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.
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 Type
OBSERVATIONAL
Enrollment
323
Sonidegib 200 mg orally taken once daily (dose modifications according to the approved local country prescribing information are permitted)
Proportion of patients with AEs/SAEs
including on-treatment deaths and discontinuation due to AEs/SAEs
Time frame: 3 years
Proportion of patients with AEs of special interest (AESI) or populations
in patients with: relevant polymorphism, ≥65 yrs, hepatic or renal impairment, female patients with child bearing potential using anticonceptives, anemia (hemoglobin \<9 g/dL), recent myocardial ischemia or cardiac failure, concomitant medications with known risk of creatine kinase elevation
Time frame: 3 years
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