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This study was a multicenter observational study with a central registration system and all-case surveillance system without a control group.
From the date of the first dose of this drug until 40 weeks after the date of the last dose (64 weeks if 4 doses are administered 8 weeks apart).
For patients who discontinue treatment with this drug during the observation period, necessary variables were examined until 40 weeks after the last dose of this drug during the observation period and recorded in the case report forms (CRF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LUTATHERA | patients treated with LUTATHERA Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LUTATHERA | Other | There was no treatment allocation. Patients administered LUTATHERA by prescription could be enrolled. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with Renal dysfunction, Myelosuppression, Myelodysplastic syndrome/acute myeloid leukaemia and Hormone release induced crises | To evaluate the safety about Renal dysfunction, Myelosuppression, Myelodysplastic syndrome/acute myeloid leukaemia and Hormone release induced crises after administration of this drug in a real world setting | Until 40 weeks after the date of the last dose (64 weeks if 4 doses are administered 8 weeks apart). |
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Inclusion Criteria:
All patients treated with this drug for the following indications during a certain post-marketing period
Exclusion Criteria:
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All patients treated with this drug for the following indications during a certain post-marketing period
• Indication: Somatostatin receptor-positive neuroendocrine tumor
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Nagoya | Aichi-ken | 464 8681 | Japan | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Link to study results | View source |
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| Hirosaki |
| Aomori |
| 036 8563 |
| Japan |
| Novartis Investigative Site | Kamogawa | Chiba | 296-8602 | Japan |
| Novartis Investigative Site | Kashiwa | Chiba | 277 8577 | Japan |
| Novartis Investigative Site | Tōon | Ehime | 7910295 | Japan |
| Novartis Investigative Site | Fukui-shi | Fukui | 910-8526 | Japan |
| Novartis Investigative Site | Gifu | Gifu | 501-1194 | Japan |
| Novartis Investigative Site | Maebashi | Gunma | 371 8511 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 060 8648 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 608543 | Japan |
| Novartis Investigative Site | Akashi | Hyōgo | 673-8558 | Japan |
| Novartis Investigative Site | Kobe | Hyōgo | 6500047 | Japan |
| Novartis Investigative Site | Kanazawa | Ishikawa-ken | 920 8641 | Japan |
| Novartis Investigative Site | Kita-gun | Kagawa-ken | 7610793 | Japan |
| Novartis Investigative Site | Kagoshima | Kagoshima-ken | 890 8520 | Japan |
| Novartis Investigative Site | Kamakura | Kanagawa | 247-8533 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa-ku | 236-0004 | Japan |
| Novartis Investigative Site | Sendai | Miyagi | 980 8574 | Japan |
| Novartis Investigative Site | Suwa | Nagano | 392-8510 | Japan |
| Novartis Investigative Site | Niigata | Niigata | 951-8566 | Japan |
| Novartis Investigative Site | Kurashiki | Okayama-ken | 7108602 | Japan |
| Novartis Investigative Site | Osaka | Osaka | 5418567 | Japan |
| Novartis Investigative Site | Osaka | Osaka | 553-0003 | Japan |
| Novartis Investigative Site | Sakai | Osaka | 590-0197 | Japan |
| Novartis Investigative Site | Suita | Osaka | 565 0871 | Japan |
| Novartis Investigative Site | Hamamatsu | Shizuoka | 4313192 | Japan |
| Novartis Investigative Site | Iwata | Shizuoka | 438-8550 | Japan |
| Novartis Investigative Site | Shizuoka | Shizuoka | 420-8527 | Japan |
| Novartis Investigative Site | Sunto Gun | Shizuoka | 411 8777 | Japan |
| Novartis Investigative Site | Tokushima | Tokushima | 7708503 | Japan |
| Novartis Investigative Site | Bunkyo-ku | Tokyo | 1138519 | Japan |
| Novartis Investigative Site | Chuo Ku | Tokyo | 104 0045 | Japan |
| Novartis Investigative Site | Koto Ku | Tokyo | 135 8550 | Japan |
| Novartis Investigative Site | Toyama | Toyama | 9300194 | Japan |
| Novartis Investigative Site | Yamagata | Yamagata | 990 9585 | Japan |
| Novartis Investigative Site | Chūō | Yamanashi | 409-3898 | Japan |
| Novartis Investigative Site | Chiba | 260-8717 | Japan |
| Novartis Investigative Site | Fukuoka | 8128582 | Japan |
| Novartis Investigative Site | Fukuoka | 814-0001 | Japan |
| Novartis Investigative Site | Fukushima | 960 1295 | Japan |
| Novartis Investigative Site | Hiroshima | 7348551 | Japan |
| Novartis Investigative Site | Kobe | 650-0017 | Japan |
| Novartis Investigative Site | Kumamoto | 860-8556 | Japan |
| Novartis Investigative Site | Kyoto | 606 8507 | Japan |
| Novartis Investigative Site | Okayama | 7008558 | Japan |
| Novartis Investigative Site | Osaka | 5458586 | Japan |
| ID | Term |
|---|---|
| C447941 | lutetium Lu 177 dotatate |
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