Lymphoma, Non-Hodgkin Clinical Trial
Official title:
An Exploratory Comparative Effectiveness Analysis of Granulocyte Colony Stimulating Factor Originator Products Versus Biosimilars in Real-world Practice
Verified date | July 2023 |
Source | Biologics & Biosimilars Collective Intelligence Consortium |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This comparative effectiveness and descriptive retrospective cohort study will evaluate safety and effectiveness outcomes among commercially insured adults who received a granulocyte colony stimulating factor (G-CSF) biosimilar or originator product during the first cycle of clinical guideline-indicated intermediate or high febrile neutropenia risk chemotherapy.
Status | Completed |
Enrollment | 16506 |
Est. completion date | December 31, 2022 |
Est. primary completion date | September 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: - Patients age 20 or older - Diagnosis of lung, breast, colon, ovarian, pancreatic, testicular, cervical, uterine, or NHL cancer - Beginning intermediate or high neutropenia risk chemotherapy Exclusion Criteria: - One inpatient or two outpatient cancer diagnoses at least 30 days apart in the 183 days prior to the Index Date for cancer different from enrolling cancer diagnosis - Any of the following in 183 days prior to Index Date: - Any chemotherapy or G-CSF product receipt - 2< medical claims at least 30 days apart for a skilled nursing facility or hospice care - 2< diagnoses/procedure codes at least 1 day apart for cancer-related radiotherapy, bone marrow or stem cell transplant, diagnosis of HIV/AIDS, severe hepatic disease, chronic kidney disease, or any non-oncology related neutropenia |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Catherine M. Lockhart | Harvard Pilgrim Health Care, HealthPartners Institute |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients who develop febrile neutropenia | ICD-9 or ICD-10 codes for inpatient or outpatient visit indicating fever with infection per validated algorithms. | Within 30 days of receipt of first chemotherapy | |
Secondary | Number of patients who develop G-CSF associated adverse events | ICD-9 or ICD-10 codes indicating splenic rupture, anaphylaxis, or leukocytosis. | Within 30 days of receipt of first chemotherapy |
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