ 25
8th PERIODIC SAFETY UPDATE REPORT for Evoltra® / Clolar® (clofarabine) 1 mg/ml concentrate for solutioli for infusion
5.3.7 患者データ一覧表及び症例記録 22 -24 ／ 25
5.3.7.1 用量設定の根拠となった主要な試験及び主要な有効性の検証試験の
症例一覧
22 ／ 25
5.3.7.1.1 ID99-383 22 ／ 25
Listing of Individual Patient Data Summary – ID99-383
5.3.7.1.2 CLO-212 22 ／ 25
Listing of Individual Patient Data Summary – CLO-212
5.3.7.1.3 CLO-222 22 ／ 25
Listing of Individual Patient Data Summary – CLO-222
5.3.7.1.4 BIOV-111 22 ／ 25
Listing of Individual Patient Data Summary – BIOV-111
5.3.7.1.5 CLO05908 22 ／ 25
Listing of Individual Patient Data Summary – CLO05908
5.3.7.1.6 CLOAML10508 22 ／ 25
Listing of Individual Patient Data Summary – CLOAML10508
5.3.7.2 実施された臨床試験において副作用が観察された症例の一覧表 22 ／ 25
5.3.7.2.1 ID99-383 22 ／ 25
Listing of Adverse Reactions – ID99-383
5.3.7.2.2 CLO-212 22 ／ 25
Listing of Adverse Reactions – CLO-212
5.3.7.2.3 CLO-222 22 ／ 25
Listing of Adverse Reactions – CLO-222
5.3.7.2.4 BIOV-111 22 ／ 25
Listing of Adverse Reactions – BIOV-111
5.3.7.2.5 CLO05908 22 ／ 25
Listing of Adverse Reactions – CLO05908
5.3.7.2.6 CLOAML10508 22 ／ 25
Listing of Adverse Reactions – CLOAML10508
5.3.7.3 実施された臨床試験において重篤な有害事象が観察された症例の一
覧表
22 ／ 25
5.3.7.3.1 ID99-383 22 ／ 25
エボルトラ点滴静注20mg モジュール2.1 CTDの目次（第2部から第5部）
2.1 - 38
巻／巻数 Listing of Serious Adverse Events – ID99-383
5.3.7.3.2 CLO-212 22 ／ 25
Listing of Serious Adverse Events - CLO-212
5.3.7.3.3 CLO-222 22 ／ 25
Listing of Serious Adverse Events – CLO-222
5.3.7.3.4 BIOV-111 22 ／ 25
Listing of Serious Adverse Events – BIOV-111
5.3.7.3.5 CLO05908 22 ／ 25
Listing of Serious Adverse Events – CLO05908
5.3.7.3.6 CLOAML10508 22 ／ 25
Listing of Serious Adverse Events – CLOAML10508
5.3.7.4 実施された臨床試験において臨床検査異常変動が観察された症例の
一覧表
22 - 24 ／ 25
5.3.7.4.1 ID99-383 22 ／ 25
Listing of Clinical Laboratory Abnormalities – ID99-383
5.3.7.4.2 CLO-212 23 ／ 25
Listing of Clinical Laboratory Abnormalities - CLO-212
5.3.7.4.3 CLO-222 24 ／ 25
Listing of Clinical Laboratory Abnormalities – CLO-222
5.3.7.4.4 BIOV-111 24 ／ 25
Listing of Clinical Laboratory Abnormalities – BIOV-111
5.3.7.4.5 CLO05908 24 ／ 25
Listing of Clinical Laboratory Abnormalities – CLO05908
5.3.7.4.6 CLOAML10508 24 ／ 25
Listing of Clinical Laboratory Abnormalities – CLOAML10508
5.4 参考文献
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5.4.2 松尾恵太郎、 新しい診断と治療のABC 急性白血病、第1章 概念・
分類と疫学、疫学．大野竜三 編．最新医学社． 2006:20-2.
25 ／ 25
5.4.3 木崎昌弘、カラーテキスト血液病学、第9章 造血器腫瘍と関連疾患
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25 ／ 25
エボルトラ点滴静注20mg モジュール2.1 CTDの目次（第2部から第5部）
2.1 - 39
巻／巻数
5.4.4 厚生労働省平成20年度患者調査、閲覧第4表、推計患者数、性 ×
傷病小分類別［白血病のみ］、政府統計の総合窓口
25 ／ 25
5.4.5 堀部敬三、厚生労働省科学研究費補助金 （効果的医療技術の確立推
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25 ／ 25
5.4.6 小児白血病・リンパ腫の診療ガイドライン 2007年版、各論 急性リ
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報告書, 平成17年10月31日
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エボルトラ点滴静注20mg モジュール2.1 CTDの目次（第2部から第5部）
2.1 - 40
巻／巻数 LB-115.
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