{
    "info": {
        "nct_id": "NCT01844791",
        "official_title": "A Phase IIa Exploratory Study of OCZ103-OS in Combination With Platinum-Gemcitabine Based Doublet First Line Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC) Patients",
        "inclusion_criteria": "* Written Informed Consent;\n* Males or females;\n* 18-75 years;\n* Histologically or cytologically confirmed stage IV NSCLC patients that are eligible to platinum-gemcitabine based doublet therapy (M1a and M1b, seventh edition descriptor of the Revised International System for Staging Lung Cancer, adopted by the AJCC.) Patients with a prior diagnosis of stage IIIa or IIIb NSCLC who have progressed to stage IV are also eligible;\n* ECOG performance 0 or 1;\n* One or more tumor lesions measurable by RECIST criteria version 1.1, on CT scan or MRI;\n* Patients with previous radiotherapy as definitive therapy for locally advanced non-small cell lung cancer are eligible, as long as the selected measurable lesions are outside the original radiation therapy port unless there has been demonstrated progression in the lesion. Radiation therapy must have been completed > 4 weeks prior to study entry;\n* Palliative radiotherapy must have been completed > 2 weeks prior to study entry. Concomitant palliative radiotherapy to an existing bone lesion for pain control is allowed;\n* Life expectancy of at least 3 months\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Any prior systemic therapy for recurrent or metastatic NSCLC, except prior neoadjuvant or adjuvant systemic chemotherapy for NSCLC if administered at least 6 months prior to enrolment;\n* Any of the following conditions: Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2; atrial fibrillation of any grade; QTc interval > 450 msec for males or > 470 msec for females or uncontrolled intercurrent illness, e.g. unstable angina; severe coronary disease, ventricular arrhythmias, bradycardia < 50 bpm; a history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia or family history of Long QT Syndrome);\n* Systolic Blood Pressure < 100 mmHg (if deemed clinically significant by the treating physician);\n* Uncontrolled diabetes. Patients with well controlled diabetes, with a HbA1C of less than 7%, on stable hypoglycaemic therapy and diet, are eligible;\n* Clinically significant renal impairment or chronic pancreatitis;\n* History of clinically significant hypoglycemia, with fasting blood glucose < 3 mmol/L;\n* Inadequate baseline organ function as shown by following laboratory values:\n* Hemoglobin < 100 g/L\n* Absolute neutrophil count <1.5 x 10e9/L\n* Platelet count < 100 x 10e9/L\n* Total bilirubin > 1.5 x ULN\n* AST and ALT > 2.5 x ULN or > 5 ULN in the presence of liver metastases\n* Serum creatinine > 1.5 x ULN or calculated creatinine clearance < 60 ml/min\n* To be dependent of oxygen treatment;\n* Active infections requiring antibiotics;\n* A major surgical procedure, open biopsy, or significant traumatic injury within 28 days of beginning treatment, or anticipation of the need for major surgery during the course of the study;\n* Pregnancy or breastfeeding. All women of child-bearing potential must have a negative pregnancy test prior to first receiving protocol therapy;\n* Active alcohol or drug abuse;\n* Known or suspected allergy/hypersensitivity to any agent given in the course of this trial;\n* Any co-morbid condition that in the judgment of the investigator renders the subject at high risk of treatment complication or reduces the probability of assessing clinical effect;\n* Other malignancies diagnosed within the last 5 years with the exception of Basal Cell Carcinoma of the skin;\n* Patients unable to comply with the study protocol and follow-up schedule for any psychological, familial, sociological or geographical reason.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Written Informed Consent;",
            "criterions": [
                {
                    "exact_snippets": "Written Informed Consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "form",
                            "expected_value": "written"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Males or females;",
            "criterions": [
                {
                    "exact_snippets": "Males or females",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 18-75 years;",
            "criterions": [
                {
                    "exact_snippets": "18-75 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically or cytologically confirmed stage IV NSCLC patients that are eligible to platinum-gemcitabine based doublet therapy (M1a and M1b, seventh edition descriptor of the Revised International System for Staging Lung Cancer, adopted by the AJCC.) Patients with a prior diagnosis of stage IIIa or IIIb NSCLC who have progressed to stage IV are also eligible;",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "stage IV NSCLC",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        }
                    ]
                },
                {
                    "exact_snippets": "eligible to platinum-gemcitabine based doublet therapy",
                    "criterion": "therapy eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": "platinum-gemcitabine based doublet therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "M1a and M1b, seventh edition descriptor of the Revised International System for Staging Lung Cancer",
                    "criterion": "staging descriptor",
                    "requirements": [
                        {
                            "requirement_type": "descriptor",
                            "expected_value": [
                                "M1a",
                                "M1b"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with a prior diagnosis of stage IIIa or IIIb NSCLC who have progressed to stage IV",
                    "criterion": "prior cancer stage progression",
                    "requirements": [
                        {
                            "requirement_type": "prior stage",
                            "expected_value": [
                                "IIIa",
                                "IIIb"
                            ]
                        },
                        {
                            "requirement_type": "current stage",
                            "expected_value": "IV"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance 0 or 1;",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* One or more tumor lesions measurable by RECIST criteria version 1.1, on CT scan or MRI;",
            "criterions": [
                {
                    "exact_snippets": "tumor lesions measurable by RECIST criteria version 1.1",
                    "criterion": "tumor lesions",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": "RECIST criteria version 1.1"
                        }
                    ]
                },
                {
                    "exact_snippets": "on CT scan or MRI",
                    "criterion": "imaging modality",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "CT scan",
                                "MRI"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with previous radiotherapy as definitive therapy for locally advanced non-small cell lung cancer are eligible, as long as the selected measurable lesions are outside the original radiation therapy port unless there has been demonstrated progression in the lesion. Radiation therapy must have been completed > 4 weeks prior to study entry;",
            "criterions": [
                {
                    "exact_snippets": "previous radiotherapy as definitive therapy for locally advanced non-small cell lung cancer",
                    "criterion": "previous radiotherapy for locally advanced non-small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "selected measurable lesions are outside the original radiation therapy port",
                    "criterion": "location of measurable lesions",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "outside the original radiation therapy port"
                        }
                    ]
                },
                {
                    "exact_snippets": "unless there has been demonstrated progression in the lesion",
                    "criterion": "progression in the lesion",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Radiation therapy must have been completed > 4 weeks prior to study entry",
                    "criterion": "completion of radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Palliative radiotherapy must have been completed > 2 weeks prior to study entry. Concomitant palliative radiotherapy to an existing bone lesion for pain control is allowed;",
            "criterions": [
                {
                    "exact_snippets": "Palliative radiotherapy must have been completed > 2 weeks prior to study entry.",
                    "criterion": "palliative radiotherapy completion",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Concomitant palliative radiotherapy to an existing bone lesion for pain control is allowed",
                    "criterion": "concomitant palliative radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of at least 3 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of at least 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Any prior systemic therapy for recurrent or metastatic NSCLC, except prior neoadjuvant or adjuvant systemic chemotherapy for NSCLC if administered at least 6 months prior to enrolment;",
            "criterions": [
                {
                    "exact_snippets": "Any prior systemic therapy for recurrent or metastatic NSCLC",
                    "criterion": "prior systemic therapy for recurrent or metastatic NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except prior neoadjuvant or adjuvant systemic chemotherapy for NSCLC if administered at least 6 months prior to enrolment",
                    "criterion": "prior neoadjuvant or adjuvant systemic chemotherapy for NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Systolic Blood Pressure < 100 mmHg (if deemed clinically significant by the treating physician);",
            "criterions": [
                {
                    "exact_snippets": "Systolic Blood Pressure < 100 mmHg",
                    "criterion": "systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 100,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "if deemed clinically significant by the treating physician",
                    "criterion": "clinical significance",
                    "requirements": [
                        {
                            "requirement_type": "determination",
                            "expected_value": "treating physician"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled diabetes. Patients with well controlled diabetes, with a HbA1C of less than 7%, on stable hypoglycaemic therapy and diet, are eligible;",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "HbA1C of less than 7%",
                    "criterion": "HbA1C level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 7,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "on stable hypoglycaemic therapy",
                    "criterion": "hypoglycaemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "stable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant renal impairment or chronic pancreatitis;",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant renal impairment",
                    "criterion": "renal impairment",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic pancreatitis",
                    "criterion": "pancreatitis",
                    "requirements": [
                        {
                            "requirement_type": "chronicity",
                            "expected_value": "chronic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of clinically significant hypoglycemia, with fasting blood glucose < 3 mmol/L;",
            "criterions": [
                {
                    "exact_snippets": "History of clinically significant hypoglycemia",
                    "criterion": "clinically significant hypoglycemia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "fasting blood glucose < 3 mmol/L",
                    "criterion": "fasting blood glucose",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "mmol/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inadequate baseline organ function as shown by following laboratory values:",
            "criterions": [
                {
                    "exact_snippets": "Inadequate baseline organ function",
                    "criterion": "baseline organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin < 100 g/L",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin < 100 g/L",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 100,
                                "unit": "g/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count <1.5 x 10e9/L",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count <1.5 x 10e9/L",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x 10e9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count < 100 x 10e9/L",
            "criterions": [
                {
                    "exact_snippets": "Platelet count < 100 x 10e9/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 100,
                                "unit": "x 10e9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin > 1.5 x ULN",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin > 1.5 x ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST and ALT > 2.5 x ULN or > 5 ULN in the presence of liver metastases",
            "criterions": [
                {
                    "exact_snippets": "AST and ALT > 2.5 x ULN",
                    "criterion": "AST and ALT levels",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST and ALT ... > 5 ULN in the presence of liver metastases",
                    "criterion": "AST and ALT levels with liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine > 1.5 x ULN or calculated creatinine clearance < 60 ml/min",
            "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"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "calculated creatinine clearance < 60 ml/min",
                    "criterion": "calculated creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "ml/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* To be dependent of oxygen treatment;",
            "criterions": [
                {
                    "exact_snippets": "dependent of oxygen treatment",
                    "criterion": "oxygen treatment dependency",
                    "requirements": [
                        {
                            "requirement_type": "dependency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active infections requiring antibiotics;",
            "criterions": [
                {
                    "exact_snippets": "Active infections requiring antibiotics",
                    "criterion": "active infections",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "antibiotics"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A major surgical procedure, open biopsy, or significant traumatic injury within 28 days of beginning treatment, or anticipation of the need for major surgery during the course of the study;",
            "criterions": [
                {
                    "exact_snippets": "A major surgical procedure, open biopsy, or significant traumatic injury within 28 days of beginning treatment",
                    "criterion": "recent major surgical procedure, open biopsy, or significant traumatic injury",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "anticipation of the need for major surgery during the course of the study",
                    "criterion": "anticipated need for major surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy or breastfeeding. All women of child-bearing potential must have a negative pregnancy test prior to first receiving protocol therapy;",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "All women of child-bearing potential must have a negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active alcohol or drug abuse;",
            "criterions": [
                {
                    "exact_snippets": "Active alcohol ... abuse",
                    "criterion": "alcohol abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Active ... drug abuse",
                    "criterion": "drug abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known or suspected allergy/hypersensitivity to any agent given in the course of this trial;",
            "criterions": [
                {
                    "exact_snippets": "Known or suspected allergy/hypersensitivity to any agent given in the course of this trial",
                    "criterion": "allergy/hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any co-morbid condition that in the judgment of the investigator renders the subject at high risk of treatment complication or reduces the probability of assessing clinical effect;",
            "criterions": [
                {
                    "exact_snippets": "Any co-morbid condition ... renders the subject at high risk of treatment complication",
                    "criterion": "co-morbid condition",
                    "requirements": [
                        {
                            "requirement_type": "risk of treatment complication",
                            "expected_value": "high"
                        }
                    ]
                },
                {
                    "exact_snippets": "Any co-morbid condition ... reduces the probability of assessing clinical effect",
                    "criterion": "co-morbid condition",
                    "requirements": [
                        {
                            "requirement_type": "probability of assessing clinical effect",
                            "expected_value": "reduced"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other malignancies diagnosed within the last 5 years with the exception of Basal Cell Carcinoma of the skin;",
            "criterions": [
                {
                    "exact_snippets": "Other malignancies diagnosed within the last 5 years",
                    "criterion": "other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "exception of Basal Cell Carcinoma of the skin",
                    "criterion": "Basal Cell Carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients unable to comply with the study protocol and follow-up schedule for any psychological, familial, sociological or geographical reason.",
            "criterions": [
                {
                    "exact_snippets": "unable to comply with the study protocol and follow-up schedule",
                    "criterion": "compliance with study protocol and follow-up schedule",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "psychological",
                    "criterion": "psychological reason",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "familial",
                    "criterion": "familial reason",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sociological",
                    "criterion": "sociological reason",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "geographical",
                    "criterion": "geographical reason",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Any of the following conditions: Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2; atrial fibrillation of any grade; QTc interval > 450 msec for males or > 470 msec for females or uncontrolled intercurrent illness, e.g. unstable angina; severe coronary disease, ventricular arrhythmias, bradycardia < 50 bpm; a history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia or family history of Long QT Syndrome);",
            "criterions": [
                {
                    "exact_snippets": "Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2",
                    "criterion": "cardiac dysrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "NCI CTCAE grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "atrial fibrillation of any grade",
                    "criterion": "atrial fibrillation",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "any grade"
                        }
                    ]
                },
                {
                    "exact_snippets": "QTc interval > 450 msec for males",
                    "criterion": "QTc interval for males",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 450,
                                "unit": "msec"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "QTc interval > 470 msec for females",
                    "criterion": "QTc interval for females",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 470,
                                "unit": "msec"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled intercurrent illness, e.g. unstable angina",
                    "criterion": "uncontrolled intercurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "severe coronary disease",
                    "criterion": "coronary disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "ventricular arrhythmias",
                    "criterion": "ventricular arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "bradycardia < 50 bpm",
                    "criterion": "bradycardia",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "bpm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "a history of additional risk factors for torsades de pointes",
                    "criterion": "risk factors for torsades de pointes",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "heart failure",
                    "criterion": "heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypokalemia",
                    "criterion": "hypokalemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "family history of Long QT Syndrome",
                    "criterion": "family history of Long QT Syndrome",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}