{
    "info": {
        "nct_id": "NCT00238420",
        "official_title": "A Phase I/II Trial of a Combination of Paclitaxel and Trastuzumab With Daily Irradiation or Paclitaxel Alone With Daily Irradiation Following Transurethral Surgery for Non-Cystectomy Candidates With Muscle-Invasive Bladder Cancer",
        "inclusion_criteria": "* Histologically or cytologically confirmed primary transitional cell carcinoma (TCC) of the bladder\n\n  * Histologic evidence of muscularis propria invasion\n* Meets 1 of the following stage criteria:\n\n  * Stage T2-4a; NX, N0, or N1; and M0 disease\n  * Clinical stage T1, grade 3/3 disease AND requires definitive local therapy\n* Tumor involvement of the prostatic urethra allowed provided the following criteria are met:\n\n  * Tumor was visibly completely resected\n  * No evidence of stromal invasion of the prostate\n  * No evidence of distant metastases by chest x-ray (or chest CT scan) within 8 weeks prior to registration\n  * No evidence of distant metastases by abdominal/pelvic CT scan (or MRI scan) within 8 weeks prior to registration\n* Has undergone transurethral bladder resection (as thorough as is judged safely possible) within the past 3-8 weeks, including bimanual examination with tumor mapping\n* Sufficient tumor tissue available for HER2/neu analysis\n* Not a candidate for radical cystectomy\n* Performance status - Zubrod 0-2\n* Absolute neutrophil count >= 1,800/mm^3\n* Platelet count >= 100,000/mm^3\n* Hemoglobin >= 8.0 g/dL (transfusion or other intervention allowed)\n* Bilirubin < 2.0 mg/dL\n* Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) < 2.5 times upper limit of normal\n* No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects\n* Creatinine =< 3.0 mg/dL\n* Left ventricular ejection fraction (LVEF) >= 40% by multigated acquisition scan (MUGA) scan or echocardiogram\n* No unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months\n* No transmural myocardial infarction within the past 6 months\n* Not pregnant or nursing\n* No nursing for 6 months after completion of study treatment (for patients receiving trastuzumab [Herceptin®])\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 6 months after completion of study treatment\n* Able to tolerate systemic chemotherapy and pelvic radiotherapy\n* No other invasive malignancy within the past 3 years except nonmelanoma skin cancer\n* No history of allergic reaction to study drugs\n* No history of inflammatory bowel disease\n* No acute bacterial or fungal infection requiring IV antibiotics\n* No AIDS\n* No other severe active comorbidity\n* No prior systemic chemotherapy with anthracyclines or taxanes\n* No prior systemic chemotherapy for TCC\n* No prior pelvic radiotherapy\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically or cytologically confirmed primary transitional cell carcinoma (TCC) of the bladder",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed primary transitional cell carcinoma (TCC) of the bladder",
                    "criterion": "transitional cell carcinoma (TCC) of the bladder",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        },
                        {
                            "requirement_type": "primary",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologic evidence of muscularis propria invasion",
            "criterions": [
                {
                    "exact_snippets": "Histologic evidence of muscularis propria invasion",
                    "criterion": "muscularis propria invasion",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "histologic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Meets 1 of the following stage criteria:",
            "criterions": [
                {
                    "exact_snippets": "Meets 1 of the following stage criteria",
                    "criterion": "stage",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "1 of the following"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stage T2-4a; NX, N0, or N1; and M0 disease",
            "criterions": [
                {
                    "exact_snippets": "Stage T2-4a",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "T"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "a"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "NX, N0, or N1",
                    "criterion": "lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "NX",
                                "N0",
                                "N1"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "M0 disease",
                    "criterion": "metastasis",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "M0"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinical stage T1, grade 3/3 disease AND requires definitive local therapy",
            "criterions": [
                {
                    "exact_snippets": "Clinical stage T1",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "T1"
                        }
                    ]
                },
                {
                    "exact_snippets": "grade 3/3 disease",
                    "criterion": "disease grade",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": "3/3"
                        }
                    ]
                },
                {
                    "exact_snippets": "requires definitive local therapy",
                    "criterion": "definitive local therapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumor involvement of the prostatic urethra allowed provided the following criteria are met:",
            "criterions": [
                {
                    "exact_snippets": "Tumor involvement of the prostatic urethra",
                    "criterion": "tumor involvement of the prostatic urethra",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumor was visibly completely resected",
            "criterions": [
                {
                    "exact_snippets": "Tumor was visibly completely resected",
                    "criterion": "tumor resection",
                    "requirements": [
                        {
                            "requirement_type": "completeness",
                            "expected_value": "visibly completely"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No evidence of stromal invasion of the prostate",
            "criterions": [
                {
                    "exact_snippets": "No evidence of stromal invasion of the prostate",
                    "criterion": "stromal invasion of the prostate",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No evidence of distant metastases by chest x-ray (or chest CT scan) within 8 weeks prior to registration",
            "criterions": [
                {
                    "exact_snippets": "No evidence of distant metastases",
                    "criterion": "distant metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "chest x-ray (or chest CT scan)",
                    "criterion": "imaging method",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "chest x-ray",
                                "chest CT scan"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "within 8 weeks prior to registration",
                    "criterion": "imaging timeframe",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 8 weeks prior to registration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No evidence of distant metastases by abdominal/pelvic CT scan (or MRI scan) within 8 weeks prior to registration",
            "criterions": [
                {
                    "exact_snippets": "No evidence of distant metastases",
                    "criterion": "distant metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "abdominal/pelvic CT scan (or MRI scan) within 8 weeks prior to registration",
                    "criterion": "imaging scan",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "abdominal/pelvic CT scan",
                                "MRI scan"
                            ]
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 8 weeks prior to registration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has undergone transurethral bladder resection (as thorough as is judged safely possible) within the past 3-8 weeks, including bimanual examination with tumor mapping",
            "criterions": [
                {
                    "exact_snippets": "Has undergone transurethral bladder resection",
                    "criterion": "transurethral bladder resection",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within the past 3-8 weeks",
                    "criterion": "time since transurethral bladder resection",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "weeks"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 8,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "bimanual examination with tumor mapping",
                    "criterion": "bimanual examination with tumor mapping",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Sufficient tumor tissue available for HER2/neu analysis",
            "criterions": [
                {
                    "exact_snippets": "Sufficient tumor tissue available",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": "sufficient"
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2/neu analysis",
                    "criterion": "HER2/neu analysis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not a candidate for radical cystectomy",
            "criterions": [
                {
                    "exact_snippets": "Not a candidate for radical cystectomy",
                    "criterion": "radical cystectomy candidacy",
                    "requirements": [
                        {
                            "requirement_type": "candidacy",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Performance status - Zubrod 0-2",
            "criterions": [
                {
                    "exact_snippets": "Performance status - Zubrod 0-2",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": "Zubrod"
                        },
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count >= 1,800/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count >= 1,800/mm^3",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1800,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count >= 100,000/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Platelet count >= 100,000/mm^3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin >= 8.0 g/dL (transfusion or other intervention allowed)",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin >= 8.0 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin < 2.0 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin < 2.0 mg/dL",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) < 2.5 times upper limit of normal",
            "criterions": [
                {
                    "exact_snippets": "Serum glutamic oxaloacetic transaminase (SGOT) ... < 2.5 times upper limit of normal",
                    "criterion": "Serum glutamic oxaloacetic transaminase (SGOT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "times upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum glutamate pyruvate transaminase (SGPT) < 2.5 times upper limit of normal",
                    "criterion": "serum glutamate pyruvate transaminase (SGPT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "times upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects",
            "criterions": [
                {
                    "exact_snippets": "No hepatic insufficiency",
                    "criterion": "hepatic insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical jaundice",
                    "criterion": "clinical jaundice",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "coagulation defects",
                    "criterion": "coagulation defects",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine =< 3.0 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Creatinine =< 3.0 mg/dL",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Left ventricular ejection fraction (LVEF) >= 40% by multigated acquisition scan (MUGA) scan or echocardiogram",
            "criterions": [
                {
                    "exact_snippets": "Left ventricular ejection fraction (LVEF) >= 40%",
                    "criterion": "left ventricular ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 40,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months",
            "criterions": [
                {
                    "exact_snippets": "No unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... congestive heart failure requiring hospitalization within the past 6 months",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "hospitalization",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "times"
                            }
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No transmural myocardial infarction within the past 6 months",
            "criterions": [
                {
                    "exact_snippets": "No transmural myocardial infarction within the past 6 months",
                    "criterion": "transmural myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since last occurrence",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No nursing for 6 months after completion of study treatment (for patients receiving trastuzumab [Herceptin®])",
            "criterions": [
                {
                    "exact_snippets": "No nursing for 6 months after completion of study treatment (for patients receiving trastuzumab [Herceptin®])",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "prohibition",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Negative pregnancy test",
            "criterions": [
                {
                    "exact_snippets": "Negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fertile patients must use effective contraception during and for 6 months after completion of study treatment",
            "criterions": [
                {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "must use effective contraception during and for 6 months after completion of study treatment",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during and for 6 months after completion of study treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to tolerate systemic chemotherapy and pelvic radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "Able to tolerate systemic chemotherapy",
                    "criterion": "systemic chemotherapy tolerance",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Able to tolerate ... pelvic radiotherapy",
                    "criterion": "pelvic radiotherapy tolerance",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other invasive malignancy within the past 3 years except nonmelanoma skin cancer",
            "criterions": [
                {
                    "exact_snippets": "No other invasive malignancy within the past 3 years",
                    "criterion": "invasive malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except nonmelanoma skin cancer",
                    "criterion": "nonmelanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of allergic reaction to study drugs",
            "criterions": [
                {
                    "exact_snippets": "No history of allergic reaction to study drugs",
                    "criterion": "allergic reaction to study drugs",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of inflammatory bowel disease",
            "criterions": [
                {
                    "exact_snippets": "No history of inflammatory bowel disease",
                    "criterion": "inflammatory bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No acute bacterial or fungal infection requiring IV antibiotics",
            "criterions": [
                {
                    "exact_snippets": "No acute bacterial or fungal infection",
                    "criterion": "acute bacterial or fungal infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring IV antibiotics",
                    "criterion": "IV antibiotics",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No AIDS",
            "criterions": [
                {
                    "exact_snippets": "No AIDS",
                    "criterion": "AIDS",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other severe active comorbidity",
            "criterions": [
                {
                    "exact_snippets": "No other severe active comorbidity",
                    "criterion": "severe active comorbidity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior systemic chemotherapy with anthracyclines or taxanes",
            "criterions": [
                {
                    "exact_snippets": "No prior systemic chemotherapy with anthracyclines",
                    "criterion": "prior systemic chemotherapy with anthracyclines",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior systemic chemotherapy with ... taxanes",
                    "criterion": "prior systemic chemotherapy with taxanes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior systemic chemotherapy for TCC",
            "criterions": [
                {
                    "exact_snippets": "No prior systemic chemotherapy for TCC",
                    "criterion": "prior systemic chemotherapy for TCC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior pelvic radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "No prior pelvic radiotherapy",
                    "criterion": "pelvic radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Not pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not ... nursing",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}