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Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Advanced Cell Carcinoma — NISSO  

Basal Cell Carcinoma Clinical Trial

Official title:
A Non-interventional, Multi-national, Multi-center Post-authorization Safety Study (PASS) to Assess the Long Term Safety and Tolerability of Odomzo (Sonidegib) Administered in Patients With Locally Advanced Cell Carcinoma (laBCC)

Clinical Trial Summary

Collect real world safety data on the use of sonidegib in adult patients with laBCC. Document major safety parameters such as on treatment deaths, adverse events (AEs)/ serious adverse events (SAEs) and discontinuation secondary to AEs.

Clinical Trial Description

This is a non-interventional, multinational, multi-center post-authorization safety study (PASS), to assess the safety of sonidegib administered in routine clinical practice in patients with laBCC who are not amendable to curative surgery or radiation therapy. This study is observational in nature and does not impose a therapy protocol, diagnostic/therapeutic interventions or a specific visit schedule. For this study, each enrolled patient will be followed up for 3 years after enrollment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04066504
Study type Observational
Source Sun Pharmaceutical Industries Limited
Contact
Status Active, not recruiting
Phase
Start date March 11, 2019
Completion date November 30, 2025
View Details
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