Clincosm LogoSign in Get a demo

Retrospective Assessment of AE-Related Healthcare Resource Utilization and Costs of Immune Checkpoint Inhibitor and Targeted Therapy for Adjuvant Treatment of Melanoma

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT05874817
Collaborator
(none)
17,517
Enrollment
1
Location
12.6
Actual Duration (Months)
1388.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This was a retrospective cohort study using Truven Health Analytics' MarketScan Commercial Claims and Encounters and Medicare Supplement and Coordination of Benefit administrative claims databases. The analysis was conducted using the most recent 5 years of data from the database, 01 January 2015, to 28 February 2021 (study period). 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 of end of continuous eligibility or end of the study period.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    17517 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Retrospective Assessment of Adverse Events-Related Healthcare Resource Utilization and Costs of Immune Checkpoint Inhibitor and Targeted Therapy for Adjuvant Treatment of Melanoma
    Actual Study Start Date :
    May 1, 2021
    Actual Primary Completion Date :
    May 20, 2022
    Actual Study Completion Date :
    May 20, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of patients with adverse events (AEs) following first systemic adjuvant therapy [Up to 5 years]

    Secondary Outcome Measures

    1. Percentage of patients with AEs following first systemic adjuvant therapy completion/discontinuation [Up to 5 years]

    2. Healthcare resource utilization (HCRU) associated with AEs following first systemic adjuvant therapy [30 days]

    3. Healthcare costs associated with AEs following first systemic adjuvant therapy [30 days]

    4. HCRU associated with AEs following first systemic adjuvant therapy completion/discontinuation [30 days]

    5. Healthcare costs associated with AEs following first systemic adjuvant therapy completion/discontinuation [30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with at least one diagnosis of malignant melanoma of skin (The International
    Classification of Diseases, 9th Revision, Clinical Modification [ICD-9] codes:

    172.0-172.9 or V10.82; ICD-10 (10th revision) codes: C43.0 C43.10, C43.11, C43.111, C43.112, C43.12, C43.121, C43.122, C43.20, C43.21, C43.22, C43.30 C43.31 C43.39 C43.4, C43.51, C43.52, C43.59 C43.60, C43.61, C43.62, C43.70, C43.71, C43.72, C43.8 C43.9 D03.0 D03.10 D03.11, D03.111, D03.112, D03.12, D03.121, D03.122, D03.20 D03.21 D03.22 D03.30 D03.39 D03.4 D03.51 D03.52 D03.59 D03.60 D03.61 D03.62 D03.70 D03.71 D03.72 D03.8 D03.9 Z85.820) anytime from the start of data collection until the start of study period.

    • Patients with a procedure of first lymph node dissection or nodal basin ultrasound surveillance, per the National Comprehensive Cancer Network (NCCN) guidelines version 2.2020. The first lymph node dissection / nodal basin ultrasound surveillance signified that the patient was eligible to receive systemic treatment as adjuvant therapy.

    • The first lymph node dissection or nodal basin ultrasound surveillance (index adjuvant date) must have had a diagnosis of malignant melanoma of skin within 6 months, to ensure that the dissection was related to melanoma.

    • Patients with at least pharmacy or medical claim for the study drugs within 1 year on and after index date. The index date was the date of first prescription of study drug, IO (i.e., nivolumab, ipilimumab + nivolumab, pembrolizumab) or dabrafenib + trametinib.

    • At least 18 years of age at the time of adjuvant treatment initiation.

    • Patients with at least 6 months of continuous enrollment prior to the index date.

    • Patients with at least 6 months of continuous enrollment after the index date.

    Exclusion Criteria:

    • Patients with a diagnosis of non-melanoma primary malignancy (ICD-9: 140.xx-165.xx, 170.xx-171.xx, 173.xx-195.xx, 200.xx-208.xx; ICD-10: C00.x - C14.x, C41.x, C49.x, C50, C51) during the 6 months pre-index period.

    • Patients with chemotherapy or interferon alpha before index date.

    • Patients with pregnancy (ICD-9: 630.xx-679.xx, V22.xx-V24.xx, V27.xx-V28.xx; ICD-10: O00 - O99) any time during the study period.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis East Hanover New Jersey United States 07936

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT05874817
    Other Study ID Numbers:
    • CTMT212AUS62
    First Posted:
    May 25, 2023
    Last Update Posted:
    May 25, 2023
    Last Verified:
    May 1, 2023
    Additional relevant MeSH terms:
    Melanoma

    Study Results

    No Results Posted as of May 25, 2023