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This study was an uncontrolled, primary data collection-based observational study to be conducted as a central registration system, multicenter special drug-use results surveillance. As an all-case study, this study collected all patients treated with Tabrecta in a specified post-marketing period. The observation period of each patient was up to 1 year (52 weeks)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tabrecta tablets | Patients administered Tabrecta by prescription |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tabrecta tablets | Drug | There was no treatment allocation. Patients administered Tabrecta by prescription that had started before inclusion of the patient into the study were enrolled. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse reactions | An adverse reaction is defined as an adverse event that is suspected by the investigator to be causally related to Tabrecta or whose causality is not recorded. | 1 year |
| Response rate | A response rate is defined as a proportion of patients whose best overall response is CR or PR as assessed by the RECIST version 1.1(Eisenhauer et al. 2009). Patients assessed as not evaluable (NE) were handled as non-responders, and included in the denominator for the calculation of response rates. | 1 year |
| Overall survival rate | The Kaplan-Meier method was used to estimate the survival curve. Overall survival is defined as the duration from the start date of Tabrecta administration to death of any cause. For patients surviving to the end, OS was censored at the end date of the observation period. | 1 year |
| Progression-free survival (PFS) | the Kaplan-Meier method was used to estimate the PFS curve according to RECIST version 1.1 (Eisenhauer et al. 2009). PFS is defined as the duration from the start date of Tabrecta administration to the date of the date of the first PD observed or death of any cause, whichever comes first. For patients without these events, PFS was censored at the end date of the observation period. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
-
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All patients receiving Tabrecta for MET exon 14 skipping mutation-positive unresectable advanced/recurrent NSCLC during a specified post-marketing period. By allowing patients who started Tabrecta administration before the conclusion of a contract for this study to be included in the study population after the contract, all patients treated with Tabrecta were enrolled in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | KĊnan | Aichi-ken | 4838704 | Japan | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Link to study results | View source |
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| Nagoya |
| Aichi-ken |
| 457-0818 |
| Japan |
| Novartis Investigative Site | Nagoya | Aichi-ken | 462-0057 | Japan |
| Novartis Investigative Site | Nagoya | Aichi-ken | 464 8681 | Japan |
| Novartis Investigative Site | Okazaki | Aichi-ken | 444-8553 | Japan |
| Novartis Investigative Site | Toyoake | Aichi-ken | 470 1192 | Japan |
| Novartis Investigative Site | Toyota | Aichi-ken | 470-0343 | Japan |
| Novartis Investigative Site | Daisen | Akita | 014-0027 | Japan |
| Novartis Investigative Site | Hachinohe | Aomori | 031-0011 | Japan |
| Novartis Investigative Site | Sakura | Chiba | 285-8741 | Japan |
| Novartis Investigative Site | Fukui-shi | Fukui | 918-8501 | Japan |
| Novartis Investigative Site | Yoshida-gun | Fukui | 910-1193 | Japan |
| Novartis Investigative Site | Fukuoka | Fukuoka | 811-1395 | Japan |
| Novartis Investigative Site | Fukuoka | Fukuoka | 812-8582 | Japan |
| Novartis Investigative Site | Fukuoka | Fukuoka | 814 0180 | Japan |
| Novartis Investigative Site | Iizuka | Fukuoka | 820-0076 | Japan |
| Novartis Investigative Site | Kitakyushu | Fukuoka | 802-0077 | Japan |
| Novartis Investigative Site | Kitakyushu | Fukuoka | 8058508 | Japan |
| Novartis Investigative Site | Kitakyushu | Fukuoka | 806-8501 | Japan |
| Novartis Investigative Site | Fukushima | Fukushima | 960 1295 | Japan |
| Novartis Investigative Site | Ċgaki | Gifu | 503-8502 | Japan |
| Novartis Investigative Site | Higashihiroshima | Hiroshima | 739-0041 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 003-0804 | Japan |
| Novartis Investigative Site | Akashi | HyĊgo | 673-8558 | Japan |
| Novartis Investigative Site | Himeji | HyĊgo | 670-8520 | Japan |
| Novartis Investigative Site | Nishinomiya | HyĊgo | 663 8501 | Japan |
| Novartis Investigative Site | Tsuchiura | Ibaraki | 300-0028 | Japan |
| Novartis Investigative Site | Tsukuba | Ibaraki | 305-8558 | Japan |
| Novartis Investigative Site | KanâonjichĊ | Kagawa-ken | 769-1695 | Japan |
| Novartis Investigative Site | SakaidechĊ | Kagawa-ken | 762-8550 | Japan |
| Novartis Investigative Site | Takamatsu | Kagawa-ken | 760-0017 | Japan |
| Novartis Investigative Site | Fujisawa | Kanagawa | 251-8550 | Japan |
| Novartis Investigative Site | Kawasaki | Kanagawa | 216-8511 | Japan |
| Novartis Investigative Site | Sagamihara | Kanagawa | 252-0375 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 220-8521 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 221-0855 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 232 0024 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 234-0054 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 236 0037 | Japan |
| Novartis Investigative Site | Tsu | Mie-ken | 514-8507 | Japan |
| Novartis Investigative Site | Yokkaichi | Mie-ken | 510-8567 | Japan |
| Novartis Investigative Site | MiyakonojĊ | Miyazaki | 885-0014 | Japan |
| Novartis Investigative Site | Matsumoto | Nagano | 390-8621 | Japan |
| Novartis Investigative Site | Nagasaki | Nagasaki | 852-8501 | Japan |
| Novartis Investigative Site | Kurashiki | Okayama-ken | 701-0192 | Japan |
| Novartis Investigative Site | Okayama | Okayama-ken | 700-8558 | Japan |
| Novartis Investigative Site | Kishiwada | Osaka | 596-8501 | Japan |
| Novartis Investigative Site | Osaka | Osaka | 534-0021 | Japan |
| Novartis Investigative Site | Osaka | Osaka | 540-0006 | Japan |
| Novartis Investigative Site | Osaka | Osaka | 541-8567 | Japan |
| Novartis Investigative Site | Osaka | Osaka | 543-8555 | Japan |
| Novartis Investigative Site | Saga | Saga-ken | 849-8501 | Japan |
| Novartis Investigative Site | Kawaguchi | Saitama | 332-8558 | Japan |
| Novartis Investigative Site | Kumagaya | Saitama | 360-0197 | Japan |
| Novartis Investigative Site | Saitama | Saitama | 330 8503 | Japan |
| Novartis Investigative Site | Saitama | Saitama | 330-8553 | Japan |
| Novartis Investigative Site | Izumo | Shimane | 693 8501 | Japan |
| Novartis Investigative Site | Hamamatsu | Shizuoka | 431-3192 | Japan |
| Novartis Investigative Site | Bunkyo Ku | Tokyo | 113-8431 | Japan |
| Novartis Investigative Site | Chuo Ku | Tokyo | 104 0045 | Japan |
| Novartis Investigative Site | Edogawa City | Tokyo | 133-0052 | Japan |
| Novartis Investigative Site | Kiyose | Tokyo | 204-8585 | Japan |
| Novartis Investigative Site | Koto Ku | Tokyo | 135 8550 | Japan |
| Novartis Investigative Site | Minato | Tokyo | 108-0073 | Japan |
| Novartis Investigative Site | Minato Ku | Tokyo | 105-8470 | Japan |
| Novartis Investigative Site | Minato-ku | Tokyo | 105-8471 | Japan |
| Novartis Investigative Site | Shibuya City | Tokyo | 150-8935 | Japan |
| Novartis Investigative Site | Shinjuku Ku | Tokyo | 160-0023 | Japan |
| Novartis Investigative Site | Tama | Tokyo | 206-8512 | Japan |
| Novartis Investigative Site | Toyama | Toyama | 930-0194 | Japan |
| Novartis Investigative Site | Higashi Okitama | Yamagata | 9920601 | Japan |
| Novartis Investigative Site | Ube | Yamaguchi | 755-0241 | Japan |
| Novartis Investigative Site | Aomori | 030 8553 | Japan |
| Novartis Investigative Site | Chiba | 261-0001 | Japan |
| Novartis Investigative Site | Hiroshima | 734 8530 | Japan |
| Novartis Investigative Site | Kumamoto | 860-8556 | Japan |
| Novartis Investigative Site | Kumamoto | 861-4193 | Japan |
| Novartis Investigative Site | Osaka | 530 0005 | Japan |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000613976 | capmatinib |
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