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Brief Title: Long-term Observation PMS for Afatinib
Official Title: Post Marketing Surveillance on Long Term Drug Use of GIOTRIF Tablets in Patients With Epidermal Growth Factor Receptor Mutation-positive Inoperable or Recurrent Non-small Cell Lung Cancer.
Study ID: NCT02131259
Brief Summary: In Japan, post-approval execution of post marketing surveillance (PMS) is requested by the Japanese Pharmaceutical Affairs Law (J-PAL) in order to accumulate safety and efficacy data for reexamination. Reexamination period is defined by J-PAL. Eight years after approval of a new substance, results of PMS need to be submitted as a part of reexamination dossier to the Japanese regulatory authority, the Ministry of Health, Labour and Welfare (MHLW).
Detailed Description:
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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Boehringer Ingelheim Investigational Site 258, Shizuoka Shizuoka, , Japan
Boehringer Ingelheim Investigational Site 259, Shizuoka Shizuoka, , Japan
Boehringer Ingelheim Investigational Site 102, Soka Saitama, , Japan
Boehringer Ingelheim Investigational Site 310, Suita Osaka, , Japan
Boehringer Ingelheim Investigational Site 311, Suita Osaka, , Japan
Boehringer Ingelheim Investigational Site 146, Sumida Tokyo, , Japan
Boehringer Ingelheim Investigational Site 332, Sumoto Hyogo, , Japan
Boehringer Ingelheim Investigational Site 256, Sunto Shizuoka, , Japan
Boehringer Ingelheim Investigational Site 245, Suwa Nagano, , Japan
Boehringer Ingelheim Investigational Site 175, Tachikawa Tokyo, , Japan
Boehringer Ingelheim Investigational Site 141, Taito Tokyo, , Japan
Boehringer Ingelheim Investigational Site 376, Takamatsu Kagawa, , Japan
Boehringer Ingelheim Investigational Site 222, Takaoka Toyama, , Japan
Boehringer Ingelheim Investigational Site 337, Takarazuka Hyogo, , Japan
Boehringer Ingelheim Investigational Site 89, Takasaki Gumma, , Japan
Boehringer Ingelheim Investigational Site 90, Takasaki Gumma, , Japan
Boehringer Ingelheim Investigational Site 313, Takatsuki Osaka, , Japan
Boehringer Ingelheim Investigational Site 314, Takatsuki Osaka, , Japan
Boehringer Ingelheim Investigational Site 254, Takayama Gifu, , Japan
Boehringer Ingelheim Investigational Site 342, Tenri Nara, , Japan
Boehringer Ingelheim Investigational Site 86, Tochigi Tochigi, , Japan
Boehringer Ingelheim Investigational Site 101, Toda Saitama, , Japan
Boehringer Ingelheim Investigational Site 373, Tokushima Tokushima, , Japan
Boehringer Ingelheim Investigational Site 374, Tokushima Tokushima, , Japan
Boehringer Ingelheim Investigational Site 375, Tokushima Tokushima, , Japan
Boehringer Ingelheim Investigational Site 6, Tomakomai Hokkaido, , Japan
Boehringer Ingelheim Investigational Site 380, Toon Ehime, , Japan
Boehringer Ingelheim Investigational Site 71, Toride Ibaraki, , Japan
Boehringer Ingelheim Investigational Site 220, Toyama Toyama, , Japan
Boehringer Ingelheim Investigational Site 221, Toyama Toyama, , Japan
Boehringer Ingelheim Investigational Site 263, Toyohashi Aichi, , Japan
Boehringer Ingelheim Investigational Site 308, Toyonaka Osaka, , Japan
Boehringer Ingelheim Investigational Site 273, Toyota Aichi, , Japan
Boehringer Ingelheim Investigational Site 279, Tsu Mie, , Japan
Boehringer Ingelheim Investigational Site 66, Tsuchiura Ibaraki, , Japan
Boehringer Ingelheim Investigational Site 67, Tsuchiura Ibaraki, , Japan
Boehringer Ingelheim Investigational Site 68, Tsuchiura Ibaraki, , Japan
Boehringer Ingelheim Investigational Site 69, Tsukuba Ibaraki, , Japan
Boehringer Ingelheim Investigational Site 72, Tsukuba Ibaraki, , Japan
Boehringer Ingelheim Investigational Site 55, Tsuruoka Yamagata, , Japan
Boehringer Ingelheim Investigational Site 354, Tsuyama Okayama, , Japan
Boehringer Ingelheim Investigational Site 370, Ube Yamaguchi, , Japan
Boehringer Ingelheim Investigational Site 240, Ueda Nagano, , Japan
Boehringer Ingelheim Investigational Site 290, Uji Kyoto, , Japan
Boehringer Ingelheim Investigational Site 431, Urasoe Okinawa, , Japan
Boehringer Ingelheim Investigational Site 404, Ureshino Saga, , Japan
Boehringer Ingelheim Investigational Site 81, Utsunomiya Tochigi, , Japan
Boehringer Ingelheim Investigational Site 82, Utsunomiya Tochigi, , Japan
Boehringer Ingelheim Investigational Site 344, Wakayama Wakayama, , Japan
Boehringer Ingelheim Investigational Site 412, Yamaga Kumamoto, , Japan
Boehringer Ingelheim Investigational Site 49, Yamagata Yamagata, , Japan
Boehringer Ingelheim Investigational Site 50, Yamagata Yamagata, , Japan
Boehringer Ingelheim Investigational Site 51, Yamagata Yamagata, , Japan
Boehringer Ingelheim Investigational Site 52, Yamagata Yamagata, , Japan
Boehringer Ingelheim Investigational Site 197, Yamato Kanagawa, , Japan
Boehringer Ingelheim Investigational Site 401, Yanagawa Fukuoka, , Japan
Boehringer Ingelheim Investigational Site 319, Yao Osaka, , Japan
Boehringer Ingelheim Investigational Site 320, Yao Osaka, , Japan
Boehringer Ingelheim Investigational Site 276, Yokkaichi Mie, , Japan
Boehringer Ingelheim Investigational Site 277, Yokkaichi Mie, , Japan
Boehringer Ingelheim Investigational Site 187, Yokohama Kanagawa, , Japan
Boehringer Ingelheim Investigational Site 188, Yokohama Kanagawa, , Japan
Boehringer Ingelheim Investigational Site 189, Yokohama Kanagawa, , Japan
Boehringer Ingelheim Investigational Site 190, Yokohama Kanagawa, , Japan
Boehringer Ingelheim Investigational Site 191, Yokohama Kanagawa, , Japan
Boehringer Ingelheim Investigational Site 194, Yokohama Kanagawa, , Japan
Boehringer Ingelheim Investigational Site 195, Yokohama Kanagawa, , Japan
Boehringer Ingelheim Investigational Site 196, Yokohama Kanagawa, , Japan
Boehringer Ingelheim Investigational Site 199, Yokohama Kanagawa, , Japan
Boehringer Ingelheim Investigational Site 200, Yokohama Kanagawa, , Japan
Boehringer Ingelheim Investigational Site 192, Yokosuka Kanagawa, , Japan
Boehringer Ingelheim Investigational Site 193, Yokosuka Kanagawa, , Japan
Boehringer Ingelheim Investigational Site 345, Yonago Tottori, , Japan
Boehringer Ingelheim Investigational Site 229, Yoshida Fukui, , Japan
Boehringer Ingelheim Investigational Site 230, Yoshida Fukui, , Japan
Boehringer Ingelheim Investigational Site 400, Yukuhashi Fukuoka, , Japan
Name: Boehringer Ingelheim
Affiliation: Boehringer Ingelheim
Role: STUDY_CHAIR