{
    "info": {
        "nct_id": "NCT02093962",
        "official_title": "A Randomized Phase 2, Double-blind, Placebo-controlled, Multi-center Study Comparing Pemetrexed in Combination With TH-302 vs. Pemetrexed in Combination With Placebo as Second-line Chemotherapy for Advanced Non-Squamous, Non-Small Cell Lung Cancer",
        "inclusion_criteria": "* Men and women ≥ 18 years of age.\n* Histologically or cytologically confirmed stage IIIB or IV NSCLC with non-squamous histology\n* Recurrent or progressive disease after one prior platinum-based non-pemetrexed chemotherapy treatment for advanced disease with or without maintenance\n* Neoadjuvant/adjuvant cytotoxic chemotherapy initiated < 12 months prior to study randomization will be counted as one prior treatment\n* Neoadjuvant/adjuvant cytotoxic chemotherapy initiated ≥ 12 months prior to study randomization will not be counted as one prior chemotherapy treatment\n* Use of targeted agents (e.g., monoclonal antibodies or kinase inhibitors) will not be counted as a prior chemotherapy treatment\n* Patients with known EGFR-activating mutations or ALK rearrangements should have received treatment with a targeted kinase inhibitor (e.g., erlotinib, crizotinib) and no longer be considered as a candidate for such treatment\n* Measurable disease according to RECIST 1.1\n* ECOG performance status 0-1\n* Resolution to Grade ≤ 1 Adverse Events, of all clinically significant toxic effects of prior therapy\n* Adequate hematologic, hepatic, cardiac, and renal function\n* Female patients of childbearing potential must have a negative serum or urine pregnancy test, whichever is considered standard by the institution\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Diagnosis of small cell carcinoma of the lung, squamous cell carcinoma of the lung or NSCLC NOS\n* Prior therapy with pemetrexed\n* Inability or unwillingness to take folic acid, vitamin B12 supplementation or corticosteroids\n* Inability to discontinue non-steroidal anti-inflammatory drugs for 5 days (long half-life) or for 2 days (short half-life, if CrCL <80 mL/min) before pemetrexed dosing and until 2 days after pemetrexed dosing\n* Leptomeningeal disease or any untreated or symptomatic brain metastases, unless the following criteria are met:\n\n  * brain metastases are stable and have been previously treated with either whole-brain radiotherapy or gamma-knife surgery\n  * steroids are currently not required and more than 14 days since last steroid treatment\n* Symptomatic pleural effusion (> CTCAE Grade 1 dyspnea) that is not amenable to drainage\n* Treatment with other systemic anticancer therapy within 4 weeks prior to the first dose of study medication\n* Treatment with full field radiation therapy within 4 weeks or limited field radiation therapy within 2 weeks prior to the first dose of study medication\n* Major surgery within 4 weeks or minor surgery within 2 weeks prior the first dose of study medication\n* Elective or a planned major surgery while on study treatment\n* Radiation therapy to greater than 25% of the bone marrow\n* Clinically significant active infection (e.g. tuberculosis, viral hepatitis, HIV)\n* Any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct\n* Concurrent active malignancy other than adequately treated basal cell or squamous cell carcinoma of the skin or pre-invasive carcinoma of the cervix.\n* Pregnant or breast feeding\n* Patients who are taking medications that prolong QT interval and have a risk of Torsades de Pointes (Appendix F) or who have a history of long QT syndrome\n* Patients who are taking medications that are strong inducers or inhibitors of CYP3A4",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Men and women ≥ 18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "Men and women",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "≥ 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically or cytologically confirmed stage IIIB or IV NSCLC with non-squamous histology",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "stage IIIB or IV NSCLC",
                    "criterion": "NSCLC stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IIIB",
                                "IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "non-squamous histology",
                    "criterion": "NSCLC histology",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "non-squamous"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recurrent or progressive disease after one prior platinum-based non-pemetrexed chemotherapy treatment for advanced disease with or without maintenance",
            "criterions": [
                {
                    "exact_snippets": "Recurrent or progressive disease",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "recurrent",
                                "progressive"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "one prior platinum-based non-pemetrexed chemotherapy treatment",
                    "criterion": "prior chemotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "treatment"
                            }
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": "platinum-based non-pemetrexed"
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Neoadjuvant/adjuvant cytotoxic chemotherapy initiated < 12 months prior to study randomization will be counted as one prior treatment",
            "criterions": [
                {
                    "exact_snippets": "Neoadjuvant/adjuvant cytotoxic chemotherapy initiated < 12 months prior to study randomization",
                    "criterion": "neoadjuvant/adjuvant cytotoxic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "initiation time",
                            "expected_value": {
                                "operator": "<",
                                "value": 12,
                                "unit": "months prior to study randomization"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Neoadjuvant/adjuvant cytotoxic chemotherapy initiated ≥ 12 months prior to study randomization will not be counted as one prior chemotherapy treatment",
            "criterions": [
                {
                    "exact_snippets": "Neoadjuvant/adjuvant cytotoxic chemotherapy initiated ≥ 12 months prior to study randomization",
                    "criterion": "neoadjuvant/adjuvant cytotoxic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "initiation time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of targeted agents (e.g., monoclonal antibodies or kinase inhibitors) will not be counted as a prior chemotherapy treatment",
            "criterions": [
                {
                    "exact_snippets": "Use of targeted agents (e.g., monoclonal antibodies or kinase inhibitors) ... will not be counted as a prior chemotherapy treatment",
                    "criterion": "targeted agents",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": "not counted as prior chemotherapy treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with known EGFR-activating mutations or ALK rearrangements should have received treatment with a targeted kinase inhibitor (e.g., erlotinib, crizotinib) and no longer be considered as a candidate for such treatment",
            "criterions": [
                {
                    "exact_snippets": "Patients with known EGFR-activating mutations",
                    "criterion": "EGFR-activating mutations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ALK rearrangements",
                    "criterion": "ALK rearrangements",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "should have received treatment with a targeted kinase inhibitor",
                    "criterion": "treatment with a targeted kinase inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no longer be considered as a candidate for such treatment",
                    "criterion": "candidate for targeted kinase inhibitor treatment",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease according to RECIST 1.1",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease according to RECIST 1.1",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "criteria",
                            "expected_value": "RECIST 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status 0-1",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Resolution to Grade ≤ 1 Adverse Events, of all clinically significant toxic effects of prior therapy",
            "criterions": [
                {
                    "exact_snippets": "Resolution to Grade ≤ 1 Adverse Events",
                    "criterion": "adverse events",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant toxic effects of prior therapy",
                    "criterion": "toxic effects of prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate hematologic, hepatic, cardiac, and renal function",
            "criterions": [
                {
                    "exact_snippets": "Adequate hematologic ... function",
                    "criterion": "hematologic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... hepatic ... function",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... cardiac ... function",
                    "criterion": "cardiac function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female patients of childbearing potential must have a negative serum or urine pregnancy test, whichever is considered standard by the institution",
            "criterions": [
                {
                    "exact_snippets": "Female patients of childbearing potential",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive status",
                            "expected_value": "childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "must have a negative serum or urine pregnancy test",
                    "criterion": "pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Diagnosis of small cell carcinoma of the lung, squamous cell carcinoma of the lung or NSCLC NOS",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of small cell carcinoma of the lung",
                    "criterion": "small cell carcinoma of the lung",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Diagnosis of ... squamous cell carcinoma of the lung",
                    "criterion": "squamous cell carcinoma of the lung",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Diagnosis of ... NSCLC NOS",
                    "criterion": "NSCLC NOS",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior therapy with pemetrexed",
            "criterions": [
                {
                    "exact_snippets": "Prior therapy with pemetrexed",
                    "criterion": "pemetrexed therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability or unwillingness to take folic acid, vitamin B12 supplementation or corticosteroids",
            "criterions": [
                {
                    "exact_snippets": "Inability or unwillingness to take folic acid",
                    "criterion": "folic acid supplementation",
                    "requirements": [
                        {
                            "requirement_type": "ability or willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Inability or unwillingness to take ... vitamin B12 supplementation",
                    "criterion": "vitamin B12 supplementation",
                    "requirements": [
                        {
                            "requirement_type": "ability or willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Inability or unwillingness to take ... corticosteroids",
                    "criterion": "corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "ability or willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability to discontinue non-steroidal anti-inflammatory drugs for 5 days (long half-life) or for 2 days (short half-life, if CrCL <80 mL/min) before pemetrexed dosing and until 2 days after pemetrexed dosing",
            "criterions": [
                {
                    "exact_snippets": "Inability to discontinue non-steroidal anti-inflammatory drugs",
                    "criterion": "discontinuation of non-steroidal anti-inflammatory drugs",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "CrCL <80 mL/min",
                    "criterion": "creatinine clearance (CrCL)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 80,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Leptomeningeal disease or any untreated or symptomatic brain metastases, unless the following criteria are met:",
            "criterions": [
                {
                    "exact_snippets": "Leptomeningeal disease",
                    "criterion": "leptomeningeal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "untreated ... brain metastases",
                    "criterion": "untreated brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic brain metastases",
                    "criterion": "symptomatic brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* brain metastases are stable and have been previously treated with either whole-brain radiotherapy or gamma-knife surgery",
            "criterions": [
                {
                    "exact_snippets": "brain metastases are stable",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "stable"
                        }
                    ]
                },
                {
                    "exact_snippets": "brain metastases ... have been previously treated with either whole-brain radiotherapy or gamma-knife surgery",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "whole-brain radiotherapy",
                                "gamma-knife surgery"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* steroids are currently not required and more than 14 days since last steroid treatment",
            "criterions": [
                {
                    "exact_snippets": "steroids are currently not required",
                    "criterion": "steroid requirement",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "more than 14 days since last steroid treatment",
                    "criterion": "time since last steroid treatment",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Symptomatic pleural effusion (> CTCAE Grade 1 dyspnea) that is not amenable to drainage",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic pleural effusion",
                    "criterion": "pleural effusion",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "(> CTCAE Grade 1 dyspnea)",
                    "criterion": "dyspnea",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "CTCAE Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "not amenable to drainage",
                    "criterion": "pleural effusion",
                    "requirements": [
                        {
                            "requirement_type": "amenability to drainage",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment with other systemic anticancer therapy within 4 weeks prior to the first dose of study medication",
            "criterions": [
                {
                    "exact_snippets": "Treatment with other systemic anticancer therapy within 4 weeks prior to the first dose of study medication",
                    "criterion": "treatment with other systemic anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment with full field radiation therapy within 4 weeks or limited field radiation therapy within 2 weeks prior to the first dose of study medication",
            "criterions": [
                {
                    "exact_snippets": "Treatment with full field radiation therapy within 4 weeks",
                    "criterion": "full field radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "limited field radiation therapy within 2 weeks",
                    "criterion": "limited field radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgery within 4 weeks or minor surgery within 2 weeks prior the first dose of study medication",
            "criterions": [
                {
                    "exact_snippets": "Major surgery within 4 weeks",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "minor surgery within 2 weeks",
                    "criterion": "minor surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Elective or a planned major surgery while on study treatment",
            "criterions": [
                {
                    "exact_snippets": "Elective or a planned major surgery",
                    "criterion": "surgery type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "elective",
                                "planned major"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "while on study treatment",
                    "criterion": "timing of surgery",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "while on study treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Radiation therapy to greater than 25% of the bone marrow",
            "criterions": [
                {
                    "exact_snippets": "Radiation therapy to greater than 25% of the bone marrow",
                    "criterion": "radiation therapy to bone marrow",
                    "requirements": [
                        {
                            "requirement_type": "extent",
                            "expected_value": {
                                "operator": ">",
                                "value": 25,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant active infection (e.g. tuberculosis, viral hepatitis, HIV)",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant active infection",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "tuberculosis",
                    "criterion": "tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "viral hepatitis",
                    "criterion": "viral hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HIV",
                    "criterion": "HIV",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct",
            "criterions": [
                {
                    "exact_snippets": "serious uncontrolled medical disorders",
                    "criterion": "medical disorders",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "psychological conditions that may interfere with study conduct",
                    "criterion": "psychological conditions",
                    "requirements": [
                        {
                            "requirement_type": "interference with study conduct",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent active malignancy other than adequately treated basal cell or squamous cell carcinoma of the skin or pre-invasive carcinoma of the cervix.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent active malignancy",
                    "criterion": "concurrent active malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated basal cell or squamous cell carcinoma of the skin",
                    "criterion": "adequately treated basal cell or squamous cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pre-invasive carcinoma of the cervix",
                    "criterion": "pre-invasive carcinoma of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or breast feeding",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are taking medications that prolong QT interval and have a risk of Torsades de Pointes (Appendix F) or who have a history of long QT syndrome",
            "criterions": [
                {
                    "exact_snippets": "Patients who are taking medications that prolong QT interval",
                    "criterion": "medications that prolong QT interval",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "have a risk of Torsades de Pointes",
                    "criterion": "risk of Torsades de Pointes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of long QT syndrome",
                    "criterion": "history of long QT syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are taking medications that are strong inducers or inhibitors of CYP3A4",
            "criterions": [
                {
                    "exact_snippets": "Patients who are taking medications that are strong inducers or inhibitors of CYP3A4",
                    "criterion": "medications affecting CYP3A4",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "strong inducers",
                                "strong inhibitors"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}