Clinical trial NCT02131259: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-05-06
Enrollment: 1605
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: 1500

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).


Eligibility criteria: Inclusion criteria:

- Patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive inoperable or recurrent non-small cell lung cancer (NSCLC)will be included.

Exclusion criteria:

- None

Primary outcomes:
measure: Incidence of Adverse Drug Reactions (ADRs)
timeFrame: From first drug administration until 28 days after the last drug administration, up to 52 weeks.
Secondary outcomes:
measure: Objective Overall Response Based on Physician's Assessment [According to RECIST Version 1.1]
timeFrame: 52 weeks.
Other outcomes:
Locations:
city: Adachi Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 145
city: Aira Kagoshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 429
city: Aizuwakamatsu Fukushima
country: Japan
facility: Boehringer Ingelheim Investigational Site 64
city: Akita Akita
country: Japan
facility: Boehringer Ingelheim Investigational Site 44
city: Akita Akita
country: Japan
facility: Boehringer Ingelheim Investigational Site 45
city: Akita Akita
country: Japan
facility: Boehringer Ingelheim Investigational Site 46
city: Akita Akita
country: Japan
facility: Boehringer Ingelheim Investigational Site 47
city: Amagasaki Hyogo
country: Japan
facility: Boehringer Ingelheim Investigational Site 333
city: Anjo Aichi
country: Japan
facility: Boehringer Ingelheim Investigational Site 266
city: Aomori Aomori
country: Japan
facility: Boehringer Ingelheim Investigational Site 27
city: Aomori Aomori
country: Japan
facility: Boehringer Ingelheim Investigational Site 28
city: Asahi Chiba
country: Japan
facility: Boehringer Ingelheim Investigational Site 127
city: Asahi Chiba
country: Japan
facility: Boehringer Ingelheim Investigational Site 128
city: Asahikawa Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 18
city: Asahikawa Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 19
city: Asahikawa Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 20
city: Asahikawa Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 21
city: Atsugi Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 198
city: Ayabe Kyoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 294
city: Bunkyo Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 142
city: Bunkyo Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 143
city: Bunkyo Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 144
city: Chiba Chiba
country: Japan
facility: Boehringer Ingelheim Investigational Site 112
city: Chiba Chiba
country: Japan
facility: Boehringer Ingelheim Investigational Site 113
city: Chiba Chiba
country: Japan
facility: Boehringer Ingelheim Investigational Site 114
city: Chiba Chiba
country: Japan
facility: Boehringer Ingelheim Investigational Site 115
city: Chiba Chiba
country: Japan
facility: Boehringer Ingelheim Investigational Site 116
city: Chiba Chiba
country: Japan
facility: Boehringer Ingelheim Investigational Site 117
city: Chikugo Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 402
city: Chitose Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 16
city: Chiyoda Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 132
city: Chiyoda Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 133
city: Chiyoda Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 134
city: Chuo Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 135
city: Chuo Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 136
city: Chuo Yamanashi
country: Japan
facility: Boehringer Ingelheim Investigational Site 234
city: Chuo Yamanashi
country: Japan
facility: Boehringer Ingelheim Investigational Site 235
city: Daisen Akita
country: Japan
facility: Boehringer Ingelheim Investigational Site 48
city: Edogawa Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 147
city: Edogawa Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 148
city: Fuchu Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 173
city: Fuji Shizuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 257
city: Fujieda Shizuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 260
city: Fujioka Gumma
country: Japan
facility: Boehringer Ingelheim Investigational Site 97
city: Fujisawa Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 203
city: Fukaya Saitama
country: Japan
facility: Boehringer Ingelheim Investigational Site 111
city: Fukui Fukui
country: Japan
facility: Boehringer Ingelheim Investigational Site 231
city: Fukui Fukui
country: Japan
facility: Boehringer Ingelheim Investigational Site 232
city: Fukuoka Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 393
city: Fukuoka Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 394
city: Fukuoka Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 395
city: Fukuoka Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 396
city: Fukuoka Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 399
city: Fukushima Fukushima
country: Japan
facility: Boehringer Ingelheim Investigational Site 58
city: Fukushima Fukushima
country: Japan
facility: Boehringer Ingelheim Investigational Site 59
city: Fukushima Fukushima
country: Japan
facility: Boehringer Ingelheim Investigational Site 60
city: Fukuyama Hiroshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 356
city: Fukuyama Hiroshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 357
city: Funabashi Chiba
country: Japan
facility: Boehringer Ingelheim Investigational Site 121
city: Gifu Gifu
country: Japan
facility: Boehringer Ingelheim Investigational Site 251
city: Gifu Gifu
country: Japan
facility: Boehringer Ingelheim Investigational Site 252
city: Ginowan Okinawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 432
city: Habikino Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 321
city: Hachinohe Aomori
country: Japan
facility: Boehringer Ingelheim Investigational Site 29
city: Hachinohe Aomori
country: Japan
facility: Boehringer Ingelheim Investigational Site 30
city: Hachioji Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 176
city: Hadano Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 209
city: Hakodate Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 3
city: Hamada Shimane
country: Japan
facility: Boehringer Ingelheim Investigational Site 349
city: Hamamatsu Shizuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 261
city: Hatsukaichi Hiroshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 367
city: Hidaka Saitama
country: Japan
facility: Boehringer Ingelheim Investigational Site 107
city: Higashiibaraki Ibaraki
country: Japan
facility: Boehringer Ingelheim Investigational Site 76
city: Higashiokitama Yamagata
country: Japan
facility: Boehringer Ingelheim Investigational Site 53
city: Higashiokitama Yamagata
country: Japan
facility: Boehringer Ingelheim Investigational Site 54
city: Higashiosaka Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 318
city: Himeji Hyogo
country: Japan
facility: Boehringer Ingelheim Investigational Site 339
city: Hirakata Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 316
city: Hirakata Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 317
city: Hiratsuka Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 208
city: Hirosaki Aomori
country: Japan
facility: Boehringer Ingelheim Investigational Site 31
city: Hirosaki Aomori
country: Japan
facility: Boehringer Ingelheim Investigational Site 32
city: Hiroshima Hiroshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 359
city: Hiroshima Hiroshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 360
city: Hiroshima Hiroshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 361
city: Hiroshima Hiroshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 362
city: Hiroshima Hiroshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 363
city: Hiroshima Hiroshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 364
city: Hitachi Ibaraki
country: Japan
facility: Boehringer Ingelheim Investigational Site 79
city: Hitachinaka Ibaraki
country: Japan
facility: Boehringer Ingelheim Investigational Site 77
city: Hitachinaka Ibaraki
country: Japan
facility: Boehringer Ingelheim Investigational Site 78
city: Ibaraki Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 312
city: Ichihara Chiba
country: Japan
facility: Boehringer Ingelheim Investigational Site 131
city: Ichikawa Chiba
country: Japan
facility: Boehringer Ingelheim Investigational Site 120
city: Iida Nagano
country: Japan
facility: Boehringer Ingelheim Investigational Site 246
city: Iida Nagano
country: Japan
facility: Boehringer Ingelheim Investigational Site 247
city: Ikeda Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 309
city: Ina Nagano
country: Japan
facility: Boehringer Ingelheim Investigational Site 248
city: Inzai Chiba
country: Japan
facility: Boehringer Ingelheim Investigational Site 118
city: Iruma Saitama
country: Japan
facility: Boehringer Ingelheim Investigational Site 105
city: Isa Kagoshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 428
city: Isahaya Nagasaki
country: Japan
facility: Boehringer Ingelheim Investigational Site 407
city: Ise Mie
country: Japan
facility: Boehringer Ingelheim Investigational Site 281
city: Isesaki Gumma
country: Japan
facility: Boehringer Ingelheim Investigational Site 95
city: Itabashi Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 168
city: Iwaki Fukushima
country: Japan
facility: Boehringer Ingelheim Investigational Site 65
city: Iwakuni Yamaguchi
country: Japan
facility: Boehringer Ingelheim Investigational Site 368
city: Iwamizawa Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 17
city: Izumi Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 324
city: Izumo Shimane
country: Japan
facility: Boehringer Ingelheim Investigational Site 348
city: Izunokuni Shizuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 255
city: Joetsu Niigata
country: Japan
facility: Boehringer Ingelheim Investigational Site 213
city: Joetsu Niigata
country: Japan
facility: Boehringer Ingelheim Investigational Site 214
city: Joyo Kyoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 289
city: Kagoshima Kagoshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 422
city: Kagoshima Kagoshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 423
city: Kagoshima Kagoshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 424
city: Kagoshima Kagoshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 425
city: Kagoshima Kagoshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 426
city: Kakegawa Shizuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 262
city: Kakogawa Hyogo
country: Japan
facility: Boehringer Ingelheim Investigational Site 340
city: Kamakura Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 201
city: Kamakura Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 202
city: Kamogawa Chiba
country: Japan
facility: Boehringer Ingelheim Investigational Site 130
city: Kanazawa Ishikawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 223
city: Kanazawa Ishikawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 224
city: Kanazawa Ishikawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 225
city: Kanazawa Ishikawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 226
city: Kanazawa Ishikawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 227
city: Kasama Ibaraki
country: Japan
facility: Boehringer Ingelheim Investigational Site 74
city: Kashihara Nara
country: Japan
facility: Boehringer Ingelheim Investigational Site 343
city: Kashiwa Chiba
country: Japan
facility: Boehringer Ingelheim Investigational Site 123
city: Kashiwa Chiba
country: Japan
facility: Boehringer Ingelheim Investigational Site 124
city: Kashiwa Chiba
country: Japan
facility: Boehringer Ingelheim Investigational Site 125
city: Kasukabe Saitama
country: Japan
facility: Boehringer Ingelheim Investigational Site 104
city: Kawagoe Saitama
country: Japan
facility: Boehringer Ingelheim Investigational Site 106
city: Kawaguchi Saitama
country: Japan
facility: Boehringer Ingelheim Investigational Site 100
city: Kawaguchi Saitama
country: Japan
facility: Boehringer Ingelheim Investigational Site 99
city: Kawasaki Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 182
city: Kawasaki Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 183
city: Kawasaki Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 184
city: Kawasaki Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 185
city: Kawasaki Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 186
city: Kesennuma Miyagi
country: Japan
facility: Boehringer Ingelheim Investigational Site 42
city: Kisarazu Chiba
country: Japan
facility: Boehringer Ingelheim Investigational Site 129
city: Kishiwada Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 325
city: Kishiwada Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 326
city: Kita Kagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 377
city: Kitaadachi Saitama
country: Japan
facility: Boehringer Ingelheim Investigational Site 110
city: Kitakyushu Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 387
city: Kitakyushu Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 388
city: Kitakyushu Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 389
city: Kitakyushu Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 390
city: Kitakyushu Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 391
city: Kitakyushu Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 392
city: Kitami Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 25
city: Kitami Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 26
city: Kiyose Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 180
city: Kiyose Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 181
city: Kobe Hyogo
country: Japan
facility: Boehringer Ingelheim Investigational Site 327
city: Kobe Hyogo
country: Japan
facility: Boehringer Ingelheim Investigational Site 328
city: Kobe Hyogo
country: Japan
facility: Boehringer Ingelheim Investigational Site 329
city: Kobe Hyogo
country: Japan
facility: Boehringer Ingelheim Investigational Site 330
city: Kobe Hyogo
country: Japan
facility: Boehringer Ingelheim Investigational Site 331
city: Kochi Kochi
country: Japan
facility: Boehringer Ingelheim Investigational Site 383
city: Kochi Kochi
country: Japan
facility: Boehringer Ingelheim Investigational Site 384
city: Kochi Kochi
country: Japan
facility: Boehringer Ingelheim Investigational Site 385
city: Kochi Kochi
country: Japan
facility: Boehringer Ingelheim Investigational Site 386
city: Kodaira Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 174
city: Kofu Yamanashi
country: Japan
facility: Boehringer Ingelheim Investigational Site 233
city: Koga Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 397
city: Koga Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 398
city: Komae Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 179
city: Komatsu Ishikawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 228
city: Koriyama Fukushima
country: Japan
facility: Boehringer Ingelheim Investigational Site 61
city: Koriyama Fukushima
country: Japan
facility: Boehringer Ingelheim Investigational Site 62
city: Koriyama Fukushima
country: Japan
facility: Boehringer Ingelheim Investigational Site 63
city: Koshigaya Saitama
country: Japan
facility: Boehringer Ingelheim Investigational Site 103
city: Koto Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 149
city: Koto Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 150
city: Kumagaya Saitama
country: Japan
facility: Boehringer Ingelheim Investigational Site 108
city: Kumagaya Saitama
country: Japan
facility: Boehringer Ingelheim Investigational Site 109
city: Kumamoto Kumamoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 411
city: Kumamoto Kumamoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 413
city: Kumamoto Kumamoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 414
city: Kumamoto Kumamoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 415
city: Kurashiki Okayama
country: Japan
facility: Boehringer Ingelheim Investigational Site 352
city: Kurashiki Okayama
country: Japan
facility: Boehringer Ingelheim Investigational Site 355
city: Kure Hiroshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 365
city: Kure Hiroshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 366
city: Kushiro Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 24
city: Kuwana Mie
country: Japan
facility: Boehringer Ingelheim Investigational Site 278
city: Kyoto Kyoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 285
city: Kyoto Kyoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 286
city: Kyoto Kyoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 287
city: Kyoto Kyoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 288
city: Kyoto Kyoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 291
city: Kyoto Kyoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 292
city: Kyoto Kyoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 293
city: Machida Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 177
city: Maebashi Gumma
country: Japan
facility: Boehringer Ingelheim Investigational Site 91
city: Maebashi Gumma
country: Japan
facility: Boehringer Ingelheim Investigational Site 92
city: Maebashi Gumma
country: Japan
facility: Boehringer Ingelheim Investigational Site 93
city: Maebashi Gumma
country: Japan
facility: Boehringer Ingelheim Investigational Site 94
city: Matsudo Chiba
country: Japan
facility: Boehringer Ingelheim Investigational Site 119
city: Matsue Shimane
country: Japan
facility: Boehringer Ingelheim Investigational Site 346
city: Matsue Shimane
country: Japan
facility: Boehringer Ingelheim Investigational Site 347
city: Matsumoto Nagano
country: Japan
facility: Boehringer Ingelheim Investigational Site 241
city: Matsumoto Nagano
country: Japan
facility: Boehringer Ingelheim Investigational Site 242
city: Matsumoto Nagano
country: Japan
facility: Boehringer Ingelheim Investigational Site 243
city: Matsumoto Nagano
country: Japan
facility: Boehringer Ingelheim Investigational Site 244
city: Matsumoto Nagano
country: Japan
facility: Boehringer Ingelheim Investigational Site 249
city: Matsumoto Nagano
country: Japan
facility: Boehringer Ingelheim Investigational Site 250
city: Matsusaka Mie
country: Japan
facility: Boehringer Ingelheim Investigational Site 280
city: Matsuyama Ehime
country: Japan
facility: Boehringer Ingelheim Investigational Site 378
city: Matsuyama Ehime
country: Japan
facility: Boehringer Ingelheim Investigational Site 379
city: Matsuyama Ehime
country: Japan
facility: Boehringer Ingelheim Investigational Site 381
city: Meguro Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 158
city: Meguro Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 159
city: Minamata Kumamoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 416
city: Minato Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 137
city: Minato Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 138
city: Minato Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 139
city: Minato Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 140
city: Mitaka Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 171
city: Mitaka Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 172
city: Mito Ibaraki
country: Japan
facility: Boehringer Ingelheim Investigational Site 75
city: Miyazaki Miyazaki
country: Japan
facility: Boehringer Ingelheim Investigational Site 419
city: Miyazaki Miyazaki
country: Japan
facility: Boehringer Ingelheim Investigational Site 420
city: Miyazaki Miyazaki
country: Japan
facility: Boehringer Ingelheim Investigational Site 421
city: Moriguchi Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 315
city: Morioka Iwate
country: Japan
facility: Boehringer Ingelheim Investigational Site 33
city: Morioka Iwate
country: Japan
facility: Boehringer Ingelheim Investigational Site 34
city: Moriyama Shiga
country: Japan
facility: Boehringer Ingelheim Investigational Site 282
city: Moriyama Shiga
country: Japan
facility: Boehringer Ingelheim Investigational Site 283
city: Muroran Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 5
city: Nagahama Shiga
country: Japan
facility: Boehringer Ingelheim Investigational Site 284
city: Nagakute Aichi
country: Japan
facility: Boehringer Ingelheim Investigational Site 274
city: Nagano Nagano
country: Japan
facility: Boehringer Ingelheim Investigational Site 236
city: Nagano Nagano
country: Japan
facility: Boehringer Ingelheim Investigational Site 237
city: Nagano Nagano
country: Japan
facility: Boehringer Ingelheim Investigational Site 238
city: Nagaoka Niigata
country: Japan
facility: Boehringer Ingelheim Investigational Site 210
city: Nagaoka Niigata
country: Japan
facility: Boehringer Ingelheim Investigational Site 211
city: Nagaoka Niigata
country: Japan
facility: Boehringer Ingelheim Investigational Site 212
city: Nagasaki Nagasaki
country: Japan
facility: Boehringer Ingelheim Investigational Site 405
city: Nagasaki Nagasaki
country: Japan
facility: Boehringer Ingelheim Investigational Site 406
city: Nagoya Aichi
country: Japan
facility: Boehringer Ingelheim Investigational Site 267
city: Nagoya Aichi
country: Japan
facility: Boehringer Ingelheim Investigational Site 268
city: Nagoya Aichi
country: Japan
facility: Boehringer Ingelheim Investigational Site 269
city: Nagoya Aichi
country: Japan
facility: Boehringer Ingelheim Investigational Site 270
city: Nagoya Aichi
country: Japan
facility: Boehringer Ingelheim Investigational Site 271
city: Nagoya Aichi
country: Japan
facility: Boehringer Ingelheim Investigational Site 272
city: Naka Ibaraki
country: Japan
facility: Boehringer Ingelheim Investigational Site 80
city: Nakano Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 167
city: Nara Nara
country: Japan
facility: Boehringer Ingelheim Investigational Site 341
city: Narashino Chiba
country: Japan
facility: Boehringer Ingelheim Investigational Site 122
city: Natori Miyagi
country: Japan
facility: Boehringer Ingelheim Investigational Site 39
city: Nerima Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 169
city: Nerima Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 170
city: Niigata Niigata
country: Japan
facility: Boehringer Ingelheim Investigational Site 215
city: Niigata Niigata
country: Japan
facility: Boehringer Ingelheim Investigational Site 216
city: Niigata Niigata
country: Japan
facility: Boehringer Ingelheim Investigational Site 217
city: Niigata Niigata
country: Japan
facility: Boehringer Ingelheim Investigational Site 218
city: Niihama Ehime
country: Japan
facility: Boehringer Ingelheim Investigational Site 382
city: Nishinomiya Hyogo
country: Japan
facility: Boehringer Ingelheim Investigational Site 334
city: Nishinomiya Hyogo
country: Japan
facility: Boehringer Ingelheim Investigational Site 335
city: Nishinomiya Hyogo
country: Japan
facility: Boehringer Ingelheim Investigational Site 336
city: Obihiro Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 22
city: Obihiro Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 23
city: Ogaki Gifu
country: Japan
facility: Boehringer Ingelheim Investigational Site 253
city: Oita Oita
country: Japan
facility: Boehringer Ingelheim Investigational Site 417
city: Oita Oita
country: Japan
facility: Boehringer Ingelheim Investigational Site 418
city: Okayama Okayama
country: Japan
facility: Boehringer Ingelheim Investigational Site 350
city: Okayama Okayama
country: Japan
facility: Boehringer Ingelheim Investigational Site 351
city: Okayama Okayama
country: Japan
facility: Boehringer Ingelheim Investigational Site 353
city: Okazaki Aichi
country: Japan
facility: Boehringer Ingelheim Investigational Site 264
city: Okazaki Aichi
country: Japan
facility: Boehringer Ingelheim Investigational Site 265
city: Ome Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 178
city: Onomichi Hiroshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 358
city: Osaka Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 295
city: Osaka Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 296
city: Osaka Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 297
city: Osaka Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 298
city: Osaka Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 299
city: Osaka Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 300
city: Osaka Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 301
city: Osaka Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 302
city: Osaka Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 303
city: Osaka Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 304
city: Osaka Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 305
city: Osaka Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 306
city: Osaka Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 307
city: Osaki Miyagi
country: Japan
facility: Boehringer Ingelheim Investigational Site 43
city: Oshu Iwate
country: Japan
facility: Boehringer Ingelheim Investigational Site 35
city: Ota Gumma
country: Japan
facility: Boehringer Ingelheim Investigational Site 96
city: Ota Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 153
city: Ota Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 154
city: Ota Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 155
city: Ota Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 156
city: Otaru Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 4
city: Otawara Tochigi
country: Japan
facility: Boehringer Ingelheim Investigational Site 85
city: Ryugasaki Ibaraki
country: Japan
facility: Boehringer Ingelheim Investigational Site 70
city: Saga Saga
country: Japan
facility: Boehringer Ingelheim Investigational Site 403
city: Sagamihara Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 204
city: Sagamihara Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 205
city: Sagamihara Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 206
city: Sagamihara Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 207
city: Sakai Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 322
city: Sakai Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 323
city: Sakata Yamagata
country: Japan
facility: Boehringer Ingelheim Investigational Site 56
city: Sakata Yamagata
country: Japan
facility: Boehringer Ingelheim Investigational Site 57
city: Saku Nagano
country: Japan
facility: Boehringer Ingelheim Investigational Site 239
city: Sakura Chiba
country: Japan
facility: Boehringer Ingelheim Investigational Site 126
city: Sanda Hyogo
country: Japan
facility: Boehringer Ingelheim Investigational Site 338
city: Sapporo Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 10
city: Sapporo Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 11
city: Sapporo Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 12
city: Sapporo Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 13
city: Sapporo Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 14
city: Sapporo Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 15
city: Sapporo Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Sapporo Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Sapporo Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 7
city: Sapporo Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 8
city: Sapporo Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 9
city: Sasebo Nagasaki
country: Japan
facility: Boehringer Ingelheim Investigational Site 409
city: Sasebo Nagasaki
country: Japan
facility: Boehringer Ingelheim Investigational Site 410
city: Sashima Ibaraki
country: Japan
facility: Boehringer Ingelheim Investigational Site 73
city: Satsumasendai Kagoshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 427
city: Sendai Miyagi
country: Japan
facility: Boehringer Ingelheim Investigational Site 36
city: Sendai Miyagi
country: Japan
facility: Boehringer Ingelheim Investigational Site 37
city: Sendai Miyagi
country: Japan
facility: Boehringer Ingelheim Investigational Site 38
city: Sendai Miyagi
country: Japan
facility: Boehringer Ingelheim Investigational Site 40
city: Seto Aichi
country: Japan
facility: Boehringer Ingelheim Investigational Site 275
city: Shibata Niigata
country: Japan
facility: Boehringer Ingelheim Investigational Site 219
city: Shibukawa Gumma
country: Japan
facility: Boehringer Ingelheim Investigational Site 98
city: Shibuya Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 157
city: Shimabara Nagasaki
country: Japan
facility: Boehringer Ingelheim Investigational Site 408
city: Shimajiri Okinawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 430
city: Shimonoseki Yamaguchi
country: Japan
facility: Boehringer Ingelheim Investigational Site 369
city: Shimonoseki Yamaguchi
country: Japan
facility: Boehringer Ingelheim Investigational Site 371
city: Shimonoseki Yamaguchi
country: Japan
facility: Boehringer Ingelheim Investigational Site 372
city: Shimotsuga Tochigi
country: Japan
facility: Boehringer Ingelheim Investigational Site 83
city: Shimotsuga Tochigi
country: Japan
facility: Boehringer Ingelheim Investigational Site 84
city: Shimotsuke Tochigi
country: Japan
facility: Boehringer Ingelheim Investigational Site 87
city: Shimotsuke Tochigi
country: Japan
facility: Boehringer Ingelheim Investigational Site 88
city: Shinagawa Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 151
city: Shinagawa Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 152
city: Shinjuku Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 160
city: Shinjuku Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 161
city: Shinjuku Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 162
city: Shinjuku Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 163
city: Shinjuku Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 164
city: Shinjuku Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 165
city: Shinjuku Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 166
city: Shiogama Miyagi
country: Japan
facility: Boehringer Ingelheim Investigational Site 41
city: Shizuoka Shizuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 258
city: Shizuoka Shizuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 259
city: Soka Saitama
country: Japan
facility: Boehringer Ingelheim Investigational Site 102
city: Suita Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 310
city: Suita Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 311
city: Sumida Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 146
city: Sumoto Hyogo
country: Japan
facility: Boehringer Ingelheim Investigational Site 332
city: Sunto Shizuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 256
city: Suwa Nagano
country: Japan
facility: Boehringer Ingelheim Investigational Site 245
city: Tachikawa Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 175
city: Taito Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 141
city: Takamatsu Kagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 376
city: Takaoka Toyama
country: Japan
facility: Boehringer Ingelheim Investigational Site 222
city: Takarazuka Hyogo
country: Japan
facility: Boehringer Ingelheim Investigational Site 337
city: Takasaki Gumma
country: Japan
facility: Boehringer Ingelheim Investigational Site 89
city: Takasaki Gumma
country: Japan
facility: Boehringer Ingelheim Investigational Site 90
city: Takatsuki Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 313
city: Takatsuki Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 314
city: Takayama Gifu
country: Japan
facility: Boehringer Ingelheim Investigational Site 254
city: Tenri Nara
country: Japan
facility: Boehringer Ingelheim Investigational Site 342
city: Tochigi Tochigi
country: Japan
facility: Boehringer Ingelheim Investigational Site 86
city: Toda Saitama
country: Japan
facility: Boehringer Ingelheim Investigational Site 101
city: Tokushima Tokushima
country: Japan
facility: Boehringer Ingelheim Investigational Site 373
city: Tokushima Tokushima
country: Japan
facility: Boehringer Ingelheim Investigational Site 374
city: Tokushima Tokushima
country: Japan
facility: Boehringer Ingelheim Investigational Site 375
city: Tomakomai Hokkaido
country: Japan
facility: Boehringer Ingelheim Investigational Site 6
city: Toon Ehime
country: Japan
facility: Boehringer Ingelheim Investigational Site 380
city: Toride Ibaraki
country: Japan
facility: Boehringer Ingelheim Investigational Site 71
city: Toyama Toyama
country: Japan
facility: Boehringer Ingelheim Investigational Site 220
city: Toyama Toyama
country: Japan
facility: Boehringer Ingelheim Investigational Site 221
city: Toyohashi Aichi
country: Japan
facility: Boehringer Ingelheim Investigational Site 263
city: Toyonaka Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 308
city: Toyota Aichi
country: Japan
facility: Boehringer Ingelheim Investigational Site 273
city: Tsu Mie
country: Japan
facility: Boehringer Ingelheim Investigational Site 279
city: Tsuchiura Ibaraki
country: Japan
facility: Boehringer Ingelheim Investigational Site 66
city: Tsuchiura Ibaraki
country: Japan
facility: Boehringer Ingelheim Investigational Site 67
city: Tsuchiura Ibaraki
country: Japan
facility: Boehringer Ingelheim Investigational Site 68
city: Tsukuba Ibaraki
country: Japan
facility: Boehringer Ingelheim Investigational Site 69
city: Tsukuba Ibaraki
country: Japan
facility: Boehringer Ingelheim Investigational Site 72
city: Tsuruoka Yamagata
country: Japan
facility: Boehringer Ingelheim Investigational Site 55
city: Tsuyama Okayama
country: Japan
facility: Boehringer Ingelheim Investigational Site 354
city: Ube Yamaguchi
country: Japan
facility: Boehringer Ingelheim Investigational Site 370
city: Ueda Nagano
country: Japan
facility: Boehringer Ingelheim Investigational Site 240
city: Uji Kyoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 290
city: Urasoe Okinawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 431
city: Ureshino Saga
country: Japan
facility: Boehringer Ingelheim Investigational Site 404
city: Utsunomiya Tochigi
country: Japan
facility: Boehringer Ingelheim Investigational Site 81
city: Utsunomiya Tochigi
country: Japan
facility: Boehringer Ingelheim Investigational Site 82
city: Wakayama Wakayama
country: Japan
facility: Boehringer Ingelheim Investigational Site 344
city: Yamaga Kumamoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 412
city: Yamagata Yamagata
country: Japan
facility: Boehringer Ingelheim Investigational Site 49
city: Yamagata Yamagata
country: Japan
facility: Boehringer Ingelheim Investigational Site 50
city: Yamagata Yamagata
country: Japan
facility: Boehringer Ingelheim Investigational Site 51
city: Yamagata Yamagata
country: Japan
facility: Boehringer Ingelheim Investigational Site 52
city: Yamato Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 197
city: Yanagawa Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 401
city: Yao Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 319
city: Yao Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 320
city: Yokkaichi Mie
country: Japan
facility: Boehringer Ingelheim Investigational Site 276
city: Yokkaichi Mie
country: Japan
facility: Boehringer Ingelheim Investigational Site 277
city: Yokohama Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 187
city: Yokohama Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 188
city: Yokohama Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 189
city: Yokohama Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 190
city: Yokohama Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 191
city: Yokohama Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 194
city: Yokohama Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 195
city: Yokohama Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 196
city: Yokohama Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 199
city: Yokohama Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 200
city: Yokosuka Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 192
city: Yokosuka Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 193
city: Yonago Tottori
country: Japan
facility: Boehringer Ingelheim Investigational Site 345
city: Yoshida Fukui
country: Japan
facility: Boehringer Ingelheim Investigational Site 229
city: Yoshida Fukui
country: Japan
facility: Boehringer Ingelheim Investigational Site 230
city: Yukuhashi Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 400
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: