LUTATHERA Injection General Use Result Survey

Novartis Pharmaceuticals347 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

347

Conditions

Somatostatin Receptor-positive Neuroendocrine Tumor

Interventions

LUTATHERAOTHER

There was no treatment allocation. Patients administered LUTATHERA by prescription could be enrolled.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All patients treated with this drug for the following indications during a certain post-marketing period * Indication: Somatostatin receptor-positive neuroendocrine tumor Patients who started to receive this drug before the contract for this study will also be included in the study population and it will be allowed to register them after the contract so that all patients who receive this drug will be included in this study. Patients treated with this drug for off-label indication will also be included in this study to register all patients received this drug. Exclusion Criteria: * Not applicable

Locations (46)

Outcomes

Primary Outcomes

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

Time frame: Until 40 weeks after the date of the last dose (64 weeks if 4 doses are administered 8 weeks apart).

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Novartis Investigative Site

Hirosaki, Aomori, Japan

Novartis Investigative Site

Kamogawa, Chiba, Japan

Novartis Investigative Site

Kashiwa, Chiba, Japan

Novartis Investigative Site

Tōon, Ehime, Japan

Novartis Investigative Site

Fukui-shi, Fukui, Japan

Novartis Investigative Site

Gifu, Gifu, Japan

Novartis Investigative Site

Maebashi, Gunma, Japan

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Novartis Investigative Site

Sapporo, Hokkaido, Japan

...and 36 more locations