Clinical trial NCT03625895: Agrylin Drug Use-Result Survey
Official title: Agrylin Capsules 0.5 mg Drug Use-Result Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Essential Thrombocythemia (ET)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2018-08-10
Enrollment: 1826
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with essential thrombocythemia (ET) being treated with agrylin will be evaluated for this study.

Brief summary: 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).

Detailed description: Anagrelide hydrochloride Drug Use-Result Survey

Eligibility criteria: Inclusion Criteria:

- All cases who received treatment with Agrylin.

Exclusion Criteria:

-

Primary outcomes:
measure: Number of Participants Who Had One or More Adverse Events
timeFrame: From start of study drug administration up to 12 months
measure: Number of Participants Who Had One or More Serious Adverse Event
timeFrame: From start of study drug administration up to 12 months
measure: Number of Participants Who Had One or More Adverse Drug Reactions
timeFrame: From start of study drug administration up to 12 months
measure: Number of Participants Who Had One or More Serious Adverse Drug Reactions
timeFrame: From start of study drug administration up to 12 months
measure: Percentage of Participants Who Responded in Platelet Count
timeFrame: From 3 months after the start of study drug administration, up to 12 months
measure: Percentage of Participants With Normalization in Platelet Count
timeFrame: From 3 months after the start of study drug administration, up to 12 months
Secondary outcomes:
measure: Percentage of Participants With at Least 50% Reduction in Platelet Count
timeFrame: From start of study drug administration up to 12 months
Other outcomes:
Locations:
city: Gamagori-city
country: Japan
facility: Gamagori-city
state: Aichi
city: Handa-city
country: Japan
facility: Handa City
state: Aichi
city: Hekinan-city
country: Japan
facility: Hekinan-city
state: Aichi
city: Ichinomiya-city
country: Japan
facility: Ichinomiya-city
state: Aichi
city: Ichinomiya-city
country: Japan
facility: Ichinomiya-city
state: Aichi
city: Ichinomiya-city
country: Japan
facility: Ichinomiya-city
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city: Komaki-city
country: Japan
facility: Komaki-city
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city: Nagakute-city
country: Japan
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city: Nagoya-city
country: Japan
facility: Nagoya-city
state: Aichi
city: Nagoya-city
country: Japan
facility: Nagoya-city
state: Aichi
city: Nagoya-city
country: Japan
facility: Nagoya-city
state: Aichi
city: Nagoya-city
country: Japan
facility: Nagoya-city
state: Aichi
city: Nagoya-city
country: Japan
facility: Nagoya-city
state: Aichi
city: Nagoya-city
country: Japan
facility: Nagoya-city
state: Aichi
city: Nagoya-city
country: Japan
facility: Nagoya-city
state: Aichi
city: Nagoya-city
country: Japan
facility: Nagoya-city
state: Aichi
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facility: Obu-city
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facility: Okazaki-city
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city: Seto-city
country: Japan
facility: Seto-city
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facility: Toyoake-city
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facility: Toyohashi-city
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city: Toyohashi-city
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facility: Toyohashi-city
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city: Toyota-city
country: Japan
facility: Toyota-city
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facility: Akita-city
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facility: Akita-city
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country: Japan
facility: Kyoto-city
state: Kyoto
city: Kyoto-city
country: Japan
facility: Kyoto-city
state: Kyoto
city: Kyoto-city
country: Japan
facility: Kyoto-city
state: Kyoto
city: Kyoto-city
country: Japan
facility: Kyoto-city
state: Kyoto
city: Kyoto-city
country: Japan
facility: Kyoto-city
state: Kyoto
city: Kyoto-city
country: Japan
facility: Kyoto-city
state: Kyoto
city: Kyoto-city
country: Japan
facility: Kyoto-city
state: Kyoto
city: Kyoto-city
country: Japan
facility: Kyoto-city
state: Kyoto
city: Kyoto-city
country: Japan
facility: Kyoto-city
state: Kyoto
city: Kyoto-city
country: Japan
facility: Kyoto-city
state: Kyoto
city: Maizuru-city
country: Japan
facility: Maizuru-city
state: Kyoto
city: Uji-city
country: Japan
facility: Uji-city
state: Kyoto
city: Yawata-city
country: Japan
facility: Yawata-city
state: Kyoto
city: Ise-city
country: Japan
facility: Ise-city
state: Mie
city: Ise-city
country: Japan
facility: Ise-city
state: Mie
city: Kumano-city
country: Japan
facility: Kumano-city
state: Mie
city: Kuwana-city
country: Japan
facility: Kuwana-city
state: Mie
city: Kuwana-city
country: Japan
facility: Kuwana-city
state: Mie
city: Matsusaka-city
country: Japan
facility: Matsusaka-city
state: Mie
city: Suzuka-city
country: Japan
facility: Suzuka-city
state: Mie
city: Tsu-city
country: Japan
facility: Tsu-city
state: Mie
city: Yokkaichi-city
country: Japan
facility: Yokkaichi-city
state: Mie
city: Natori-city
country: Japan
facility: Natori-city
state: Miyagi
city: Osaki-city
country: Japan
facility: Osaki-city
state: Miyagi
city: Sendai-city
country: Japan
facility: Sendai-city
state: Miyagi
city: Sendai-city
country: Japan
facility: Sendai-city
state: Miyagi
city: Sendai-city
country: Japan
facility: Sendai-city
state: Miyagi
city: Sendai-city
country: Japan
facility: Sendai-city
state: Miyagi
city: Sendai-city
country: Japan
facility: Sendai-city
state: Miyagi
city: Sendai-city
country: Japan
facility: Sendai-city
state: Miyagi
city: Miyakonojo-city
country: Japan
facility: Miyakonojo-city
state: Miyazaki
city: Miyazaki-city
country: Japan
facility: Miyazaki-city
state: Miyazaki
city: Kitaazumi-gun
country: Japan
facility: Kitaazumi-gun
state: Nagano
city: Matsumoto-city
country: Japan
facility: Matsumoto-city
state: Nagano
city: Nagano-city
country: Japan
facility: Nagano-city
state: Nagano
city: Saku-city
country: Japan
facility: Saku-city
state: Nagano
city: Suwa-city
country: Japan
facility: Suwa-city
state: Nagano
city: Suzaka-city
country: Japan
facility: Suzaka-city
state: Nagano
city: Iki-city
country: Japan
facility: Iki-city
state: Nagasaki
city: Isahaya-city
country: Japan
facility: Isahaya-city
state: Nagasaki
city: Nagasaki-city
country: Japan
facility: Nagasaki-city
state: Nagasaki
city: Nagasaki-city
country: Japan
facility: Nagasaki-city
state: Nagasaki
city: Nagasaki-city
country: Japan
facility: Nagasaki-city
state: Nagasaki
city: Nagasaki-city
country: Japan
facility: Nagasaki-city
state: Nagasaki
city: Omura-city
country: Japan
facility: Omura-city
state: Nagasaki
city: Sasebo-city
country: Japan
facility: Sasebo-city
state: Nagasaki
city: Ikoma-city
country: Japan
facility: Ikoma-city
state: Nara
city: Nara-city
country: Japan
facility: Nara-city
state: Nara
city: Sakurai-city
country: Japan
facility: Sakurai-city
state: Nara
city: Tenri-city
country: Japan
facility: Tenri-city
state: Nara
city: Yamatokoriyama-city
country: Japan
facility: Yamatokoriyama-city
state: Nara
city: Itoigawa-city
country: Japan
facility: Itoigawa-city
state: Niigata
city: Joetsu-city
country: Japan
facility: Joetsu-city
state: Niigata
city: Kashiwazaki-city
country: Japan
facility: Kashiwazaki-city
state: Niigata
city: Kashiwazaki-city
country: Japan
facility: Kashiwazaki-city
state: Niigata
city: Minamiuonuma-city
country: Japan
facility: Minamiuonuma-city
state: Niigata
city: Nagaoka-city
country: Japan
facility: Nagaoka-city
state: Niigata
city: Niigata-city
country: Japan
facility: Niigata-city
state: Niigata
city: Niigata-city
country: Japan
facility: Niigata-city
state: Niigata
city: Niigata-city
country: Japan
facility: Niigata-city
state: Niigata
city: Niigata-city
country: Japan
facility: Niigata-city
state: Niigata
city: Ojiya-city
country: Japan
facility: Ojiya-city
state: Niigata
city: Sado-city
country: Japan
facility: Sado-city
state: Niigata
city: Shibata-city
country: Japan
facility: Shibata-city
state: Niigata
city: Tsubame-city
country: Japan
facility: Tsubame-city
state: Niigata
city: Bungotakada-city
country: Japan
facility: Bungotakada-city
state: Oita
city: Nakatsu-city
country: Japan
facility: Nakatsu-city
state: Oita
city: Oita-city
country: Japan
facility: Oita-city
state: Oita
city: Oita-city
country: Japan
facility: Oita-city
state: Oita
city: Oita-city
country: Japan
facility: Oita-city
state: Oita
city: Kurashiki-city
country: Japan
facility: Kurashiki-city
state: Okayama
city: Kurashiki-city
country: Japan
facility: Kurashiki-city
state: Okayama
city: Kurashiki-city
country: Japan
facility: Kurashiki-city
state: Okayama
city: Maniwa-city
country: Japan
facility: Maniwa-city
state: Okayama
city: Okayama-city
country: Japan
facility: Okayama-city
state: Okayama
city: Okayama-city
country: Japan
facility: Okayama-city
state: Okayama
city: Okayama-city
country: Japan
facility: Okayama-city
state: Okayama
city: Okayama-city
country: Japan
facility: Okayama-city
state: Okayama
city: Tamano-city
country: Japan
facility: Tamano-city
state: Okayama
city: Kunigami-gun
country: Japan
facility: Kunigami-gun
state: Okinawa
city: Nago-city
country: Japan
facility: Nago-city
state: Okinawa
city: Naha-city
country: Japan
facility: Naha-city
state: Okinawa
city: Naha-city
country: Japan
facility: Naha-city
state: Okinawa
city: Nakagami-gun
country: Japan
facility: Nakagami-gun
state: Okinawa
city: Okinawa-city
country: Japan
facility: Okinawa-city
state: Okinawa
city: Uruma-city
country: Japan
facility: Uruma-city
state: Okinawa
city: Higashiosaka-city
country: Japan
facility: Higashiosaka-city
state: Osaka
city: Hirakata-city
country: Japan
facility: Hirakata-city
state: Osaka
city: Ikeda-city
country: Japan
facility: Ikeda-city
state: Osaka
city: Izumiootsu-city
country: Japan
facility: Izumiootsu-city
state: Osaka
city: Izumiotsu-city
country: Japan
facility: Izumiotsu-city
state: Osaka
city: Izumisano-city
country: Japan
facility: Izumisano-city
state: Osaka
city: Kaizuka-city
country: Japan
facility: Kaizuka-city
state: Osaka
city: Kawachinagano-city
country: Japan
facility: Kawachinagano-city
state: Osaka
city: Kawachinagano-city
country: Japan
facility: Kawachinagano-city
state: Osaka
city: Kishiwada-city
country: Japan
facility: Kishiwada-city
state: Osaka
city: Kishiwada-city
country: Japan
facility: Kishiwada-city
state: Osaka
city: Mino-city
country: Japan
facility: Mino-city
state: Osaka
city: Moriguchi-city
country: Japan
facility: Moriguchi-city
state: Osaka
city: Moriguchi-city
country: Japan
facility: Moriguchi-city
state: Osaka
city: Neyagawa-city
country: Japan
facility: Neyagawa-city
state: Osaka
city: Osaka-city
country: Japan
facility: Osaka-city
state: Osaka
city: Osaka-city
country: Japan
facility: Osaka-city
state: Osaka
city: Osaka-city
country: Japan
facility: Osaka-city
state: Osaka
city: Osaka-city
country: Japan
facility: Osaka-city
state: Osaka
city: Osaka-city
country: Japan
facility: Osaka-city
state: Osaka
city: Osaka-city
country: Japan
facility: Osaka-city
state: Osaka
city: Osaka-city
country: Japan
facility: Osaka-city
state: Osaka
city: Osaka-city
country: Japan
facility: Osaka-city
state: Osaka
city: Osaka-city
country: Japan
facility: Osaka-city
state: Osaka
city: Osaka-city
country: Japan
facility: Osaka-city
state: Osaka
city: Osaka-city
country: Japan
facility: Osaka-city
state: Osaka
city: Osaka-city
country: Japan
facility: Osaka-city
state: Osaka
city: Osaka-city
country: Japan
facility: Osaka-city
state: Osaka
city: Osaka-city
country: Japan
facility: Osaka-city
state: Osaka
city: Osakasayama-city
country: Japan
facility: Osakasayama-city
state: Osaka
city: Sakai-city
country: Japan
facility: Sakai-city
state: Osaka
city: Sakai-city
country: Japan
facility: Sakai-city
state: Osaka
city: Suit-city
country: Japan
facility: Suit-city
state: Osaka
city: Suita-city
country: Japan
facility: Suita-city
state: Osaka
city: Takatsuki-city
country: Japan
facility: Takatsuki-city
state: Osaka
city: Takatsuki-city
country: Japan
facility: Takatsuki-city
state: Osaka
city: Takatsuki-city
country: Japan
facility: Takatsuki-city
state: Osaka
city: Tondabayashi-city
country: Japan
facility: Tondabayashi-city
state: Osaka
city: Toyonaka-city
country: Japan
facility: Toyonaka-city
state: Osaka
city: Saga-city
country: Japan
facility: Saga-city
state: Saga
city: Saga-city
country: Japan
facility: Saga-city
state: Saga
city: Chichibu-city
country: Japan
facility: Chichibu-city
state: Saitama
city: Fukaya-city
country: Japan
facility: Fukaya-city
state: Saitama
city: Hasuda-city
country: Japan
facility: Hasuda-city
state: Saitama
city: Iruma-gun
country: Japan
facility: Iruma-gun
state: Saitama
city: Kawagoe-city
country: Japan
facility: Kawagoe-city
state: Saitama
city: Kawaguchi-city
country: Japan
facility: Kawaguchi-city
state: Saitama
city: Kawaguchi-city
country: Japan
facility: Kawaguchi-city
state: Saitama
city: Kitaadachi-gun
country: Japan
facility: Kitaadachi-gun
state: Saitama
city: Koshigaya-city
country: Japan
facility: Koshigaya-city
state: Saitama
city: Niiza-city
country: Japan
facility: Niiza-city
state: Saitama
city: Soka-city
country: Japan
facility: Soka-city
state: Saitama
city: Tokorozawa-city
country: Japan
facility: Tokorozawa-city
state: Saitama
city: Tsurugashima-city
country: Japan
facility: Tsurugashima-city
state: Saitama
city: Moriyama-city
country: Japan
facility: Moriyama-city
state: Shiga
city: Nagahama-city
country: Japan
facility: Nagahama-city
state: Shiga
city: Omihachiman-city
country: Japan
facility: Omihachiman-city
state: Shiga
city: Otsu-city
country: Japan
facility: Otsu-city
state: Shiga
city: Ritto-city
country: Japan
facility: Ritto-city
state: Shiga
city: Gotsu-city
country: Japan
facility: Gotsu-city
state: Shimane
city: Hamada-city
country: Japan
facility: Hamada-city
state: Shimane
city: Hamada-city
country: Japan
facility: Hamada-city
state: Shimane
city: Izumo-city
country: Japan
facility: Izumo-city
state: Shimane
city: Izumo-city
country: Japan
facility: Izumo-city
state: Shimane
city: Masuda-city
country: Japan
facility: Masuda-city
state: Shimane
city: Matsue-city
country: Japan
facility: Matsue-city
state: Shimane
city: Nita-gun
country: Japan
facility: Nita-gun
state: Shimane
city: Unnan-city
country: Japan
facility: Unnan-city
state: Shimane
city: Fujieda-city
country: Japan
facility: Fujieda-city
state: Shizuoka
city: Hamamatsu-city
country: Japan
facility: Hamamatsu-city
state: Shizuoka
city: Hamamatsu-city
country: Japan
facility: Hamamatsu-city
state: Shizuoka
city: Hamamatsu-city
country: Japan
facility: Hamamatsu-city
state: Shizuoka
city: Iwata-city
country: Japan
facility: Iwata-city
state: Shizuoka
city: Izunokuni-city
country: Japan
facility: Izunokuni-city
state: Shizuoka
city: Mishima-city
country: Japan
facility: Mishima-city
state: Shizuoka
city: Shizuoka-city
country: Japan
facility: Shizuoka-city
state: Shizuoka
city: Shizuoka-city
country: Japan
facility: Shizuoka-city
state: Shizuoka
city: Shizuoka-city
country: Japan
facility: Shizuoka-city
state: Shizuoka
city: Ashikaga-city
country: Japan
facility: Ashikaga-city
state: Tochigi
city: Sano-city
country: Japan
facility: Sano-city
state: Tochigi
city: Shimotsuga-gun
country: Japan
facility: Shimotsuga-gun
state: Tochigi
city: Shimotsuke-city
country: Japan
facility: Shimotsuke-city
state: Tochigi
city: Utsunomiya-city
country: Japan
facility: Utsunomiya-city
state: Tochigi
city: Utsunomiya-city
country: Japan
facility: Utsunomiya-city
state: Tochigi
city: Yaita-city
country: Japan
facility: Yaita-city
state: Tochigi
city: Itano-gun
country: Japan
facility: Itano-gun
state: Tokushima
city: Naruto-city
country: Japan
facility: Naruto-city
state: Tokushima
city: Tokushima-city
country: Japan
facility: Tokushima-city
state: Tokushima
city: Tokushima-city
country: Japan
facility: Tokushima-city
state: Tokushima
city: Adachi-ku
country: Japan
facility: Adachi-ku
state: Tokyo
city: Akishima-city
country: Japan
facility: Akishima-city
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Bunkyo-ku
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Bunkyo-ku
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Bunkyo-ku
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Bunkyo-ku
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Chiyoda-ku
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Chiyoda-ku
state: Tokyo
city: Chofu-city
country: Japan
facility: Chofu-city
state: Tokyo
city: Chuo-ku
country: Japan
facility: Chuo-ku
state: Tokyo
city: Edogawa-ku
country: Japan
facility: Edogawa-ku
state: Tokyo
city: Fuchu-city
country: Japan
facility: Fuchu-city
state: Tokyo
city: Hachioji-city
country: Japan
facility: Hachioji-city
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Itabashi-ku
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Itabashi-ku
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Itabashi-ku
state: Tokyo
city: Katsushika-ku
country: Japan
facility: Katsushika-ku
state: Tokyo
city: Katsushika-ku
country: Japan
facility: Katsushika-ku
state: Tokyo
city: Koganei-city
country: Japan
facility: Koganei-city
state: Tokyo
city: Meguro-ku
country: Japan
facility: Meguro-ku
state: Tokyo
city: Minato-ku
country: Japan
facility: Minato-ku
state: Tokyo
city: Minato-ku
country: Japan
facility: Minato-ku
state: Tokyo
city: Nerima-ku
country: Japan
facility: Nerima-ku
state: Tokyo
city: Ome-city
country: Japan
facility: Ome-city
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Setagaya-ku
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Shibuya-ku
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Shibuya-ku
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Shinagawa-ku
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Shinjuku-ku
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Shinjuku-ku
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Shinjuku-ku
state: Tokyo
city: Sumida-ku
country: Japan
facility: Sumida-ku
state: Tokyo
city: Tachikawa-city
country: Japan
facility: Tachikawa-city
state: Tokyo
city: Taito-ku
country: Japan
facility: Taito-ku
state: Tokyo
city: Tottori-city
country: Japan
facility: Tottori-city
state: Tottori
city: Tottori-city
country: Japan
facility: Tottori-city
state: Tottori
city: Tottori-city
country: Japan
facility: Tottori-city
state: Tottori
city: Tottori-city
country: Japan
facility: Tottori-city
state: Tottori
city: Kurobe-city
country: Japan
facility: Kurobe-city
state: Toyama
city: Oyabe-city
country: Japan
facility: Oyabe-city
state: Toyama
city: Takaoka-city
country: Japan
facility: Takaoka-city
state: Toyama
city: Tonami-city
country: Japan
facility: Tonami-city
state: Toyama
city: Toyama-city
country: Japan
facility: Toyama-city
state: Toyama
city: Toyama-city
country: Japan
facility: Toyama-city
state: Toyama
city: Toyama-city
country: Japan
facility: Toyama-city
state: Toyama
city: Toyama-city
country: Japan
facility: Toyama-city
state: Toyama
city: Arida-gun
country: Japan
facility: Arida-gun
state: Wakayama
city: Gobo-city
country: Japan
facility: Gobo-city
state: Wakayama
city: Higashimuro-gun
country: Japan
facility: Higashimuro-gun
state: Wakayama
city: Nishimuro-gun
country: Japan
facility: Nishimuro-gun
state: Wakayama
city: Nishimuro-gun
country: Japan
facility: Nishimuro-gun
state: Wakayama
city: Tanabe-city
country: Japan
facility: Tanabe-city
state: Wakayama
city: Wakayama-city
country: Japan
facility: Wakayama-city
state: Wakayama
city: Yamagata-city
country: Japan
facility: Yamagata-city
state: Yamagata
city: Hofu-city
country: Japan
facility: Hofu-city
state: Yamaguchi
city: Oshima-gun
country: Japan
facility: Oshima-gun
state: Yamaguchi
city: Shimonoseki-city
country: Japan
facility: Shimonoseki-city
state: Yamaguchi
city: Shimonoseki-city
country: Japan
facility: Shimonoseki-city
state: Yamaguchi
city: Shunan-city
country: Japan
facility: Shunan-city
state: Yamaguchi
city: Yamaguchi-city
country: Japan
facility: Yamaguchi-city
state: Yamaguchi
city: Kofu-city
country: Japan
facility: Kofu-city
state: Yamanashi
city: Kofu-city
country: Japan
facility: Kofu-city
state: Yamanashi
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: