{
    "info": {
        "nct_id": "NCT02698891",
        "official_title": "Feasibility and Safety of Avoiding Granulocyte Colony-stimulating Factor Prophylaxis During the Paclitaxel Portion of Dose Dense Doxorubicin-Cyclophosphamide and Paclitaxel Regimen",
        "inclusion_criteria": "* Patients must have histologically or cytologically confirmed Stage I-III breast cancer (as defined by the revised, American Joint Committee on Cancer 7th edition criteria) and be at sufficient risk for tumor recurrence. Staging studies to exclude metastatic disease are not required in asymptomatic patients. However, patients with findings considered suspicious for metastatic disease on any staging studies that are obtained need to be evaluated to exclude stage IV breast cancer.\n* Patients must be deemed by their treating oncologist as candidates for (neo) adjuvant chemotherapy with dose dense AC and T.\n* Age ≥ 18 years and < 65 at the time of informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1.\n* Any grade 3 or clinically significant grade 2 treatment-related non-hematological toxicity must be resolved to grade 1 before retreatment with chemotherapy (with exception of alopecia)\n* Laboratory Evaluations:\n\n  * Adequate blood marrow function defined as:\n\n    * Absolute neutrophil count (ANC) ≥1500 µL\n    * Hemoglobin ≥9.0 g/dl\n    * Platelets ≥100,000/mm3\n  * Adequate hepatic function defined as:\n\n    * Total bilirubin ≤ 1.2 institutional upper limit of normal (ULN)\n    * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase ≤ 1.5 X upper limit normal (ULN)\n  * Adequate renal function defined as:\n\n    --- Serum creatinine ≤ 1.5 X ULN\n  * Premenopausal women (including women who have had a tubal ligation and for women less than 12 months after the onset of menopause) must have a negative serum pregnancy test.\n* Patients with risk factors for Hepatitis B or C should be tested (anti-hepatitis C virus (HCV) antibody, hepatitis B surface antigen [HBsAg] or Hepatitis B core antibody). Risk factors include: history of unprotected sexual intercourse, intravenous drug use, or originally from endemic regions. If infection is suspected, hepatitis B virus (HBV) DNA and HCV RNA should be requested as appropriate.\n* Note: Patients with positive Hepatitis B or C serologies without known active disease must meet the eligibility requirements for ALT, AST, total bilirubin, and alkaline phosphatase and must have a normal international normalized ratio (INR) on at least two consecutive occasions, separated by at least 1 week, within the 30 day screening period.\n* Ability to understand and the willingness to sign a written informed consent document\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 65 Years",
        "exclusion_criteria": "* Patients who have received previous cytotoxic chemotherapy including an AC-T regimen or previous therapeutic radiation therapy for any reason in the last 5 years. Because of possible limitations in bone marrow reserve, patients with such prior treatments are not appropriate candidates for this trial. Patients who have had prior hormonal therapy (for instance, tamoxifen for prevention of breast cancer) are eligible. Patients who have participated in a window study (treatment with an investigational agent prior to surgery for ≤2 weeks) are eligible but must have discontinued the investigational agent at least 14 days before enrollment.\n* Participants who are receiving any other investigational agents\n* Have had at least one prior episode of fever and neutropenia (ANC< 500/mm3 or expected to fall below < 500/mm3) during AC.\n* Patients taking lithium.\n* Patients receiving chronic treatment with oral steroids or another immunosuppressive agent (excluding steroids as part of the chemotherapy pre-medication or emetic medication).\n* Known HIV-positive individuals or with any immunodeficiency status.\n* Patients with history of hematologic disease, including myelodysplasia or bone marrow malignancies.\n* History of allergic reaction attributed to compounds of similar chemical or biologic composition to Paclitaxel, which cannot be managed by premedication.\n* Currently pregnant or breast-feeding.\n* Uncontrolled intercurrent illness including, not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or other significant diseases or disorders that, in the investigator's opinion, would exclude the subject from participating in the study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients must have histologically or cytologically confirmed Stage I-III breast cancer (as defined by the revised, American Joint Committee on Cancer 7th edition criteria) and be at sufficient risk for tumor recurrence. Staging studies to exclude metastatic disease are not required in asymptomatic patients. However, patients with findings considered suspicious for metastatic disease on any staging studies that are obtained need to be evaluated to exclude stage IV breast cancer.",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically confirmed Stage I-III breast cancer",
                    "criterion": "breast cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "Stage"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "Stage"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "sufficient risk for tumor recurrence",
                    "criterion": "risk for tumor recurrence",
                    "requirements": [
                        {
                            "requirement_type": "risk level",
                            "expected_value": "sufficient"
                        }
                    ]
                },
                {
                    "exact_snippets": "findings considered suspicious for metastatic disease ... need to be evaluated to exclude stage IV breast cancer",
                    "criterion": "suspicious findings for metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "evaluation",
                            "expected_value": "required to exclude stage IV breast cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be deemed by their treating oncologist as candidates for (neo) adjuvant chemotherapy with dose dense AC and T.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be deemed by their treating oncologist as candidates for (neo) adjuvant chemotherapy with dose dense AC and T.",
                    "criterion": "candidate for (neo) adjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "determination by oncologist",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥ 18 years and < 65 at the time of informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years and < 65",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 65,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any grade 3 or clinically significant grade 2 treatment-related non-hematological toxicity must be resolved to grade 1 before retreatment with chemotherapy (with exception of alopecia)",
            "criterions": [
                {
                    "exact_snippets": "Any grade 3 or clinically significant grade 2 treatment-related non-hematological toxicity must be resolved to grade 1 before retreatment with chemotherapy",
                    "criterion": "treatment-related non-hematological toxicity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "grade 1"
                        }
                    ]
                },
                {
                    "exact_snippets": "(with exception of alopecia)",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Laboratory Evaluations:",
            "criterions": [
                {
                    "exact_snippets": "Laboratory Evaluations",
                    "criterion": "laboratory evaluations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate blood marrow function defined as:",
            "criterions": [
                {
                    "exact_snippets": "Adequate blood marrow function",
                    "criterion": "blood marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count (ANC) ≥1500 µL",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) ≥1500 µL",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "µL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin ≥9.0 g/dl",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin ≥9.0 g/dl",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9.0,
                                "unit": "g/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets ≥100,000/mm3",
            "criterions": [
                {
                    "exact_snippets": "Platelets ≥100,000/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate hepatic function defined as:",
            "criterions": [
                {
                    "exact_snippets": "Adequate hepatic function",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin ≤ 1.2 institutional upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin ≤ 1.2 institutional upper limit of normal (ULN)",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.2,
                                "unit": "institutional upper limit of normal (ULN)"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase ≤ 1.5 X upper limit normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Aspartate aminotransferase (AST) ... ≤ 1.5 X upper limit normal (ULN)",
                    "criterion": "Aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "X ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine aminotransferase (ALT) ... ≤ 1.5 X upper limit normal (ULN)",
                    "criterion": "alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "X ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alkaline phosphatase ≤ 1.5 X upper limit normal (ULN)",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "X ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate renal function defined as:",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "--- Serum creatinine ≤ 1.5 X ULN",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine ≤ 1.5 X ULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "X ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Premenopausal women (including women who have had a tubal ligation and for women less than 12 months after the onset of menopause) must have a negative serum pregnancy test.",
            "criterions": [
                {
                    "exact_snippets": "Premenopausal women (including women who have had a tubal ligation and for women less than 12 months after the onset of menopause)",
                    "criterion": "premenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must have a negative serum pregnancy test",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with risk factors for Hepatitis B or C should be tested (anti-hepatitis C virus (HCV) antibody, hepatitis B surface antigen [HBsAg] or Hepatitis B core antibody). Risk factors include: history of unprotected sexual intercourse, intravenous drug use, or originally from endemic regions. If infection is suspected, hepatitis B virus (HBV) DNA and HCV RNA should be requested as appropriate.",
            "criterions": [
                {
                    "exact_snippets": "risk factors for Hepatitis B or C",
                    "criterion": "risk factors for Hepatitis B or C",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "anti-hepatitis C virus (HCV) antibody",
                    "criterion": "anti-hepatitis C virus (HCV) antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis B surface antigen [HBsAg]",
                    "criterion": "hepatitis B surface antigen [HBsAg]",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatitis B core antibody",
                    "criterion": "Hepatitis B core antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of unprotected sexual intercourse",
                    "criterion": "history of unprotected sexual intercourse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "intravenous drug use",
                    "criterion": "intravenous drug use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "originally from endemic regions",
                    "criterion": "originally from endemic regions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis B virus (HBV) DNA",
                    "criterion": "hepatitis B virus (HBV) DNA",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HCV RNA",
                    "criterion": "HCV RNA",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Note: Patients with positive Hepatitis B or C serologies without known active disease must meet the eligibility requirements for ALT, AST, total bilirubin, and alkaline phosphatase and must have a normal international normalized ratio (INR) on at least two consecutive occasions, separated by at least 1 week, within the 30 day screening period.",
            "criterions": [
                {
                    "exact_snippets": "positive Hepatitis B or C serologies",
                    "criterion": "Hepatitis B or C serologies",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "known active disease",
                    "criterion": "active disease",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "eligibility requirements for ALT",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": "must meet"
                        }
                    ]
                },
                {
                    "exact_snippets": "eligibility requirements for ... AST",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": "must meet"
                        }
                    ]
                },
                {
                    "exact_snippets": "eligibility requirements for ... total bilirubin",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": "must meet"
                        }
                    ]
                },
                {
                    "exact_snippets": "eligibility requirements for ... alkaline phosphatase",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": "must meet"
                        }
                    ]
                },
                {
                    "exact_snippets": "must have a normal international normalized ratio (INR)",
                    "criterion": "international normalized ratio (INR)",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "on at least two consecutive occasions, separated by at least 1 week, within the 30 day screening period",
                    "criterion": "INR testing frequency",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": "at least two consecutive occasions, separated by at least 1 week, within the 30 day screening period"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to understand and the willingness to sign a written informed consent document",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign a written informed consent document",
                    "criterion": "willingness to consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 65 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 65 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 65,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients who have received previous cytotoxic chemotherapy including an AC-T regimen or previous therapeutic radiation therapy for any reason in the last 5 years. Because of possible limitations in bone marrow reserve, patients with such prior treatments are not appropriate candidates for this trial. Patients who have had prior hormonal therapy (for instance, tamoxifen for prevention of breast cancer) are eligible. Patients who have participated in a window study (treatment with an investigational agent prior to surgery for ≤2 weeks) are eligible but must have discontinued the investigational agent at least 14 days before enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have received previous cytotoxic chemotherapy including an AC-T regimen ... in the last 5 years",
                    "criterion": "previous cytotoxic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "previous therapeutic radiation therapy for any reason in the last 5 years",
                    "criterion": "previous therapeutic radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who have had prior hormonal therapy (for instance, tamoxifen for prevention of breast cancer) are eligible",
                    "criterion": "prior hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who have participated in a window study (treatment with an investigational agent prior to surgery for ≤2 weeks) are eligible",
                    "criterion": "participation in a window study",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "must have discontinued the investigational agent at least 14 days before enrollment",
                    "criterion": "discontinuation of investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants who are receiving any other investigational agents",
            "criterions": [
                {
                    "exact_snippets": "Participants who are receiving any other investigational agents",
                    "criterion": "investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have had at least one prior episode of fever and neutropenia (ANC< 500/mm3 or expected to fall below < 500/mm3) during AC.",
            "criterions": [
                {
                    "exact_snippets": "at least one prior episode of fever and neutropenia",
                    "criterion": "prior episode of fever and neutropenia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ANC< 500/mm3 or expected to fall below < 500/mm3",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 500,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "during AC",
                    "criterion": "treatment phase",
                    "requirements": [
                        {
                            "requirement_type": "specific phase",
                            "expected_value": "AC"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients taking lithium.",
            "criterions": [
                {
                    "exact_snippets": "Patients taking lithium.",
                    "criterion": "lithium use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients receiving chronic treatment with oral steroids or another immunosuppressive agent (excluding steroids as part of the chemotherapy pre-medication or emetic medication).",
            "criterions": [
                {
                    "exact_snippets": "Patients receiving chronic treatment with oral steroids",
                    "criterion": "chronic treatment with oral steroids",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients receiving chronic treatment with ... another immunosuppressive agent",
                    "criterion": "chronic treatment with another immunosuppressive agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known HIV-positive individuals or with any immunodeficiency status.",
            "criterions": [
                {
                    "exact_snippets": "Known HIV-positive individuals",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "any immunodeficiency status",
                    "criterion": "immunodeficiency status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with history of hematologic disease, including myelodysplasia or bone marrow malignancies.",
            "criterions": [
                {
                    "exact_snippets": "history of hematologic disease",
                    "criterion": "hematologic disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... myelodysplasia",
                    "criterion": "myelodysplasia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... bone marrow malignancies",
                    "criterion": "bone marrow malignancies",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of allergic reaction attributed to compounds of similar chemical or biologic composition to Paclitaxel, which cannot be managed by premedication.",
            "criterions": [
                {
                    "exact_snippets": "History of allergic reaction attributed to compounds of similar chemical or biologic composition to Paclitaxel",
                    "criterion": "allergic reaction to compounds similar to Paclitaxel",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "which cannot be managed by premedication",
                    "criterion": "management of allergic reaction by premedication",
                    "requirements": [
                        {
                            "requirement_type": "manageability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Currently pregnant or breast-feeding.",
            "criterions": [
                {
                    "exact_snippets": "Currently pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not pregnant"
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breast-feeding status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not breast-feeding"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled intercurrent illness including, not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or other significant diseases or disorders that, in the investigator's opinion, would exclude the subject from participating in the study.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled intercurrent illness including, not limited to ongoing or active infection",
                    "criterion": "intercurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina pectoris",
                    "criterion": "angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "psychiatric illness/social situations that would limit compliance with study requirements",
                    "criterion": "psychiatric illness/social situations",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": "limit"
                        }
                    ]
                },
                {
                    "exact_snippets": "other significant diseases or disorders that, in the investigator's opinion, would exclude the subject from participating in the study",
                    "criterion": "significant diseases or disorders",
                    "requirements": [
                        {
                            "requirement_type": "investigator's opinion",
                            "expected_value": "exclude from study"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}