Retrospective Assessment of Adverse Events-related Healthcare Resource Utilization and Costs of Immune Checkpoint Inhibitor and Targeted Therapy for Adjuvant Treatment of Melanoma
Part of paid clinical trials in East Hanover, New Jersey.
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT05714371
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nivolumab — DRUGPatients receiving nivolumab
- Ipilimumab + nivolumab — DRUGPatients receiving ipilimumab + nivolumab
- Pembrolizumab — DRUGPatients receiving pembrolizumab
- Dabrafenib + trametinib — DRUGDabrafenib + trametinib
Study Details
This was a retrospective cohort study using the PharMetrics database. The analysis was conducted using the most recent 5 years of data from the database, January 1, 2015, to October 30, 2020. Included patients were followed for outcome evaluation from the index date (first prescription of treatment, immunotherapy \[IO\], or targeted therapy \[TT\] following diagnosis of non-metastatic malignant melanoma and evidence of first lymph node resection), until the first occurrence or end of continuous eligibility or end of the study period.
Key Dates
- Start date
- Oct 2, 2021
- Status verified
- Jan 2023
- Primary completion
- Jan 27, 2022
- Completion
- Jan 27, 2022
Study Design
- Enrollment
- 618 participants (actual)
Arms
- Arm: Immunotherapy (IO)Patients receiving IO
- Arm: Targeted therapy (TT)Patients receiving TT
Primary Outcome Measure
Number of patients on first systemic adjuvant therapy with adverse avents (AEs) [ Time Frame: Up to approximately 5 years ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Novartis Pharmaceuticals | East Hanover | New Jersey | 07936 | - |
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