NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
A Study of Patient Characteristics and Treatment Patterns in Real-world Melanoma Patients Treated With Dabrafenib and Trametinib or Encorafenib and Binimetinib in Japan
A Study of Patient Characteristics and Treatment Patterns in Real-world Melanoma Patients Treated With Dabrafenib and Trametinib or Encorafenib and Binimetinib in Japan
CompletedN/A
Sponsor: Novartis Pharmaceuticals
Conditions: Melanoma
Countries: Japan
The aim of this study was to describe the patient profile and treatment patterns of adult melanoma patients that were treated with either dabrafenib and trametinib (Dab+Tram) or encorafenib and binimetinib (Enco+Bini) between 01 January 2012 and 30 November 2021 in Japan.
Eligibility overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: OBSERVATIONAL
Eligibility criteria
Inclusion criteria: All patients who met all of the following criteria were included: * Had a confirmed diagnosis of melanoma recorded during the identification period, and * Had at least 6 months of enrollment before the index date A, where index date A was defined as the first date of a confirmed diagnosis of melanoma recorded during the identification period, and * Were at least 18 years old at the time of initiation of the first line of treatment (LoT). The Adjuvant Dab+Tram Cohort included all patients who met all of the following criteria: * Satisfied all of the general inclusion criteria, and * Had a dabrafenib prescription claim and a trametinib prescription claim recorded after or at the index date A, and * Had at least 6 months of follow-up after the index date B, where index B was defined as the first date of a prescription recorded at or after index date A, and * Had the first dabrafenib or trametinib prescription claim recorded within 12 weeks of an excision surgery, and * Did not have a confirmed metastasis diagnosis recorded within 1 month before, at, or within 12 weeks after the index date A. The Non-adjuvant Dab+Tram Cohort included all patients that met all of the following criteria: * Satisfied all of the general inclusion criteria, and * Had a dabrafenib prescription claim and a trametinib prescription claim recorded after or at the index date A, and * Had at least 6 months of follow-up after the index date B, and * Not included in the Adjuvant Dab+Tram Cohort. The Cohort Enco+Bini included all patients that met all of the following criteria: * Satisfied all of the general inclusion criteria, and * Had an encorafenib prescription claim and a binimetinib prescription claim recorded after or at the index date A, and * Had at least 6 months of follow-up after the index date B. The Overall Cohort included all patients that met all of the following criteria: • Included in either the Adjuvant Dab+Tram Cohort, the Non-adjuvant Dab+Tram Cohort, or the Enco+Bini Cohort. A patient could be considered in multiple cohorts and was considered once only in analysis of the Overall Cohort. Exclusion criteria: * Had a prescription claim with a melanoma treatment recorded within 6 months before the index date A, or * Had a confirmed diagnosis of a non-small cell lung cancer recorded any time before the index date A for the Adjuvant Dab+Tram Cohort and the Non-adjuvant Dab+Tram Cohort, or * Had a confirmed diagnosis of a colorectal cancer recorded any time before the index date A for the Enco+Bini Cohort.
Locations (1)
- Tokyo, Japan