Clinical trial NCT05421091: Special Drug Use-results Surveillance of Scemblix Tablets
Official title: Special Drug Use-results Surveillance of Scemblix Tablets (Resistant or Intolerant Chronic Myeloid Leukemia , CABL001A1401)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Myeloid Leukemia
Keywords: chronic myeloid leukemia
CML
Scemblix Tablets
Asciminib
resistant or intolerant CML
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-06-16
Enrollment: 550
Sex: ALL
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with asciminib

Brief summary: Uncontrolled, central registration system, all-case, multicenter, special drug use-results surveillance.

Detailed description: The objective of this study is to collect data on the occurrence, severity, clinical courses of the safety specifications of asciminib, identify factors etc. involved in occurrence and assess its clinical safety inresistant/intolerant chronic myelogenous leukemia patients during an observational period of 48 weeks from the start of treatment with asciminib.

Eligibility criteria: Inclusion Criteria:

* patients treated with asciminib in Japan.

Exclusion Criteria:

NA

Primary outcomes:
measure: Type, frequency, seriousness and severity of adverse event (AE)/treatment-related AE of the safety specifications
timeFrame: Up to 48 Weeks
measure: AEs leading to interruption/discontinuation of the safety specifications
timeFrame: Up to 48 Weeks
measure: Number of patients with changes in relevant laboratory parameters for the safety specifications
timeFrame: Up to 48 Weeks
measure: Frequency of AEs/Treatment-related AEs by patient characteristic factor
timeFrame: Up to 48 Weeks
Secondary outcomes:
measure: Type, frequency, seriousness, severity of AEs/treatment-related AEs of the safety analysis set
timeFrame: Up to 48 Weeks
measure: AEs leading to interruption/discontinuation in the safety analysis set
timeFrame: Up to 48 Weeks
measure: Frequency of AEs/treatment-related AEs summarized by patient characteristic factor
timeFrame: Up to 48 Weeks
measure: Type, frequency, seriousness, severity of AEs/treatment-related AEs in patients with special characteristics
timeFrame: Up to 48 Weeks
measure: AEs leading to interruption/discontinuation in patients with special characteristics
timeFrame: Up to 48 Weeks
measure: Type, frequency, seriousness, severity and outcome of AEs/treatment-related AEs by treatment line
timeFrame: Up to 48 Weeks
measure: Factors affecting occurrence of AEs by treatment line
timeFrame: Up to 48 Weeks
measure: AEs leading to interruption/discontinuation by treatment line
timeFrame: Up to 48 Weeks
measure: Major molecular response (MMR) rates
timeFrame: Week 12, Week 24, Week 48
measure: MMR rates by Week 48 by patient characteristics factor
timeFrame: Up to 48 Weeks
measure: MR4.0 and MR4.5 rates
timeFrame: Week 12, Week 24 and Week 48
measure: Complete cytogenetic response (CCyR) rates
timeFrame: Week 12, Week 24 and Week 48
measure: Complete hematological response (CHR) rates
timeFrame: Week 12, Week 24 and Week 48
measure: Rate of patients with BCR-ABL1 gene mutations
timeFrame: Up to 48 Weeks
measure: MMR rates by Week 48 in patients with special characteristics
timeFrame: Week 48
measure: MMR rates by treatment line
timeFrame: Week 12, Week 24 and Week 48
measure: MR4.0 and MR4.5 rates by treatment line
timeFrame: Week 12, Week 24 and Week 48
measure: CCyR rates by treatment line
timeFrame: Week 12, Week 24 and Week 48
measure: CHR rates by treatment line
timeFrame: Week 12, Week 24 and Week 48
Other outcomes:
Locations:
city: Anjo
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Ichinomiya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Kasugai
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Komaki
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Konan
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nagakute-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nagoya-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nagoya-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Seto-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Tokai
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Toyoake city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Toyohashi
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Toyohashi
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Yatomi
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Odate
country: Japan
facility: Novartis Investigative Site
state: Akita
city: Funabashi
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Ichihara
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Ichikawa
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Kashiwa-city
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Kashiwa
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Kisarazu
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Matsudo
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Narita
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Matsuyama-city
country: Japan
facility: Novartis Investigative Site
state: Ehime
city: Matsuyama-city
country: Japan
facility: Novartis Investigative Site
state: Ehime
city: Matsuyama
country: Japan
facility: Novartis Investigative Site
state: Ehime
city: Toon city
country: Japan
facility: Novartis Investigative Site
state: Ehime
city: Yoshida-gun
country: Japan
facility: Novartis Investigative Site
state: Fukui
city: Fukuoka city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kitakyushu-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kitakyushu-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kitakyushu-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kurume-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Yanagawa-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Aizuwakamatsu
country: Japan
facility: Novartis Investigative Site
state: Fukushima
city: Fukushima city
country: Japan
facility: Novartis Investigative Site
state: Fukushima
city: Iwaki
country: Japan
facility: Novartis Investigative Site
state: Fukushima
city: Gifu-city
country: Japan
facility: Novartis Investigative Site
state: Gifu
city: Seki
country: Japan
facility: Novartis Investigative Site
state: Gifu
city: Takayama
country: Japan
facility: Novartis Investigative Site
state: Gifu
city: Fujioka city
country: Japan
facility: Novartis Investigative Site
state: Gunma
city: Maebashi city
country: Japan
facility: Novartis Investigative Site
state: Gunma
city: Maebashi-city
country: Japan
facility: Novartis Investigative Site
state: Gunma
city: Maebashi
country: Japan
facility: Novartis Investigative Site
state: Gunma
city: Ota-city
country: Japan
facility: Novartis Investigative Site
state: Gunma
city: Fukuyama
country: Japan
facility: Novartis Investigative Site
state: Hiroshima
city: Mihara
country: Japan
facility: Novartis Investigative Site
state: Hiroshima
city: Asahikawa-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Hakodate
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Iwamizawa-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Kushiro
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Obihiro
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Akashi
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Amagasaki city
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Amagasaki
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Himeji
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kakogawa-shi
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kobe-city
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kobe-city
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kobe-shi
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kobe
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kobe
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kobe
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Nishinomiya-city
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Nishinomiya-city
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Nishinomiya
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Sumoto
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Toyooka
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Higashiibaraki-gun
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Hitachi-city
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Ishioka
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Koga
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Tsuchiura
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Tsukuba city
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Tsukuba
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Kanazawa-city
country: Japan
facility: Novartis Investigative Site
state: Ishikawa
city: Kanazawa
country: Japan
facility: Novartis Investigative Site
state: Ishikawa
city: Nanao
country: Japan
facility: Novartis Investigative Site
state: Ishikawa
city: Nomi
country: Japan
facility: Novartis Investigative Site
state: Ishikawa
city: Kitakami
country: Japan
facility: Novartis Investigative Site
state: Iwate
city: Morioka
country: Japan
facility: Novartis Investigative Site
state: Iwate
city: Shiwa-gun
country: Japan
facility: Novartis Investigative Site
state: Iwate
city: Kita-gun
country: Japan
facility: Novartis Investigative Site
state: Kagawa
city: Takamatsu city
country: Japan
facility: Novartis Investigative Site
state: Kagawa
city: Takamatsu-city
country: Japan
facility: Novartis Investigative Site
state: Kagawa
city: Takamatsu
country: Japan
facility: Novartis Investigative Site
state: Kagawa
city: Kanoya
country: Japan
facility: Novartis Investigative Site
state: Kagoshima
city: Kirishima
country: Japan
facility: Novartis Investigative Site
state: Kagoshima
city: Kamakura-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kawasaki-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kawasaki-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kawasaki
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yamato
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kochi city
country: Japan
facility: Novartis Investigative Site
state: Kochi
city: Kumamoto City
country: Japan
facility: Novartis Investigative Site
state: Kumamoto
city: Kumamoto City
country: Japan
facility: Novartis Investigative Site
state: Kumamoto
city: Kumamoto-city
country: Japan
facility: Novartis Investigative Site
state: Kumamoto
city: Kumamoto-city
country: Japan
facility: Novartis Investigative Site
state: Kumamoto
city: Fukuchiyama
country: Japan
facility: Novartis Investigative Site
state: Kyoto
city: Kyoto-city
country: Japan
facility: Novartis Investigative Site
state: Kyoto
city: Maizuru
country: Japan
facility: Novartis Investigative Site
state: Kyoto
city: Tsu-city
country: Japan
facility: Novartis Investigative Site
state: Mie
city: Tsu
country: Japan
facility: Novartis Investigative Site
state: Mie
city: Yokkaichi
country: Japan
facility: Novartis Investigative Site
state: Mie
city: Ishinomaki-city
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Sendai city
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Sendai city
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Sendai-shi
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Sendai
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Miyakonojo
country: Japan
facility: Novartis Investigative Site
state: Miyazaki
city: Miyakonojo
country: Japan
facility: Novartis Investigative Site
state: Miyazaki
city: Nobeoka
country: Japan
facility: Novartis Investigative Site
state: Miyazaki
city: Nagano-city
country: Japan
facility: Novartis Investigative Site
state: Nagano
city: Saku-city
country: Japan
facility: Novartis Investigative Site
state: Nagano
city: Suwa
country: Japan
facility: Novartis Investigative Site
state: Nagano
city: Isahaya
country: Japan
facility: Novartis Investigative Site
state: Nagasaki
city: Nagasaki-shi
country: Japan
facility: Novartis Investigative Site
state: Nagasaki
city: Ikoma
country: Japan
facility: Novartis Investigative Site
state: Nara
city: Kashihara city
country: Japan
facility: Novartis Investigative Site
state: Nara
city: Tenri
country: Japan
facility: Novartis Investigative Site
state: Nara
city: Joetsu
country: Japan
facility: Novartis Investigative Site
state: Niigata
city: Minamiuonuma
country: Japan
facility: Novartis Investigative Site
state: Niigata
city: Nagaoka
country: Japan
facility: Novartis Investigative Site
state: Niigata
city: Shibata
country: Japan
facility: Novartis Investigative Site
state: Niigata
city: Yufu
country: Japan
facility: Novartis Investigative Site
state: Oita
city: Kurashiki-city
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Okayama city
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Okayama-city
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Okayama-city
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Tsuyama
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Nago
country: Japan
facility: Novartis Investigative Site
state: Okinawa
city: Naha
country: Japan
facility: Novartis Investigative Site
state: Okinawa
city: Shimajiri-Gun
country: Japan
facility: Novartis Investigative Site
state: Okinawa
city: Hirakata-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Izumisano-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Kawachinagano
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Kawachinagano
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Moriguchi
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Moriguchi
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Osaka Sayama
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Osaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Osaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Osaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Osaka-City
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Suita
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Suita
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Takatsuki
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Tondabayashi
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Toyonaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Karatsu
country: Japan
facility: Novartis Investigative Site
state: Saga
city: Saga-city
country: Japan
facility: Novartis Investigative Site
state: Saga
city: Asaka
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Fukaya
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Hidaka-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Iruma-gun
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Kawagoe
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Koshigaya
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Sayama-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Tokorozawa city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Tokorozawa
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Kusatsu city
country: Japan
facility: Novartis Investigative Site
state: Shiga
city: Moriyama-City
country: Japan
facility: Novartis Investigative Site
state: Shiga
city: Nagahama
country: Japan
facility: Novartis Investigative Site
state: Shiga
city: Omihachiman
country: Japan
facility: Novartis Investigative Site
state: Shiga
city: Izumo-city
country: Japan
facility: Novartis Investigative Site
state: Shimane
city: Izumo
country: Japan
facility: Novartis Investigative Site
state: Shimane
city: Masuda
country: Japan
facility: Novartis Investigative Site
state: Shimane
city: Matsue
country: Japan
facility: Novartis Investigative Site
state: Shimane
city: Hamamatsu-city
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Hamamatsu-city
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Iwata City
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Izunokuni
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Shimada
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Shizuoka-city
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Sunto Gun
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Sano
country: Japan
facility: Novartis Investigative Site
state: Tochigi
city: Shimotsuke
country: Japan
facility: Novartis Investigative Site
state: Tochigi
city: Itano
country: Japan
facility: Novartis Investigative Site
state: Tokushima
city: Komatsushima-city
country: Japan
facility: Novartis Investigative Site
state: Tokushima
city: Bunkyo ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Bunkyo ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Hachioji-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Hachioji-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Itabashi ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Itabashi ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Komae
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Koto ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Meguro-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Meguro
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Minato ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Mitaka-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Musashino-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Nerima-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Ome
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shibuya
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinagawa ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Suginami
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Sumida-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Tachikawa-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Yonago-city
country: Japan
facility: Novartis Investigative Site
state: Tottori
city: Tonami
country: Japan
facility: Novartis Investigative Site
state: Toyama
city: Toyama-city
country: Japan
facility: Novartis Investigative Site
state: Toyama
city: Toyama-City
country: Japan
facility: Novartis Investigative Site
state: Toyama
city: Kinokawa
country: Japan
facility: Novartis Investigative Site
state: Wakayama
city: Sakata-city
country: Japan
facility: Novartis Investigative Site
state: Yamagata
city: Ube
country: Japan
facility: Novartis Investigative Site
state: Yamaguchi
city: Chuo-city
country: Japan
facility: Novartis Investigative Site
state: Yamanashi
city: Kofu-city
country: Japan
facility: Novartis Investigative Site
state: Yamanashi
city: Akita
country: Japan
facility: Novartis Investigative Site
city: Aomori
country: Japan
facility: Novartis Investigative Site
city: Chiba
country: Japan
facility: Novartis Investigative Site
city: Chiba
country: Japan
facility: Novartis Investigative Site
city: Chiba
country: Japan
facility: Novartis Investigative Site
city: Fukui
country: Japan
facility: Novartis Investigative Site
city: Fukui
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Fukushima
country: Japan
facility: Novartis Investigative Site
city: Gifu
country: Japan
facility: Novartis Investigative Site
city: Hiroshima
country: Japan
facility: Novartis Investigative Site
city: Hiroshima
country: Japan
facility: Novartis Investigative Site
city: Hiroshima
country: Japan
facility: Novartis Investigative Site
city: Hiroshima
country: Japan
facility: Novartis Investigative Site
city: Kyoto
country: Japan
facility: Novartis Investigative Site
city: Kyoto
country: Japan
facility: Novartis Investigative Site
city: Kyoto
country: Japan
facility: Novartis Investigative Site
city: Kyoto
country: Japan
facility: Novartis Investigative Site
city: Kyoto
country: Japan
facility: Novartis Investigative Site
city: Miyazaki
country: Japan
facility: Novartis Investigative Site
city: Miyazaki
country: Japan
facility: Novartis Investigative Site
city: Nagasaki
country: Japan
facility: Novartis Investigative Site
city: Nara
country: Japan
facility: Novartis Investigative Site
city: Niigata
country: Japan
facility: Novartis Investigative Site
city: Oita
country: Japan
facility: Novartis Investigative Site
city: Okayama
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Saitama
country: Japan
facility: Novartis Investigative Site
city: Saitama
country: Japan
facility: Novartis Investigative Site
city: Saitama
country: Japan
facility: Novartis Investigative Site
city: Tochigi
country: Japan
facility: Novartis Investigative Site
city: Tokushima
country: Japan
facility: Novartis Investigative Site
city: Toyama
country: Japan
facility: Novartis Investigative Site
city: Toyama
country: Japan
facility: Novartis Investigative Site
city: Wakayama
country: Japan
facility: Novartis Investigative Site
city: Wakayama
country: Japan
facility: Novartis Investigative Site
city: Yamagata
country: Japan
facility: Novartis Investigative Site
city: Yamagata
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: