Assessment of a Large US EHR Database as Meeting FDA Fit-for-Purpose Requirements to Provide External Controls for Study BPM31510 in Participants With Glioblastoma

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• Cohort 1 inclusion Criteria:
• Between 01-01-2021 and 06-30-2025, an ICD-10-CM code C71.X (malignant brain neoplasm) and/or SNOMED CT 276826005 (malignant glioma of brain)
• Between 01-01-2021 and 06-30-2025, current procedural terminology (CPT) codes indicating surgery with either a biopsy or excision of a brain tumor
• Patients must be adults at least 18 years of age at time of surgery
• CPT codes indicating submission of surgical sample for pathology for IDH testing
• SNOMED CT codes for "glioblastoma" after IDH testing
• Note that while a diagnosis can be made based on IDH from a biopsy or resection sample, resection is required for study inclusion.
• A post-resection CPT code for brain MRI
• At least one visit meeting all eligibility criteria between 15- and 50-days post-resection.
  • Cohort 1 exclusion Criteria:
• History of malignant neoplasm of the brain >12 months before index
• Patients with prior chemotherapy, radiotherapy, immunotherapy or targeted treatment agents (including anti-angiogenic drugs) less than 12 months before and/or 14 days after resection.
  • Cohort 2 inclusion Criteria:
  • Patients must meet all eligibility criteria for Cohort 1 and the following:
• Brain MRI scan post-resection available for evaluation
• Karnofsky performance score of at least 60
• Laboratory values within the following specified ranges:
  • Absolute neutrophil count of at least 1.5 k/microliter (μL)
  • Platelet count of at least 100 k/μL
  • Hemoglobin level of at least 9 gram/deciliter (dL)
  • Serum creatinine level of at most 1.8 milligram(mg)/dL or creatinine clearance of more than 50 milliliter/min
  • Bilirubin level of at least 1.5 mg/dL
  • ALT level of at most 3.0 × upper limit of normal (ULN)
  • AST of at most 3.0 × ULN
  • PT of at most 1.5 × ULN
  • INR of at most 1.5 × ULN
  • PTT of at most 1.5 × ULN
  • Cohort 2 exclusion Criteria:
• No resection was performed
• One-year pre-index history of spontaneous or tumor-related intracranial hemorrhage
• One-year pre-index history of diffuse leptomeningeal disease
• Patients on dexamethasone daily dosing more than 2 mg at index
• Three-month pre-index history of cardiovascular disease (myocardial infarction, coronary artery disease, arrhythmia, unstable angina pectoris, cerebrovascular accident)
• Six-month pre-index history of acquired coagulopathies (hemorrhagic disorder due to circulating anticoagulants or acquired coagulation factor deficiency)
• Six-month pre-index history of clinically significant bleeding
• Known predisposition for bleeding such as von Willebrand's disease or other such condition(s) (i.e., hereditary deficiency of factor VIII, IX and XI)
• Six-month pre-index history of significant psychiatric illness
• Six-month pre-index history of major infection
• Prior malignancy except for non-melanoma skin cancer and carcinoma in situ of the cervix or bladder
• Receiving any of the following medications at the index date:
  • Any anticoagulant, including low-molecular weight heparin and warfarin within two months pre-index
  • Any digitalis alkaloid (digoxin, digitoxin, lanatoside C) within two months pre-index
  • Antiangiogenic drugs (e.g., bevacizumab) two weeks before or two weeks after index
  • Theophylline two weeks before or two weeks after index
• Patients with a record of pregnancy, pregnancy termination, or hospital admissions for birth/delivery, or a positive laboratory test indicating pregnancy up to 9 months before index date
• Known to be positive for the human immunodeficiency virus
• Patients not receiving radiation therapy in the year after diagnosis.