{
    "info": {
        "nct_id": "NCT01540682",
        "official_title": "Phase I Study of MLN8237 in Combination With Cetuximab and Definitive Radiation in Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck",
        "inclusion_criteria": "1. Male or females greater than 18 years of age.\n2. ECOG performance status of 0-1\n3. Patients must have histologically or cytologically confirmed HNSCC of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx or paranasal sinuses that is considered after a multidisciplinary evaluation (surgery, medical oncology & radiation oncology) to be appropriate for definitive cetuximab-based radiation therapy\n4. No distant metastatic disease. Minimum work-up includes:\n\n   * History/physical examination within 4 weeks prior to registration, including assessment of weight and weight loss in past 6 months and an examination by a Medical Oncologist\n   * PET/CT scan within 6 weeks prior to registration\n   * CT scan or MRI of the head and neck (of the primary tumor and neck nodes) within 4 weeks prior to registration\n5. Adequate organ and marrow function\n6. Negative pregnancy test within 2 weeks prior to registration for women of childbearing potential. The effects of MLN8237 on the developing human fetus are unknown. For this reason and because MLN8237 agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n7. Male subject agrees to use an acceptable method for contraception during the entire study treatment period through 4 months after the last dose of MLN8237.\n8. Ability to understand and willingness to sign a written informed consent document with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Systemic anti-neoplastic treatment within 21 days preceding the first dose of MLN8237. Patients treated with non-cytotoxic small molecule drugs (eg, tyrosine kinase inhibitors, such as erlotinib and hormonal agents, such as letrozole) must not have received treatment with these drugs for at least 2 weeks before the first dose of MLN8237 is administered.\n2. Patient has already had definitive surgical treatment, excluding diagnostic biopsy of the primary site or nodal sampling of neck disease. Prior radical or modified neck dissection is also not permitted.\n3. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.\n4. Primary tumor site is skin or salivary gland.\n5. Uncorrected CTCAE, v. 4.0 grade 3-4 electrolyte abnormalities\n6. Patients may not be receiving any other investigational agents or treatment with any investigational products within 21 days before the first dose of study drug.\n7. Patients with known brain metastasis are excluded from this clinical trial because of their poor prognosis and because they often develop rapid progressive neurologic dysfunction that would confound the evaluation of neurological and other adverse events.\n8. History of known allergic reactions attributed to compounds of similar chemical or biologic composition to MLN8237 or cetuximab.\n9. Patients may not be taking proton pump inhibitors, H2 antagonists or pancreatic enzyme replacement. Subjects who refuse to limit use of alcohol are also excluded.\n10. Severe, active co-morbidity\n11. Clinical evidence of intestinal malabsorption. Examples include resection of pancreas or upper small bowel, requirement for pancreatic enzymes, or any other condition that would modify small bowel absorption of oral medications.\n12. Prior treatment with high-dose chemotherapy, defined as chemotherapy requiring the use of peripheral blood or bone marrow stem cell support for hematopoietic reconstitution, including prior allogeneic bone marrow transplantation.\n13. Prior radiotherapy to greater or equal to 25% of bone marrow. Whole pelvic radiation is considered to be over 25%.\n14. Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.\n15. Major surgery within 14 days prior to the first dose of study drug treatment.\n16. Inability to swallow oral medication or to maintain a fast as required 2 hours before and 1 hour after MLN8237 administration.\n17. Known history of HIV infection, or active hepatitis B, or hepatitis C infection. Testing is NOT required in the absence of clinical findings or suspicion.\n18. Known history of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness, such as severe chronic obstructive pulmonary disease; requirement for supplemental oxygen.\n19. Patient has Grade 2 or higher peripheral neuropathy within 14 days before enrollment.\n20. Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum -human chorionic gonadotropin (-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.\n21. Treatment with clinically significant enzyme inducers, such as the enzyme-inducing antiepileptic drugs phenytoin, carbamazepine or phenobarbital, or rifampin, rifabutin, rifapentine or St. John's wort within 14 days prior to the first dose of MLN8237 and during the study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Male or females greater than 18 years of age.",
                "criterions": [
                    {
                        "exact_snippets": "Male or females",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "greater than 18 years of age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Male or females",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "greater than 18 years of age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. ECOG performance status of 0-1",
                "criterions": [
                    {
                        "exact_snippets": "ECOG performance status of 0-1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ECOG performance status of 0-1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Patients must have histologically or cytologically confirmed HNSCC of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx or paranasal sinuses that is considered after a multidisciplinary evaluation (surgery, medical oncology & radiation oncology) to be appropriate for definitive cetuximab-based radiation therapy",
                "criterions": [
                    {
                        "exact_snippets": "histologically or cytologically confirmed HNSCC",
                        "criterion": "HNSCC confirmation",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "HNSCC of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx or paranasal sinuses",
                        "criterion": "HNSCC location",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": [
                                "oral cavity",
                                "oropharynx",
                                "hypopharynx",
                                "larynx",
                                "nasopharynx",
                                "paranasal sinuses"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "considered after a multidisciplinary evaluation (surgery, medical oncology & radiation oncology) to be appropriate for definitive cetuximab-based radiation therapy",
                        "criterion": "multidisciplinary evaluation for cetuximab-based radiation therapy",
                        "requirement": {
                            "requirement_type": "evaluation",
                            "expected_value": "multidisciplinary (surgery, medical oncology & radiation oncology)"
                        }
                    },
                    {
                        "exact_snippets": "considered after a multidisciplinary evaluation (surgery, medical oncology & radiation oncology) to be appropriate for definitive cetuximab-based radiation therapy",
                        "criterion": "multidisciplinary evaluation for cetuximab-based radiation therapy",
                        "requirement": {
                            "requirement_type": "appropriateness",
                            "expected_value": "definitive cetuximab-based radiation therapy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "histologically or cytologically confirmed HNSCC",
                                        "criterion": "HNSCC confirmation",
                                        "requirement": {
                                            "requirement_type": "confirmation method",
                                            "expected_value": [
                                                "histologically",
                                                "cytologically"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "HNSCC of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx or paranasal sinuses",
                                        "criterion": "HNSCC location",
                                        "requirement": {
                                            "requirement_type": "location",
                                            "expected_value": [
                                                "oral cavity",
                                                "oropharynx",
                                                "hypopharynx",
                                                "larynx",
                                                "nasopharynx",
                                                "paranasal sinuses"
                                            ]
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "considered after a multidisciplinary evaluation (surgery, medical oncology & radiation oncology) to be appropriate for definitive cetuximab-based radiation therapy",
                                "criterion": "multidisciplinary evaluation for cetuximab-based radiation therapy",
                                "requirement": {
                                    "requirement_type": "evaluation",
                                    "expected_value": "multidisciplinary (surgery, medical oncology & radiation oncology)"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "considered after a multidisciplinary evaluation (surgery, medical oncology & radiation oncology) to be appropriate for definitive cetuximab-based radiation therapy",
                        "criterion": "multidisciplinary evaluation for cetuximab-based radiation therapy",
                        "requirement": {
                            "requirement_type": "appropriateness",
                            "expected_value": "definitive cetuximab-based radiation therapy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. No distant metastatic disease. Minimum work-up includes:",
                "criterions": [
                    {
                        "exact_snippets": "No distant metastatic disease",
                        "criterion": "distant metastatic disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No distant metastatic disease",
                        "criterion": "distant metastatic disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History/physical examination within 4 weeks prior to registration, including assessment of weight and weight loss in past 6 months and an examination by a Medical Oncologist",
                "criterions": [
                    {
                        "exact_snippets": "History/physical examination within 4 weeks prior to registration",
                        "criterion": "history/physical examination",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 4 weeks prior to registration"
                        }
                    },
                    {
                        "exact_snippets": "assessment of weight",
                        "criterion": "weight",
                        "requirement": {
                            "requirement_type": "assessment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "weight loss in past 6 months",
                        "criterion": "weight loss",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "in past 6 months"
                        }
                    },
                    {
                        "exact_snippets": "examination by a Medical Oncologist",
                        "criterion": "examination by a Medical Oncologist",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "History/physical examination within 4 weeks prior to registration",
                        "criterion": "history/physical examination",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 4 weeks prior to registration"
                        }
                    },
                    {
                        "exact_snippets": "assessment of weight",
                        "criterion": "weight",
                        "requirement": {
                            "requirement_type": "assessment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "weight loss in past 6 months",
                        "criterion": "weight loss",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "in past 6 months"
                        }
                    },
                    {
                        "exact_snippets": "examination by a Medical Oncologist",
                        "criterion": "examination by a Medical Oncologist",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* PET/CT scan within 6 weeks prior to registration",
                "criterions": [
                    {
                        "exact_snippets": "PET/CT scan within 6 weeks prior to registration",
                        "criterion": "PET/CT scan",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 6 weeks prior to registration"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "PET/CT scan within 6 weeks prior to registration",
                        "criterion": "PET/CT scan",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 6 weeks prior to registration"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Adequate organ and marrow function",
                "criterions": [
                    {
                        "exact_snippets": "Adequate organ and marrow function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate organ and marrow function",
                        "criterion": "marrow function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate organ and marrow function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate organ and marrow function",
                        "criterion": "marrow function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Negative pregnancy test within 2 weeks prior to registration for women of childbearing potential. The effects of MLN8237 on the developing human fetus are unknown. For this reason and because MLN8237 agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.",
                "criterions": [
                    {
                        "exact_snippets": "Negative pregnancy test within 2 weeks prior to registration for women of childbearing potential.",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "Negative pregnancy test within 2 weeks prior to registration for women of childbearing potential.",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 2 weeks prior to registration"
                        }
                    },
                    {
                        "exact_snippets": "Negative pregnancy test within 2 weeks prior to registration for women of childbearing potential.",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "applicability",
                            "expected_value": "women of childbearing potential"
                        }
                    },
                    {
                        "exact_snippets": "women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "applicability",
                            "expected_value": [
                                "women of child-bearing potential",
                                "men"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "methods",
                            "expected_value": [
                                "hormonal",
                                "barrier method of birth control",
                                "abstinence"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": [
                                "prior to study entry",
                                "for the duration of study participation"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Negative pregnancy test within 2 weeks prior to registration for women of childbearing potential.",
                                        "criterion": "pregnancy test",
                                        "requirement": {
                                            "requirement_type": "result",
                                            "expected_value": "negative"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Negative pregnancy test within 2 weeks prior to registration for women of childbearing potential.",
                                        "criterion": "pregnancy test",
                                        "requirement": {
                                            "requirement_type": "timing",
                                            "expected_value": "within 2 weeks prior to registration"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Negative pregnancy test within 2 weeks prior to registration for women of childbearing potential.",
                                "criterion": "pregnancy test",
                                "requirement": {
                                    "requirement_type": "applicability",
                                    "expected_value": "women of childbearing potential"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.",
                                        "criterion": "contraception use",
                                        "requirement": {
                                            "requirement_type": "agreement",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.",
                                        "criterion": "contraception use",
                                        "requirement": {
                                            "requirement_type": "applicability",
                                            "expected_value": [
                                                "women of child-bearing potential",
                                                "men"
                                            ]
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.",
                                        "criterion": "contraception use",
                                        "requirement": {
                                            "requirement_type": "methods",
                                            "expected_value": [
                                                "hormonal",
                                                "barrier method of birth control",
                                                "abstinence"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.",
                                        "criterion": "contraception use",
                                        "requirement": {
                                            "requirement_type": "timing",
                                            "expected_value": [
                                                "prior to study entry",
                                                "for the duration of study participation"
                                            ]
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Male subject agrees to use an acceptable method for contraception during the entire study treatment period through 4 months after the last dose of MLN8237.",
                "criterions": [
                    {
                        "exact_snippets": "Male subject",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "male"
                        }
                    },
                    {
                        "exact_snippets": "agrees to use an acceptable method for contraception",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "during the entire study treatment period through 4 months after the last dose of MLN8237",
                        "criterion": "contraception use duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "entire study treatment period through 4 months after the last dose of MLN8237"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Male subject",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "male"
                        }
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "agrees to use an acceptable method for contraception",
                                "criterion": "contraception use",
                                "requirement": {
                                    "requirement_type": "agreement",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "during the entire study treatment period through 4 months after the last dose of MLN8237",
                                "criterion": "contraception use duration",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": "entire study treatment period through 4 months after the last dose of MLN8237"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Ability to understand and willingness to sign a written informed consent document with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.",
                "criterions": [
                    {
                        "exact_snippets": "Ability to understand",
                        "criterion": "cognitive ability",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willingness to sign a written informed consent document",
                        "criterion": "willingness to consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Ability to understand",
                        "criterion": "cognitive ability",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willingness to sign a written informed consent document",
                        "criterion": "willingness to consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "1. Systemic anti-neoplastic treatment within 21 days preceding the first dose of MLN8237. Patients treated with non-cytotoxic small molecule drugs (eg, tyrosine kinase inhibitors, such as erlotinib and hormonal agents, such as letrozole) must not have received treatment with these drugs for at least 2 weeks before the first dose of MLN8237 is administered.",
                "criterions": [
                    {
                        "exact_snippets": "Systemic anti-neoplastic treatment within 21 days preceding the first dose of MLN8237.",
                        "criterion": "systemic anti-neoplastic treatment",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Patients treated with non-cytotoxic small molecule drugs (eg, tyrosine kinase inhibitors, such as erlotinib and hormonal agents, such as letrozole) must not have received treatment with these drugs for at least 2 weeks before the first dose of MLN8237 is administered.",
                        "criterion": "non-cytotoxic small molecule drugs",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Systemic anti-neoplastic treatment within 21 days preceding the first dose of MLN8237.",
                                "criterion": "systemic anti-neoplastic treatment",
                                "requirement": {
                                    "requirement_type": "time since last treatment",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 21,
                                        "unit": "days"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Patients treated with non-cytotoxic small molecule drugs (eg, tyrosine kinase inhibitors, such as erlotinib and hormonal agents, such as letrozole) must not have received treatment with these drugs for at least 2 weeks before the first dose of MLN8237 is administered.",
                                "criterion": "non-cytotoxic small molecule drugs",
                                "requirement": {
                                    "requirement_type": "time since last treatment",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.",
                "criterions": [
                    {
                        "exact_snippets": "Prior radiotherapy to the region of the study cancer",
                        "criterion": "prior radiotherapy",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "region of the study cancer"
                        }
                    },
                    {
                        "exact_snippets": "overlap of radiation therapy fields",
                        "criterion": "overlap of radiation therapy fields",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Prior radiotherapy to the region of the study cancer",
                        "criterion": "prior radiotherapy",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "region of the study cancer"
                        }
                    },
                    {
                        "exact_snippets": "overlap of radiation therapy fields",
                        "criterion": "overlap of radiation therapy fields",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Primary tumor site is skin or salivary gland.",
                "criterions": [
                    {
                        "exact_snippets": "Primary tumor site is skin",
                        "criterion": "primary tumor site",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "skin"
                        }
                    },
                    {
                        "exact_snippets": "Primary tumor site is ... salivary gland",
                        "criterion": "primary tumor site",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "salivary gland"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Primary tumor site is skin",
                        "criterion": "primary tumor site",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "skin"
                        }
                    },
                    {
                        "exact_snippets": "Primary tumor site is ... salivary gland",
                        "criterion": "primary tumor site",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "salivary gland"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Uncorrected CTCAE, v. 4.0 grade 3-4 electrolyte abnormalities",
                "criterions": [
                    {
                        "exact_snippets": "CTCAE, v. 4.0 grade 3-4 electrolyte abnormalities",
                        "criterion": "electrolyte abnormalities",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "CTCAE grade"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "CTCAE grade"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "CTCAE, v. 4.0 grade 3-4 electrolyte abnormalities",
                                "criterion": "electrolyte abnormalities",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": ">=",
                                                "value": 3,
                                                "unit": "CTCAE grade"
                                            },
                                            {
                                                "operator": "<=",
                                                "value": 4,
                                                "unit": "CTCAE grade"
                                            }
                                        ]
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Uncorrected",
                                "criterion": "electrolyte abnormalities correction status",
                                "requirement": {
                                    "requirement_type": "corrected",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Patients may not be receiving any other investigational agents or treatment with any investigational products within 21 days before the first dose of study drug.",
                "criterions": [
                    {
                        "exact_snippets": "Patients may not be receiving any other investigational agents",
                        "criterion": "receiving investigational agents",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "treatment with any investigational products within 21 days before the first dose of study drug",
                        "criterion": "treatment with investigational products",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 21,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "Patients may not be receiving any other investigational agents",
                            "criterion": "receiving investigational agents",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "treatment with any investigational products within 21 days before the first dose of study drug",
                            "criterion": "treatment with investigational products",
                            "requirement": {
                                "requirement_type": "time frame",
                                "expected_value": {
                                    "comparisons": [
                                        {
                                            "operator": "<",
                                            "value": 21,
                                            "unit": "days"
                                        }
                                    ]
                                }
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Patients with known brain metastasis are excluded from this clinical trial because of their poor prognosis and because they often develop rapid progressive neurologic dysfunction that would confound the evaluation of neurological and other adverse events.",
                "criterions": [
                    {
                        "exact_snippets": "Patients with known brain metastasis are excluded",
                        "criterion": "brain metastasis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Patients with known brain metastasis are excluded",
                    "criterion": "brain metastasis",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "8. History of known allergic reactions attributed to compounds of similar chemical or biologic composition to MLN8237 or cetuximab.",
                "criterions": [
                    {
                        "exact_snippets": "History of known allergic reactions attributed to compounds of similar chemical or biologic composition to MLN8237",
                        "criterion": "allergic reactions to compounds similar to MLN8237",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of known allergic reactions attributed to compounds of similar chemical or biologic composition to ... cetuximab",
                        "criterion": "allergic reactions to compounds similar to cetuximab",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "History of known allergic reactions attributed to compounds of similar chemical or biologic composition to MLN8237",
                        "criterion": "allergic reactions to compounds similar to MLN8237",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of known allergic reactions attributed to compounds of similar chemical or biologic composition to ... cetuximab",
                        "criterion": "allergic reactions to compounds similar to cetuximab",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. Patients may not be taking proton pump inhibitors, H2 antagonists or pancreatic enzyme replacement. Subjects who refuse to limit use of alcohol are also excluded.",
                "criterions": [
                    {
                        "exact_snippets": "Patients may not be taking proton pump inhibitors",
                        "criterion": "proton pump inhibitors",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients may not be taking ... H2 antagonists",
                        "criterion": "H2 antagonists",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients may not be taking ... pancreatic enzyme replacement",
                        "criterion": "pancreatic enzyme replacement",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Subjects who refuse to limit use of alcohol are also excluded",
                        "criterion": "alcohol use",
                        "requirement": {
                            "requirement_type": "willingness to limit",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Patients may not be taking proton pump inhibitors",
                                "criterion": "proton pump inhibitors",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Patients may not be taking ... H2 antagonists",
                                "criterion": "H2 antagonists",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Patients may not be taking ... pancreatic enzyme replacement",
                                "criterion": "pancreatic enzyme replacement",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Subjects who refuse to limit use of alcohol are also excluded",
                        "criterion": "alcohol use",
                        "requirement": {
                            "requirement_type": "willingness to limit",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "10. Severe, active co-morbidity",
                "criterions": [
                    {
                        "exact_snippets": "Severe, active co-morbidity",
                        "criterion": "co-morbidity",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "Severe, active co-morbidity",
                        "criterion": "co-morbidity",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Severe, active co-morbidity",
                        "criterion": "co-morbidity",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "Severe, active co-morbidity",
                        "criterion": "co-morbidity",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "11. Clinical evidence of intestinal malabsorption. Examples include resection of pancreas or upper small bowel, requirement for pancreatic enzymes, or any other condition that would modify small bowel absorption of oral medications.",
                "criterions": [
                    {
                        "exact_snippets": "Clinical evidence of intestinal malabsorption",
                        "criterion": "intestinal malabsorption",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "resection of pancreas",
                        "criterion": "resection of pancreas",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "resection of ... upper small bowel",
                        "criterion": "resection of upper small bowel",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "requirement for pancreatic enzymes",
                        "criterion": "requirement for pancreatic enzymes",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "any other condition that would modify small bowel absorption of oral medications",
                        "criterion": "condition modifying small bowel absorption of oral medications",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Clinical evidence of intestinal malabsorption",
                    "criterion": "intestinal malabsorption",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "or_criteria": [
                        {
                            "exact_snippets": "resection of pancreas",
                            "criterion": "resection of pancreas",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        },
                        {
                            "exact_snippets": "resection of ... upper small bowel",
                            "criterion": "resection of upper small bowel",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        },
                        {
                            "exact_snippets": "requirement for pancreatic enzymes",
                            "criterion": "requirement for pancreatic enzymes",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        },
                        {
                            "exact_snippets": "any other condition that would modify small bowel absorption of oral medications",
                            "criterion": "condition modifying small bowel absorption of oral medications",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "12. Prior treatment with high-dose chemotherapy, defined as chemotherapy requiring the use of peripheral blood or bone marrow stem cell support for hematopoietic reconstitution, including prior allogeneic bone marrow transplantation.",
                "criterions": [
                    {
                        "exact_snippets": "Prior treatment with high-dose chemotherapy",
                        "criterion": "prior high-dose chemotherapy treatment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "chemotherapy requiring the use of peripheral blood or bone marrow stem cell support",
                        "criterion": "chemotherapy requiring stem cell support",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "prior allogeneic bone marrow transplantation",
                        "criterion": "prior allogeneic bone marrow transplantation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Prior treatment with high-dose chemotherapy",
                                "criterion": "prior high-dose chemotherapy treatment",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "chemotherapy requiring the use of peripheral blood or bone marrow stem cell support",
                                "criterion": "chemotherapy requiring stem cell support",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "prior allogeneic bone marrow transplantation",
                        "criterion": "prior allogeneic bone marrow transplantation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "13. Prior radiotherapy to greater or equal to 25% of bone marrow. Whole pelvic radiation is considered to be over 25%.",
                "criterions": [
                    {
                        "exact_snippets": "Prior radiotherapy to greater or equal to 25% of bone marrow.",
                        "criterion": "prior radiotherapy to bone marrow",
                        "requirement": {
                            "requirement_type": "extent",
                            "expected_value": {
                                "operator": ">=",
                                "value": 25,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Prior radiotherapy to greater or equal to 25% of bone marrow.",
                        "criterion": "prior radiotherapy to bone marrow",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Whole pelvic radiation is considered to be over 25%.",
                        "criterion": "whole pelvic radiation",
                        "requirement": {
                            "requirement_type": "extent",
                            "expected_value": {
                                "operator": ">",
                                "value": 25,
                                "unit": "%"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Prior radiotherapy to greater or equal to 25% of bone marrow.",
                                        "criterion": "prior radiotherapy to bone marrow",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "Prior radiotherapy to greater or equal to 25% of bone marrow.",
                                        "criterion": "prior radiotherapy to bone marrow",
                                        "requirement": {
                                            "requirement_type": "extent",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 25,
                                                "unit": "%"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Whole pelvic radiation is considered to be over 25%.",
                                "criterion": "whole pelvic radiation",
                                "requirement": {
                                    "requirement_type": "extent",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 25,
                                        "unit": "%"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "14. Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.",
                "criterions": [
                    {
                        "exact_snippets": "Diagnosed or treated for another malignancy within 3 years of enrollment",
                        "criterion": "other malignancy",
                        "requirement": {
                            "requirement_type": "diagnosis or treatment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Diagnosed or treated for another malignancy within 3 years of enrollment",
                        "criterion": "other malignancy",
                        "requirement": {
                            "requirement_type": "time since diagnosis or treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "complete resection of basal cell carcinoma or squamous cell carcinoma of the skin",
                        "criterion": "basal cell carcinoma or squamous cell carcinoma of the skin",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "complete resection"
                        }
                    },
                    {
                        "exact_snippets": "in situ malignancy",
                        "criterion": "in situ malignancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "low-risk prostate cancer after curative therapy",
                        "criterion": "low-risk prostate cancer",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "curative therapy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Diagnosed or treated for another malignancy within 3 years of enrollment",
                                    "criterion": "other malignancy",
                                    "requirement": {
                                        "requirement_type": "diagnosis or treatment",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "exact_snippets": "Diagnosed or treated for another malignancy within 3 years of enrollment",
                                    "criterion": "other malignancy",
                                    "requirement": {
                                        "requirement_type": "time since diagnosis or treatment",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 3,
                                            "unit": "years"
                                        }
                                    }
                                }
                            ]
                        }
                    ]
                },
                "then_criteria": {
                    "not_criteria": {
                        "or_criteria": [
                            {
                                "exact_snippets": "complete resection of basal cell carcinoma or squamous cell carcinoma of the skin",
                                "criterion": "basal cell carcinoma or squamous cell carcinoma of the skin",
                                "requirement": {
                                    "requirement_type": "treatment",
                                    "expected_value": "complete resection"
                                }
                            },
                            {
                                "exact_snippets": "in situ malignancy",
                                "criterion": "in situ malignancy",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "low-risk prostate cancer after curative therapy",
                                "criterion": "low-risk prostate cancer",
                                "requirement": {
                                    "requirement_type": "treatment",
                                    "expected_value": "curative therapy"
                                }
                            }
                        ]
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "15. Major surgery within 14 days prior to the first dose of study drug treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Major surgery within 14 days prior to the first dose of study drug treatment.",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Major surgery within 14 days prior to the first dose of study drug treatment.",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "17. Known history of HIV infection, or active hepatitis B, or hepatitis C infection. Testing is NOT required in the absence of clinical findings or suspicion.",
                "criterions": [
                    {
                        "exact_snippets": "Known history of HIV infection",
                        "criterion": "HIV infection",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "active hepatitis B",
                        "criterion": "hepatitis B infection",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "hepatitis C infection",
                        "criterion": "hepatitis C infection",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Known history of HIV infection",
                                "criterion": "HIV infection",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "active hepatitis B",
                                "criterion": "hepatitis B infection",
                                "requirement": {
                                    "requirement_type": "activity",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "hepatitis C infection",
                                "criterion": "hepatitis C infection",
                                "requirement": {
                                    "requirement_type": "activity",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "18. Known history of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness, such as severe chronic obstructive pulmonary disease; requirement for supplemental oxygen.",
                "criterions": [
                    {
                        "exact_snippets": "Known history of uncontrolled sleep apnea syndrome",
                        "criterion": "uncontrolled sleep apnea syndrome",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "other conditions that could result in excessive daytime sleepiness",
                        "criterion": "conditions resulting in excessive daytime sleepiness",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "severe chronic obstructive pulmonary disease",
                        "criterion": "severe chronic obstructive pulmonary disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "requirement for supplemental oxygen",
                        "criterion": "requirement for supplemental oxygen",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Known history of uncontrolled sleep apnea syndrome",
                                "criterion": "uncontrolled sleep apnea syndrome",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "other conditions that could result in excessive daytime sleepiness",
                                "criterion": "conditions resulting in excessive daytime sleepiness",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "severe chronic obstructive pulmonary disease",
                                "criterion": "severe chronic obstructive pulmonary disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "requirement for supplemental oxygen",
                                "criterion": "requirement for supplemental oxygen",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "19. Patient has Grade 2 or higher peripheral neuropathy within 14 days before enrollment.",
                "criterions": [
                    {
                        "exact_snippets": "Grade 2 or higher peripheral neuropathy",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "within 14 days before enrollment",
                        "criterion": "time since peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Grade 2 or higher peripheral neuropathy",
                                "criterion": "peripheral neuropathy",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "grade"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "within 14 days before enrollment",
                                "criterion": "time since peripheral neuropathy",
                                "requirement": {
                                    "requirement_type": "time since",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 14,
                                        "unit": "days"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "20. Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum -human chorionic gonadotropin (-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.",
                "criterions": [
                    {
                        "exact_snippets": "Female subject is pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breast-feeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "negative serum -human chorionic gonadotropin (-hCG) pregnancy test result",
                        "criterion": "serum -hCG pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "post-menopausal",
                        "criterion": "menopausal status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "post-menopausal"
                        }
                    },
                    {
                        "exact_snippets": "surgically sterilized",
                        "criterion": "surgical sterilization",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Female subject is pregnant",
                                        "criterion": "pregnancy",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "negative serum -human chorionic gonadotropin (-hCG) pregnancy test result",
                                        "criterion": "serum -hCG pregnancy test",
                                        "requirement": {
                                            "requirement_type": "result",
                                            "expected_value": "negative"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "breast-feeding",
                                "criterion": "breastfeeding",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "not_criteria": {
                            "or_criteria": [
                                {
                                    "exact_snippets": "post-menopausal",
                                    "criterion": "menopausal status",
                                    "requirement": {
                                        "requirement_type": "status",
                                        "expected_value": "post-menopausal"
                                    }
                                },
                                {
                                    "exact_snippets": "surgically sterilized",
                                    "criterion": "surgical sterilization",
                                    "requirement": {
                                        "requirement_type": "status",
                                        "expected_value": true
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "21. Treatment with clinically significant enzyme inducers, such as the enzyme-inducing antiepileptic drugs phenytoin, carbamazepine or phenobarbital, or rifampin, rifabutin, rifapentine or St. John's wort within 14 days prior to the first dose of MLN8237 and during the study.",
                "criterions": [
                    {
                        "exact_snippets": "Treatment with clinically significant enzyme inducers, such as the enzyme-inducing antiepileptic drugs phenytoin, carbamazepine or phenobarbital, or rifampin, rifabutin, rifapentine or St. John's wort",
                        "criterion": "treatment with enzyme inducers",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "within 14 days prior to the first dose of MLN8237",
                        "criterion": "time since last enzyme inducer treatment",
                        "requirement": {
                            "requirement_type": "time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Treatment with clinically significant enzyme inducers, such as the enzyme-inducing antiepileptic drugs phenytoin, carbamazepine or phenobarbital, or rifampin, rifabutin, rifapentine or St. John's wort",
                        "criterion": "treatment with enzyme inducers",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "within 14 days prior to the first dose of MLN8237",
                        "criterion": "time since last enzyme inducer treatment",
                        "requirement": {
                            "requirement_type": "time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "16. Inability to swallow oral medication or to maintain a fast as required 2 hours before and 1 hour after MLN8237 administration.",
                "criterions": [
                    {
                        "exact_snippets": "Inability to swallow oral medication",
                        "criterion": "ability to swallow oral medication",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "inability ... to maintain a fast as required 2 hours before and 1 hour after MLN8237 administration",
                        "criterion": "ability to maintain a fast",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "Inability to swallow oral medication",
                            "criterion": "ability to swallow oral medication",
                            "requirement": {
                                "requirement_type": "ability",
                                "expected_value": true
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "inability ... to maintain a fast as required 2 hours before and 1 hour after MLN8237 administration",
                            "criterion": "ability to maintain a fast",
                            "requirement": {
                                "requirement_type": "ability",
                                "expected_value": true
                            }
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* CT scan or MRI of the head and neck (of the primary tumor and neck nodes) within 4 weeks prior to registration",
                "criterions": [
                    {
                        "exact_snippets": "CT scan or MRI of the head and neck (of the primary tumor and neck nodes)",
                        "criterion": "CT scan or MRI of the head and neck",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "within 4 weeks prior to registration",
                        "criterion": "timing of CT scan or MRI",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "CT scan or MRI of the head and neck (of the primary tumor and neck nodes)",
                                        "criterion": "CT scan of the head and neck",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "CT scan or MRI of the head and neck (of the primary tumor and neck nodes)",
                                        "criterion": "MRI of the head and neck",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "within 4 weeks prior to registration",
                                "criterion": "timing of CT scan or MRI",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "2. Patient has already had definitive surgical treatment, excluding diagnostic biopsy of the primary site or nodal sampling of neck disease. Prior radical or modified neck dissection is also not permitted.",
                "criterions": [
                    {
                        "exact_snippets": "Patient has already had definitive surgical treatment",
                        "criterion": "definitive surgical treatment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "excluding diagnostic biopsy of the primary site",
                        "criterion": "diagnostic biopsy of the primary site",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "excluding ... nodal sampling of neck disease",
                        "criterion": "nodal sampling of neck disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior radical or modified neck dissection is also not permitted",
                        "criterion": "radical or modified neck dissection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "not_criteria": {
                                "exact_snippets": "Patient has already had definitive surgical treatment",
                                "criterion": "definitive surgical treatment",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "not_criteria": {
                                "exact_snippets": "Prior radical or modified neck dissection is also not permitted",
                                "criterion": "radical or modified neck dissection",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        }
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}