Long-term Observation PMS for Afatinib
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.
1 other identifier
observational
1,605
1 country
432
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2014
Typical duration for all trials
432 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2014
CompletedFirst Posted
Study publicly available on registry
May 6, 2014
CompletedStudy Start
First participant enrolled
May 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2016
CompletedResults Posted
Study results publicly available
September 7, 2018
CompletedSeptember 7, 2018
September 1, 2018
2.6 years
May 5, 2014
December 8, 2017
September 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Adverse Drug Reactions (ADRs)
This outcome measure presents incidence of adverse drug reactions (ADRs). An ADR was defined as an AE if either the investigator or the sponsor (or both) assessed the causal relationship to GIOTRIF® Tablets either as "Yes", "Probably yes" or "Can't be denied". The number of patients with Adverse Drug Reactions (ADRs): "Malignant progression" reported as ADRs were included.
From first drug administration until 28 days after the last drug administration, up to 52 weeks.
Secondary Outcomes (1)
Objective Overall Response Based on Physician's Assessment [According to RECIST Version 1.1]
52 weeks.
Study Arms (1)
Afatinib
Interventions
Eligibility Criteria
1500
You may qualify if:
- \- Patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive inoperable or recurrent non-small cell lung cancer (NSCLC)will be included.
You may not qualify if:
- \- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (432)
Boehringer Ingelheim Investigational Site 145
Adachi Tokyo, Japan
Boehringer Ingelheim Investigational Site 429
Aira Kagoshima, Japan
Boehringer Ingelheim Investigational Site 64
Aizuwakamatsu Fukushima, Japan
Boehringer Ingelheim Investigational Site 44
Akita Akita, Japan
Boehringer Ingelheim Investigational Site 45
Akita Akita, Japan
Boehringer Ingelheim Investigational Site 46
Akita Akita, Japan
Boehringer Ingelheim Investigational Site 47
Akita Akita, Japan
Boehringer Ingelheim Investigational Site 333
Amagasaki Hyogo, Japan
Boehringer Ingelheim Investigational Site 266
Anjo Aichi, Japan
Boehringer Ingelheim Investigational Site 27
Aomori Aomori, Japan
Boehringer Ingelheim Investigational Site 28
Aomori Aomori, Japan
Boehringer Ingelheim Investigational Site 127
Asahi Chiba, Japan
Boehringer Ingelheim Investigational Site 128
Asahi Chiba, Japan
Boehringer Ingelheim Investigational Site 18
Asahikawa Hokkaido, Japan
Boehringer Ingelheim Investigational Site 19
Asahikawa Hokkaido, Japan
Boehringer Ingelheim Investigational Site 20
Asahikawa Hokkaido, Japan
Boehringer Ingelheim Investigational Site 21
Asahikawa Hokkaido, Japan
Boehringer Ingelheim Investigational Site 198
Atsugi Kanagawa, Japan
Boehringer Ingelheim Investigational Site 294
Ayabe Kyoto, Japan
Boehringer Ingelheim Investigational Site 142
Bunkyo Tokyo, Japan
Boehringer Ingelheim Investigational Site 143
Bunkyo Tokyo, Japan
Boehringer Ingelheim Investigational Site 144
Bunkyo Tokyo, Japan
Boehringer Ingelheim Investigational Site 112
Chiba Chiba, Japan
Boehringer Ingelheim Investigational Site 113
Chiba Chiba, Japan
Boehringer Ingelheim Investigational Site 114
Chiba Chiba, Japan
Boehringer Ingelheim Investigational Site 115
Chiba Chiba, Japan
Boehringer Ingelheim Investigational Site 116
Chiba Chiba, Japan
Boehringer Ingelheim Investigational Site 117
Chiba Chiba, Japan
Boehringer Ingelheim Investigational Site 402
Chikugo Fukuoka, Japan
Boehringer Ingelheim Investigational Site 16
Chitose Hokkaido, Japan
Boehringer Ingelheim Investigational Site 132
Chiyoda Tokyo, Japan
Boehringer Ingelheim Investigational Site 133
Chiyoda Tokyo, Japan
Boehringer Ingelheim Investigational Site 134
Chiyoda Tokyo, Japan
Boehringer Ingelheim Investigational Site 135
Chuo Tokyo, Japan
Boehringer Ingelheim Investigational Site 136
Chuo Tokyo, Japan
Boehringer Ingelheim Investigational Site 234
Chuo Yamanashi, Japan
Boehringer Ingelheim Investigational Site 235
Chuo Yamanashi, Japan
Boehringer Ingelheim Investigational Site 48
Daisen Akita, Japan
Boehringer Ingelheim Investigational Site 147
Edogawa Tokyo, Japan
Boehringer Ingelheim Investigational Site 148
Edogawa Tokyo, Japan
Boehringer Ingelheim Investigational Site 173
Fuchu Tokyo, Japan
Boehringer Ingelheim Investigational Site 257
Fuji Shizuoka, Japan
Boehringer Ingelheim Investigational Site 260
Fujieda Shizuoka, Japan
Boehringer Ingelheim Investigational Site 97
Fujioka Gumma, Japan
Boehringer Ingelheim Investigational Site 203
Fujisawa Kanagawa, Japan
Boehringer Ingelheim Investigational Site 111
Fukaya Saitama, Japan
Boehringer Ingelheim Investigational Site 231
Fukui Fukui, Japan
Boehringer Ingelheim Investigational Site 232
Fukui Fukui, Japan
Boehringer Ingelheim Investigational Site 393
Fukuoka Fukuoka, Japan
Boehringer Ingelheim Investigational Site 394
Fukuoka Fukuoka, Japan
Boehringer Ingelheim Investigational Site 395
Fukuoka Fukuoka, Japan
Boehringer Ingelheim Investigational Site 396
Fukuoka Fukuoka, Japan
Boehringer Ingelheim Investigational Site 399
Fukuoka Fukuoka, Japan
Boehringer Ingelheim Investigational Site 58
Fukushima Fukushima, Japan
Boehringer Ingelheim Investigational Site 59
Fukushima Fukushima, Japan
Boehringer Ingelheim Investigational Site 60
Fukushima Fukushima, Japan
Boehringer Ingelheim Investigational Site 356
Fukuyama Hiroshima, Japan
Boehringer Ingelheim Investigational Site 357
Fukuyama Hiroshima, Japan
Boehringer Ingelheim Investigational Site 121
Funabashi Chiba, Japan
Boehringer Ingelheim Investigational Site 251
Gifu Gifu, Japan
Boehringer Ingelheim Investigational Site 252
Gifu Gifu, Japan
Boehringer Ingelheim Investigational Site 432
Ginowan Okinawa, Japan
Boehringer Ingelheim Investigational Site 321
Habikino Osaka, Japan
Boehringer Ingelheim Investigational Site 29
Hachinohe Aomori, Japan
Boehringer Ingelheim Investigational Site 30
Hachinohe Aomori, Japan
Boehringer Ingelheim Investigational Site 176
Hachioji Tokyo, Japan
Boehringer Ingelheim Investigational Site 209
Hadano Kanagawa, Japan
Boehringer Ingelheim Investigational Site 3
Hakodate Hokkaido, Japan
Boehringer Ingelheim Investigational Site 349
Hamada Shimane, Japan
Boehringer Ingelheim Investigational Site 261
Hamamatsu Shizuoka, Japan
Boehringer Ingelheim Investigational Site 367
Hatsukaichi Hiroshima, Japan
Boehringer Ingelheim Investigational Site 107
Hidaka Saitama, Japan
Boehringer Ingelheim Investigational Site 76
Higashiibaraki Ibaraki, Japan
Boehringer Ingelheim Investigational Site 53
Higashiokitama Yamagata, Japan
Boehringer Ingelheim Investigational Site 54
Higashiokitama Yamagata, Japan
Boehringer Ingelheim Investigational Site 318
Higashiosaka Osaka, Japan
Boehringer Ingelheim Investigational Site 339
Himeji Hyogo, Japan
Boehringer Ingelheim Investigational Site 316
Hirakata Osaka, Japan
Boehringer Ingelheim Investigational Site 317
Hirakata Osaka, Japan
Boehringer Ingelheim Investigational Site 208
Hiratsuka Kanagawa, Japan
Boehringer Ingelheim Investigational Site 31
Hirosaki Aomori, Japan
Boehringer Ingelheim Investigational Site 32
Hirosaki Aomori, Japan
Boehringer Ingelheim Investigational Site 359
Hiroshima Hiroshima, Japan
Boehringer Ingelheim Investigational Site 360
Hiroshima Hiroshima, Japan
Boehringer Ingelheim Investigational Site 361
Hiroshima Hiroshima, Japan
Boehringer Ingelheim Investigational Site 362
Hiroshima Hiroshima, Japan
Boehringer Ingelheim Investigational Site 363
Hiroshima Hiroshima, Japan
Boehringer Ingelheim Investigational Site 364
Hiroshima Hiroshima, Japan
Boehringer Ingelheim Investigational Site 79
Hitachi Ibaraki, Japan
Boehringer Ingelheim Investigational Site 77
Hitachinaka Ibaraki, Japan
Boehringer Ingelheim Investigational Site 78
Hitachinaka Ibaraki, Japan
Boehringer Ingelheim Investigational Site 312
Ibaraki Osaka, Japan
Boehringer Ingelheim Investigational Site 131
Ichihara Chiba, Japan
Boehringer Ingelheim Investigational Site 120
Ichikawa Chiba, Japan
Boehringer Ingelheim Investigational Site 246
Iida Nagano, Japan
Boehringer Ingelheim Investigational Site 247
Iida Nagano, Japan
Boehringer Ingelheim Investigational Site 309
Ikeda Osaka, Japan
Boehringer Ingelheim Investigational Site 248
Ina Nagano, Japan
Boehringer Ingelheim Investigational Site 118
Inzai Chiba, Japan
Boehringer Ingelheim Investigational Site 105
Iruma Saitama, Japan
Boehringer Ingelheim Investigational Site 428
Isa Kagoshima, Japan
Boehringer Ingelheim Investigational Site 407
Isahaya Nagasaki, Japan
Boehringer Ingelheim Investigational Site 281
Ise Mie, Japan
Boehringer Ingelheim Investigational Site 95
Isesaki Gumma, Japan
Boehringer Ingelheim Investigational Site 168
Itabashi Tokyo, Japan
Boehringer Ingelheim Investigational Site 65
Iwaki Fukushima, Japan
Boehringer Ingelheim Investigational Site 368
Iwakuni Yamaguchi, Japan
Boehringer Ingelheim Investigational Site 17
Iwamizawa Hokkaido, Japan
Boehringer Ingelheim Investigational Site 324
Izumi Osaka, Japan
Boehringer Ingelheim Investigational Site 348
Izumo Shimane, Japan
Boehringer Ingelheim Investigational Site 255
Izunokuni Shizuoka, Japan
Boehringer Ingelheim Investigational Site 213
Joetsu Niigata, Japan
Boehringer Ingelheim Investigational Site 214
Joetsu Niigata, Japan
Boehringer Ingelheim Investigational Site 289
Joyo Kyoto, Japan
Boehringer Ingelheim Investigational Site 422
Kagoshima Kagoshima, Japan
Boehringer Ingelheim Investigational Site 423
Kagoshima Kagoshima, Japan
Boehringer Ingelheim Investigational Site 424
Kagoshima Kagoshima, Japan
Boehringer Ingelheim Investigational Site 425
Kagoshima Kagoshima, Japan
Boehringer Ingelheim Investigational Site 426
Kagoshima Kagoshima, Japan
Boehringer Ingelheim Investigational Site 262
Kakegawa Shizuoka, Japan
Boehringer Ingelheim Investigational Site 340
Kakogawa Hyogo, Japan
Boehringer Ingelheim Investigational Site 201
Kamakura Kanagawa, Japan
Boehringer Ingelheim Investigational Site 202
Kamakura Kanagawa, Japan
Boehringer Ingelheim Investigational Site 130
Kamogawa Chiba, Japan
Boehringer Ingelheim Investigational Site 223
Kanazawa Ishikawa, Japan
Boehringer Ingelheim Investigational Site 224
Kanazawa Ishikawa, Japan
Boehringer Ingelheim Investigational Site 225
Kanazawa Ishikawa, Japan
Boehringer Ingelheim Investigational Site 226
Kanazawa Ishikawa, Japan
Boehringer Ingelheim Investigational Site 227
Kanazawa Ishikawa, Japan
Boehringer Ingelheim Investigational Site 74
Kasama Ibaraki, Japan
Boehringer Ingelheim Investigational Site 343
Kashihara Nara, Japan
Boehringer Ingelheim Investigational Site 123
Kashiwa Chiba, Japan
Boehringer Ingelheim Investigational Site 124
Kashiwa Chiba, Japan
Boehringer Ingelheim Investigational Site 125
Kashiwa Chiba, Japan
Boehringer Ingelheim Investigational Site 104
Kasukabe Saitama, Japan
Boehringer Ingelheim Investigational Site 106
Kawagoe Saitama, Japan
Boehringer Ingelheim Investigational Site 100
Kawaguchi Saitama, Japan
Boehringer Ingelheim Investigational Site 99
Kawaguchi Saitama, Japan
Boehringer Ingelheim Investigational Site 182
Kawasaki Kanagawa, Japan
Boehringer Ingelheim Investigational Site 183
Kawasaki Kanagawa, Japan
Boehringer Ingelheim Investigational Site 184
Kawasaki Kanagawa, Japan
Boehringer Ingelheim Investigational Site 185
Kawasaki Kanagawa, Japan
Boehringer Ingelheim Investigational Site 186
Kawasaki Kanagawa, Japan
Boehringer Ingelheim Investigational Site 42
Kesennuma Miyagi, Japan
Boehringer Ingelheim Investigational Site 129
Kisarazu Chiba, Japan
Boehringer Ingelheim Investigational Site 325
Kishiwada Osaka, Japan
Boehringer Ingelheim Investigational Site 326
Kishiwada Osaka, Japan
Boehringer Ingelheim Investigational Site 377
Kita Kagawa, Japan
Boehringer Ingelheim Investigational Site 110
Kitaadachi Saitama, Japan
Boehringer Ingelheim Investigational Site 387
Kitakyushu Fukuoka, Japan
Boehringer Ingelheim Investigational Site 388
Kitakyushu Fukuoka, Japan
Boehringer Ingelheim Investigational Site 389
Kitakyushu Fukuoka, Japan
Boehringer Ingelheim Investigational Site 390
Kitakyushu Fukuoka, Japan
Boehringer Ingelheim Investigational Site 391
Kitakyushu Fukuoka, Japan
Boehringer Ingelheim Investigational Site 392
Kitakyushu Fukuoka, Japan
Boehringer Ingelheim Investigational Site 25
Kitami Hokkaido, Japan
Boehringer Ingelheim Investigational Site 26
Kitami Hokkaido, Japan
Boehringer Ingelheim Investigational Site 180
Kiyose Tokyo, Japan
Boehringer Ingelheim Investigational Site 181
Kiyose Tokyo, Japan
Boehringer Ingelheim Investigational Site 327
Kobe Hyogo, Japan
Boehringer Ingelheim Investigational Site 328
Kobe Hyogo, Japan
Boehringer Ingelheim Investigational Site 329
Kobe Hyogo, Japan
Boehringer Ingelheim Investigational Site 330
Kobe Hyogo, Japan
Boehringer Ingelheim Investigational Site 331
Kobe Hyogo, Japan
Boehringer Ingelheim Investigational Site 383
Kochi Kochi, Japan
Boehringer Ingelheim Investigational Site 384
Kochi Kochi, Japan
Boehringer Ingelheim Investigational Site 385
Kochi Kochi, Japan
Boehringer Ingelheim Investigational Site 386
Kochi Kochi, Japan
Boehringer Ingelheim Investigational Site 174
Kodaira Tokyo, Japan
Boehringer Ingelheim Investigational Site 233
Kofu Yamanashi, Japan
Boehringer Ingelheim Investigational Site 397
Koga Fukuoka, Japan
Boehringer Ingelheim Investigational Site 398
Koga Fukuoka, Japan
Boehringer Ingelheim Investigational Site 179
Komae Tokyo, Japan
Boehringer Ingelheim Investigational Site 228
Komatsu Ishikawa, Japan
Boehringer Ingelheim Investigational Site 61
Koriyama Fukushima, Japan
Boehringer Ingelheim Investigational Site 62
Koriyama Fukushima, Japan
Boehringer Ingelheim Investigational Site 63
Koriyama Fukushima, Japan
Boehringer Ingelheim Investigational Site 103
Koshigaya Saitama, Japan
Boehringer Ingelheim Investigational Site 149
Koto Tokyo, Japan
Boehringer Ingelheim Investigational Site 150
Koto Tokyo, Japan
Boehringer Ingelheim Investigational Site 108
Kumagaya Saitama, Japan
Boehringer Ingelheim Investigational Site 109
Kumagaya Saitama, Japan
Boehringer Ingelheim Investigational Site 411
Kumamoto Kumamoto, Japan
Boehringer Ingelheim Investigational Site 413
Kumamoto Kumamoto, Japan
Boehringer Ingelheim Investigational Site 414
Kumamoto Kumamoto, Japan
Boehringer Ingelheim Investigational Site 415
Kumamoto Kumamoto, Japan
Boehringer Ingelheim Investigational Site 352
Kurashiki Okayama, Japan
Boehringer Ingelheim Investigational Site 355
Kurashiki Okayama, Japan
Boehringer Ingelheim Investigational Site 365
Kure Hiroshima, Japan
Boehringer Ingelheim Investigational Site 366
Kure Hiroshima, Japan
Boehringer Ingelheim Investigational Site 24
Kushiro, Japan
Boehringer Ingelheim Investigational Site 278
Kuwana Mie, Japan
Boehringer Ingelheim Investigational Site 285
Kyoto Kyoto, Japan
Boehringer Ingelheim Investigational Site 286
Kyoto Kyoto, Japan
Boehringer Ingelheim Investigational Site 287
Kyoto Kyoto, Japan
Boehringer Ingelheim Investigational Site 288
Kyoto Kyoto, Japan
Boehringer Ingelheim Investigational Site 291
Kyoto Kyoto, Japan
Boehringer Ingelheim Investigational Site 292
Kyoto Kyoto, Japan
Boehringer Ingelheim Investigational Site 293
Kyoto Kyoto, Japan
Boehringer Ingelheim Investigational Site 177
Machida Tokyo, Japan
Boehringer Ingelheim Investigational Site 91
Maebashi Gumma, Japan
Boehringer Ingelheim Investigational Site 92
Maebashi Gumma, Japan
Boehringer Ingelheim Investigational Site 93
Maebashi Gumma, Japan
Boehringer Ingelheim Investigational Site 94
Maebashi Gumma, Japan
Boehringer Ingelheim Investigational Site 119
Matsudo Chiba, Japan
Boehringer Ingelheim Investigational Site 346
Matsue Shimane, Japan
Boehringer Ingelheim Investigational Site 347
Matsue Shimane, Japan
Boehringer Ingelheim Investigational Site 241
Matsumoto Nagano, Japan
Boehringer Ingelheim Investigational Site 242
Matsumoto Nagano, Japan
Boehringer Ingelheim Investigational Site 243
Matsumoto Nagano, Japan
Boehringer Ingelheim Investigational Site 244
Matsumoto Nagano, Japan
Boehringer Ingelheim Investigational Site 249
Matsumoto Nagano, Japan
Boehringer Ingelheim Investigational Site 250
Matsumoto Nagano, Japan
Boehringer Ingelheim Investigational Site 280
Matsusaka Mie, Japan
Boehringer Ingelheim Investigational Site 378
Matsuyama Ehime, Japan
Boehringer Ingelheim Investigational Site 379
Matsuyama Ehime, Japan
Boehringer Ingelheim Investigational Site 381
Matsuyama Ehime, Japan
Boehringer Ingelheim Investigational Site 158
Meguro Tokyo, Japan
Boehringer Ingelheim Investigational Site 159
Meguro Tokyo, Japan
Boehringer Ingelheim Investigational Site 416
Minamata Kumamoto, Japan
Boehringer Ingelheim Investigational Site 137
Minato Tokyo, Japan
Boehringer Ingelheim Investigational Site 138
Minato Tokyo, Japan
Boehringer Ingelheim Investigational Site 139
Minato Tokyo, Japan
Boehringer Ingelheim Investigational Site 140
Minato Tokyo, Japan
Boehringer Ingelheim Investigational Site 171
Mitaka Tokyo, Japan
Boehringer Ingelheim Investigational Site 172
Mitaka Tokyo, Japan
Boehringer Ingelheim Investigational Site 75
Mito Ibaraki, Japan
Boehringer Ingelheim Investigational Site 419
Miyazaki Miyazaki, Japan
Boehringer Ingelheim Investigational Site 420
Miyazaki Miyazaki, Japan
Boehringer Ingelheim Investigational Site 421
Miyazaki Miyazaki, Japan
Boehringer Ingelheim Investigational Site 315
Moriguchi Osaka, Japan
Boehringer Ingelheim Investigational Site 33
Morioka Iwate, Japan
Boehringer Ingelheim Investigational Site 34
Morioka Iwate, Japan
Boehringer Ingelheim Investigational Site 282
Moriyama Shiga, Japan
Boehringer Ingelheim Investigational Site 283
Moriyama Shiga, Japan
Boehringer Ingelheim Investigational Site 5
Muroran Hokkaido, Japan
Boehringer Ingelheim Investigational Site 284
Nagahama Shiga, Japan
Boehringer Ingelheim Investigational Site 274
Nagakute Aichi, Japan
Boehringer Ingelheim Investigational Site 236
Nagano Nagano, Japan
Boehringer Ingelheim Investigational Site 237
Nagano Nagano, Japan
Boehringer Ingelheim Investigational Site 238
Nagano Nagano, Japan
Boehringer Ingelheim Investigational Site 210
Nagaoka Niigata, Japan
Boehringer Ingelheim Investigational Site 211
Nagaoka Niigata, Japan
Boehringer Ingelheim Investigational Site 212
Nagaoka Niigata, Japan
Boehringer Ingelheim Investigational Site 405
Nagasaki Nagasaki, Japan
Boehringer Ingelheim Investigational Site 406
Nagasaki Nagasaki, Japan
Boehringer Ingelheim Investigational Site 267
Nagoya Aichi, Japan
Boehringer Ingelheim Investigational Site 268
Nagoya Aichi, Japan
Boehringer Ingelheim Investigational Site 269
Nagoya Aichi, Japan
Boehringer Ingelheim Investigational Site 270
Nagoya Aichi, Japan
Boehringer Ingelheim Investigational Site 271
Nagoya Aichi, Japan
Boehringer Ingelheim Investigational Site 272
Nagoya Aichi, Japan
Boehringer Ingelheim Investigational Site 80
Naka Ibaraki, Japan
Boehringer Ingelheim Investigational Site 167
Nakano Tokyo, Japan
Boehringer Ingelheim Investigational Site 341
Nara Nara, Japan
Boehringer Ingelheim Investigational Site 122
Narashino Chiba, Japan
Boehringer Ingelheim Investigational Site 39
Natori Miyagi, Japan
Boehringer Ingelheim Investigational Site 169
Nerima Tokyo, Japan
Boehringer Ingelheim Investigational Site 170
Nerima Tokyo, Japan
Boehringer Ingelheim Investigational Site 215
Niigata Niigata, Japan
Boehringer Ingelheim Investigational Site 216
Niigata Niigata, Japan
Boehringer Ingelheim Investigational Site 217
Niigata Niigata, Japan
Boehringer Ingelheim Investigational Site 218
Niigata Niigata, Japan
Boehringer Ingelheim Investigational Site 382
Niihama Ehime, Japan
Boehringer Ingelheim Investigational Site 334
Nishinomiya Hyogo, Japan
Boehringer Ingelheim Investigational Site 335
Nishinomiya Hyogo, Japan
Boehringer Ingelheim Investigational Site 336
Nishinomiya Hyogo, Japan
Boehringer Ingelheim Investigational Site 22
Obihiro Hokkaido, Japan
Boehringer Ingelheim Investigational Site 23
Obihiro Hokkaido, Japan
Boehringer Ingelheim Investigational Site 253
Ogaki Gifu, Japan
Boehringer Ingelheim Investigational Site 417
Oita Oita, Japan
Boehringer Ingelheim Investigational Site 418
Oita Oita, Japan
Boehringer Ingelheim Investigational Site 350
Okayama Okayama, Japan
Boehringer Ingelheim Investigational Site 351
Okayama Okayama, Japan
Boehringer Ingelheim Investigational Site 353
Okayama Okayama, Japan
Boehringer Ingelheim Investigational Site 264
Okazaki Aichi, Japan
Boehringer Ingelheim Investigational Site 265
Okazaki Aichi, Japan
Boehringer Ingelheim Investigational Site 178
Ome Tokyo, Japan
Boehringer Ingelheim Investigational Site 358
Onomichi Hiroshima, Japan
Boehringer Ingelheim Investigational Site 295
Osaka Osaka, Japan
Boehringer Ingelheim Investigational Site 296
Osaka Osaka, Japan
Boehringer Ingelheim Investigational Site 297
Osaka Osaka, Japan
Boehringer Ingelheim Investigational Site 298
Osaka Osaka, Japan
Boehringer Ingelheim Investigational Site 299
Osaka Osaka, Japan
Boehringer Ingelheim Investigational Site 300
Osaka Osaka, Japan
Boehringer Ingelheim Investigational Site 301
Osaka Osaka, Japan
Boehringer Ingelheim Investigational Site 302
Osaka Osaka, Japan
Boehringer Ingelheim Investigational Site 303
Osaka Osaka, Japan
Boehringer Ingelheim Investigational Site 304
Osaka Osaka, Japan
Boehringer Ingelheim Investigational Site 305
Osaka Osaka, Japan
Boehringer Ingelheim Investigational Site 306
Osaka Osaka, Japan
Boehringer Ingelheim Investigational Site 307
Osaka Osaka, Japan
Boehringer Ingelheim Investigational Site 43
Osaki Miyagi, Japan
Boehringer Ingelheim Investigational Site 35
Oshu Iwate, Japan
Boehringer Ingelheim Investigational Site 96
Ota Gumma, Japan
Boehringer Ingelheim Investigational Site 153
Ota Tokyo, Japan
Boehringer Ingelheim Investigational Site 154
Ota Tokyo, Japan
Boehringer Ingelheim Investigational Site 155
Ota Tokyo, Japan
Boehringer Ingelheim Investigational Site 156
Ota Tokyo, Japan
Boehringer Ingelheim Investigational Site 4
Otaru Hokkaido, Japan
Boehringer Ingelheim Investigational Site 85
Otawara Tochigi, Japan
Boehringer Ingelheim Investigational Site 70
Ryugasaki Ibaraki, Japan
Boehringer Ingelheim Investigational Site 403
Saga Saga, Japan
Boehringer Ingelheim Investigational Site 204
Sagamihara Kanagawa, Japan
Boehringer Ingelheim Investigational Site 205
Sagamihara Kanagawa, Japan
Boehringer Ingelheim Investigational Site 206
Sagamihara Kanagawa, Japan
Boehringer Ingelheim Investigational Site 207
Sagamihara Kanagawa, Japan
Boehringer Ingelheim Investigational Site 322
Sakai Osaka, Japan
Boehringer Ingelheim Investigational Site 323
Sakai Osaka, Japan
Boehringer Ingelheim Investigational Site 56
Sakata, Japan
Boehringer Ingelheim Investigational Site 57
Sakata, Japan
Boehringer Ingelheim Investigational Site 239
Saku Nagano, Japan
Boehringer Ingelheim Investigational Site 126
Sakura Chiba, Japan
Boehringer Ingelheim Investigational Site 338
Sanda Hyogo, Japan
Boehringer Ingelheim Investigational Site 10
Sapporo Hokkaido, Japan
Boehringer Ingelheim Investigational Site 11
Sapporo Hokkaido, Japan
Boehringer Ingelheim Investigational Site 12
Sapporo Hokkaido, Japan
Boehringer Ingelheim Investigational Site 13
Sapporo Hokkaido, Japan
Boehringer Ingelheim Investigational Site 14
Sapporo Hokkaido, Japan
Boehringer Ingelheim Investigational Site 15
Sapporo Hokkaido, Japan
Boehringer Ingelheim Investigational Site 1
Sapporo Hokkaido, Japan
Boehringer Ingelheim Investigational Site 2
Sapporo Hokkaido, Japan
Boehringer Ingelheim Investigational Site 7
Sapporo Hokkaido, Japan
Boehringer Ingelheim Investigational Site 8
Sapporo Hokkaido, Japan
Boehringer Ingelheim Investigational Site 9
Sapporo Hokkaido, Japan
Boehringer Ingelheim Investigational Site 409
Sasebo Nagasaki, Japan
Boehringer Ingelheim Investigational Site 410
Sasebo Nagasaki, Japan
Boehringer Ingelheim Investigational Site 73
Sashima Ibaraki, Japan
Boehringer Ingelheim Investigational Site 427
Satsumasendai Kagoshima, Japan
Boehringer Ingelheim Investigational Site 36
Sendai Miyagi, Japan
Boehringer Ingelheim Investigational Site 37
Sendai Miyagi, Japan
Boehringer Ingelheim Investigational Site 38
Sendai Miyagi, Japan
Boehringer Ingelheim Investigational Site 40
Sendai Miyagi, Japan
Boehringer Ingelheim Investigational Site 275
Seto Aichi, Japan
Boehringer Ingelheim Investigational Site 219
Shibata Niigata, Japan
Boehringer Ingelheim Investigational Site 98
Shibukawa Gumma, Japan
Boehringer Ingelheim Investigational Site 157
Shibuya Tokyo, Japan
Boehringer Ingelheim Investigational Site 408
Shimabara Nagasaki, Japan
Boehringer Ingelheim Investigational Site 430
Shimajiri Okinawa, Japan
Boehringer Ingelheim Investigational Site 369
Shimonoseki Yamaguchi, Japan
Boehringer Ingelheim Investigational Site 371
Shimonoseki Yamaguchi, Japan
Boehringer Ingelheim Investigational Site 372
Shimonoseki Yamaguchi, Japan
Boehringer Ingelheim Investigational Site 83
Shimotsuga Tochigi, Japan
Boehringer Ingelheim Investigational Site 84
Shimotsuga Tochigi, Japan
Boehringer Ingelheim Investigational Site 87
Shimotsuke Tochigi, Japan
Boehringer Ingelheim Investigational Site 88
Shimotsuke Tochigi, Japan
Boehringer Ingelheim Investigational Site 151
Shinagawa Tokyo, Japan
Boehringer Ingelheim Investigational Site 152
Shinagawa Tokyo, Japan
Boehringer Ingelheim Investigational Site 160
Shinjuku Tokyo, Japan
Boehringer Ingelheim Investigational Site 161
Shinjuku Tokyo, Japan
Boehringer Ingelheim Investigational Site 162
Shinjuku Tokyo, Japan
Boehringer Ingelheim Investigational Site 163
Shinjuku Tokyo, Japan
Boehringer Ingelheim Investigational Site 164
Shinjuku Tokyo, Japan
Boehringer Ingelheim Investigational Site 165
Shinjuku Tokyo, Japan
Boehringer Ingelheim Investigational Site 166
Shinjuku Tokyo, Japan
Boehringer Ingelheim Investigational Site 41
Shiogama Miyagi, Japan
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The general scientific objective of this non-interventional study was to obtain an estimate of occurrence of AEs in the population under study. This study did not include a comparator, hindering the ability to this real world data into perspective.
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2014
First Posted
May 6, 2014
Study Start
May 7, 2014
Primary Completion
December 28, 2016
Study Completion
December 28, 2016
Last Updated
September 7, 2018
Results First Posted
September 7, 2018
Record last verified: 2018-09