- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04813263
Undersøgelse af orale Venetoclax-tabletter til evaluering af uønskede hændelser og ændring i sygdomsaktivitet hos deltagere i alle aldre med akut myeloid leukæmi
En post-marketing observationsundersøgelse for Venetoclax hos patienter diagnosticeret med akut myeloid leukæmi i Japan
Akut myeloid leukæmi (AML) er en aggressiv og sjælden kræft i myeloidceller (en hvide blodlegeme, der er ansvarlig for at bekæmpe infektioner) og er den mest almindelige akutte leukæmi hos voksne. Denne undersøgelse vil vurdere, hvor sikker og effektiv oral venetoclax er hos deltagere med AML. Bivirkninger og ændringer i sygdomsaktivitet vil blive overvåget under rutinemæssig klinisk praksis.
Venetoclax er et godkendt lægemiddel til behandling af akut myeloid leukæmi (AML). Omkring 400 deltagere i alle aldre, der behandles med orale venetoclax-tabletter for AML i overensstemmelse med den godkendte etiket, vil blive tilmeldt undersøgelsen i hele Japan.
Deltagerne vil blive fulgt op til 52 uger efter den første dosis orale venetoclax-tabletter.
Der forventes ingen yderligere byrde for deltagerne i denne undersøgelse. Data vil blive indsamlet ved hjælp af oplysninger leveret af deltagende læger baseret på rutinemæssige lægejournaler.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Chiba, Japan, 260-0027
- Inoue Memorial Hospital /ID# 239351
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Chiba, Japan, 260-0042
- National Hospital Organization Chiba Medical Center /ID# 266755
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Fujisawa-shi, Japan, 251-8550
- Fujisawa City Hospital /ID# 239375
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Fukuoka-shi, Japan, 812-0033
- Harasanshin Hospital /ID# 240881
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Hachinohe-shi, Japan, 039-1104
- Hachinohe Red Cross Hospital /ID# 250850
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Hachioji, Japan, 192-0032
- Tokai University Hachioji Hospital /ID# 266804
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Higashihiroshima-shi, Japan, 739-0041
- Higashihiroshima Medical Center /ID# 250849
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Hiroshima, Japan, 734-8530
- Hiroshima Prefecture Hospital /ID# 252215
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Ikeda, Japan, 563-0025
- Ikeda City Hospital /ID# 266802
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Kawaguchi-shi, Japan, 333-0833
- Kawaguchi Municipal Medical Center /ID# 246080
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Kitakyushu-shi, Japan, 800-0257
- Kitakyusyu General Hospital /ID# 244212
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Mitaka, Japan, 181-8611
- Kyorin University - Mitaka Campus /ID# 243777
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Saiki-shi, Japan, 876-0857
- Nankai Medical Center /ID# 241914
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Saitama, Japan, 336-8522
- Saitama City Hospital /ID# 240567
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Sakata-shi, Japan, 998-0828
- Nihonkai General Hospital /ID# 242024
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Tachikawa, Japan
- Tachikawa Hospital /ID# 245878
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Takatsuki, Japan, 569-1045
- Takatsuki Red Cross Hospital /ID# 266756
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Tokyo, Japan, 140-8522
- Toshiba General Hospital /ID# 250294
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Toyama, Japan, 939-8511
- Toyama Hospital /ID# 243779
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Yamagata, Japan, 9978515
- Shonai Hospital /ID# 254514
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Aichi
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Anjo-shi, Aichi, Japan, 446-8602
- Anjou Kousei Hospital /ID# 244213
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Nagoya shi, Aichi, Japan, 467-8602
- Nagoya City University Hospital /ID# 256177
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Nagoya-shi, Aichi, Japan, 462-8508
- Nagoya City West Medical Center /ID# 250844
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Nagoya-shi, Aichi, Japan, 464-8681
- Aichi Cancer Center Hospital /ID# 243785
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Nagoya-shi, Aichi, Japan, 466-8650
- Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 242173
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Nagoya-shi, Aichi, Japan, 4668560
- Nagoya University Hospital /ID# 246009
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Obu-shi, Aichi, Japan, 474-8511
- National Center for Geriatrics and Gerontology /ID# 251683
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Toyohashi-shi, Aichi, Japan, 441-8570
- Toyohashi Municipal Hospital /ID# 243784
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Toyokawa-shi, Aichi, Japan, 442-8561
- Toyokawa City Hospital /ID# 242707
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Toyota-shi, Aichi, Japan, 471-8513
- Toyota Memorial Hospital /ID# 242175
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Akita
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Akita-shi, Akita, Japan, 010-0933
- Akita city Hospital /ID# 240008
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Odate-shi, Akita, Japan, 017-0885
- Odate Municipal General Hospital /ID# 258238
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Aomori
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Aomori-shi, Aomori, Japan, 030-8553
- Aomori Prefectural Central Hospital /ID# 249442
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Hirosaki-shi, Aomori, Japan, 036-8545
- National Hospital Organization Hirosaki General Medical Center /ID# 246008
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Chiba
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Asahi-shi, Chiba, Japan, 289-2511
- Asahi General Hospital /ID# 233889
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Chiba-shi, Chiba, Japan, 260-0852
- Chiba Aoba Municipal Hospital /ID# 240565
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Chiba-shi, Chiba, Japan, 260-8677
- Chiba University Hospital /ID# 246011
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Chiba-shi, Chiba, Japan, 260-8717
- Duplicate_Chiba Cancer Center /ID# 248122
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Ichihara City, Chiba, Japan, 290-0035
- KK Clinic Ichihara /ID# 250859
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Ichihara-shi, Chiba, Japan, 290-0003
- Chiba Rosai Hospital /ID# 238767
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Ichikawa-shi, Chiba, Japan, 272-0824
- Tokyo Dental College Ichikawa General Hospital /ID# 262626
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Inzai-shi, Chiba, Japan, 270-1613
- Nippon Medical Chiba Hokusoh Hospital /ID# 250297
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Kamogawa-shi, Chiba, Japan, 296-8602
- Kameda General Hospital /ID# 241877
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Kashiwa-shi, Chiba, Japan, 277-8567
- The Jikei University Kashiwa Hospital /ID# 259510
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Kashiwa-shi, Chiba, Japan, 277-8577
- National Cancer Center Hospital East /ID# 241917
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Kisarazu-shi, Chiba, Japan, 292-8535
- Kimitsu Chuo Hospital /ID# 248776
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Matsudo-shi, Chiba, Japan, 270-2251
- Chiba West General Hospital /ID# 262918
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Narashino-shi, Chiba, Japan, 275-0026
- Tsudanuma Central General Hospital /ID# 245890
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Narita-shi, Chiba, Japan, 286-8523
- Japanese Red Cross Narita Hospital /ID# 243775
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Narita-shi, Chiba, Japan, 2868520
- IUHW Narita Hospital /ID# 240574
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Narshino-shi, Chiba, Japan, 275-8580
- Chibaken Saiseikai Narashino Hospital /ID# 254491
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Sakura-shi, Chiba, Japan, 285-8741
- Toho University Sakura Medical Center /ID# 252187
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Ehime
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Matsuyama City, Ehime, Japan, 108-0073
- Watanabe Hospital /ID# 254476
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Matsuyama-shi, Ehime, Japan, 790-0024
- Ehime Prefectural Central Hospital /ID# 261348
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Matsuyama-shi, Ehime, Japan, 790-0067
- Matsuyama Shimin Hospital /ID# 243050
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Matsuyama-shi, Ehime, Japan, 791-0280
- National Hospital Organization Shikoku Cancer Center /ID# 242171
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Toon-shi, Ehime, Japan, 791-0295
- Ehime University Hospital /ID# 244207
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Fukui
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Fukui-shi, Fukui, Japan, 918-8503
- Fukuiken Saiseikai Hospital /ID# 245062
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Fukui-shi, Fukui, Japan, 918-8503
- Fukuiken Saiseikai Hospital /ID# 246005
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Fukuoka
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Fukuoka shi, Fukuoka, Japan, 810-8563
- National Hospital Organization Kyushu Medical Center /ID# 242026
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Fukuoka-shi, Fukuoka, Japan, 810-0001
- Saiseikai Fukuoka Genaral Hospital /ID# 255193
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Fukuoka-shi, Fukuoka, Japan, 811-0213
- Fukuoka Wajiro Hospital /ID# 238755
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Fukuoka-shi, Fukuoka, Japan, 811-1395
- National Hospital Organization Kyushu Cancer Center /ID# 244217
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Fukuoka-shi, Fukuoka, Japan, 812-8582
- Kyushu University Hospital /ID# 248781
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Fukuoka-shi, Fukuoka, Japan, 814-0180
- Fukuoka University Hospital /ID# 244214
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Fukuoka-shi, Fukuoka, Japan, 815-8555
- Japanese Red Cross Fukuoka Hospital /ID# 241181
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Fukuoka-shi, Fukuoka, Japan, 819-0032
- Murakami Karindoh Hospital /ID# 256179
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Iizuka, Fukuoka, Japan, 820-8505
- Aso Iizuka Hospital /ID# 266806
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Kitakyusyu-shi, Fukuoka, Japan, 802-8533
- NHO Kokura Medical Center /ID# 257008
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Kitakyusyu-shi, Fukuoka, Japan, 808-0024
- Wakamatsu Hospital /ID# 251728
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Kurume City, Fukuoka, Japan, 830-0033
- Shinkoga Hospital /ID# 248786
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Kurume-shi, Fukuoka, Japan, 830-0011
- Kurume University Hospital /ID# 240885
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Kurume-shi, Fukuoka, Japan, 830-8543
- St. Mary's Hospital /ID# 242332
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Omuta-shi, Fukuoka, Japan, 836-0861
- Omuta City Hospital /ID# 246823
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Yanagawa-shi, Fukuoka, Japan, 832-0059
- Nagata Hospital /ID# 256180
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Fukushima
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Date-shi, Fukushima, Japan, 960-0502
- Kita Fukushima Medical Center /ID# 250296
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Fukushima-shi, Fukushima, Japan, 960-8163
- Fukushima Minami Cardiovascular Hospital /ID# 252216
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Iwaki-shi, Fukushima, Japan, 972-8322
- Tokiwakai Jyoban Hospital /ID# 257007
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Iwaki-shi, Fukushima, Japan, 973-8555
- Iwaki Kyoritsu General Hospital /ID# 260209
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Koriyama-shi, Fukushima, Japan, 963-8558
- Ohta Nishinouchi Hospital /ID# 243052
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Shirakawa-shi, Fukushima, Japan, 961-0005
- Shirakawa Kosei General Hosp. /ID# 245815
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Gifu
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Gifu-shi, Gifu, Japan, 500-8513
- Gifu Municipal Hospital /ID# 241156
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Gifu-shi, Gifu, Japan, 501-1194
- Gifu University Hospital /ID# 241183
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Gifu-shi, Gifu, Japan, 502-8511
- Gifu Red Cross Hospital /ID# 240562
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Ogaki-shi, Gifu, Japan, 503-8502
- Ogaki Municipal Hospital /ID# 239353
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高山市, Gifu, Japan, 506-0025
- Japanese Red Cross Takayama Hospital /ID# 240568
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Gunma
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Fujioka-shi, Gunma, Japan, 375-0015
- Fujioka General Hospital /ID# 255196
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Maebashi-shi, Gunma, Japan, 371-0821
- Gunmaken Saiseikai Maebashi Hospital /ID# 239383
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Ota-shi, Gunma, Japan, 373-8550
- Gunma Prefectural Cancer Center /ID# 242177
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Shibukawa-shi, Gunma, Japan, 377-0280
- National Hospital Organization Shibukawa Medical Center /ID# 245026
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Tatebayashi-shi, Gunma, Japan, 374-0055
- Tatebayashi Kosei General Hospital /ID# 252188
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Hiroshima
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Hiroshima-shi, Hiroshima, Japan, 730-8619
- Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 240880
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Mihara, Hiroshima, Japan, 723-0014
- Mihara Shiromachi Hospital /ID# 246754
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Otake-shi, Hiroshima, Japan, 739-0696
- NHO Hiroshima-Nishi Medical center /ID# 238766
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Hokkaido
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Kitami-shi, Hokkaido, Japan, 090-0026
- Kitami Red Cross Hospital /ID# 251065
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Muroran-shi, Hokkaido, Japan, 050-0076
- Steel Memorial Muroran Hospita /ID# 231383
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Obihiro-shi, Hokkaido, Japan, 080-0024
- Obihiro kosei Hospital /ID# 252218
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Sapporo, Hokkaido, Japan, 003-0803
- Homecareclinicn-Consept /Id# 239377
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Sapporo, Hokkaido, Japan, 065-0012
- Tenshi Hospital /ID# 243051
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Sapporo-shi, Hokkaido, Japan, 003-0006
- Sapporo Hokuyu Hospital /ID# 250856
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Sapporo-shi, Hokkaido, Japan, 003-0804
- Hokkaido Cancer Center /ID# 249441
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Sapporo-shi, Hokkaido, Japan, 004-0052
- Sapporo Hokushin Hospital /ID# 241878
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Sapporo-shi, Hokkaido, Japan, 060-0033
- Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 249446
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Sapporo-shi, Hokkaido, Japan, 060-8543
- Sapporo Medical University Hospital /ID# 252217
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Sapporo-shi, Hokkaido, Japan, 060-8648
- Hokkaido University Hospital /ID# 244223
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Sapporo-shi, Hokkaido, Japan, 064-0804
- Aiiku Hospital /ID# 239047
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Sunagawa, Hokkaido, Japan, 073-0164
- Sunagawa City Medical Center /ID# 239382
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Wakkanai City, Hokkaido, Japan, 097-0022
- Wakkanai City Hospital /ID# 243782
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札幌市, Hokkaido, Japan, 004-0831
- Sapporo Kiyota Hospital /ID# 231385
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Hyogo
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Ako-shi, Hyogo, Japan, 678-0241
- Ako Central Hospital /ID# 239721
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Amagasaki-shi, Hyogo, Japan, 660-8550
- Hyogo Prefectural Amagasaki General Medical Center /ID# 239355
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Itami-shi, Hyogo, Japan, 6640006
- Itami City Hospital /ID# 233888
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Kobe-shi, Hyogo, Japan, 650-0047
- Hyogo Prefectural Kobe Children's Hospital /ID# 245817
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Kobe-shi, Hyogo, Japan, 650-0047
- Kobe City Medical Center General Hospital /ID# 246010
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Kobe-shi, Hyogo, Japan, 651-0072
- Shinko Hospital /ID# 233782
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Kobe-shi, Hyogo, Japan, 658-0064
- Konan Medical Center /ID# 246079
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Nishinomiya-shi, Hyogo, Japan, 662-0918
- Hyogo?Prefectural?Nishinomiya Hospital /ID# 239354
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Nishinomiya-shi, Hyogo, Japan, 663-8501
- Hyogo Medical University Hospital /ID# 240569
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Ono-shi, Hyogo, Japan, 675-1327
- Kita-harima Medical Center /ID# 254490
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Tamba-shi, Hyogo, Japan, 669-3464
- Hyogo Prefectural Tamba Medical Center /ID# 240884
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Tanbasasayama-shi, Hyogo, Japan, 669-2321
- Hyogo College of Medicine Sasayama Medical Center /ID# 240888
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洲本市, Hyogo, Japan, 656-0021
- Hyogo Prefectural Awaji Medical Center /ID# 240823
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Ibaraki
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Higashi Ibaraki-gun, Ibaraki, Japan, 311-3193
- National Hospital Organization Mito Medical Center /ID# 239719
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Hitachi-shi, Ibaraki, Japan, 317-0077
- Hitachi General Hospital /ID# 239376
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Toride-shi, Ibaraki, Japan, 302-0022
- JA Toride Medical Center /ID# 240573
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Tsukuba-shi, Ibaraki, Japan, 305-8576
- University of Tsukuba Hospital /ID# 242023
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Ishikawa
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Kanazawa-Shi, Ishikawa, Japan, 920-0013
- JCHO Kanazawa Hospital /ID# 239379
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Iwate
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Oshu-shi, Iwate, Japan, 0230864
- Iwate Prefectural Isawa Hospital /ID# 246819
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Shiwa-gun, Iwate, Japan, 028-3695
- Iwate Medical University Hospital /ID# 251009
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Kagawa
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Sakaide City, Kagawa, Japan, 7620043
- Sakaide City Hospital /ID# 240563
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Kagoshima
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Kagoshima-shi, Kagoshima, Japan, 890-0051
- Imakiire General Hospital /ID# 258237
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Kagoshima-shi, Kagoshima, Japan, 890-0064
- Imamura General Hospital /ID# 234006
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Kanoya-shi, Kagoshima, Japan, 893-0024
- Medical Corporation Seijinkai Ikeda Hospital /ID# 242174
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Kanagawa
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CHIGASAKI-shi, Kanagawa, Japan, 253-0083
- Shonan Tobu Sogo Hospital /ID# 241913
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Kamakura-shi, Kanagawa, Japan, 247-8533
- Shonan Kamakura General Hospital /ID# 243053
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Kawasaki, Kanagawa, Japan, 213-8507
- Teikyo University Mizonokuchi Hospital /ID# 244842
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Kawasaki-shi, Kanagawa, Japan, 2100013
- Kawasaki Municipal Hospital /ID# 241162
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Kawasaki-shi, Kanagawa, Japan, 211-8510
- Japan Organization of Occupational Health and Society Kanto Rosai Hospital /ID# 255195
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Kawasaki-shi, Kanagawa, Japan, 213-8587
- Toranomon Hospital Kajigaya /ID# 256186
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Yokohama, Kanagawa, Japan, 241-0811
- St. Marianna University School of Medicine Yokohama City Seibu Hospital /ID# 266803
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Yokohama shi, Kanagawa, Japan, 232-0024
- Yokohama City University Medical Center /ID# 248777
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Yokohama-shi, Kanagawa, Japan, 234-8503
- Saiseikai Yokohamashi Nanbu Hospital /ID# 247955
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Yokohama-shi, Kanagawa, Japan, 241-8515
- Kanagawa Cancer Center /ID# 246822
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Kochi
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高知市, Kochi, Japan, 781-0111
- Kochi Health Sciences Center /ID# 241182
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Kumamoto
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Kumamoto shi, Kumamoto, Japan, 8608556
- Kumamoto University Hospital /ID# 239720
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Kumamoto-shi, Kumamoto, Japan, 860-0008
- National Hospital Organization Kumamoto Medical Center /ID# 240886
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Kumamoto-shi, Kumamoto, Japan, 862-8655
- Kumamoto Shinto General Hospital /ID# 242176
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Kumamoto-shi,Kumamoto, Kumamoto, Japan, 862-8505
- Kumamoto City Hospital /ID# 254494
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Tamana-shi, Kumamoto, Japan, 865-0005
- Kumamoto Kenhoku Hospital /ID# 258240
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Uki, Kumamoto, Japan, 869-0524
- Kumamoto Minami National Hospital /ID# 242169
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Yatsushiro City, Kumamoto, Japan, 866-0856
- JCHO Kumamoto General Hospital /ID# 248779
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Kyoto
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Kyoto-shi, Kyoto, Japan, 602-8566
- University Hospital Kyoto Prefectural University of Medicine /ID# 244843
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Kyoto-shi, Kyoto, Japan, 603-8151
- JCHO Kyoto Kuramaguchi Medical /ID# 248775
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Kyoto-shi, Kyoto, Japan, 605-0981
- Japanese Red Cross Kyoto Daiichi Hosital /ID# 248124
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Kyoto-shi, Kyoto, Japan, 606-8507
- Kyoto University Hospital /ID# 244844
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Kyoto-shi, Kyoto, Japan, 612-8555
- National Hospital Organization Kyoto Medical Center /ID# 239092
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Uji-shi, Kyoto, Japan, 611-0042
- Uji Tokushukai Medical Center /ID# 241876
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Mie
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津市, Mie, Japan, 514-0031
- Takeuchi Hospital /ID# 238750
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Miyagi
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Natori-shi, Miyagi, Japan, 981-1293
- Miyagi Cancer Center /ID# 241879
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Osaki-shi, Miyagi, Japan, 989-6183
- Osaki Citizen Hospital /ID# 249447
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Sendai-shi, Miyagi, Japan, 980-0011
- Miyagi Chuo Hospital /ID# 259511
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Sendai-shi, Miyagi, Japan, 9808574
- Tohoku University Hospital /ID# 243757
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Sendai-shi, Miyagi, Japan, 983-8520
- National Hospital Organization Sendai Medical Center /ID# 239384
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Miyazaki
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Miyazaki-shi, Miyazaki, Japan, 880-8510
- Miyazaki Prefectural Miyazaki Hospital /ID# 251730
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Miyazaki-shi, Miyazaki, Japan, 8800041
- Koga General Hospital /ID# 248120
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Miyazaki-shi, Miyazaki, Japan, 889-1692
- University of Miyazaki Hospital /ID# 248805
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Nabeoka-shi, Miyazaki, Japan, 882-0835
- Miyazaki Prefectural Nobeoka Hospital /ID# 248715
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Nagasaki
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Goto-shi, Nagasaki, Japan, 853-0031
- Nagasaki Goto Chuoh Hospital /ID# 239723
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Nagasaki-shi, Nagasaki, Japan, 852-8104
- Jap Red Cross Nagasaki Genbaku /ID# 245029
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Nagasaki-shi, Nagasaki, Japan, 852-8501
- Nagasaki University Hospital /ID# 245028
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Omura-shi, Nagasaki, Japan, 856-8562
- NHO Nagasaki Medical Center /ID# 240571
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Sasebo-shi, Nagasaki, Japan, 857-0056
- Sasebo City General Hospital /ID# 238759
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Nara
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Ikoma-shi, Nara, Japan, 630-0227
- Nara Hospital Kinki University Faculty of Medicine, /ID# 250295
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Kashihara-shi, Nara, Japan, 634-8522
- Nara Medical University Hospital /ID# 251726
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Nara-shi, Nara, Japan, 630-8054
- Nara Prefecture General Medical Center /ID# 254492
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Tenri-shi, Nara, Japan, 632-8552
- Tenri Hospital /ID# 250855
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Niigata
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Niigata-shi, Niigata, Japan, 951-8520
- Niigata University Medical & Dental Hospital /ID# 245027
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Oita
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Beppu-shi, Oita, Japan, 874-0011
- National Hospital Organization Beppu Medical Center /ID# 247894
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Beppu-shi, Oita, Japan, 874-0838
- Kyushu University Beppu Hospital /ID# 249444
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Oita City, Oita, Japan, 870-1133
- Almeida Memorial Hospital /ID# 241916
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Oita-shi, Oita, Japan, 870-0854
- Oita Memorial Hospital /ID# 246818
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Oita-shi, Oita, Japan, 870-0855
- Oita Prefectural Hospital /ID# 243786
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Yufu City, Oita, Japan, 879-5503
- Oita University Hospital /ID# 261976
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Okayama
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Kurashiki-shi, Okayama, Japan, 701-0192
- Kawasaki Medical School Hospital /ID# 242709
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Kurashiki-shi, Okayama, Japan, 710-8602
- Kurashiki Central Hospital /ID# 244205
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Maniwa, Okayama, Japan, 719-3105
- Kaneda Hospital /ID# 238757
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Okayama-shi, Okayama, Japan, 700-8558
- Duplicate_Okayama University Hospital /ID# 240887
-
Okayama-shi, Okayama, Japan, 700-8558
- Duplicate_Okayama University Hospital /ID# 243755
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Okayama-shi, Okayama, Japan, 700-8607
- Japanese Red Cross Okayama Hospital /ID# 240879
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Okayama-shi, Okayama, Japan, 701-1192
- Okayama Medical Center /ID# 243759
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-
Okinawa
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Naha, Okinawa, Japan, 902-0061
- Naha City Hospital /ID# 242027
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Nakagami-gun, Okinawa, Japan, 903-0215
- University of the Ryukyus Hospital /ID# 246821
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Okinawa-shi, Okinawa, Japan, 904-2195
- Nakagami Hospital /ID# 243787
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Osaka
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Habikino-shi, Osaka, Japan, 583-0872
- Shiroyama Hospital /ID# 246762
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Hirakata-shi, Osaka, Japan, 573-1191
- Kansai Medical University Hospital /ID# 246820
-
Izumi-Shi, Osaka, Japan, 594-1101
- Osaka Women's and Children's Hospital /ID# 266805
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Izumi-shi, Osaka, Japan, 594-0073
- Izumi City General Hospital /ID# 253204
-
Kishiwada-shi, Osaka, Japan, 596-8501
- Kishiwada City Hospital /ID# 234002
-
Kita-ku, Osaka, Japan, 530-0005
- Sumitomo Hospital /ID# 243774
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Neyagawa City, Osaka, Japan, 572-0022
- Seijukai Hospital /ID# 248788
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Osaka-shi, Osaka, Japan, 530-0012
- Osaka Saiseikai Nakatsu Hospital /ID# 244209
-
Osaka-shi, Osaka, Japan, 530-8480
- Kitano Hospital /ID# 248785
-
Osaka-shi, Osaka, Japan, 534-0021
- Osaka City General Hospital /ID# 244210
-
Osaka-shi, Osaka, Japan, 540-0006
- National Hospital Organization Osaka National Hospital /ID# 238764
-
Osaka-shi, Osaka, Japan, 540-0008
- Otemae Hospital /ID# 250857
-
Osaka-shi, Osaka, Japan, 541-8567
- Osaka International Cancer Institute /ID# 248783
-
Osaka-shi, Osaka, Japan, 543-8555
- Japanese Red Cross Osaka Hospi /ID# 248784
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Osaka-shi, Osaka, Japan, 543-8922
- Daini Osaka Police Hospital /ID# 240560
-
Osaka-shi, Osaka, Japan, 545-8586
- Osaka Metropolitan University Hospital /ID# 253203
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Osaka-shi, Osaka, Japan, 550-0006
- Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 243783
-
Osakasayama-shi, Osaka, Japan, 589-8511
- Kindai University Hospital /ID# 250851
-
Takatsuki-shi, Osaka, Japan, 569-8686
- Osaka Medical and Pharmaceutical University Hospital /ID# 249440
-
Yao City, Osaka, Japan, 581-0011
- Yao Tokushukai General Hospital /ID# 247884
-
東大阪市, Osaka, Japan, 579-8026
- Ishikiriseiki Hospital /ID# 246077
-
泉大津市, Osaka, Japan, 595-0006
- Hara Hospital /ID# 244846
-
-
Saga
-
Saga-shi, Saga, Japan, 840-8571
- Saga Medical Center Koseikan /ID# 245816
-
-
Saitama
-
Ageo-shi, Saitama, Japan, 362-8588
- Ageo Central General Hospital /ID# 254515
-
Asaka-shi, Saitama, Japan, 351-0023
- TMG Asaka Medical Center /ID# 238761
-
Fujimino City, Saitama, Japan, 356-0011
- Kamifukuoka General Hospital /ID# 247890
-
Kuki-shi, Saitama, Japan, 346-0021
- Shinkuki General Hospital /ID# 254516
-
Saitama-shi, Saitama, Japan, 331-0054
- Saitama Citizens Medical Center /ID# 252573
-
Wako-shi, Saitama, Japan, 351-0102
- NHO Saitama National Hospital /ID# 245061
-
-
Shiga
-
Kusatsu-shi, Shiga, Japan, 525-0066
- Omi Medical Center /ID# 258233
-
Ritto, Shiga, Japan, 520-3046
- Saiseikai Shiga Hospital /ID# 239381
-
-
Shimane
-
Hamada City, Shimane, Japan, 697-0022
- National Hospital Organization Hamada Medical Center /ID# 250858
-
Izumo-shi, Shimane, Japan, 693-8501
- Shimane University Hospital /ID# 255194
-
Izumo-shi, Shimane, Japan, 693-8555
- Shimane Prefectural Central Ho /ID# 247895
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Masuda-shi, Shimane, Japan, 698-0003
- Masuda Red Cross Hospital /ID# 248780
-
-
Shizuoka
-
Shizuoka-shi, Shizuoka, Japan, 422-8527
- Shizuoka Saiseikai Genaral Hospital /ID# 239722
-
-
Tochigi
-
Shimotsuga-gun, Tochigi, Japan, 321-0293
- Duplicate_Dokkyo Medical University Hospital /ID# 246764
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Shimotsuke City, Tochigi, Japan, 329-0502
- Ishibashi General Hospital /ID# 243762
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Utsunomiya-shi, Tochigi, Japan, 320-0834
- Tochigi Cancer Center /ID# 249445
-
-
Tokushima
-
Anan-shi, Tokushima, Japan, 774-0045
- Anan Medical Center /ID# 243781
-
Naruto-shi, Tokushima, Japan, 772-0001
- Tokushima Prefecture Naruto Hospital /ID# 239095
-
Tokushima-shi, Tokushima, Japan, 770-8503
- Tokushima University Hospital /ID# 252572
-
-
Tokyo
-
Bei Qu, Tokyo, Japan, 114-0001
- Meirikai Chuo General Hospital /ID# 238751
-
Bunkyo-ku, Tokyo, Japan, 113-8431
- Juntendo University Hospital /ID# 239096
-
Bunkyo-ku, Tokyo, Japan, 113-8519
- Tokyo Medical And Dental University Hospital /ID# 242178
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Chuo-ku, Tokyo, Japan, 104-8560
- St.Luke's International Hospital /ID# 248787
-
Edogawa Ward, Tokyo, Japan, 133-0052
- Medical Plaza Edogawa /ID# 244220
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Edogawa-ku, Tokyo, Japan, 133-0052
- Edogawa Hospital /ID# 239352
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Fuchu, Tokyo, Japan, 183-8524
- Tama Medical Center /ID# 247954
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Fuchu City, Tokyo, Japan, 183-8524
- Tokyo Metropolitan Children's Medical Center /ID# 252189
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Fussa, Tokyo, Japan, 1970012
- Fussa Hospital /ID# 240570
-
Higashimurayama-shi, Tokyo, Japan, 189-8511
- Tama-Hokubu Medical Center /ID# 245879
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Itabashi-ku, Tokyo, Japan, 173-0015
- Tokyo Metropolitan Geriatric /ID# 249448
-
Itabashi-ku, Tokyo, Japan, 173-8606
- Duplicate_Teikyo University Hospital /ID# 247896
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Kodaira, Tokyo, Japan, 187-8510
- Showa General Hospital /ID# 258235
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Koto-ku, Tokyo, Japan, 135-8550
- Duplicate_The Cancer Institute Hospital Of JFCR /ID# 244216
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Meguro-ku, Tokyo, Japan, 153-0051
- Mishuku Hospital /ID# 239378
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Meguro-ku, Tokyo, Japan, 1538581
- Kosei Chuo General Hospital /ID# 251011
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Minato-ku, Tokyo, Japan, 105-8470
- Toranomon Hospital /ID# 251010
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Musashino-shi, Tokyo, Japan, 180-8610
- Japanese Red Cross Musashino Hospital /ID# 246765
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Nerima-ku, Tokyo, Japan, 177-0033
- Juntendo Univ Nerima Hospital /ID# 250292
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Ome, Tokyo, Japan, 198-0042
- P_Ome Municipal General Hospital /ID# 248778
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Setagaya Ward, Tokyo, Japan, 156-0052
- Metropolitan Research and Treatment Center for Blood Disorders /ID# 231384
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Setagaya-ku, Tokyo, Japan, 157-8535
- National Center for Child Health and Development /ID# 243778
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Shibuya-ku, Tokyo, Japan, 150-8935
- Japanese Red Cross Medical Center /ID# 239385
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Shinagawa-ku, Tokyo, Japan, 141-8625
- NTT Medical Center Tokyo /ID# 240566
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Shinjuku-ku, Tokyo, Japan, 160-0023
- Tokyo Medical University Hospital /ID# 252571
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Shinjuku-ku, Tokyo, Japan, 162-8655
- Center hospital of the National Center for Global Health and Medicine /ID# 256189
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Suginami-ku, Tokyo, Japan, 166-8588
- Kawakita General Hospital /ID# 257009
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Sumida-ku, Tokyo, Japan, 130-8575
- Tokyo Metropolitan Bokutoh Hospital /ID# 241912
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Sumida-ku, Tokyo, Japan, 1308587
- The Fraternity Memorial Hospital /ID# 251685
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Taito, Tokyo, Japan, 110-0015
- Eiju General Hospital /ID# 243763
-
板橋区, Tokyo, Japan, 173-0015
- Toshima Hospital /ID# 240878
-
-
Tottori
-
Tottori-shi, Tottori, Japan, 680-0901
- Tottori Prefectural Central Ho /ID# 245877
-
Yonago-shi, Tottori, Japan, 683-0006
- Yonago Medical Center /ID# 240572
-
Yonago-shi, Tottori, Japan, 683-8504
- Tottori University Hospital /ID# 244215
-
-
Toyama
-
Kurobe-shi, Toyama, Japan, 938-8502
- Kurobe City Hospital /ID# 254493
-
-
Wakayama
-
Kinokawa City, Wakayama, Japan, 649-6414
- Naga municipal Hospital /ID# 250259
-
Tanabe-shi, Wakayama, Japan, 646-0011
- Social Insurance Kinan Hosp /ID# 251684
-
Wakayama-shi, Wakayama, Japan, 640-8505
- Wakayama Rosai Hospital /ID# 250293
-
海南市, Wakayama, Japan, 642-0002
- Kainan Medical Center /ID# 240825
-
-
Yamagata
-
Higashiokitama-gun, Yamagata, Japan, 992-0601
- Okitama Public General Hospital /ID# 242710
-
Yamagata-shi, Yamagata, Japan, 990-9585
- Yamagata University Hospital /ID# 246763
-
-
Yamaguchi
-
Iwakuni-shi, Yamaguchi, Japan, 740-8510
- NHO Iwakuni Clinical Center /ID# 242170
-
Shunan-shi, Yamaguchi, Japan, 745-8522
- Tokuyama Central Hospital /ID# 242380
-
Ube-shi, Yamaguchi, Japan, 755-8505
- Yamaguchi University Hospital /ID# 245060
-
Yamaguchi City, Yamaguchi, Japan, 754-0002
- Ogori Daiichi General Hospital /ID# 246761
-
-
Yamanashi
-
Chuo-shi, Yamanashi, Japan, 409-3821
- University of Yamanashi Hospital /ID# 246006
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inklusionskriterier:
- Alle deltagere, der får venetoclax til behandling af AML.
Ekskluderingskriterier:
Ingen
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
---|
Deltagere behandlet med Venetoclax
Deltagere, der får venetoclax til behandling af AML under rutinemæssig klinisk praksis.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Procentdel af deltagere med ≥ grad 3 neutropeni af Venetoclax-regimer med uegnet akut myeloid leukæmi (AML)
Tidsramme: Op til 52 uger.
|
Procentdel af deltagere med en høj grad (≥ grad 3) protokol specificerede neutropeni under og efter behandling med venetoclax.
|
Op til 52 uger.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Procentdel af deltagere med febril neutropeni og trombocytopeni
Tidsramme: Op til 52 uger
|
Procentdel af deltagere med protokol specificeret febril neutropeni og trombocytopeni under og efter behandling med venetoclax.
|
Op til 52 uger
|
Procentdel af deltagere med Tumor Lysis Syndrome (TLS)
Tidsramme: Op til 52 uger
|
Procentdel af deltagere med protokol specificeret TLS under og efter behandling med venetoclax.
|
Op til 52 uger
|
Procentdel af rapporterede deltagere >= Grad 3 bivirkninger (AE)/bivirkninger (ADR)
Tidsramme: Op til 52 uger
|
Grad 3 og derover AE/ADR er alvorlige bivirkninger (SAE), som resulterer i død, er livstruende, kræver eller forlænger hospitalsindlæggelse, resulterer i en medfødt anomali, vedvarende eller betydelig invaliditet/inhabilitet eller er en vigtig medicinsk hændelse, der baseret på på medicinsk bedømmelse, kan bringe emnet i fare og kan kræve medicinsk eller kirurgisk indgreb for at forhindre nogen af de udfald, der er anført ovenfor.
|
Op til 52 uger
|
Procentdel af deltagere rapporterede bivirkninger (AE)/bivirkninger (ADR)
Tidsramme: Op til 52 uger
|
En uønsket hændelse (AE) er defineret som enhver uønsket medicinsk hændelse i en patient eller klinisk forsøgsperson, der har administreret et farmaceutisk produkt, og som ikke nødvendigvis har en årsagssammenhæng med denne behandling.
Investigatoren vurderede forholdet mellem hver hændelse og brugen af undersøgelseslægemidlet som enten definitivt relateret, sandsynligvis relateret, muligvis relateret eller ikke-relateret.
|
Op til 52 uger
|
Procentdel af deltagere med AE/ADR, når de bruges samtidig med CYP3A-hæmmere eller vækstkolonistimulerende faktor (G-CSF)
Tidsramme: Op til 52 uger
|
En uønsket hændelse (AE) er defineret som enhver uønsket medicinsk hændelse i en patient eller klinisk forsøgsperson, der har administreret et farmaceutisk produkt, og som ikke nødvendigvis har en årsagssammenhæng med denne behandling.
Investigatoren vurderede forholdet mellem hver hændelse og brugen af undersøgelseslægemidlet som enten definitivt relateret, sandsynligvis relateret, muligvis relateret eller ikke-relateret.
|
Op til 52 uger
|
Procentdel af deltagere med sammensat fuldstændig remissionsrate (CR + CRi)
Tidsramme: Op til 52 uger
|
Composite Complete Remission (CRc) er defineret som Complete Remission (CR) + CRi (CR med ufuldstændig gendannelse af blodtal) baseret på protokolkriterier.
|
Op til 52 uger
|
Mediantid til bedste respons
Tidsramme: Op til 52 uger.
|
Tid til bedste respons måles som tiden i måneder fra den første dosis af undersøgelsesbehandlingen til datoen for den første dokumenterede dokumentation for et bekræftet respons med delvist respons (PR) eller bedre.
|
Op til 52 uger.
|
Median behandlingsvarighed
Tidsramme: Op til 52 uger
|
Mediantid for varigheden af oral venetoclax-behandling hos deltagere med akut myeloid leukæmi.
|
Op til 52 uger
|
Median samlet overlevelse
Tidsramme: Op til 52 uger
|
Tid fra datoen for første orale Venetoclax-indtagelse til datoen for dødsfald uanset årsag.
|
Op til 52 uger
|
Medianvarighed af sammensat fuldstændig remission
Tidsramme: Op til 52 uger
|
Tid fra datoen for første orale Venetoclax-indtagelse og datoen for vurderingen, der har dokumenteret fuldstændig remission med ufuldstændig hæmatologisk genopretning (CRi).
|
Op til 52 uger
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: ABBVIE INC., AbbVie
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- P20-408
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Akut myeloid leukæmi (AML)
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Elucida OncologyTherapeutic Advances in Childhood Leukemia and Lymphoma (TACL)Trukket tilbageAkut myeloid leukæmi | AML, barndom | Recidiverende pædiatrisk AML | Refraktær Pædiatrisk AML
-
Maximilian Stahl, MDSyndax PharmaceuticalsIkke rekrutterer endnuAkut myeloid leukæmi | Leukæmi | AML | AML, voksen | AML med genmutationerForenede Stater
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Goethe UniversityAfsluttet
-
Daiichi Sankyo, Inc.AfsluttetAMLForenede Stater, Korea, Republikken, Taiwan, Det Forenede Kongerige, Frankrig, Australien, Spanien, Italien, Canada, Singapore, Tyskland, Holland, Hong Kong, Belgien, Kroatien, Tjekkiet, Ungarn, Polen, Serbien
-
Gemin XAfsluttetAMLForenede Stater, Canada
-
French Innovative Leukemia OrganisationAcute Leukemia French AssociationRekrutteringAML, voksen | Tilbagefaldende voksen AML | Ildfast AML | FLT3-TKD mutation | FLT3-ITDFrankrig
-
Grupo Argentino de Tratamiento de la Leucemia AgudaAfsluttet
-
Zhejiang ACEA Pharmaceutical Co. Ltd.Rekruttering
-
AvenCell Europe GmbHGCP-Service International Ltd. & Co. KGAfsluttetAkut myeloid leukæmi | Tilbagefaldende AML | Ildfast AMLTyskland
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.RekrutteringNydiagnosticeret akut myeloid leukæmi (AML)Kina