- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00614575
Survey on PD Patients With Depressive Symptoms
BI_Sifrol Tablets Special Drug Use Surveillance(Survey on the Safety and Efficacy in Parkinson's Disease Patients With Depressive Symptoms)
The primary objective of this investigation is to conduct a 12-week prospective survey in PD patients with depressive symptoms treated with BI Sifrol Tablets (hereinafter referred to as this drug) in the routine clinical settings to determine the following items related to the safety and efficacy.
i. Adverse drug reaction symptoms, incidence, and severity ii. Motor capacity during the investigation iii. Depressive symptoms during the investigation
Przegląd badań
Status
Warunki
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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Akashi, Japonia
- Boehringer Ingelheim Investigational Site
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Akita, Japonia
- Boehringer Ingelheim Investigational Site 1
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Akita, Japonia
- Boehringer Ingelheim Investigational Site 2
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Asahikawa, Japonia
- Boehringer Ingelheim Investigational Site
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Ashikaga, Japonia
- Boehringer Ingelheim Investigational Site
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Awaji, Japonia
- Boehringer Ingelheim Investigational Site
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Chitose, Japonia
- Boehringer Ingelheim Investigational Site
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Chuo, Japonia
- Boehringer Ingelheim Investigational Site
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Fuchu, Japonia
- Boehringer Ingelheim Investigational Site 1
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Fuchu, Japonia
- Boehringer Ingelheim Investigational Site 2
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Fuefuki, Japonia
- Boehringer Ingelheim Investigational Site
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Fuehuki, Japonia
- Boehringer Ingelheim Investigational Site
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Fujioka, Japonia
- Boehringer Ingelheim Investigational Site
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Fujisaki, Japonia
- Boehringer Ingelheim Investigational Site
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Fujisawa, Japonia
- Boehringer Ingelheim Investigational Site
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Fukaya, Japonia
- Boehringer Ingelheim Investigational Site
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Fukuoka, Japonia
- Boehringer Ingelheim Investigational Site 1
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Fukuoka, Japonia
- Boehringer Ingelheim Investigational Site 2
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Fukuoka, Japonia
- Boehringer Ingelheim Investigational Site 3
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Fukuoka, Japonia
- Boehringer Ingelheim Investigational Site 4
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Fukuoka, Japonia
- Boehringer Ingelheim Investigational Site 5
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Fukushima, Japonia
- Boehringer Ingelheim Investigational Site 1
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Fukushima, Japonia
- Boehringer Ingelheim Investigational Site 2
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Funabashi, Japonia
- Boehringer Ingelheim Investigational Site
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Gifu, Japonia
- Boehringer Ingelheim Investigational Site 1
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Gifu, Japonia
- Boehringer Ingelheim Investigational Site 2
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Habikino, Japonia
- Boehringer Ingelheim Investigational Site
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Hachioji, Japonia
- Boehringer Ingelheim Investigational Site
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Hamamatsu, Japonia
- Boehringer Ingelheim Investigational Site 1
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Hamamatsu, Japonia
- Boehringer Ingelheim Investigational Site 2
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Hamamatsu, Japonia
- Boehringer Ingelheim Investigational Site 3
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Hamamatsu, Japonia
- Boehringer Ingelheim Investigational Site 4
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Hamamatsu, Japonia
- Boehringer Ingelheim Investigational Site 5
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Hanamaki, Japonia
- Boehringer Ingelheim Investigational Site
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Hayashima, Japonia
- Boehringer Ingelheim Investigational Site
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Higashiosaka, Japonia
- Boehringer Ingelheim Investigational Site 1
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Higashiosaka, Japonia
- Boehringer Ingelheim Investigational Site 2
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Himeji, Japonia
- Boehringer Ingelheim Investigational Site
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Hirakata, Japonia
- Boehringer Ingelheim Investigational Site
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Hirishima, Japonia
- Boehringer Ingelheim Investigational Site
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Hirosaki, Japonia
- Boehringer Ingelheim Investigational Site
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Ibaragi, Japonia
- Boehringer Ingelheim Investigational Site
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Iizuka, Japonia
- Boehringer Ingelheim Investigational Site
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Inag, Japonia
- Boehringer Ingelheim Investigational Site
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Irima, Japonia
- Boehringer Ingelheim Investigational Site
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Isahaya, Japonia
- Boehringer Ingelheim Investigational Site
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Iwaki, Japonia
- Boehringer Ingelheim Investigational Site
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Iwamizawa, Japonia
- Boehringer Ingelheim Investigational Site
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Iwata, Japonia
- Boehringer Ingelheim Investigational Site
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Jyoetsu, Japonia
- Boehringer Ingelheim Investigational Site 1
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Jyoetsu, Japonia
- Boehringer Ingelheim Investigational Site 2
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Jyoyo, Japonia
- Boehringer Ingelheim Investigational Site
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Kagoshima, Japonia
- Boehringer Ingelheim Investigational Site 1
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Kagoshima, Japonia
- Boehringer Ingelheim Investigational Site 2
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Kagoshima, Japonia
- Boehringer Ingelheim Investigational Site 3
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Kahoku, Japonia
- Boehringer Ingelheim Investigational Site
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Kamakura, Japonia
- Boehringer Ingelheim Investigational Site
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Kanazawa, Japonia
- Boehringer Ingelheim Investigational Site 1
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Kanazawa, Japonia
- Boehringer Ingelheim Investigational Site 2
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Kanoya, Japonia
- Boehringer Ingelheim Investigational Site 1
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Kanoya, Japonia
- Boehringer Ingelheim Investigational Site 2
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Kashihara, Japonia
- Boehringer Ingelheim Investigational Site 1
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Kashihara, Japonia
- Boehringer Ingelheim Investigational Site 2
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Kasuga, Japonia
- Boehringer Ingelheim Investigational Site
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Kawagchi, Japonia
- Boehringer Ingelheim Investigational Site
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Kawaguchi, Japonia
- Boehringer Ingelheim Investigational Site
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Kawasaki, Japonia
- Boehringer Ingelheim Investigational Site 1
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Kawasaki, Japonia
- Boehringer Ingelheim Investigational Site 2
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Kitakami, Japonia
- Boehringer Ingelheim Investigational Site
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Kiyose, Japonia
- Boehringer Ingelheim Investigational Site 1
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Kiyose, Japonia
- Boehringer Ingelheim Investigational Site 2
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Kodaira, Japonia
- Boehringer Ingelheim Investigational Site
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Kofu, Japonia
- Boehringer Ingelheim Investigational Site
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Koga, Japonia
- Boehringer Ingelheim Investigational Site
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Komae, Japonia
- Boehringer Ingelheim Investigational Site
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Komatsu, Japonia
- Boehringer Ingelheim Investigational Site
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Komatsushima, Japonia
- Boehringer Ingelheim Investigational Site
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Koriyama, Japonia
- Boehringer Ingelheim Investigational Site 1
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Koriyama, Japonia
- Boehringer Ingelheim Investigational Site 2
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Koshigaya, Japonia
- Boehringer Ingelheim Investigational Site
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Kumamoto, Japonia
- Boehringer Ingelheim Investigational Site 1
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Kumamoto, Japonia
- Boehringer Ingelheim Investigational Site 2
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Kumamoto, Japonia
- Boehringer Ingelheim Investigational Site 3
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Kure, Japonia
- Boehringer Ingelheim Investigational Site
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Kusatsu, Japonia
- Boehringer Ingelheim Investigational Site
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Kyoto, Japonia
- Boehringer Ingelheim Investigational Site 1
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Kyoto, Japonia
- Boehringer Ingelheim Investigational Site 2
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Kyoto, Japonia
- Boehringer Ingelheim Investigational Site 3
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Kyoto, Japonia
- Boehringer Ingelheim Investigational Site 4
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Maebashi, Japonia
- Boehringer Ingelheim Investigational Site
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Matsudo, Japonia
- Boehringer Ingelheim Investigational Site
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Matsumoto, Japonia
- Boehringer Ingelheim Investigational Site
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Mibu, Japonia
- Boehringer Ingelheim Investigational Site
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Mihara, Japonia
- Boehringer Ingelheim Investigational Site
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Mihoro, Japonia
- Boehringer Ingelheim Investigational Site
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Miriyama, Japonia
- Boehringer Ingelheim Investigational Site
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Misato, Japonia
- Boehringer Ingelheim Investigational Site
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Miyako, Japonia
- Boehringer Ingelheim Investigational Site
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Miyazaki, Japonia
- Boehringer Ingelheim Investigational Site 1
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Miyazaki, Japonia
- Boehringer Ingelheim Investigational Site 2
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Moriguchi, Japonia
- Boehringer Ingelheim Investigational Site
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Morioka, Japonia
- Boehringer Ingelheim Investigational Site 1
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Morioka, Japonia
- Boehringer Ingelheim Investigational Site 2
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Moriya, Japonia
- Boehringer Ingelheim Investigational Site
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Musashino, Japonia
- Boehringer Ingelheim Investigational Site
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Nagano, Japonia
- Boehringer Ingelheim Investigational Site
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Nagaoka, Japonia
- Boehringer Ingelheim Investigational Site
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Nagaokakyo, Japonia
- Boehringer Ingelheim Investigational Site
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Nagoya, Japonia
- Boehringer Ingelheim Investigational Site 1
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Nagoya, Japonia
- Boehringer Ingelheim Investigational Site 2
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Nagoya, Japonia
- Boehringer Ingelheim Investigational Site 3
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Nagoya, Japonia
- Boehringer Ingelheim Investigational Site 4
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Nara, Japonia
- Boehringer Ingelheim Investigational Site 1
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Nara, Japonia
- Boehringer Ingelheim Investigational Site 2
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Narashino, Japonia
- Boehringer Ingelheim Investigational Site
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Narita, Japonia
- Boehringer Ingelheim Investigational Site
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Naruto, Japonia
- Boehringer Ingelheim Investigational Site
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Nasushiobara, Japonia
- Boehringer Ingelheim Investigational Site
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Nichinan, Japonia
- Boehringer Ingelheim Investigational Site
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Ninohe, Japonia
- Boehringer Ingelheim Investigational Site
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Nishinomiya, Japonia
- Boehringer Ingelheim Investigational Site
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Nishitokyo, Japonia
- Boehringer Ingelheim Investigational Site
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Ogaki, Japonia
- Boehringer Ingelheim Investigational Site
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Oiso, Japonia
- Boehringer Ingelheim Investigational Site
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Oita, Japonia
- Boehringer Ingelheim Investigational Site 1
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Oita, Japonia
- Boehringer Ingelheim Investigational Site 2
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Oita, Japonia
- Boehringer Ingelheim Investigational Site 3
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Okaya, Japonia
- Boehringer Ingelheim Investigational Site
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Okayama, Japonia
- Boehringer Ingelheim Investigational Site 1
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Okayama, Japonia
- Boehringer Ingelheim Investigational Site 2
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Okazaki, Japonia
- Boehringer Ingelheim Investigational Site
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Okinawa, Japonia
- Boehringer Ingelheim Investigational Site
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Omura, Japonia
- Boehringer Ingelheim Investigational Site
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Omuta, Japonia
- Boehringer Ingelheim Investigational Site
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Onojyo, Japonia
- Boehringer Ingelheim Investigational Site
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Osaka, Japonia
- Boehringer Ingelheim Investigational Site 1
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Osaka, Japonia
- Boehringer Ingelheim Investigational Site 2
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Osaka, Japonia
- Boehringer Ingelheim Investigational Site 3
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Osaka, Japonia
- Boehringer Ingelheim Investigational Site 4
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Osaka, Japonia
- Boehringer Ingelheim Investigational Site 5
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Osaka, Japonia
- Boehringer Ingelheim Investigational Site 6
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Ota, Japonia
- Boehringer Ingelheim Investigational Site
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Otake, Japonia
- Boehringer Ingelheim Investigational Site
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Otsu, Japonia
- Boehringer Ingelheim Investigational Site
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Ryugasaki, Japonia
- Boehringer Ingelheim Investigational Site
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Saeki, Japonia
- Boehringer Ingelheim Investigational Site
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Saga, Japonia
- Boehringer Ingelheim Investigational Site
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Sagamihara, Japonia
- Boehringer Ingelheim Investigational Site 1
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Sagamihara, Japonia
- Boehringer Ingelheim Investigational Site 2
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Sagamihara, Japonia
- Boehringer Ingelheim Investigational Site 3
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Saijyo, Japonia
- Boehringer Ingelheim Investigational Site
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Saitama, Japonia
- Boehringer Ingelheim Investigational Site
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Sakai, Japonia
- Boehringer Ingelheim Investigational Site 1
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Sakai, Japonia
- Boehringer Ingelheim Investigational Site 2
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Sapporo, Japonia
- Boehringer Ingelheim Investigational Site 3
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Sapporo, Japonia
- Boehringer Ingelheim Investigational Site 4
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Sapporo, Japonia
- Boehringer Ingelheim Investigational Site 5
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Sapporo, Japonia
- Boehringer Ingelheim Investigational Site 6
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Sapporo, Japonia
- Boehringer Ingelheim Investigational Site 8
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Sapporo, Japonia
- Boehringer Ingelheim Investigational Site 9
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Sapporo, Japonia
- Boehringer Ingelheim Investigational Site 7
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Sapporo, Japonia
- Boehringer Ingelheim Investigational Site 1
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Sapporo, Japonia
- Boehringer Ingelheim Investigational Site 2
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Sekigahara, Japonia
- Boehringer Ingelheim Investigational Site
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Sendai, Japonia
- Boehringer Ingelheim Investigational Site 1
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Sendai, Japonia
- Boehringer Ingelheim Investigational Site 2
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Shimoda, Japonia
- Boehringer Ingelheim Investigational Site
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Shimotsuke, Japonia
- Boehringer Ingelheim Investigational Site 1
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Shimotsuke, Japonia
- Boehringer Ingelheim Investigational Site 2
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Shinngu, Japonia
- Boehringer Ingelheim Investigational Site
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Shiroishi, Japonia
- Boehringer Ingelheim Investigational Site
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Shizuoka, Japonia
- Boehringer Ingelheim Investigational Site 1
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Shizuoka, Japonia
- Boehringer Ingelheim Investigational Site 2
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Showajima, Japonia
- Boehringer Ingelheim Investigational Site
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Suita, Japonia
- Boehringer Ingelheim Investigational Site 1
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Suita, Japonia
- Boehringer Ingelheim Investigational Site 2
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Susono, Japonia
- Boehringer Ingelheim Investigational Site
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Suzuka, Japonia
- Boehringer Ingelheim Investigational Site
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Takaoka, Japonia
- Boehringer Ingelheim Investigational Site 1
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Takaoka, Japonia
- Boehringer Ingelheim Investigational Site 2
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Takatsuki, Japonia
- Boehringer Ingelheim Investigational Site
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Tarimizu, Japonia
- Boehringer Ingelheim Investigational Site
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Togitsu, Japonia
- Boehringer Ingelheim Investigational Site
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Tokoname, Japonia
- Boehringer Ingelheim Investigational Site
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Tokushima, Japonia
- Boehringer Ingelheim Investigational Site
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Tokyo Arakawa-ku, Japonia
- Boehringer Ingelheim Investigational Site
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Tokyo Bunkyo-ku, Japonia
- Boehringer Ingelheim Investigational Site
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Tokyo Chuo-ku, Japonia
- Boehringer Ingelheim Investigational Site 1
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Tokyo Chuo-ku, Japonia
- Boehringer Ingelheim Investigational Site 2
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Tokyo Daito-ku, Japonia
- Boehringer Ingelheim Investigational Site
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Tokyo Koto-ku, Japonia
- Boehringer Ingelheim Investigational Site
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Tokyo Meguro-ku, Japonia
- Boehringer Ingelheim Investigational Site 1
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Tokyo Meguro-ku, Japonia
- Boehringer Ingelheim Investigational Site 2
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Tokyo Minato-ku, Japonia
- Boehringer Ingelheim Investigational Site 1
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Tokyo Minato-ku, Japonia
- Boehringer Ingelheim Investigational Site 2
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Tokyo Minato-ku, Japonia
- Boehringer Ingelheim Investigational Site 3
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Tokyo Nakano-ku, Japonia
- Boehringer Ingelheim Investigational Site
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Tokyo Nerima-ku, Japonia
- Boehringer Ingelheim Investigational Site
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Tokyo Ota-ku, Japonia
- Boehringer Ingelheim Investigational Site 1
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Tokyo Ota-ku, Japonia
- Boehringer Ingelheim Investigational Site 2
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Tokyo Setagaya, Japonia
- Boehringer Ingelheim Investigational Site
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Tokyo Setagaya-ku, Japonia
- Boehringer Ingelheim Investigational Site
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Tokyo Shibuya-ku, Japonia
- Boehringer Ingelheim Investigational Site
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Tokyo Shinagawa-ku, Japonia
- Boehringer Ingelheim Investigational Site
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Tokyo Shinjyuku-ku, Japonia
- Boehringer Ingelheim Investigational Site 1
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Tokyo Shinjyuku-ku, Japonia
- Boehringer Ingelheim Investigational Site 2
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Tokyo Shinjyuku-ku, Japonia
- Boehringer Ingelheim Investigational Site 3
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Tokyo Sibuya-ku, Japonia
- Boehringer Ingelheim Investigational Site
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Tokyo Toshima-ku, Japonia
- Boehringer Ingelheim Investigational Site
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Tokyo-Edogawa-ku, Japonia
- Boehringer Ingelheim Investigational Site
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Tokyo-Itabashi-ku, Japonia
- Boehringer Ingelheim Investigational Site
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Toride, Japonia
- Boehringer Ingelheim Investigational Site
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Tosu, Japonia
- Boehringer Ingelheim Investigational Site
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Toyama, Japonia
- Boehringer Ingelheim Investigational Site 1
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Toyama, Japonia
- Boehringer Ingelheim Investigational Site 2
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Toyama, Japonia
- Boehringer Ingelheim Investigational Site 3
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Toyohashi, Japonia
- Boehringer Ingelheim Investigational Site
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Toyokawa, Japonia
- Boehringer Ingelheim Investigational Site
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Toyonaka, Japonia
- Boehringer Ingelheim Investigational Site
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Ube, Japonia
- Boehringer Ingelheim Investigational Site
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Uchinada, Japonia
- Boehringer Ingelheim Investigational Site
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Ueda, Japonia
- Boehringer Ingelheim Investigational Site
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Ushiku, Japonia
- Boehringer Ingelheim Investigational Site
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Utsunomiya, Japonia
- Boehringer Ingelheim Investigational Site 1
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Utsunomiya, Japonia
- Boehringer Ingelheim Investigational Site 2
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Wakayama, Japonia
- Boehringer Ingelheim Investigational Site
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Yachiyo, Japonia
- Boehringer Ingelheim Investigational Site 1
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Yachiyo, Japonia
- Boehringer Ingelheim Investigational Site 2
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Yachiyo, Japonia
- Boehringer Ingelheim Investigational Site 3
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Yamanashi, Japonia
- Boehringer Ingelheim Investigational Site
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Yanago, Japonia
- Boehringer Ingelheim Investigational Site
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Yoichi, Japonia
- Boehringer Ingelheim Investigational Site
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Yokohama, Japonia
- Boehringer Ingelheim Investigational Site 1
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Yokohama, Japonia
- Boehringer Ingelheim Investigational Site 2
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Yokohama, Japonia
- Boehringer Ingelheim Investigational Site 3
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Yokohama, Japonia
- Boehringer Ingelheim Investigational Site 4
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Yokosuka, Japonia
- Boehringer Ingelheim Investigational Site
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Yoshinogawa, Japonia
- Boehringer Ingelheim Investigational Site
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
Inclusion criteria:
**PD patients with depressive symptoms Patients who have not received pramipexole hydrochloride hydrate preparations within 1 month before survey entrance.
Exclusion criteria:
- PD patients with the past history of suicidal attempt, suicidal ideation or tendency
- PD patients with suicidal ideation
- PD patients with the past history of suicidal tendency
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
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BI-Sifrol® Tablets (Pramipexole)
BI-Sifrol® Tablets, pramipexole dose: 0.125 mg, 0.5 mg, No reference therapy
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events
Ramy czasowe: for 12 weeks
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The aim of this Post Marketing Surveillance (PMS) was to obtain safety data with treatment of pramipexole in Parkinson's disease patients with depressive symptoms.
The percentage of participants with adverse events, adverse drug reactions, and serious adverse events are presented.
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for 12 weeks
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Clinical Global Impression of Improvement
Ramy czasowe: for 12 weeks after initiation of the treatment
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Investigators evaluation of the Parkinson's disease (PD) symptoms on the Clinical Global Impression (CGI) with 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).
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for 12 weeks after initiation of the treatment
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Mean Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score
Ramy czasowe: Baseline and after 12 weeks (or at the time of discontinuation)
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Part III of the UPDRS contains the clinician-scored motor evaluation, and includes 14 individual items each scored from 0 (Normal) to 4 (Extreme dysfunction).
The total score ranged from 0 to 56.
A negative change in the Part III total score indicates improvement.
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Baseline and after 12 weeks (or at the time of discontinuation)
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Mean Change From Baseline in Beck's Depression Inventory (BDI) Total Score
Ramy czasowe: Baseline and after 12 weeks (or at the time of discontinuation)
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The degree of severity in depressive state are scored between 0-63 in BDI.
A decrease in the score means improvement.
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Baseline and after 12 weeks (or at the time of discontinuation)
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Mean Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I Item 3 Score
Ramy czasowe: Baseline and after 12 weeks (or at the time of discontinuation)
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Unified Parkinson's Disease Rating Scale Part I Item 3 assesses the participant for symptoms of depression.
Item 3 scores range from 0 (None) to 4 (Sustained depression with suicidal thoughts or intent).
A higher score indicates more severe depression symptoms.
A negative change in the item 3 score indicates improvement.
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Baseline and after 12 weeks (or at the time of discontinuation)
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Mean Change From Baseline in Modified Hoehn & Yahr Rating Scale
Ramy czasowe: After 12 weeks or at the time of discontinuation
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This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease.
The scale ranges from 0 (No signs) to 5 (Bedridden).
A negative change in the Yahr rating scale indicates improvement.
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After 12 weeks or at the time of discontinuation
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Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 248.635
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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Spero TherapeuticsZakończonyKompleks Mycobacterium Avium | Niegruźlicze Mycobacterium Pulmonary DiseaseStany Zjednoczone
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Janssen Pharmaceutical K.K.RekrutacyjnyOporna na leczenie Mycobacterium Avium Complex-lung Disease (MAC-LD)Tajwan, Republika Korei, Japonia
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Adelphi Values LLCBlueprint Medicines CorporationZakończonyBiałaczka z komórek tucznych (MCL) | Agresywna mastocytoza układowa (ASM) | SM w Assoc Clonal Hema Lineage Non-mast Cell Lineage Disease (SM-AHNMD) | Tląca się mastocytoza układowa (SSM) | Indolentna układowa mastocytoza (ISM) Podgrupa ISM w pełni zatrudnionaStany Zjednoczone