{
    "info": {
        "nct_id": "NCT03706573",
        "official_title": "Managed Access Program (MAP) to Provide Alpelisib for Patients With HR+ Advanced or Metastatic Breast Cancer Resistant or Refractory to Available Treatment Options",
        "inclusion_criteria": "1. Patient can and will sign the Informed Consent (ICF) prior to eligibility evaluations being performed and is able to comply with treatment plan requirements\n2. Patient is an adult and ≥ 18 years old at the time of informed consent\n3. Patient has locally advanced or metastatic HR+ breast cancer and no comparable or satisfactory alternative therapy is available\n4. PIK3CA mutation in tumor tissue or ctDNA as determined by a local laboratory\n5. Patient is not:\n\n   1. eligible for participation in any ongoing clinical trials with alpelisib, or has recently completed a clinical trial with alpelisib that has been terminated\n   2. being transferred from or participating in an ongoing clinical trial, and after considering other options (e.g. trial extensions, amendments, etc.), treating physician has determined that treatment is necessary and there are no other feasible alternatives for the patient\n6. Patient has adequate bone marrow and organ function as defined by the following laboratory values:\n\n   1. Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L\n   2. Platelets ≥ 100 x 109/L (For patients with hematologic malignancies involving the bone marrow, platelet count > 75 x 109/L may be acceptable)\n   3. Hemoglobin ≥ 9.0 g/dL\n   4. INR ≤ 1.5\n   5. Potassium, magnesium and calcium (corrected for albumin), within normal limits for the institution, or ≤ Grade 1 severity according to NCI-CTCAE version 4.03 if judged clinically not significant by the investigator\n   6. Serum creatinine ≤ 1.5 x ULN and/or creatinine clearance > 50% LLN (Lower Limit of Normal)\n   7. Total serum bilirubin < ULN (or ≤ 1.5 x ULN if liver metastases are present; or total bilirubin ≤ 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert's Syndrome, (defined as presence of several episodes of unconjugated hyperbilirubinemia with normal CBC results including normal reticulocyte count and peripheral blood smear, normal liver function test results, and absence of other contributing disease processes at the time of diagnosis)\n   8. Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) ≤ 2.5 ULN (or < 5.0 x ULN if liver metastases are present)\n   9. Fasting plasma glucose (FPG) ≤ 140mg/dL or ≤ 7.7 mmol/L* or Glycosylated Hemoglobin (HbA1c)≤ 6.4% (both criteria have to be met).\n7. Patient is deemed by the Treating Physician to have the initiative and means to be compliant with the treatment plan (treatment and follow-up requested by the Treating Physician)\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Patient has history of hypersensitivity to any drugs or metabolites of PI3K inhibitor.\n2. Patient has not recovered to grade 1 or better (except alopecia) from side effects of any prior antineoplastic therapy\n3. Patient has had major surgery within 14 days prior to starting treatment with alpelisib or has not recovered from major side effects\n4. Patient is currently receiving high doses of systemic corticosteroids ≤ 2 weeks prior to starting treatment with alpelisib, or has not fully recovered from side effects of such treatment. (Note: low dose corticosteroids are permitted: single doses, topical applications, inhaled sprays, eye applications or local injections, stable low dose, for patients with CNS tumors, for at least 2 weeks prior to start of alpelisib treatment.)\n5. Patient with uncontrolled diabetes mellitus.\n6. Patient is being treated at start of treatment with alpelisib with any of the following drugs:\n\n   Drugs known to be strong inhibitors or inducers of isoenzyme CYP3A4 including herbal medications (list of prohibited CYP3A4 inhibitors and inducers provided in Table 13-2 in Appendix) Note: The patient must have discontinued strong inducers for at least one week and must have discontinued strong inhibitors before the treatment with alpelisib is initiated. Switching to a different medication prior to starting treatment with alpelisib is allowed.\n7. Patient is currently receiving warfarin or other coumarin derived anti-coagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed. Patients receiving therapies listed in Table 13-2 would not be allowed.\n8. Patients who have other concurrent severe and/or uncontrolled medical conditions that would, in the Treating Physician's judgment, contraindicate patient participation in the individual patient program (eg. active or uncontrolled severe infection, chronic active hepatitis, immuno-compromised, acute or chronic pancreatitis, uncontrolled high blood pressure, interstitial lung disease, etc.)\n9. Patient has a known history of Steven Johnson's syndrome or toxic epidermal necrolysis\n10. Patient with active HIV infection (testing not mandatory) infection\n11. Patient has any of the following cardiac abnormalities:\n\n    1. symptomatic congestive heart failure\n    2. history of documented congestive heart failure (New York Heart Association functional classification III-IV), documented cardiomyopathy\n    3. Left Ventricular Ejection Fraction (LVEF) <50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO)\n    4. myocardial infarction ≤ 6 months prior to enrolment\n    5. unstable angina pectoris\n    6. serious uncontrolled cardiac arrhythmia\n    7. symptomatic pericarditis\n12. Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of alpelisib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Patient can and will sign the Informed Consent (ICF) prior to eligibility evaluations being performed and is able to comply with treatment plan requirements",
                "criterions": [
                    {
                        "exact_snippets": "Patient can and will sign the Informed Consent (ICF)",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patient can and will sign the Informed Consent (ICF)",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "able to comply with treatment plan requirements",
                        "criterion": "compliance with treatment plan",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Patient can and will sign the Informed Consent (ICF)",
                                "criterion": "informed consent",
                                "requirement": {
                                    "requirement_type": "ability",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Patient can and will sign the Informed Consent (ICF)",
                                "criterion": "informed consent",
                                "requirement": {
                                    "requirement_type": "willingness",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "able to comply with treatment plan requirements",
                        "criterion": "compliance with treatment plan",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Patient is an adult and ≥ 18 years old at the time of informed consent",
                "criterions": [
                    {
                        "exact_snippets": "Patient is an adult",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "adult"
                        }
                    },
                    {
                        "exact_snippets": "≥ 18 years old",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patient is an adult",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "adult"
                        }
                    },
                    {
                        "exact_snippets": "≥ 18 years old",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Patient has locally advanced or metastatic HR+ breast cancer and no comparable or satisfactory alternative therapy is available",
                "criterions": [
                    {
                        "exact_snippets": "locally advanced or metastatic HR+ breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "locally advanced or metastatic HR+ breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "hormone receptor status",
                            "expected_value": "HR+"
                        }
                    },
                    {
                        "exact_snippets": "no comparable or satisfactory alternative therapy is available",
                        "criterion": "alternative therapy",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "locally advanced or metastatic HR+ breast cancer",
                                "criterion": "breast cancer",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": [
                                        "locally advanced",
                                        "metastatic"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "locally advanced or metastatic HR+ breast cancer",
                                "criterion": "breast cancer",
                                "requirement": {
                                    "requirement_type": "hormone receptor status",
                                    "expected_value": "HR+"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "no comparable or satisfactory alternative therapy is available",
                        "criterion": "alternative therapy",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. PIK3CA mutation in tumor tissue or ctDNA as determined by a local laboratory",
                "criterions": [
                    {
                        "exact_snippets": "PIK3CA mutation in tumor tissue",
                        "criterion": "PIK3CA mutation in tumor tissue",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "PIK3CA mutation in ... ctDNA",
                        "criterion": "PIK3CA mutation in ctDNA",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "PIK3CA mutation in tumor tissue",
                        "criterion": "PIK3CA mutation in tumor tissue",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "PIK3CA mutation in ... ctDNA",
                        "criterion": "PIK3CA mutation in ctDNA",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Patient is not:",
                "criterions": [
                    {
                        "exact_snippets": "Patient is not",
                        "criterion": "patient status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "not specified"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patient is not",
                        "criterion": "patient status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "not specified"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. eligible for participation in any ongoing clinical trials with alpelisib, or has recently completed a clinical trial with alpelisib that has been terminated",
                "criterions": [
                    {
                        "exact_snippets": "eligible for participation in any ongoing clinical trials with alpelisib",
                        "criterion": "participation in ongoing clinical trials with alpelisib",
                        "requirement": {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "has recently completed a clinical trial with alpelisib that has been terminated",
                        "criterion": "completion of a terminated clinical trial with alpelisib",
                        "requirement": {
                            "requirement_type": "recency",
                            "expected_value": "recently"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "eligible for participation in any ongoing clinical trials with alpelisib",
                        "criterion": "participation in ongoing clinical trials with alpelisib",
                        "requirement": {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "has recently completed a clinical trial with alpelisib that has been terminated",
                        "criterion": "completion of a terminated clinical trial with alpelisib",
                        "requirement": {
                            "requirement_type": "recency",
                            "expected_value": "recently"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. being transferred from or participating in an ongoing clinical trial, and after considering other options (e.g. trial extensions, amendments, etc.), treating physician has determined that treatment is necessary and there are no other feasible alternatives for the patient",
                "criterions": [
                    {
                        "exact_snippets": "being transferred from or participating in an ongoing clinical trial",
                        "criterion": "participation in an ongoing clinical trial",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "treating physician has determined that treatment is necessary",
                        "criterion": "treatment necessity",
                        "requirement": {
                            "requirement_type": "determination",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "there are no other feasible alternatives for the patient",
                        "criterion": "feasibility of alternatives",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
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                        "and_criteria": [
                            {
                                "exact_snippets": "being transferred from or participating in an ongoing clinical trial",
                                "criterion": "participation in an ongoing clinical trial",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "treating physician has determined that treatment is necessary",
                                "criterion": "treatment necessity",
                                "requirement": {
                                    "requirement_type": "determination",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "there are no other feasible alternatives for the patient",
                        "criterion": "feasibility of alternatives",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Patient has adequate bone marrow and organ function as defined by the following laboratory values:",
                "criterions": [
                    {
                        "exact_snippets": "adequate bone marrow",
                        "criterion": "bone marrow function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "adequate ... organ function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "adequate bone marrow",
                        "criterion": "bone marrow function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "adequate ... organ function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L",
                "criterions": [
                    {
                        "exact_snippets": "Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L",
                        "criterion": "Absolute Neutrophil Count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10^9/L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L",
                        "criterion": "Absolute Neutrophil Count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10^9/L"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Platelets ≥ 100 x 109/L (For patients with hematologic malignancies involving the bone marrow, platelet count > 75 x 109/L may be acceptable)",
                "criterions": [
                    {
                        "exact_snippets": "Platelets ≥ 100 x 109/L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "hematologic malignancies involving the bone marrow, platelet count > 75 x 109/L",
                        "criterion": "platelet count for patients with hematologic malignancies involving the bone marrow",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 75,
                                "unit": "x 10^9/L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "hematologic malignancies involving the bone marrow, platelet count > 75 x 109/L",
                    "criterion": "platelet count for patients with hematologic malignancies involving the bone marrow",
                    "requirement": {
                        "requirement_type": "quantity",
                        "expected_value": {
                            "operator": ">",
                            "value": 75,
                            "unit": "x 10^9/L"
                        }
                    }
                },
                "then_criteria": null,
                "else_criteria": {
                    "exact_snippets": "Platelets ≥ 100 x 109/L",
                    "criterion": "platelet count",
                    "requirement": {
                        "requirement_type": "quantity",
                        "expected_value": {
                            "operator": ">=",
                            "value": 100,
                            "unit": "x 10^9/L"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "3. Hemoglobin ≥ 9.0 g/dL",
                "criterions": [
                    {
                        "exact_snippets": "Hemoglobin ≥ 9.0 g/dL",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hemoglobin ≥ 9.0 g/dL",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. INR ≤ 1.5",
                "criterions": [
                    {
                        "exact_snippets": "INR ≤ 1.5",
                        "criterion": "INR",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "INR ≤ 1.5",
                        "criterion": "INR",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Potassium, magnesium and calcium (corrected for albumin), within normal limits for the institution, or ≤ Grade 1 severity according to NCI-CTCAE version 4.03 if judged clinically not significant by the investigator",
                "criterions": [
                    {
                        "exact_snippets": "Potassium, ... within normal limits for the institution, or ≤ Grade 1 severity according to NCI-CTCAE version 4.03 if judged clinically not significant by the investigator",
                        "criterion": "potassium level",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": "within normal limits for the institution"
                        }
                    },
                    {
                        "exact_snippets": "Potassium, ... within normal limits for the institution, or ≤ Grade 1 severity according to NCI-CTCAE version 4.03 if judged clinically not significant by the investigator",
                        "criterion": "potassium level",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade according to NCI-CTCAE version 4.03"
                            }
                        }
                    },
                    {
                        "exact_snippets": "magnesium ... within normal limits for the institution, or ≤ Grade 1 severity according to NCI-CTCAE version 4.03 if judged clinically not significant by the investigator",
                        "criterion": "magnesium level",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": "within normal limits for the institution"
                        }
                    },
                    {
                        "exact_snippets": "magnesium ... within normal limits for the institution, or ≤ Grade 1 severity according to NCI-CTCAE version 4.03 if judged clinically not significant by the investigator",
                        "criterion": "magnesium level",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade according to NCI-CTCAE version 4.03"
                            }
                        }
                    },
                    {
                        "exact_snippets": "calcium (corrected for albumin), within normal limits for the institution, or ≤ Grade 1 severity according to NCI-CTCAE version 4.03 if judged clinically not significant by the investigator",
                        "criterion": "calcium level (corrected for albumin)",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": "within normal limits for the institution"
                        }
                    },
                    {
                        "exact_snippets": "calcium (corrected for albumin), within normal limits for the institution, or ≤ Grade 1 severity according to NCI-CTCAE version 4.03 if judged clinically not significant by the investigator",
                        "criterion": "calcium level (corrected for albumin)",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade according to NCI-CTCAE version 4.03"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Potassium, ... within normal limits for the institution, or ≤ Grade 1 severity according to NCI-CTCAE version 4.03 if judged clinically not significant by the investigator",
                                        "criterion": "potassium level",
                                        "requirement": {
                                            "requirement_type": "range",
                                            "expected_value": "within normal limits for the institution"
                                        }
                                    },
                                    {
                                        "exact_snippets": "magnesium ... within normal limits for the institution, or ≤ Grade 1 severity according to NCI-CTCAE version 4.03 if judged clinically not significant by the investigator",
                                        "criterion": "magnesium level",
                                        "requirement": {
                                            "requirement_type": "range",
                                            "expected_value": "within normal limits for the institution"
                                        }
                                    },
                                    {
                                        "exact_snippets": "calcium (corrected for albumin), within normal limits for the institution, or ≤ Grade 1 severity according to NCI-CTCAE version 4.03 if judged clinically not significant by the investigator",
                                        "criterion": "calcium level (corrected for albumin)",
                                        "requirement": {
                                            "requirement_type": "range",
                                            "expected_value": "within normal limits for the institution"
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Potassium, ... within normal limits for the institution, or ≤ Grade 1 severity according to NCI-CTCAE version 4.03 if judged clinically not significant by the investigator",
                                        "criterion": "potassium level",
                                        "requirement": {
                                            "requirement_type": "severity",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 1,
                                                "unit": "Grade according to NCI-CTCAE version 4.03"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "magnesium ... within normal limits for the institution, or ≤ Grade 1 severity according to NCI-CTCAE version 4.03 if judged clinically not significant by the investigator",
                                        "criterion": "magnesium level",
                                        "requirement": {
                                            "requirement_type": "severity",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 1,
                                                "unit": "Grade according to NCI-CTCAE version 4.03"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "calcium (corrected for albumin), within normal limits for the institution, or ≤ Grade 1 severity according to NCI-CTCAE version 4.03 if judged clinically not significant by the investigator",
                                        "criterion": "calcium level (corrected for albumin)",
                                        "requirement": {
                                            "requirement_type": "severity",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 1,
                                                "unit": "Grade according to NCI-CTCAE version 4.03"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Total serum bilirubin < ULN (or ≤ 1.5 x ULN if liver metastases are present; or total bilirubin ≤ 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert's Syndrome, (defined as presence of several episodes of unconjugated hyperbilirubinemia with normal CBC results including normal reticulocyte count and peripheral blood smear, normal liver function test results, and absence of other contributing disease processes at the time of diagnosis)",
                "criterions": [
                    {
                        "exact_snippets": "Total serum bilirubin < ULN",
                        "criterion": "total serum bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "≤ 1.5 x ULN if liver metastases are present",
                        "criterion": "total serum bilirubin with liver metastases",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "total bilirubin ≤ 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert's Syndrome",
                        "criterion": "total bilirubin with Gilbert's Syndrome",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3.0,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "direct bilirubin within normal range in patients with well documented Gilbert's Syndrome",
                        "criterion": "direct bilirubin with Gilbert's Syndrome",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": "within normal range"
                        }
                    },
                    {
                        "exact_snippets": "well documented Gilbert's Syndrome, (defined as presence of several episodes of unconjugated hyperbilirubinemia with normal CBC results including normal reticulocyte count and peripheral blood smear, normal liver function test results, and absence of other contributing disease processes at the time of diagnosis)",
                        "criterion": "Gilbert's Syndrome",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": "well documented"
                        }
                    },
                    {
                        "exact_snippets": "well documented Gilbert's Syndrome, (defined as presence of several episodes of unconjugated hyperbilirubinemia with normal CBC results including normal reticulocyte count and peripheral blood smear, normal liver function test results, and absence of other contributing disease processes at the time of diagnosis)",
                        "criterion": "Gilbert's Syndrome",
                        "requirement": {
                            "requirement_type": "episodes",
                            "expected_value": "several episodes of unconjugated hyperbilirubinemia"
                        }
                    },
                    {
                        "exact_snippets": "well documented Gilbert's Syndrome, (defined as presence of several episodes of unconjugated hyperbilirubinemia with normal CBC results including normal reticulocyte count and peripheral blood smear, normal liver function test results, and absence of other contributing disease processes at the time of diagnosis)",
                        "criterion": "Gilbert's Syndrome",
                        "requirement": {
                            "requirement_type": "CBC results",
                            "expected_value": "normal"
                        }
                    },
                    {
                        "exact_snippets": "well documented Gilbert's Syndrome, (defined as presence of several episodes of unconjugated hyperbilirubinemia with normal CBC results including normal reticulocyte count and peripheral blood smear, normal liver function test results, and absence of other contributing disease processes at the time of diagnosis)",
                        "criterion": "Gilbert's Syndrome",
                        "requirement": {
                            "requirement_type": "reticulocyte count",
                            "expected_value": "normal"
                        }
                    },
                    {
                        "exact_snippets": "well documented Gilbert's Syndrome, (defined as presence of several episodes of unconjugated hyperbilirubinemia with normal CBC results including normal reticulocyte count and peripheral blood smear, normal liver function test results, and absence of other contributing disease processes at the time of diagnosis)",
                        "criterion": "Gilbert's Syndrome",
                        "requirement": {
                            "requirement_type": "peripheral blood smear",
                            "expected_value": "normal"
                        }
                    },
                    {
                        "exact_snippets": "well documented Gilbert's Syndrome, (defined as presence of several episodes of unconjugated hyperbilirubinemia with normal CBC results including normal reticulocyte count and peripheral blood smear, normal liver function test results, and absence of other contributing disease processes at the time of diagnosis)",
                        "criterion": "Gilbert's Syndrome",
                        "requirement": {
                            "requirement_type": "liver function test results",
                            "expected_value": "normal"
                        }
                    },
                    {
                        "exact_snippets": "well documented Gilbert's Syndrome, (defined as presence of several episodes of unconjugated hyperbilirubinemia with normal CBC results including normal reticulocyte count and peripheral blood smear, normal liver function test results, and absence of other contributing disease processes at the time of diagnosis)",
                        "criterion": "Gilbert's Syndrome",
                        "requirement": {
                            "requirement_type": "absence of other contributing disease processes",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Total serum bilirubin < ULN",
                                "criterion": "total serum bilirubin",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 1,
                                        "unit": "ULN"
                                    }
                                }
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "≤ 1.5 x ULN if liver metastases are present",
                                        "criterion": "total serum bilirubin with liver metastases",
                                        "requirement": {
                                            "requirement_type": "level",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 1.5,
                                                "unit": "ULN"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "well documented Gilbert's Syndrome, (defined as presence of several episodes of unconjugated hyperbilirubinemia with normal CBC results including normal reticulocyte count and peripheral blood smear, normal liver function test results, and absence of other contributing disease processes at the time of diagnosis)",
                                        "criterion": "Gilbert's Syndrome",
                                        "requirement": {
                                            "requirement_type": "documentation",
                                            "expected_value": "well documented"
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "total bilirubin ≤ 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert's Syndrome",
                                        "criterion": "total bilirubin with Gilbert's Syndrome",
                                        "requirement": {
                                            "requirement_type": "level",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 3.0,
                                                "unit": "ULN"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "direct bilirubin within normal range in patients with well documented Gilbert's Syndrome",
                                        "criterion": "direct bilirubin with Gilbert's Syndrome",
                                        "requirement": {
                                            "requirement_type": "level",
                                            "expected_value": "within normal range"
                                        }
                                    },
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "well documented Gilbert's Syndrome, (defined as presence of several episodes of unconjugated hyperbilirubinemia with normal CBC results including normal reticulocyte count and peripheral blood smear, normal liver function test results, and absence of other contributing disease processes at the time of diagnosis)",
                                                "criterion": "Gilbert's Syndrome",
                                                "requirement": {
                                                    "requirement_type": "documentation",
                                                    "expected_value": "well documented"
                                                }
                                            },
                                            {
                                                "exact_snippets": "well documented Gilbert's Syndrome, (defined as presence of several episodes of unconjugated hyperbilirubinemia with normal CBC results including normal reticulocyte count and peripheral blood smear, normal liver function test results, and absence of other contributing disease processes at the time of diagnosis)",
                                                "criterion": "Gilbert's Syndrome",
                                                "requirement": {
                                                    "requirement_type": "episodes",
                                                    "expected_value": "several episodes of unconjugated hyperbilirubinemia"
                                                }
                                            },
                                            {
                                                "exact_snippets": "well documented Gilbert's Syndrome, (defined as presence of several episodes of unconjugated hyperbilirubinemia with normal CBC results including normal reticulocyte count and peripheral blood smear, normal liver function test results, and absence of other contributing disease processes at the time of diagnosis)",
                                                "criterion": "Gilbert's Syndrome",
                                                "requirement": {
                                                    "requirement_type": "CBC results",
                                                    "expected_value": "normal"
                                                }
                                            },
                                            {
                                                "exact_snippets": "well documented Gilbert's Syndrome, (defined as presence of several episodes of unconjugated hyperbilirubinemia with normal CBC results including normal reticulocyte count and peripheral blood smear, normal liver function test results, and absence of other contributing disease processes at the time of diagnosis)",
                                                "criterion": "Gilbert's Syndrome",
                                                "requirement": {
                                                    "requirement_type": "reticulocyte count",
                                                    "expected_value": "normal"
                                                }
                                            },
                                            {
                                                "exact_snippets": "well documented Gilbert's Syndrome, (defined as presence of several episodes of unconjugated hyperbilirubinemia with normal CBC results including normal reticulocyte count and peripheral blood smear, normal liver function test results, and absence of other contributing disease processes at the time of diagnosis)",
                                                "criterion": "Gilbert's Syndrome",
                                                "requirement": {
                                                    "requirement_type": "peripheral blood smear",
                                                    "expected_value": "normal"
                                                }
                                            },
                                            {
                                                "exact_snippets": "well documented Gilbert's Syndrome, (defined as presence of several episodes of unconjugated hyperbilirubinemia with normal CBC results including normal reticulocyte count and peripheral blood smear, normal liver function test results, and absence of other contributing disease processes at the time of diagnosis)",
                                                "criterion": "Gilbert's Syndrome",
                                                "requirement": {
                                                    "requirement_type": "liver function test results",
                                                    "expected_value": "normal"
                                                }
                                            },
                                            {
                                                "exact_snippets": "well documented Gilbert's Syndrome, (defined as presence of several episodes of unconjugated hyperbilirubinemia with normal CBC results including normal reticulocyte count and peripheral blood smear, normal liver function test results, and absence of other contributing disease processes at the time of diagnosis)",
                                                "criterion": "Gilbert's Syndrome",
                                                "requirement": {
                                                    "requirement_type": "absence of other contributing disease processes",
                                                    "expected_value": true
                                                }
                                            }
                                        ]
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) ≤ 2.5 ULN (or < 5.0 x ULN if liver metastases are present)",
                "criterions": [
                    {
                        "exact_snippets": "Alanine aminotransferase (AST) ... ≤ 2.5 ULN (or < 5.0 x ULN if liver metastases are present)",
                        "criterion": "Alanine aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Alanine aminotransferase (AST) ... ≤ 2.5 ULN (or < 5.0 x ULN if liver metastases are present)",
                        "criterion": "Alanine aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "level with liver metastases",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 5.0,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "aspartate aminotransferase (ALT) ... ≤ 2.5 ULN (or < 5.0 x ULN if liver metastases are present)",
                        "criterion": "aspartate aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "aspartate aminotransferase (ALT) ... ≤ 2.5 ULN (or < 5.0 x ULN if liver metastases are present)",
                        "criterion": "aspartate aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level with liver metastases",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 5.0,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Alanine aminotransferase (AST) ... ≤ 2.5 ULN (or < 5.0 x ULN if liver metastases are present)",
                                        "criterion": "Alanine aminotransferase (AST)",
                                        "requirement": {
                                            "requirement_type": "level",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": "<=",
                                                        "value": 2.5,
                                                        "unit": "ULN"
                                                    }
                                                ]
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "aspartate aminotransferase (ALT) ... ≤ 2.5 ULN (or < 5.0 x ULN if liver metastases are present)",
                                        "criterion": "aspartate aminotransferase (ALT)",
                                        "requirement": {
                                            "requirement_type": "level",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": "<=",
                                                        "value": 2.5,
                                                        "unit": "ULN"
                                                    }
                                                ]
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Alanine aminotransferase (AST) ... ≤ 2.5 ULN (or < 5.0 x ULN if liver metastases are present)",
                                        "criterion": "Alanine aminotransferase (AST)",
                                        "requirement": {
                                            "requirement_type": "level with liver metastases",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": "<",
                                                        "value": 5.0,
                                                        "unit": "ULN"
                                                    }
                                                ]
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "aspartate aminotransferase (ALT) ... ≤ 2.5 ULN (or < 5.0 x ULN if liver metastases are present)",
                                        "criterion": "aspartate aminotransferase (ALT)",
                                        "requirement": {
                                            "requirement_type": "level with liver metastases",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": "<",
                                                        "value": 5.0,
                                                        "unit": "ULN"
                                                    }
                                                ]
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Patient is deemed by the Treating Physician to have the initiative and means to be compliant with the treatment plan (treatment and follow-up requested by the Treating Physician)",
                "criterions": [
                    {
                        "exact_snippets": "Patient is deemed by the Treating Physician to have the initiative and means to be compliant with the treatment plan",
                        "criterion": "compliance with treatment plan",
                        "requirement": {
                            "requirement_type": "assessment",
                            "expected_value": "deemed by the Treating Physician"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patient is deemed by the Treating Physician to have the initiative and means to be compliant with the treatment plan",
                        "criterion": "compliance with treatment plan",
                        "requirement": {
                            "requirement_type": "assessment",
                            "expected_value": "deemed by the Treating Physician"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "1. Patient has history of hypersensitivity to any drugs or metabolites of PI3K inhibitor.",
                "criterions": [
                    {
                        "exact_snippets": "history of hypersensitivity to any drugs",
                        "criterion": "hypersensitivity to drugs",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "hypersensitivity to any ... metabolites of PI3K inhibitor",
                        "criterion": "hypersensitivity to PI3K inhibitor metabolites",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "history of hypersensitivity to any drugs",
                        "criterion": "hypersensitivity to drugs",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "hypersensitivity to any ... metabolites of PI3K inhibitor",
                        "criterion": "hypersensitivity to PI3K inhibitor metabolites",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Patient has not recovered to grade 1 or better (except alopecia) from side effects of any prior antineoplastic therapy",
                "criterions": [
                    {
                        "exact_snippets": "Patient has not recovered to grade 1 or better ... from side effects of any prior antineoplastic therapy",
                        "criterion": "recovery from side effects of prior antineoplastic therapy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "except alopecia",
                        "criterion": "alopecia",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Patient has not recovered to grade 1 or better ... from side effects of any prior antineoplastic therapy",
                                    "criterion": "recovery from side effects of prior antineoplastic therapy",
                                    "requirement": {
                                        "requirement_type": "severity",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 1,
                                            "unit": "grade"
                                        }
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "except alopecia",
                                        "criterion": "alopecia",
                                        "requirement": {
                                            "requirement_type": "exclusion",
                                            "expected_value": true
                                        }
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Patient has had major surgery within 14 days prior to starting treatment with alpelisib or has not recovered from major side effects",
                "criterions": [
                    {
                        "exact_snippets": "Patient has had major surgery within 14 days prior to starting treatment with alpelisib",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "has not recovered from major side effects",
                        "criterion": "recovery from major side effects",
                        "requirement": {
                            "requirement_type": "recovery status",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Patient has had major surgery within 14 days prior to starting treatment with alpelisib",
                                "criterion": "major surgery",
                                "requirement": {
                                    "requirement_type": "time since surgery",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 14,
                                        "unit": "days"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "has not recovered from major side effects",
                                "criterion": "recovery from major side effects",
                                "requirement": {
                                    "requirement_type": "recovery status",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Patient with uncontrolled diabetes mellitus.",
                "criterions": [
                    {
                        "exact_snippets": "uncontrolled diabetes mellitus",
                        "criterion": "diabetes mellitus",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "uncontrolled diabetes mellitus",
                    "criterion": "diabetes mellitus",
                    "requirement": {
                        "requirement_type": "control status",
                        "expected_value": "uncontrolled"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "6. Patient is being treated at start of treatment with alpelisib with any of the following drugs:",
                "criterions": [
                    {
                        "exact_snippets": "Patient is being treated at start of treatment with alpelisib",
                        "criterion": "treatment with alpelisib",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "any of the following drugs",
                        "criterion": "treatment with any of the following drugs",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Patient is being treated at start of treatment with alpelisib",
                    "criterion": "treatment with alpelisib",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "exact_snippets": "any of the following drugs",
                    "criterion": "treatment with any of the following drugs",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "Drugs known to be strong inhibitors or inducers of isoenzyme CYP3A4 including herbal medications (list of prohibited CYP3A4 inhibitors and inducers provided in Table 13-2 in Appendix) Note: The patient must have discontinued strong inducers for at least one week and must have discontinued strong inhibitors before the treatment with alpelisib is initiated. Switching to a different medication prior to starting treatment with alpelisib is allowed.",
                "criterions": [
                    {
                        "exact_snippets": "Drugs known to be strong inhibitors or inducers of isoenzyme CYP3A4 including herbal medications",
                        "criterion": "use of strong inhibitors or inducers of isoenzyme CYP3A4",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "The patient must have discontinued strong inducers for at least one week",
                        "criterion": "discontinuation of strong inducers",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    },
                    {
                        "exact_snippets": "must have discontinued strong inhibitors before the treatment with alpelisib is initiated",
                        "criterion": "discontinuation of strong inhibitors",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "before treatment with alpelisib"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "Drugs known to be strong inhibitors or inducers of isoenzyme CYP3A4 including herbal medications",
                            "criterion": "use of strong inhibitors or inducers of isoenzyme CYP3A4",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "The patient must have discontinued strong inducers for at least one week",
                                "criterion": "discontinuation of strong inducers",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "week"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "must have discontinued strong inhibitors before the treatment with alpelisib is initiated",
                                "criterion": "discontinuation of strong inhibitors",
                                "requirement": {
                                    "requirement_type": "timing",
                                    "expected_value": "before treatment with alpelisib"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Patient is currently receiving warfarin or other coumarin derived anti-coagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed. Patients receiving therapies listed in Table 13-2 would not be allowed.",
                "criterions": [
                    {
                        "exact_snippets": "Patient is currently receiving warfarin or other coumarin derived anti-coagulant",
                        "criterion": "current anti-coagulant therapy",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "warfarin",
                                "coumarin derived anti-coagulant"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed",
                        "criterion": "allowed anti-coagulant therapy",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "heparin",
                                "low molecular weight heparin (LMWH)",
                                "fondaparinux"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Patients receiving therapies listed in Table 13-2 would not be allowed",
                        "criterion": "prohibited therapies",
                        "requirement": {
                            "requirement_type": "reference",
                            "expected_value": "Table 13-2"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "or_criteria": [
                                {
                                    "exact_snippets": "Patient is currently receiving warfarin or other coumarin derived anti-coagulant",
                                    "criterion": "current anti-coagulant therapy",
                                    "requirement": {
                                        "requirement_type": "type",
                                        "expected_value": [
                                            "warfarin",
                                            "coumarin derived anti-coagulant"
                                        ]
                                    }
                                },
                                {
                                    "exact_snippets": "Patients receiving therapies listed in Table 13-2 would not be allowed",
                                    "criterion": "prohibited therapies",
                                    "requirement": {
                                        "requirement_type": "reference",
                                        "expected_value": "Table 13-2"
                                    }
                                }
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed",
                        "criterion": "allowed anti-coagulant therapy",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "heparin",
                                "low molecular weight heparin (LMWH)",
                                "fondaparinux"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Patients who have other concurrent severe and/or uncontrolled medical conditions that would, in the Treating Physician's judgment, contraindicate patient participation in the individual patient program (eg. active or uncontrolled severe infection, chronic active hepatitis, immuno-compromised, acute or chronic pancreatitis, uncontrolled high blood pressure, interstitial lung disease, etc.)",
                "criterions": [
                    {
                        "exact_snippets": "other concurrent severe and/or uncontrolled medical conditions",
                        "criterion": "concurrent medical conditions",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "other concurrent severe and/or uncontrolled medical conditions",
                        "criterion": "concurrent medical conditions",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    },
                    {
                        "exact_snippets": "active or uncontrolled severe infection",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "active or uncontrolled severe infection",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    },
                    {
                        "exact_snippets": "active or uncontrolled severe infection",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "chronic active hepatitis",
                        "criterion": "hepatitis",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "chronic active hepatitis",
                        "criterion": "hepatitis",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "chronic"
                        }
                    },
                    {
                        "exact_snippets": "immuno-compromised",
                        "criterion": "immune system",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "compromised"
                        }
                    },
                    {
                        "exact_snippets": "acute or chronic pancreatitis",
                        "criterion": "pancreatitis",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": [
                                "acute",
                                "chronic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled high blood pressure",
                        "criterion": "blood pressure",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled high blood pressure",
                        "criterion": "blood pressure",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": "high"
                        }
                    },
                    {
                        "exact_snippets": "interstitial lung disease",
                        "criterion": "interstitial lung disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
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                    {
                        "and_criteria": [
                            {
                                "or_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "other concurrent severe and/or uncontrolled medical conditions",
                                                "criterion": "concurrent medical conditions",
                                                "requirement": {
                                                    "requirement_type": "severity",
                                                    "expected_value": "severe"
                                                }
                                            },
                                            {
                                                "exact_snippets": "other concurrent severe and/or uncontrolled medical conditions",
                                                "criterion": "concurrent medical conditions",
                                                "requirement": {
                                                    "requirement_type": "control",
                                                    "expected_value": "uncontrolled"
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "active or uncontrolled severe infection",
                                                "criterion": "infection",
                                                "requirement": {
                                                    "requirement_type": "activity",
                                                    "expected_value": "active"
                                                }
                                            },
                                            {
                                                "exact_snippets": "active or uncontrolled severe infection",
                                                "criterion": "infection",
                                                "requirement": {
                                                    "requirement_type": "control",
                                                    "expected_value": "uncontrolled"
                                                }
                                            },
                                            {
                                                "exact_snippets": "active or uncontrolled severe infection",
                                                "criterion": "infection",
                                                "requirement": {
                                                    "requirement_type": "severity",
                                                    "expected_value": "severe"
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "chronic active hepatitis",
                                                "criterion": "hepatitis",
                                                "requirement": {
                                                    "requirement_type": "activity",
                                                    "expected_value": "active"
                                                }
                                            },
                                            {
                                                "exact_snippets": "chronic active hepatitis",
                                                "criterion": "hepatitis",
                                                "requirement": {
                                                    "requirement_type": "duration",
                                                    "expected_value": "chronic"
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "immuno-compromised",
                                        "criterion": "immune system",
                                        "requirement": {
                                            "requirement_type": "status",
                                            "expected_value": "compromised"
                                        }
                                    },
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "acute or chronic pancreatitis",
                                                "criterion": "pancreatitis",
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                                                    "requirement_type": "duration",
                                                    "expected_value": [
                                                        "acute",
                                                        "chronic"
                                                    ]
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "uncontrolled high blood pressure",
                                                "criterion": "blood pressure",
                                                "requirement": {
                                                    "requirement_type": "control",
                                                    "expected_value": "uncontrolled"
                                                }
                                            },
                                            {
                                                "exact_snippets": "uncontrolled high blood pressure",
                                                "criterion": "blood pressure",
                                                "requirement": {
                                                    "requirement_type": "level",
                                                    "expected_value": "high"
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "interstitial lung disease",
                                        "criterion": "interstitial lung disease",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "in the Treating Physician's judgment, contraindicate patient participation in the individual patient program",
                        "criterion": "Treating Physician's judgment",
                        "requirement": {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. Patient has a known history of Steven Johnson's syndrome or toxic epidermal necrolysis",
                "criterions": [
                    {
                        "exact_snippets": "known history of Steven Johnson's syndrome",
                        "criterion": "Steven Johnson's syndrome",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "known history of ... toxic epidermal necrolysis",
                        "criterion": "toxic epidermal necrolysis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "known history of Steven Johnson's syndrome",
                        "criterion": "Steven Johnson's syndrome",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "known history of ... toxic epidermal necrolysis",
                        "criterion": "toxic epidermal necrolysis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "10. Patient with active HIV infection (testing not mandatory) infection",
                "criterions": [
                    {
                        "exact_snippets": "Patient with active HIV infection",
                        "criterion": "HIV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "testing not mandatory",
                        "criterion": "HIV infection testing",
                        "requirement": {
                            "requirement_type": "mandatory",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patient with active HIV infection",
                        "criterion": "HIV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "testing not mandatory",
                        "criterion": "HIV infection testing",
                        "requirement": {
                            "requirement_type": "mandatory",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "11. Patient has any of the following cardiac abnormalities:",
                "criterions": [
                    {
                        "exact_snippets": "any of the following cardiac abnormalities",
                        "criterion": "cardiac abnormalities",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "any of the following cardiac abnormalities",
                        "criterion": "cardiac abnormalities",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. symptomatic congestive heart failure",
                "criterions": [
                    {
                        "exact_snippets": "symptomatic congestive heart failure",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "symptomatic congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirement": {
                        "requirement_type": "symptomatic",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "2. history of documented congestive heart failure (New York Heart Association functional classification III-IV), documented cardiomyopathy",
                "criterions": [
                    {
                        "exact_snippets": "history of documented congestive heart failure (New York Heart Association functional classification III-IV)",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "history of documented congestive heart failure (New York Heart Association functional classification III-IV)",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "classification",
                            "expected_value": [
                                "New York Heart Association functional classification III",
                                "New York Heart Association functional classification IV"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "documented cardiomyopathy",
                        "criterion": "cardiomyopathy",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "history of documented congestive heart failure (New York Heart Association functional classification III-IV)",
                                "criterion": "congestive heart failure",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "history of documented congestive heart failure (New York Heart Association functional classification III-IV)",
                                "criterion": "congestive heart failure",
                                "requirement": {
                                    "requirement_type": "classification",
                                    "expected_value": [
                                        "New York Heart Association functional classification III",
                                        "New York Heart Association functional classification IV"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "documented cardiomyopathy",
                        "criterion": "cardiomyopathy",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Left Ventricular Ejection Fraction (LVEF) <50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO)",
                "criterions": [
                    {
                        "exact_snippets": "Left Ventricular Ejection Fraction (LVEF) <50%",
                        "criterion": "Left Ventricular Ejection Fraction (LVEF)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "as determined by Multiple Gated acquisition (MUGA) scan",
                        "criterion": "Multiple Gated acquisition (MUGA) scan",
                        "requirement": {
                            "requirement_type": "determination",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "as determined by ... echocardiogram (ECHO)",
                        "criterion": "echocardiogram (ECHO)",
                        "requirement": {
                            "requirement_type": "determination",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Left Ventricular Ejection Fraction (LVEF) <50%",
                                "criterion": "Left Ventricular Ejection Fraction (LVEF)",
                                "requirement": {
                                    "requirement_type": "value",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 50,
                                        "unit": "%"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "as determined by Multiple Gated acquisition (MUGA) scan",
                                "criterion": "Multiple Gated acquisition (MUGA) scan",
                                "requirement": {
                                    "requirement_type": "determination",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Left Ventricular Ejection Fraction (LVEF) <50%",
                                "criterion": "Left Ventricular Ejection Fraction (LVEF)",
                                "requirement": {
                                    "requirement_type": "value",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 50,
                                        "unit": "%"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "as determined by ... echocardiogram (ECHO)",
                                "criterion": "echocardiogram (ECHO)",
                                "requirement": {
                                    "requirement_type": "determination",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. unstable angina pectoris",
                "criterions": [
                    {
                        "exact_snippets": "unstable angina pectoris",
                        "criterion": "unstable angina pectoris",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
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                        "requirement_type": "presence",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "6. serious uncontrolled cardiac arrhythmia",
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                    {
                        "exact_snippets": "serious uncontrolled cardiac arrhythmia",
                        "criterion": "cardiac arrhythmia",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    },
                    {
                        "exact_snippets": "serious uncontrolled cardiac arrhythmia",
                        "criterion": "cardiac arrhythmia",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "serious uncontrolled cardiac arrhythmia",
                        "criterion": "cardiac arrhythmia",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    },
                    {
                        "exact_snippets": "serious uncontrolled cardiac arrhythmia",
                        "criterion": "cardiac arrhythmia",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. symptomatic pericarditis",
                "criterions": [
                    {
                        "exact_snippets": "symptomatic pericarditis",
                        "criterion": "pericarditis",
                        "requirement": {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
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                    "exact_snippets": "symptomatic pericarditis",
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                        "requirement_type": "symptomatic",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "12. Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of alpelisib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)",
                "criterions": [
                    {
                        "exact_snippets": "impairment of gastrointestinal (GI) function or GI disease",
                        "criterion": "gastrointestinal function or disease",
                        "requirement": {
                            "requirement_type": "impairment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "may significantly alter the absorption of alpelisib",
                        "criterion": "absorption of alpelisib",
                        "requirement": {
                            "requirement_type": "alteration",
                            "expected_value": "significant"
                        }
                    },
                    {
                        "exact_snippets": "ulcerative diseases",
                        "criterion": "ulcerative diseases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled nausea",
                        "criterion": "nausea",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "vomiting",
                        "criterion": "vomiting",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "diarrhea",
                        "criterion": "diarrhea",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "malabsorption syndrome",
                        "criterion": "malabsorption syndrome",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "small bowel resection",
                        "criterion": "small bowel resection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "impairment of gastrointestinal (GI) function or GI disease",
                                "criterion": "gastrointestinal function or disease",
                                "requirement": {
                                    "requirement_type": "impairment",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "may significantly alter the absorption of alpelisib",
                                "criterion": "absorption of alpelisib",
                                "requirement": {
                                    "requirement_type": "alteration",
                                    "expected_value": "significant"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "ulcerative diseases",
                        "criterion": "ulcerative diseases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled nausea",
                        "criterion": "nausea",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "vomiting",
                        "criterion": "vomiting",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "diarrhea",
                        "criterion": "diarrhea",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "malabsorption syndrome",
                        "criterion": "malabsorption syndrome",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "small bowel resection",
                        "criterion": "small bowel resection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "6. Serum creatinine ≤ 1.5 x ULN and/or creatinine clearance > 50% LLN (Lower Limit of Normal)",
                "criterions": [
                    {
                        "exact_snippets": "Serum creatinine ≤ 1.5 x ULN",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "creatinine clearance > 50% LLN (Lower Limit of Normal)",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "% LLN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Serum creatinine \u0010.5 x ULN",
                                "criterion": "serum creatinine",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "x ULN"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "creatinine clearance > 50% LLN (Lower Limit of Normal)",
                                "criterion": "creatinine clearance",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 50,
                                        "unit": "% LLN"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. Fasting plasma glucose (FPG) ≤ 140mg/dL or ≤ 7.7 mmol/L* or Glycosylated Hemoglobin (HbA1c)≤ 6.4% (both criteria have to be met).",
                "criterions": [
                    {
                        "exact_snippets": "Fasting plasma glucose (FPG) ≤ 140mg/dL or ≤ 7.7 mmol/L",
                        "criterion": "fasting plasma glucose",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 140,
                                        "unit": "mg/dL"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 7.7,
                                        "unit": "mmol/L"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Glycosylated Hemoglobin (HbA1c)≤ 6.4%",
                        "criterion": "glycosylated hemoglobin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6.4,
                                "unit": "%"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Fasting plasma glucose (FPG) \u00104 140mg/dL or \u00104 7.7 mmol/L",
                                "criterion": "fasting plasma glucose",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 140,
                                                "unit": "mg/dL"
                                            },
                                            {
                                                "operator": "<=",
                                                "value": 7.7,
                                                "unit": "mmol/L"
                                            }
                                        ]
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Fasting plasma glucose (FPG) \u00104 140mg/dL or \u00104 7.7 mmol/L",
                                "criterion": "fasting plasma glucose",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 140,
                                                "unit": "mg/dL"
                                            },
                                            {
                                                "operator": "<=",
                                                "value": 7.7,
                                                "unit": "mmol/L"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Glycosylated Hemoglobin (HbA1c)\u00104 6.4%",
                        "criterion": "glycosylated hemoglobin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6.4,
                                "unit": "%"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "4. Patient is currently receiving high doses of systemic corticosteroids ≤ 2 weeks prior to starting treatment with alpelisib, or has not fully recovered from side effects of such treatment. (Note: low dose corticosteroids are permitted: single doses, topical applications, inhaled sprays, eye applications or local injections, stable low dose, for patients with CNS tumors, for at least 2 weeks prior to start of alpelisib treatment.)",
                "criterions": [
                    {
                        "exact_snippets": "Patient is currently receiving high doses of systemic corticosteroids ≤ 2 weeks prior to starting treatment with alpelisib",
                        "criterion": "systemic corticosteroid use",
                        "requirement": {
                            "requirement_type": "dose",
                            "expected_value": "high"
                        }
                    },
                    {
                        "exact_snippets": "Patient is currently receiving high doses of systemic corticosteroids ≤ 2 weeks prior to starting treatment with alpelisib",
                        "criterion": "systemic corticosteroid use",
                        "requirement": {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "has not fully recovered from side effects of such treatment",
                        "criterion": "recovery from corticosteroid side effects",
                        "requirement": {
                            "requirement_type": "recovery status",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Patient is currently receiving high doses of systemic corticosteroids \u0010 2 weeks prior to starting treatment with alpelisib",
                                        "criterion": "systemic corticosteroid use",
                                        "requirement": {
                                            "requirement_type": "dose",
                                            "expected_value": "high"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Patient is currently receiving high doses of systemic corticosteroids \u0010 2 weeks prior to starting treatment with alpelisib",
                                        "criterion": "systemic corticosteroid use",
                                        "requirement": {
                                            "requirement_type": "time since last dose",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 2,
                                                "unit": "weeks"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "has not fully recovered from side effects of such treatment",
                        "criterion": "recovery from corticosteroid side effects",
                        "requirement": {
                            "requirement_type": "recovery status",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. myocardial infarction ≤ 6 months prior to enrolment",
                "criterions": [
                    {
                        "exact_snippets": "myocardial infarction ≤ 6 months prior to enrolment",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "myocardial infarction \u0010 6 months prior to enrolment",
                    "criterion": "myocardial infarction",
                    "requirement": {
                        "requirement_type": "time since event",
                        "expected_value": {
                            "operator": "<=",
                            "value": 6,
                            "unit": "months"
                        }
                    }
                }
            }
        }
    ],
    "failed_miscellaneous": []
}