Clinical trial · Observational
Comparative Effectiveness Analysis of Granulocyte Colony Stimulating Factor Originator Products Versus Biosimilars
An Exploratory Comparative Effectiveness Analysis of Granulocyte Colony Stimulating Factor Originator Products Versus Biosimilars in Real-world Practice
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer, Breast | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer, Lung | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Cancer of Colon | Malignant Colon Neoplasm | ALIAS | 0.90 |
| Cancer of Pancreas | Malignant Pancreatic Neoplasm | ALIAS | 0.90 |
| Cancer, Ovarian | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Receipt of granulocyte-colony stimulating factor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- G-CSF originator receipt
- description
- Patients receiving filgrastim (Neupogen) or pegfilgrastim (Neulasta) per Health Care Procedural Coding System (HCPCS) J-codes.
- interventionNames
- Drug: Receipt of granulocyte-colony stimulating factor
- label
- G-CSF biosimilar receipt
- description
- Patients receiving filgrastim biosimilars (filgrastim-aafi, filgrastim-sndz, tbo-filgrastim) or pegfilgrastim biosimilars (pegfilgrastim-jmdb, pegfilgrastim-bmez, pegfilgrastim-cbqv) per Health Care Procedural Coding System (HCPCS) J-codes.
- interventionNames
- Drug: Receipt of granulocyte-colony stimulating factor
Primary outcomes (1)
- measure
- Number of patients who develop febrile neutropenia
- timeFrame
- Within 30 days of receipt of first chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available