Somatostatin Receptor-positive Neuroendocrine Tumor
Conditions
Keywords
LUTATHERA
Brief summary
This study was a multicenter observational study with a central registration system and all-case surveillance system without a control group.
Detailed description
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).
Interventions
OTHERLUTATHERA
There was no treatment allocation. Patients administered LUTATHERA by prescription could be enrolled.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with Renal dysfunction, Myelosuppression, Myelodysplastic syndrome/acute myeloid leukaemia and Hormone release induced crises | Until 40 weeks after the date of the last dose (64 weeks if 4 doses are administered 8 weeks apart). | 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 |
Countries
Japan
Outcome results
None listed