{
    "info": {
        "nct_id": "NCT04019548",
        "official_title": "Patient Reported Outcomes in Term of Swallowing and Quality of Life After Prophylactic Versus Reactive Percutaneous Endoscopic Gastrostomy Tube Placement in Advanced Oropharyngeal Cancer Patients Treated With Definitive Chemo-radiotherapy",
        "inclusion_criteria": "1. Age ≥ 18 years old\n2. ECOG performance status ≤ 2\n3. Female and Male\n4. Newly diagnosed, histologically confirmed primary squamous cell carcinoma of the oropharynx\n5. Candidate for curative intent radiotherapy and systemic treatment\n6. No prior or current anticancer treatment for the HNSCC (e.g. neo-adjuvant chemotherapy, surgery)\n7. Diagnosis biopsy results\n8. HPV/p 16 testing results\n9. Serum test (for subjects of childbearing potential) negative within 7 days prior to the 1st CRT administration.\n10. Women of childbearing potential must agree to use of one highly effective method of contraception prior study entry, during the course of the study and at least 6 months after the last administration of cisplatin.\n11. Men with childbearing potential partner must agree to use condom during the course of this study and for at least 6 months after the last administration of the cisplatin.\n12. Adequate bone marrow function as defined below:\n\n    * Absolute neutrophil count (ANC) ≥1500/µL or 1.5x109/L\n    * Hemoglobin ≥ 9 g/dL\n    * Platelets ≥100000/µL or 100x109/L\n13. Adequate liver function as defined below:\n\n    * Serum total bilirubin ≤ 1.5 x ULN. In case of known Gilbert's syndrome < 3 x UNL is allowed\n    * AST (SGOT)/ALT (SGPT) ≤ 2.5 x ULN\n    * Alkaline phosphatase ≤ 2.5 x ULN\n14. Adequate renal function as defined below:\n\n    * Creatinine ≤ 1.5 x UNL and creatinine clearance > 60 mL/min\n15. Peripheral neuropathy ≤ grade 1\n16. Hear impaired ≤ grade 1\n17. Completion of all necessary screening procedures within 15 days prior to randomisation.\n18. Signed Informed Consent form (ICF) obtained prior to any study related procedure.\n19. Ability to understand and complete the questionnaires (language proficiency, cognitive functioning) as judged by principal investigator upon screening\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Severe malnutrition\n2. Dysphagia requiring a liquid or puree texture modified diet (grade ≥ 2 (CTCAE_v.5)\n3. Distant metastasis\n4. Serious coagulation disorders (INR>1.5, PTT>50s, platelets <50000/mm3)\n5. Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.\n6. Other malignancies in the 3 years prior to study entry except of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal/squamous cell carcinoma of the skin;\n7. Pregnant and/or lactating women.\n8. Known hypersensitivity to the study drug (cisplatin) or excipients.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Age ≥ 18 years old",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. ECOG performance status ≤ 2",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status ≤ 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Female and Male",
            "criterions": [
                {
                    "exact_snippets": "Female and Male",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "Female",
                                "Male"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Newly diagnosed, histologically confirmed primary squamous cell carcinoma of the oropharynx",
            "criterions": [
                {
                    "exact_snippets": "Newly diagnosed",
                    "criterion": "diagnosis status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "newly diagnosed"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically confirmed",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "histological"
                        }
                    ]
                },
                {
                    "exact_snippets": "primary squamous cell carcinoma",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "primary squamous cell carcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "oropharynx",
                    "criterion": "cancer location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "oropharynx"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Candidate for curative intent radiotherapy and systemic treatment",
            "criterions": [
                {
                    "exact_snippets": "Candidate for curative intent radiotherapy",
                    "criterion": "curative intent radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Candidate for ... systemic treatment",
                    "criterion": "systemic treatment",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. No prior or current anticancer treatment for the HNSCC (e.g. neo-adjuvant chemotherapy, surgery)",
            "criterions": [
                {
                    "exact_snippets": "No prior or current anticancer treatment for the HNSCC",
                    "criterion": "anticancer treatment for HNSCC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "(e.g. neo-adjuvant chemotherapy, surgery)",
                    "criterion": "types of anticancer treatment",
                    "requirements": [
                        {
                            "requirement_type": "examples",
                            "expected_value": [
                                "neo-adjuvant chemotherapy",
                                "surgery"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Diagnosis biopsy results",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis biopsy results",
                    "criterion": "biopsy results",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. HPV/p 16 testing results",
            "criterions": [
                {
                    "exact_snippets": "HPV/p 16 testing results",
                    "criterion": "HPV/p 16 testing",
                    "requirements": [
                        {
                            "requirement_type": "results",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Serum test (for subjects of childbearing potential) negative within 7 days prior to the 1st CRT administration.",
            "criterions": [
                {
                    "exact_snippets": "Serum test (for subjects of childbearing potential) negative within 7 days prior to the 1st CRT administration.",
                    "criterion": "serum test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days prior to the 1st CRT administration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Women of childbearing potential must agree to use of one highly effective method of contraception prior study entry, during the course of the study and at least 6 months after the last administration of cisplatin.",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential",
                    "criterion": "women of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to use of one highly effective method of contraception",
                    "criterion": "use of contraception",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior study entry",
                    "criterion": "contraception timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior study entry"
                        }
                    ]
                },
                {
                    "exact_snippets": "during the course of the study",
                    "criterion": "contraception timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "during the course of the study"
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 6 months after the last administration of cisplatin",
                    "criterion": "contraception timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "at least 6 months after the last administration of cisplatin"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Men with childbearing potential partner must agree to use condom during the course of this study and for at least 6 months after the last administration of the cisplatin.",
            "criterions": [
                {
                    "exact_snippets": "Men with childbearing potential partner must agree to use condom during the course of this study and for at least 6 months after the last administration of the cisplatin.",
                    "criterion": "contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the course of this study and for at least 6 months after the last administration of the cisplatin"
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Adequate bone marrow function as defined below:",
            "criterions": [
                {
                    "exact_snippets": "Adequate bone marrow function",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count (ANC) ≥1500/µL or 1.5x109/L",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) ≥1500/µL or 1.5x109/L",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1500,
                                        "unit": "µL"
                                    },
                                    {
                                        "operator": ">=",
                                        "value": 1.5,
                                        "unit": "x10^9/L"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin ≥ 9 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin ≥ 9 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets ≥100000/µL or 100x109/L",
            "criterions": [
                {
                    "exact_snippets": "Platelets ≥100000/µL or 100x109/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 100000,
                                        "unit": "/µL"
                                    },
                                    {
                                        "operator": ">=",
                                        "value": 100,
                                        "unit": "x10^9/L"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Adequate liver function as defined below:",
            "criterions": [
                {
                    "exact_snippets": "Adequate liver function",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum total bilirubin ≤ 1.5 x ULN. In case of known Gilbert's syndrome < 3 x UNL is allowed",
            "criterions": [
                {
                    "exact_snippets": "Serum total bilirubin ≤ 1.5 x ULN",
                    "criterion": "serum total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "In case of known Gilbert's syndrome < 3 x UNL is allowed",
                    "criterion": "serum total bilirubin in Gilbert's syndrome",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST (SGOT)/ALT (SGPT) ≤ 2.5 x ULN",
            "criterions": [
                {
                    "exact_snippets": "AST (SGOT) ... ≤ 2.5 x ULN",
                    "criterion": "AST (SGOT) level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT (SGPT) ... ≤ 2.5 x ULN",
                    "criterion": "ALT (SGPT) level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alkaline phosphatase ≤ 2.5 x ULN",
            "criterions": [
                {
                    "exact_snippets": "Alkaline phosphatase ≤ 2.5 x ULN",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Adequate renal function as defined below:",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "adequate"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine ≤ 1.5 x UNL and creatinine clearance > 60 mL/min",
            "criterions": [
                {
                    "exact_snippets": "Creatinine ≤ 1.5 x UNL",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x UNL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance > 60 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "clearance",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Peripheral neuropathy ≤ grade 1",
            "criterions": [
                {
                    "exact_snippets": "Peripheral neuropathy ≤ grade 1",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Hear impaired ≤ grade 1",
            "criterions": [
                {
                    "exact_snippets": "Hear impaired ≤ grade 1",
                    "criterion": "hearing impairment",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Completion of all necessary screening procedures within 15 days prior to randomisation.",
            "criterions": [
                {
                    "exact_snippets": "Completion of all necessary screening procedures",
                    "criterion": "screening procedures",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 15 days prior to randomisation",
                    "criterion": "screening procedures",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 15,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Signed Informed Consent form (ICF) obtained prior to any study related procedure.",
            "criterions": [
                {
                    "exact_snippets": "Signed Informed Consent form (ICF) obtained",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "signed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "19. Ability to understand and complete the questionnaires (language proficiency, cognitive functioning) as judged by principal investigator upon screening",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand and complete the questionnaires",
                    "criterion": "ability to complete questionnaires",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "language proficiency",
                    "criterion": "language proficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cognitive functioning",
                    "criterion": "cognitive functioning",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Severe malnutrition",
            "criterions": [
                {
                    "exact_snippets": "Severe malnutrition",
                    "criterion": "malnutrition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Dysphagia requiring a liquid or puree texture modified diet (grade ≥ 2 (CTCAE_v.5)",
            "criterions": [
                {
                    "exact_snippets": "Dysphagia requiring a liquid or puree texture modified diet",
                    "criterion": "dysphagia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade (CTCAE_v.5)"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Distant metastasis",
            "criterions": [
                {
                    "exact_snippets": "Distant metastasis",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Serious coagulation disorders (INR>1.5, PTT>50s, platelets <50000/mm3)",
            "criterions": [
                {
                    "exact_snippets": "Serious coagulation disorders (INR>1.5",
                    "criterion": "INR",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Serious coagulation disorders ... PTT>50s",
                    "criterion": "PTT",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "s"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Serious coagulation disorders ... platelets <50000/mm3",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 50000,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.",
            "criterions": [
                {
                    "exact_snippets": "significant medical, neuro-psychiatric, or surgical condition",
                    "criterion": "medical condition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "significant medical, neuro-psychiatric, or surgical condition",
                    "criterion": "neuro-psychiatric condition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "significant medical, neuro-psychiatric, or surgical condition",
                    "criterion": "surgical condition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Other malignancies in the 3 years prior to study entry except of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal/squamous cell carcinoma of the skin;",
            "criterions": [
                {
                    "exact_snippets": "Other malignancies in the 3 years prior to study entry",
                    "criterion": "other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "surgically cured carcinoma in situ of the cervix",
                    "criterion": "surgically cured carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in situ breast cancer",
                    "criterion": "in situ breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "incidental finding of stage T1a or T1b prostate cancer",
                    "criterion": "incidental finding of stage T1a or T1b prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "basal/squamous cell carcinoma of the skin",
                    "criterion": "basal/squamous cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Pregnant and/or lactating women.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Known hypersensitivity to the study drug (cisplatin) or excipients.",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to the study drug (cisplatin)",
                    "criterion": "hypersensitivity to cisplatin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... excipients",
                    "criterion": "hypersensitivity to excipients",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}