Agrylin Drug Use-Result Survey

May 25, 2022 updated by: Takeda

Agrylin Capsules 0.5 mg Drug Use-Result Survey

The objective of this survey is to collect data to evaluate the safety and efficacy of anagrelide hydrochloride in the post-marketing phase in participants diagnosed with Essential Thrombocythemia (ET).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Anagrelide hydrochloride Drug Use-Result Survey

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1826

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi
      • Gamagori-city, Aichi, Japan, 443-0004
        • Gamagori-city
      • Handa-city, Aichi, Japan, 475-0817
        • Handa City
      • Hekinan-city, Aichi, Japan, 447-0084
        • Hekinan-city
      • Ichinomiya-city, Aichi, Japan, 491-0036
        • Ichinomiya-city
      • Ichinomiya-city, Aichi, Japan, 491-0041
        • Ichinomiya-city
      • Ichinomiya-city, Aichi, Japan, 491-0859
        • Ichinomiya-city
      • Komaki-city, Aichi, Japan, 485-0044
        • Komaki-city
      • Nagakute-city, Aichi, Japan, 480-1103
        • Nagakute-city
      • Nagoya-city, Aichi, Japan, 453-0801
        • Nagoya-city
      • Nagoya-city, Aichi, Japan, 457-0818
        • Nagoya-city
      • Nagoya-city, Aichi, Japan, 460-0001
        • Nagoya-city
      • Nagoya-city, Aichi, Japan, 464-0808
        • Nagoya-city
      • Nagoya-city, Aichi, Japan, 466-0065
        • Nagoya-city
      • Nagoya-city, Aichi, Japan, 466-0814
        • Nagoya-city
      • Nagoya-city, Aichi, Japan, 467-0001
        • Nagoya-city
      • Nagoya-city, Aichi, Japan, 468-0011
        • Nagoya-city
      • Nishio-city, Aichi, Japan, 445-0071
        • Nishio-city
      • Obu-city, Aichi, Japan, 474-0038
        • Obu-city
      • Okazaki-city, Aichi, Japan, 444-0002
        • Okazaki-city
      • Seto-city, Aichi, Japan, 489-0065
        • Seto-city
      • Toyoake-city, Aichi, Japan, 470-1101
        • Toyoake-city
      • Toyohashi-city, Aichi, Japan, 440-0801
        • Toyohashi-city
      • Toyohashi-city, Aichi, Japan, 440-0836
        • Toyohashi-city
      • Toyota-city, Aichi, Japan, 471-0821
        • Toyota-city
    • Akita
      • Akita-city, Akita, Japan, 010-0012
        • Akita-city
      • Akita-city, Akita, Japan, 010-0852
        • Akita-city
      • Akita-city, Akita, Japan, 010-0933
        • Akita-city
      • Akita-city, Akita, Japan, 011-0948
        • Akita-city
      • Noshiro-city, Akita, Japan, 016-0014
        • Noshiro-city
      • Yurihonjo-city, Akita, Japan, 015-0051
        • Yurihonjo-city
    • Aomori
      • Aomori-city, Aomori, Japan, 030-0913
        • Aomori-city
      • Hachinohe-city, Aomori, Japan, 031-0822
        • Hachinohe-city
      • Hachinohe-city, Aomori, Japan, 039-1104
        • Hachinohe-city
    • Chiba
      • Asahi-city, Chiba, Japan, 289-2511
        • Asahi-city
      • Chiba-city, Chiba, Japan, 260-0026
        • Chiba-city
      • Chiba-city, Chiba, Japan, 260-0027
        • Chiba-city
      • Chiba-city, Chiba, Japan, 260-0801
        • Chiba-city
      • Chiba-city, Chiba, Japan, 260-0842
        • Chiba-city
      • Chiba-city, Chiba, Japan, 260-0856
        • Chiba-city
      • Chiba-city, Chiba, Japan, 263-0002
        • Chiba-city
      • Funabashi-city, Chiba, Japan, 273-0021
        • Funabashi-city
      • Funabashi-city, Chiba, Japan, 274-0065
        • Funabashi-city
      • Ichihara-city, Chiba, Japan, 290-0003
        • Ichihara-city
      • Ichihara-city, Chiba, Japan, 299-0111
        • Ichihara-city
      • Ichikawa-city, Chiba, Japan, 272-0824
        • Ichikawa-city
      • Inzai-city, Chiba, Japan, 270-1613
        • Inzai-city
      • Kamogawa-city, Chiba, Japan, 296-0041
        • Kamogawa-city
      • Kashiwa-city, Chiba, Japan, 277-0004
        • Kashiwa-city
      • Kisarazu-city, Chiba, Japan, 292-0822
        • Kisarazu-city
      • Kisarazu-city, Chiba, Japan, 292-0832
        • Kisarazu-city
      • Matsudo-city, Chiba, Japan, 270-0034
        • Matsudo-city
      • Matsudo-city, Chiba, Japan, 271-0064
        • Matsudo-city
      • Narita-city, Chiba, Japan, 286-0041
        • Narita-city
      • Oamishirasato-city, Chiba, Japan, 299-3221
        • Oamishirasato-city
      • Sakura-city, Chiba, Japan, 285-0841
        • Sakura-city
      • Urayasu-city, Chiba, Japan, 279-0021
        • Urayasu-city
    • Ehime
      • Matsuyama-city, Ehime, Japan, 790-0024
        • Matsuyama-city
      • Matsuyama-city, Ehime, Japan, 790-0826
        • Matsuyama-city
      • Toon-city, Ehime, Japan, 791-0204
        • Toon-city
    • Fukui
      • Fukui-city, Fukui, Japan, 910-0017
        • Fukui-city
      • Fukui-city, Fukui, Japan, 910-0846
        • Fukui-city
      • Fukui-city, Fukui, Japan, 918-8011
        • Fukui-city
      • Obama-city, Fukui, Japan, 917-0078
        • Obama-city
      • Tsuruga-city, Fukui, Japan, 914-0144
        • Tsuruga-city
    • Fukuoka
      • Asakura-gun, Fukuoka, Japan, 838-0815
        • Asakura-gun
      • Fukuoka-city, Fukuoka, Japan, 810-0062
        • Fukuoka-city
      • Fukuoka-city, Fukuoka, Japan, 810-0065
        • Fukuoka-city
      • Fukuoka-city, Fukuoka, Japan, 811-1347
        • Fukuoka-city
      • Fukuoka-city, Fukuoka, Japan, 812-0033
        • Fukuoka-city
      • Fukuoka-city, Fukuoka, Japan, 812-0054
        • Fukuoka-city
      • Fukuoka-city, Fukuoka, Japan, 813-0044
        • Fukuoka-city
      • Fukuoka-city, Fukuoka, Japan, 814-0006
        • Fukuoka-city
      • Fukuoka-city, Fukuoka, Japan, 814-0133
        • Fukuoka-city
      • Iizuka-city, Fukuoka, Japan, 820-0018
        • Iizuka-city
      • Kasuga-city, Fukuoka, Japan, 816-0864
        • Kasuga-city
      • Kitakyushu-city, Fukuoka, Japan, 802-0001
        • Kitakyushu-city
      • Kitakyushu-city, Fukuoka, Japan, 803-0816
        • Kitakyushu-city
      • Kitakyushu-city, Fukuoka, Japan, 806-0034
        • Kitakyushu-city
      • Kitakyushu-city, Fukuoka, Japan, 807-0804
        • Kitakyushu-city
      • Koga-city, Fukuoka, Japan, 811-3113
        • Koga-city
      • Kurume-city, Fukuoka, Japan, 830-0011
        • Kurume-city
      • Kurume-city, Fukuoka, Japan, 830-0047
        • Kurume-city
      • Munakata-city, Fukuoka, Japan, 811-3431
        • Munakata-city
    • Fukushima
      • Date-city, Fukushima, Japan, 960-0502
        • Date-city
      • Fukushima-city, Fukushima, Japan, 960-1101
        • Fukushima-city
      • Fukushima-city, Fukushima, Japan, 960-1247
        • Fukushima-city
      • Fukushima-city, Fukushima, Japan, 960-8163
        • Fukushima-city
      • Minamisoma-city, Fukushima, Japan, 975-0033
        • Minamisoma-city
      • Soma-city, Fukushima, Japan, 976-0011
        • Soma-city
    • Gifu
      • Gifu-city, Gifu, Japan, 500-8226
        • Gifu-city
      • Gifu-city, Gifu, Japan, 500-8822
        • Gifu-city
      • Gifu-city, Gifu, Japan, 501-1112
        • Gifu-city
      • Gifu-city, Gifu, Japan, 502-0844
        • Gifu-city
      • Gujo-city, Gifu, Japan, 501-4228
        • Gujo-city
      • Kani-city, Gifu, Japan, 509-0206
        • Kani-city
      • Minokamo-city, Gifu, Japan, 505-0034
        • Minokamo-city
      • Ogaki-city, Gifu, Japan, 503-0864
        • Ogaki-city
      • Seki-city, Gifu, Japan, 501-3802
        • Seki-city
      • Tajimi-city, Gifu, Japan, 507-0042
        • Tajimi-city
      • Takayama-city, Gifu, Japan, 506-0025
        • Takayama-city
    • Gumma
      • Annaka-city, Gumma, Japan, 379-0133
        • Annaka-city
      • Fujioka-city, Gumma, Japan, 375-0024
        • Fujioka-city
      • Maebashi-city, Gumma, Japan, 371-0034
        • Maebashi-city
      • Maebashi-city, Gumma, Japan, 371-0821
        • Maebashi-city
      • Maebashi-city, Gumma, Japan, 379-2115
        • Maebashi-city
      • Ota-city, Gumma, Japan, 373-0828
        • Ota-city
      • Tomioka-city, Gumma, Japan, 370-2316
        • Tomioka-city
    • Hiroshima
      • Fukuyama-city, Hiroshima, Japan, 720-0001
        • Fukuyama-city
      • Fukuyama-city, Hiroshima, Japan, 729-3103
        • Fukuyama-city
      • Higashihiroshima-city, Hiroshima, Japan, 739-0041
        • Higashihiroshima-city
      • Hiroshima-city, Hiroshima, Japan, 730-0037
        • Hiroshima-city
      • Hiroshima-city, Hiroshima, Japan, 731-5134
        • Hiroshima-city
      • Kure-city, Hiroshima, Japan, 737-0023
        • Kure-city
      • Mihara-city, Hiroshima, Japan, 723-0014
        • Mihara-city
      • Otake-city, Hiroshima, Japan, 739-0651
        • Otake-city
      • Sera-gun, Hiroshima, Japan, 722-1112
        • Sera-gun
    • Hokkaido
      • Asahikawa-city, Hokkaido, Japan, 070-0029
        • Asahikawa-city
      • Asahikawa-city, Hokkaido, Japan, 070-0061
        • Asahikawa-city
      • Asahikawa-city, Hokkaido, Japan, 078-8211
        • Asahikawa-city
      • Asahikawa-city, Hokkaido, Japan, 078-8802
        • Asahikawa-city
      • Chitose-city, Hokkaido, Japan, 066-0042
        • Chitose-city
      • Furano-city, Hokkaido, Japan, 076-0038
        • Furano-city
      • Hakodate-city, Hokkaido, Japan, 040-0025
        • Hakodate-city
      • Hakodate-city, Hokkaido, Japan, 041-0821
        • Hakodate-city
      • Kushiro-city, Hokkaido, Japan, 085-0052
        • Kushiro-city
      • Muroran-city, Hokkaido, Japan, 050-0076
        • Muroran-city
      • Nemuro-city, Hokkaido, Japan, 087-0008
        • Nemuro-city
      • Obihiro-city, Hokkaido, Japan, 080-0016
        • Obihiro-city
      • Otaru-city, Hokkaido, Japan, 047-0017
        • Otaru-city
      • Sapporo-city, Hokkaido, Japan, 003-0003
        • Sapporo-city
      • Sapporo-city, Hokkaido, Japan, 003-0006
        • Sapporo-city
      • Sapporo-city, Hokkaido, Japan, 003-0804
        • Sapporo-city
      • Sapporo-city, Hokkaido, Japan, 004-0052
        • Sapporo-city
      • Sapporo-city, Hokkaido, Japan, 006-0811
        • Sapporo-city
      • Sapporo-city, Hokkaido, Japan, 007-0805
        • Sapporo-city
      • Sapporo-city, Hokkaido, Japan, 060-0001
        • Sapporo-city
      • Sapporo-city, Hokkaido, Japan, 060-0033
        • Sapporo-city
      • Sapporo-city, Hokkaido, Japan, 060-0061
        • Sapporo-city
      • Sapporo-city, Hokkaido, Japan, 060-0811
        • Sapporo-city
      • Sapporo-city, Hokkaido, Japan, 064-0804
        • Sapporo-city
      • Sapporo-city, Hokkaido, Japan, 065-0033
        • Sapporo-city
      • Tomakomai-city, Hokkaido, Japan, 053-0034
        • Tomakomai-city
      • Wakkanai-city, Hokkaido, Japan, 097-0022
        • Wakkanai-city
    • Hyogo
      • Akashi-city, Hyogo, Japan, 673-0021
        • Akashi-city
      • Ako-city, Hyogo, Japan, 678-0241
        • Ako-city
      • Amagasaki-city, Hyogo, Japan, 660-0892
        • Amagasaki-city
      • Amagasaki-city, Hyogo, Japan, 661-0976
        • Amagasaki-city
      • Himeji-city, Hyogo, Japan, 670-0012
        • Himeji-city
      • Himeji-city, Hyogo, Japan, 670-0063
        • Himeji-city
      • Himeji-city, Hyogo, Japan, 671-1122
        • Himeji-city
      • Itami-city, Hyogo, Japan, 664-8540
        • Itami-city
      • Kasai-city, Hyogo, Japan, 675-2311
        • Kasai-city
      • Kobe-city, Hyogo, Japan, 650-0047
        • Kobe-city
      • Kobe-city, Hyogo, Japan, 651-0072
        • Kobe-city
      • Kobe-city, Hyogo, Japan, 652-0863
        • Kobe-city
      • Kobe-city, Hyogo, Japan, 657-0064
        • Kobe-city
      • Nishinomiya-city, Hyogo, Japan, 662-0884
        • Nishinomiya-city
      • Nishinomiya-city, Hyogo, Japan, 662-0918
        • Nishinomiya-city
      • Nishinomiya-city, Hyogo, Japan, 663-8131
        • Nishinomiya-city
      • Nishinomiya-city, Hyogo, Japan, 663-8501
        • Nishinomiya-city
      • Nishiwaki-city, Hyogo, Japan, 677-0043
        • Nishiwaki-city
      • Sasayama-city, Hyogo, Japan, 669-2321
        • Sasayama-city
      • Sumoto-city, Hyogo, Japan, 656-0101
        • Sumoto-city
      • Takarazuka-city, Hyogo, Japan, 665-0827
        • Takarazuka-city
      • Takarazuka-city, Hyogo, Japan, 665-0836
        • Takarazuka-city
      • Takarazuka-city, Hyogo, Japan, 665-0881
        • Takarazuka-city
      • Tamba-city, Hyogo, Japan, 669-3309
        • Tamba-city
      • Tanba-city, Hyogo, Japan, 669-3316
        • Tanba-city
    • Ibaraki
      • Higashiibaraki-gun, Ibaraki, Japan, 311-3117
        • Higashiibaraki-gun
      • Hitachi-city, Ibaraki, Japan, 317-0077
        • Hitachi-city
      • Hitachinaka-city, Ibaraki, Japan, 312-0057
        • Hitachinaka-city
      • Inashiki-gun, Ibaraki, Japan, 300-0415
        • Inashiki-gun
      • Ishioka-city, Ibaraki, Japan, 315-0023
        • Ishioka-city
      • Kasama-city, Ibaraki, Japan, 309-1703
        • Kasama-city
      • Koga-city, Ibaraki, Japan, 306-0014
        • Koga-city
      • Koga-city, Ibaraki, Japan, 306-0232
        • Koga-city
      • Mito-city, Ibaraki, Japan, 311-4145
        • Mito-city
      • Mito-city, Ibaraki, Japan, 319-0312
        • Mito-city
      • Moriya-city, Ibaraki, Japan, 302-0102
        • Moriya-city
      • Namegata-city, Ibaraki, Japan, 311-3516
        • Namegata-city
      • Toride-city, Ibaraki, Japan, 302-0022
        • Toride-city
      • Tsuchiura-city, Ibaraki, Japan, 300-0028
        • Tsuchiura-city
      • Tsukuba-city, Ibaraki, Japan, 300-2622
        • Tsukuba-city
      • Tsukuba-city, Ibaraki, Japan, 305-0005
        • Tsukuba-city
      • Tsukuba-city, Ibaraki, Japan, 305-0051
        • Tsukuba-city
      • Ushiku-city, Ibaraki, Japan, 300-1231
        • Ushiku-city
    • Ishikawa
      • Kahoku-gun, Ishikawa, Japan, 920-0265
        • Kahoku-gun
      • Kanazawa-city, Ishikawa, Japan, 920-0001
        • Kanazawa-city
      • Kanazawa-city, Ishikawa, Japan, 920-0848
        • Kanazawa-city
      • Kanazawa-city, Ishikawa, Japan, 920-0934
        • Kanazawa-city
      • Kanazawa-city, Ishikawa, Japan, 920-8201
        • Kanazawa-city
      • Komatsu-city, Ishikawa, Japan, 923-0961
        • Komatsu-city
      • Nanao-city, Ishikawa, Japan, 926-0816
        • Nanao-city
      • Nanao-city, Ishikawa, Japan, 926-0866
        • Nanao-city
    • Iwate
      • Kitakami-city, Iwate, Japan, 024-0091
        • Kitakami-city
      • Morioka-city, Iwate, Japan, 020-0023
        • Morioka-city
      • Morioka-city, Iwate, Japan, 020-0066
        • Morioka-city
      • Morioka-city, Iwate, Japan, 020-0831
        • Morioka-city
      • Ninohe-city, Iwate, Japan, 028-6105
        • Ninohe-city
      • Oshu-city, Iwate, Japan, 023-0864
        • Oshu-city
    • Kagawa
      • Kanonji-city, Kagawa, Japan, 769-1601
        • Kanonji-city
      • Sakaide-city, Kagawa, Japan, 762-0007
        • Sakaide-city
      • Sakaide-city, Kagawa, Japan, 762-0043
        • Sakaide-city
      • Sanuki-city, Kagawa, Japan, 769-2321
        • Sanuki-city
      • Takamatsu-city, Kagawa, Japan, 760-0017
        • Takamatsu-city
      • Takamatsu-city, Kagawa, Japan, 760-0065
        • Takamatsu-city
    • Kagoshima
      • Kagoshima-city, Kagoshima, Japan, 890-0063
        • Kagoshima-city
      • Kagoshima-city, Kagoshima, Japan, 890-0075
        • Kagoshima-city
      • Kagoshima-city, Kagoshima, Japan, 892-0853
        • Kagoshima-city
      • Minamisatsuma-city, Kagoshima, Japan, 897-1123
        • Minamisatsuma-city
      • Oshima-gun, Kagoshima, Japan, 891-7101
        • Oshima-gun
    • Kanagawa
      • Chigasaki-city, Kanagawa, Japan, 253-0053
        • Chigasaki-city
      • Ebina-city, Kanagawa, Japan, 243-0433
        • Ebina-city
      • Fujisawa-city, Kanagawa, Japan, 251-0054
        • Fujisawa-city
      • Isehara-city, Kanagawa, Japan, 259-1142
        • Isehara-city
      • Isehara-city, Kanagawa, Japan, 259-1143
        • Isehara-city
      • Kamakura-city, Kanagawa, Japan, 247-0056
        • Kamakura-city
      • Kamakura-city, Kanagawa, Japan, 247-0072
        • Kamakura-city
      • Kawasaki-city, Kanagawa, Japan, 210-0024
        • Kawasaki-city
      • Kawasaki-city, Kanagawa, Japan, 210-0802
        • Kawasaki-city
      • Kawasaki-city, Kanagawa, Japan, 211-0021
        • Kawasaki-city
      • Kawasaki-city, Kanagawa, Japan, 215-0026
        • Kawasaki-city
      • Kawasaki-city, Kanagawa, Japan, 216-0015
        • Kawasaki-city
      • Sagamihara-city, Kanagawa, Japan, 252-0206
        • Sagamihara-city
      • Sagamihara-city, Kanagawa, Japan, 252-0329
        • Sagamihara-city
      • Yokohama-city, Kanagawa, Japan, 224-0032
        • Yokohama-city
      • Yokohama-city, Kanagawa, Japan, 225-0024
        • Yokohama-city
      • Yokohama-city, Kanagawa, Japan, 231-0801
        • Yokohama-city
      • Yokohama-city, Kanagawa, Japan, 232-0024
        • Yokohama-city
      • Yokohama-city, Kanagawa, Japan, 234-0054
        • Yokohama-city
      • Yokohama-city, Kanagawa, Japan, 235-0022
        • Yokohama-city
      • Yokohama-city, Kanagawa, Japan, 236-0027
        • Yokohama-city
      • Yokohama-city, Kanagawa, Japan, 236-0037
        • Yokohama-city
      • Yokohama-city, Kanagawa, Japan, 241-0811
        • Yokohama-city
      • Yokosuka-city, Kanagawa, Japan, 238-0011
        • Yokosuka-city
      • Yokosuka-city, Kanagawa, Japan, 240-0101
        • Yokosuka-city
    • Kochi
      • Aki-city, Kochi, Japan, 784-0027
        • Aki-city
      • Kochi-city, Kochi, Japan, 780-0051
        • Kochi-city
      • Kochi-city, Kochi, Japan, 780-0062
        • Kochi-city
      • Kochi-city, Kochi, Japan, 780-8077
        • Kochi-city
      • Nankoku-city, Kochi, Japan, 783-0043
        • Nankoku-city
      • Shimanto-city, Kochi, Japan, 787-0025
        • Shimanto-city
      • Tosa-city, Kochi, Japan, 781-1101
        • Tosa-city
    • Kumamoto
      • Amakusa-city, Kumamoto, Japan, 863-0046
        • Amakusa-city
      • Arao-city, Kumamoto, Japan, 864-0041
        • Arao-city
      • Kumamoto-city, Kumamoto, Japan, 860-0816
        • Kumamoto-city
      • Kumamoto-city, Kumamoto, Japan, 861-8039
        • Kumamoto-city
      • Kumamoto-city, Kumamoto, Japan, 862-0975
        • Kumamoto-city
    • Kyoto
      • Fukuchiyama-city, Kyoto, Japan, 620-0056
        • Fukuchiyama-city
      • Kyoto-city, Kyoto, Japan, 601-1434
        • Kyoto-city
      • Kyoto-city, Kyoto, Japan, 602-8026
        • Kyoto-city
      • Kyoto-city, Kyoto, Japan, 602-8566
        • Kyoto-city
      • Kyoto-city, Kyoto, Japan, 603-8151
        • Kyoto-city
      • Kyoto-city, Kyoto, Japan, 604-8845
        • Kyoto-city
      • Kyoto-city, Kyoto, Japan, 605-0981
        • Kyoto-city
      • Kyoto-city, Kyoto, Japan, 606-8317
        • Kyoto-city
      • Kyoto-city, Kyoto, Japan, 607-8062
        • Kyoto-city
      • Kyoto-city, Kyoto, Japan, 607-8086
        • Kyoto-city
      • Kyoto-city, Kyoto, Japan, 612-0861
        • Kyoto-city
      • Kyoto-city, Kyoto, Japan, 615-0031
        • Kyoto-city
      • Kyoto-city, Kyoto, Japan, 615-8256
        • Kyoto-city
      • Maizuru-city, Kyoto, Japan, 625-0036
        • Maizuru-city
      • Uji-city, Kyoto, Japan, 611-0021
        • Uji-city
      • Yawata-city, Kyoto, Japan, 614-8366
        • Yawata-city
    • Mie
      • Ise-city, Mie, Japan, 516-0008
        • Ise-city
      • Ise-city, Mie, Japan, 516-0014
        • Ise-city
      • Kumano-city, Mie, Japan, 519-4324
        • Kumano-city
      • Kuwana-city, Mie, Japan, 511-0061
        • Kuwana-city
      • Kuwana-city, Mie, Japan, 511-0819
        • Kuwana-city
      • Matsusaka-city, Mie, Japan, 515-0003
        • Matsusaka-city
      • Suzuka-city, Mie, Japan, 513-0836
        • Suzuka-city
      • Tsu-city, Mie, Japan, 514-0001
        • Tsu-city
      • Yokkaichi-city, Mie, Japan, 510-0822
        • Yokkaichi-city
    • Miyagi
      • Natori-city, Miyagi, Japan, 981-1239
        • Natori-city
      • Osaki-city, Miyagi, Japan, 989-6136
        • Osaki-city
      • Sendai-city, Miyagi, Japan, 980-0872
        • Sendai-city
      • Sendai-city, Miyagi, Japan, 982-0007
        • Sendai-city
      • Sendai-city, Miyagi, Japan, 982-0033
        • Sendai-city
      • Sendai-city, Miyagi, Japan, 982-0801
        • Sendai-city
      • Sendai-city, Miyagi, Japan, 983-0045
        • Sendai-city
      • Sendai-city, Miyagi, Japan, 984-0042
        • Sendai-city
    • Miyazaki
      • Miyakonojo-city, Miyazaki, Japan, 885-0055
        • Miyakonojo-city
      • Miyazaki-city, Miyazaki, Japan, 889-1601
        • Miyazaki-city
    • Nagano
      • Kitaazumi-gun, Nagano, Japan, 399-8601
        • Kitaazumi-gun
      • Matsumoto-city, Nagano, Japan, 399-0021
        • Matsumoto-city
      • Nagano-city, Nagano, Japan, 380-0928
        • Nagano-city
      • Saku-city, Nagano, Japan, 385-0051
        • Saku-city
      • Suwa-city, Nagano, Japan, 392-0027
        • Suwa-city
      • Suzaka-city, Nagano, Japan, 382-0091
        • Suzaka-city
    • Nagasaki
      • Iki-city, Nagasaki, Japan, 811-5135
        • Iki-city
      • Isahaya-city, Nagasaki, Japan, 854-0071
        • Isahaya-city
      • Nagasaki-city, Nagasaki, Japan, 851-3101
        • Nagasaki-city
      • Nagasaki-city, Nagasaki, Japan, 852-8104
        • Nagasaki-city
      • Nagasaki-city, Nagasaki, Japan, 852-8125
        • Nagasaki-city
      • Nagasaki-city, Nagasaki, Japan, 852-8131
        • Nagasaki-city
      • Omura-city, Nagasaki, Japan, 856-0835
        • Omura-city
      • Sasebo-city, Nagasaki, Japan, 857-0056
        • Sasebo-city
    • Nara
      • Ikoma-city, Nara, Japan, 630-0227
        • Ikoma-city
      • Nara-city, Nara, Japan, 631-0805
        • Nara-city
      • Sakurai-city, Nara, Japan, 633-0054
        • Sakurai-city
      • Tenri-city, Nara, Japan, 632-0015
        • Tenri-city
      • Yamatokoriyama-city, Nara, Japan, 639-1013
        • Yamatokoriyama-city
    • Niigata
      • Itoigawa-city, Niigata, Japan, 941-0006
        • Itoigawa-city
      • Joetsu-city, Niigata, Japan, 943-0147
        • Joetsu-city
      • Kashiwazaki-city, Niigata, Japan, 945-0035
        • Kashiwazaki-city
      • Kashiwazaki-city, Niigata, Japan, 945-0847
        • Kashiwazaki-city
      • Minamiuonuma-city, Niigata, Japan, 949-7302
        • Minamiuonuma-city
      • Nagaoka-city, Niigata, Japan, 940-2108
        • Nagaoka-city
      • Niigata-city, Niigata, Japan, 950-0943
        • Niigata-city
      • Niigata-city, Niigata, Japan, 950-1141
        • Niigata-city
      • Niigata-city, Niigata, Japan, 951-8122
        • Niigata-city
      • Niigata-city, Niigata, Japan, 951-8133
        • Niigata-city
      • Ojiya-city, Niigata, Japan, 947-0028
        • Ojiya-city
      • Sado-city, Niigata, Japan, 952-1209
        • Sado-city
      • Shibata-city, Niigata, Japan, 957-0054
        • Shibata-city
      • Tsubame-city, Niigata, Japan, 959-0242
        • Tsubame-city
    • Oita
      • Bungotakada-city, Oita, Japan, 879-0627
        • Bungotakada-city
      • Nakatsu-city, Oita, Japan, 871-0011
        • Nakatsu-city
      • Oita-city, Oita, Japan, 870-0105
        • Oita-city
      • Oita-city, Oita, Japan, 870-0855
        • Oita-city
      • Oita-city, Oita, Japan, 870-1133
        • Oita-city
    • Okayama
      • Kurashiki-city, Okayama, Japan, 701-0114
        • Kurashiki-city
      • Kurashiki-city, Okayama, Japan, 710-0052
        • Kurashiki-city
      • Kurashiki-city, Okayama, Japan, 710-0824
        • Kurashiki-city
      • Maniwa-city, Okayama, Japan, 719-3105
        • Maniwa-city
      • Okayama-city, Okayama, Japan, 700-0822
        • Okayama-city
      • Okayama-city, Okayama, Japan, 700-0914
        • Okayama-city
      • Okayama-city, Okayama, Japan, 700-0962
        • Okayama-city
      • Okayama-city, Okayama, Japan, 701-1154
        • Okayama-city
      • Tamano-city, Okayama, Japan, 706-0011
        • Tamano-city
    • Okinawa
      • Kunigami-gun, Okinawa, Japan, 905-0414
        • Kunigami-gun
      • Nago-city, Okinawa, Japan, 905-0017
        • Nago-city
      • Naha-city, Okinawa, Japan, 902-0061
        • Naha-city
      • Naha-city, Okinawa, Japan, 902-0076
        • Naha-city
      • Nakagami-gun, Okinawa, Japan, 903-0129
        • Nakagami-gun
      • Okinawa-city, Okinawa, Japan, 904-2143
        • Okinawa-city
      • Uruma-city, Okinawa, Japan, 904-2243
        • Uruma-city
    • Osaka
      • Higashiosaka-city, Osaka, Japan, 577-0801
        • Higashiosaka-city
      • Hirakata-city, Osaka, Japan, 573-0153
        • Hirakata-city
      • Ikeda-city, Osaka, Japan, 563-0025
        • Ikeda-city
      • Izumiootsu-city, Osaka, Japan, 595-0072
        • Izumiootsu-city
      • Izumiotsu-city, Osaka, Japan, 595-0006
        • Izumiotsu-city
      • Izumisano-city, Osaka, Japan, 598-0048
        • Izumisano-city
      • Kaizuka-city, Osaka, Japan, 597-0015
        • Kaizuka-city
      • Kawachinagano-city, Osaka, Japan, 586-0008
        • Kawachinagano-city
      • Kawachinagano-city, Osaka, Japan, 586-0017
        • Kawachinagano-city
      • Kishiwada-city, Osaka, Japan, 596-0042
        • Kishiwada-city
      • Kishiwada-city, Osaka, Japan, 596-0822
        • Kishiwada-city
      • Mino-city, Osaka, Japan, 562-0014
        • Mino-city
      • Moriguchi-city, Osaka, Japan, 570-0074
        • Moriguchi-city
      • Moriguchi-city, Osaka, Japan, 570-0096
        • Moriguchi-city
      • Neyagawa-city, Osaka, Japan, 572-0022
        • Neyagawa-city
      • Osaka-city, Osaka, Japan, 530-0005
        • Osaka-city
      • Osaka-city, Osaka, Japan, 530-0012
        • Osaka-city
      • Osaka-city, Osaka, Japan, 530-0025
        • Osaka-city
      • Osaka-city, Osaka, Japan, 536-0001
        • Osaka-city
      • Osaka-city, Osaka, Japan, 537-0012
        • Osaka-city
      • Osaka-city, Osaka, Japan, 537-0025
        • Osaka-city
      • Osaka-city, Osaka, Japan, 540-0006
        • Osaka-city
      • Osaka-city, Osaka, Japan, 540-0008
        • Osaka-city
      • Osaka-city, Osaka, Japan, 543-0027
        • Osaka-city
      • Osaka-city, Osaka, Japan, 543-0042
        • Osaka-city
      • Osaka-city, Osaka, Japan, 543-0052
        • Osaka-city
      • Osaka-city, Osaka, Japan, 545-0053
        • Osaka-city
      • Osaka-city, Osaka, Japan, 550-0012
        • Osaka-city
      • Osaka-city, Osaka, Japan, 553-0003
        • Osaka-city
      • Osakasayama-city, Osaka, Japan, 589-0014
        • Osakasayama-city
      • Sakai-city, Osaka, Japan, 590-0132
        • Sakai-city
      • Sakai-city, Osaka, Japan, 593-8304
        • Sakai-city
      • Suit-city, Osaka, Japan, 564-0082
        • Suit-city
      • Suita-city, Osaka, Japan, 565-0871
        • Suita-city
      • Takatsuki-city, Osaka, Japan, 569-0064
        • Takatsuki-city
      • Takatsuki-city, Osaka, Japan, 569-0852
        • Takatsuki-city
      • Takatsuki-city, Osaka, Japan, 569-1045
        • Takatsuki-city
      • Tondabayashi-city, Osaka, Japan, 584-0091
        • Tondabayashi-city
      • Toyonaka-city, Osaka, Japan, 560-0055
        • Toyonaka-city
    • Saga
      • Saga-city, Saga, Japan, 840-0516
        • Saga-city
      • Saga-city, Saga, Japan, 849-0937
        • Saga-city
    • Saitama
      • Chichibu-city, Saitama, Japan, 368-0051
        • Chichibu-city
      • Fukaya-city, Saitama, Japan, 366-0052
        • Fukaya-city
      • Hasuda-city, Saitama, Japan, 349-0131
        • Hasuda-city
      • Iruma-gun, Saitama, Japan, 350-0451
        • Iruma-gun
      • Kawagoe-city, Saitama, Japan, 350-0844
        • Kawagoe-city
      • Kawaguchi-city, Saitama, Japan, 333-0831
        • Kawaguchi-city
      • Kawaguchi-city, Saitama, Japan, 333-0833
        • Kawaguchi-city
      • Kitaadachi-gun, Saitama, Japan, 362-0806
        • Kitaadachi-gun
      • Koshigaya-city, Saitama, Japan, 343-0845
        • Koshigaya-city
      • Niiza-city, Saitama, Japan, 352-0001
        • Niiza-city
      • Soka-city, Saitama, Japan, 340-0043
        • Soka-city
      • Tokorozawa-city, Saitama, Japan, 359-0042
        • Tokorozawa-city
      • Tsurugashima-city, Saitama, Japan, 350-2213
        • Tsurugashima-city
    • Shiga
      • Moriyama-city, Shiga, Japan, 524-0022
        • Moriyama-city
      • Nagahama-city, Shiga, Japan, 526-0043
        • Nagahama-city
      • Omihachiman-city, Shiga, Japan, 523-0082
        • Omihachiman-city
      • Otsu-city, Shiga, Japan, 520-0046
        • Otsu-city
      • Ritto-city, Shiga, Japan, 520-3046
        • Ritto-city
    • Shimane
      • Gotsu-city, Shimane, Japan, 695-0011
        • Gotsu-city
      • Hamada-city, Shimane, Japan, 697-0022
        • Hamada-city
      • Hamada-city, Shimane, Japan, 697-0062
        • Hamada-city
      • Izumo-city, Shimane, Japan, 693-0021
        • Izumo-city
      • Izumo-city, Shimane, Japan, 693-0068
        • Izumo-city
      • Masuda-city, Shimane, Japan, 698-0003
        • Masuda-city
      • Matsue-city, Shimane, Japan, 690-0886
        • Matsue-city
      • Nita-gun, Shimane, Japan, 699-1511
        • Nita-gun
      • Unnan-city, Shimane, Japan, 699-1221
        • Unnan-city
    • Shizuoka
      • Fujieda-city, Shizuoka, Japan, 426-0077
        • Fujieda-city
      • Hamamatsu-city, Shizuoka, Japan, 430-0906
        • Hamamatsu-city
      • Hamamatsu-city, Shizuoka, Japan, 430-0929
        • Hamamatsu-city
      • Hamamatsu-city, Shizuoka, Japan, 432-8002
        • Hamamatsu-city
      • Iwata-city, Shizuoka, Japan, 438-8550
        • Iwata-city
      • Izunokuni-city, Shizuoka, Japan, 410-2211
        • Izunokuni-city
      • Mishima-city, Shizuoka, Japan, 411-0817
        • Mishima-city
      • Shizuoka-city, Shizuoka, Japan, 421-3103
        • Shizuoka-city
      • Shizuoka-city, Shizuoka, Japan, 422-8021
        • Shizuoka-city
      • Shizuoka-city, Shizuoka, Japan, 424-0911
        • Shizuoka-city
    • Tochigi
      • Ashikaga-city, Tochigi, Japan, 326-0822
        • Ashikaga-city
      • Sano-city, Tochigi, Japan, 327-0317
        • Sano-city
      • Shimotsuga-gun, Tochigi, Japan, 321-0207
        • Shimotsuga-gun
      • Shimotsuke-city, Tochigi, Japan, 329-0431
        • Shimotsuke-city
      • Utsunomiya-city, Tochigi, Japan, 320-0834
        • Utsunomiya-city
      • Utsunomiya-city, Tochigi, Japan, 321-0974
        • Utsunomiya-city
      • Yaita-city, Tochigi, Japan, 329-2145
        • Yaita-city
    • Tokushima
      • Itano-gun, Tokushima, Japan, 771-0204
        • Itano-gun
      • Naruto-city, Tokushima, Japan, 772-0001
        • Naruto-city
      • Tokushima-city, Tokushima, Japan, 770-0042
        • Tokushima-city
      • Tokushima-city, Tokushima, Japan, 770-0847
        • Tokushima-city
    • Tokyo
      • Adachi-ku, Tokyo, Japan, 123-0864
        • Adachi-ku
      • Akishima-city, Tokyo, Japan, 196-0015
        • Akishima-city
      • Bunkyo-ku, Tokyo, Japan, 113-0021
        • Bunkyo-ku
      • Bunkyo-ku, Tokyo, Japan, 113-0022
        • Bunkyo-ku
      • Bunkyo-ku, Tokyo, Japan, 113-0033
        • Bunkyo-ku
      • Bunkyo-ku, Tokyo, Japan, 113-0034
        • Bunkyo-ku
      • Chiyoda-ku, Tokyo, Japan, 101-0024
        • Chiyoda-ku
      • Chiyoda-ku, Tokyo, Japan, 102-0071
        • Chiyoda-ku
      • Chofu-city, Tokyo, Japan, 182-0026
        • Chofu-city
      • Chuo-ku, Tokyo, Japan, 104-0044
        • Chuo-ku
      • Edogawa-ku, Tokyo, Japan, 133-0052
        • Edogawa-ku
      • Fuchu-city, Tokyo, Japan, 183-0042
        • Fuchu-city
      • Hachioji-city, Tokyo, Japan, 192-0071
        • Hachioji-city
      • Itabashi-ku, Tokyo, Japan, 173-0003
        • Itabashi-ku
      • Itabashi-ku, Tokyo, Japan, 173-0015
        • Itabashi-ku
      • Itabashi-ku, Tokyo, Japan, 174-0051
        • Itabashi-ku
      • Katsushika-ku, Tokyo, Japan, 124-0006
        • Katsushika-ku
      • Katsushika-ku, Tokyo, Japan, 125-0061
        • Katsushika-ku
      • Koganei-city, Tokyo, Japan, 184-0004
        • Koganei-city
      • Meguro-ku, Tokyo, Japan, 153-0062
        • Meguro-ku
      • Minato-ku, Tokyo, Japan, 105-0003
        • Minato-ku
      • Minato-ku, Tokyo, Japan, 108-0073
        • Minato-ku
      • Nerima-ku, Tokyo, Japan, 177-0033
        • Nerima-ku
      • Ome-city, Tokyo, Japan, 198-0042
        • Ome-city
      • Setagaya-ku, Tokyo, Japan, 158-0097
        • Setagaya-ku
      • Shibuya-ku, Tokyo, Japan, 150-0012
        • Shibuya-ku
      • Shibuya-ku, Tokyo, Japan, 151-0053
        • Shibuya-ku
      • Shinagawa-ku, Tokyo, Japan, 141-0022
        • Shinagawa-ku
      • Shinjuku-ku, Tokyo, Japan, 160-0016
        • Shinjuku-ku
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Shinjuku-ku
      • Shinjuku-ku, Tokyo, Japan, 162-0052
        • Shinjuku-ku
      • Sumida-ku, Tokyo, Japan, 130-0015
        • Sumida-ku
      • Tachikawa-city, Tokyo, Japan, 190-0014
        • Tachikawa-city
      • Taito-ku, Tokyo, Japan, 110-0015
        • Taito-ku
    • Tottori
      • Tottori-city, Tottori, Japan, 680-0873
        • Tottori-city
      • Tottori-city, Tottori, Japan, 680-0901
        • Tottori-city
      • Tottori-city, Tottori, Japan, 680-0945
        • Tottori-city
      • Tottori-city, Tottori, Japan, 689-0425
        • Tottori-city
    • Toyama
      • Kurobe-city, Toyama, Japan, 938-0031
        • Kurobe-city
      • Oyabe-city, Toyama, Japan, 932-0813
        • Oyabe-city
      • Takaoka-city, Toyama, Japan, 933-0843
        • Takaoka-city
      • Tonami-city, Toyama, Japan, 939-1343
        • Tonami-city
      • Toyama-city, Toyama, Japan, 930-0006
        • Toyama-city
      • Toyama-city, Toyama, Japan, 930-0152
        • Toyama-city
      • Toyama-city, Toyama, Japan, 930-0859
        • Toyama-city
      • Toyama-city, Toyama, Japan, 939-8282
        • Toyama-city
    • Wakayama
      • Arida-gun, Wakayama, Japan, 643-0034
        • Arida-gun
      • Gobo-city, Wakayama, Japan, 644-0002
        • Gobo-city
      • Higashimuro-gun, Wakayama, Japan, 649-5331
        • Higashimuro-gun
      • Nishimuro-gun, Wakayama, Japan, 649-2621
        • Nishimuro-gun
      • Nishimuro-gun, Wakayama, Japan, 649-3142
        • Nishimuro-gun
      • Tanabe-city, Wakayama, Japan, 646-0011
        • Tanabe-city
      • Wakayama-city, Wakayama, Japan, 640-8453
        • Wakayama-city
    • Yamagata
      • Yamagata-city, Yamagata, Japan, 990-2214
        • Yamagata-city
    • Yamaguchi
      • Hofu-city, Yamaguchi, Japan, 747-0065
        • Hofu-city
      • Oshima-gun, Yamaguchi, Japan, 742-2921
        • Oshima-gun
      • Shimonoseki-city, Yamaguchi, Japan, 750-0061
        • Shimonoseki-city
      • Shimonoseki-city, Yamaguchi, Japan, 752-0985
        • Shimonoseki-city
      • Shunan-city, Yamaguchi, Japan, 745-0822
        • Shunan-city
      • Yamaguchi-city, Yamaguchi, Japan, 754-1277
        • Yamaguchi-city
    • Yamanashi
      • Kofu-city, Yamanashi, Japan, 400-0016
        • Kofu-city
      • Kofu-city, Yamanashi, Japan, 400-0027
        • Kofu-city

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants with essential thrombocythemia (ET) being treated with agrylin will be evaluated for this study.

Description

Inclusion Criteria:

- All cases who received treatment with Agrylin.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Anagrelide hydrochloride
Participants who received treatment with Anagrelide hydrochloride will be evaluated for this study. Participants will receive interventions as part of routine medical care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants Who Had One or More Adverse Events
Time Frame: From start of study drug administration up to 12 months
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
From start of study drug administration up to 12 months
Number of Participants Who Had One or More Serious Adverse Event
Time Frame: From start of study drug administration up to 12 months
A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
From start of study drug administration up to 12 months
Number of Participants Who Had One or More Adverse Drug Reactions
Time Frame: From start of study drug administration up to 12 months
AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.
From start of study drug administration up to 12 months
Number of Participants Who Had One or More Serious Adverse Drug Reactions
Time Frame: From start of study drug administration up to 12 months
A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Serious adverse drug reaction refers to serious AE that are related to administered drug.
From start of study drug administration up to 12 months
Percentage of Participants Who Responded in Platelet Count
Time Frame: From 3 months after the start of study drug administration, up to 12 months
Percentage of participants who responded in platelet count was assessed. A response was defined as platelet counts to <60 x10^4 platelet/mcrL beyond 3 months after the start of study drug administration.
From 3 months after the start of study drug administration, up to 12 months
Percentage of Participants With Normalization in Platelet Count
Time Frame: From 3 months after the start of study drug administration, up to 12 months
Percentage of participants with normalization in platelet count was assessed. Normalization was defined as platelet counts to <40 x10^4 platelets/mcrL beyond 3 months after the start of study drug administration.
From 3 months after the start of study drug administration, up to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With at Least 50% Reduction in Platelet Count
Time Frame: From start of study drug administration up to 12 months
Participants who achieved at least 50% reduction in platelet count from their baseline during the 1-year observation period was assessed.
From start of study drug administration up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 25, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 11, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 11, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 10, 2018

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHP422-406

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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