{
    "info": {
        "nct_id": "NCT02027376",
        "official_title": "A Phase Ib Dose Escalation, Open Label, Multicenter Study Evaluating LDE225 (Sonidegib) in Combination With Docetaxel in Triple Negative (TN) Advanced Breast Cancer (ABC) Patients \"EDALINE\"",
        "inclusion_criteria": "1. The patient is capable to understand and comply with the protocol and has signed the informed consent document.\n2. Females with histologically confirmed advanced breast cancer.\n3. TN breast cancer by local laboratory determination. Hormonal Receptor (HR) negative defined as < 1% positive cells by Immunohistochemistry (IHC) for both Estrogen Receptor (ER) and Progesterone Receptor (PgR), and HER2 negative defined as in situ hybridization (ISH) negative or IHC 0 or 1+ in the absence of ISH (Note: patients with IHC 2+ must have an ISH determination in order to confirm the HER2 negativity.\n4. Measurable or non-measurable disease according to RECIST 1.1 criteria.\n5. Patient is at least 18 years of age.\n6. World Health Organization (WHO) Performance Status ≤ 1.\n7. Life expectancy ≥ 12 weeks.\n8. Common laboratory values within normal range (...)\n9. A negative serum pregnancy test ≤ 72 hours before starting study treatment for pre-menopausal women and for women < 1 year from the last menstruation date.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Have received more than 3 prior chemotherapy regimens for ABC.\n2. Patients with untreated brain metastases. However, a patient with Central Nervous System (CNS) metastases may participate in this trial if > 4 weeks from therapy completion (incl. radiation and/or surgery), is clinically stable with respect to the tumor at the time of study entry and is not receiving corticosteroid therapy.\n3. Patients with acute or chronic liver or renal disease or pancreatitis.\n4. Patients with a second primary malignancy that is clinically detectable at the time of consideration for study enrollment.\n5. Patients unable to swallow tablets.\n6. History of a positive HIV test (HIV testing is not mandatory).\n7. History of a positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result (Hepatitis B or C testing is not mandatory).\n8. Impairment of gastrointestinal (GI) function or GI disease (e.g. ulcerative disease, uncontrolled nausea, vomiting, grade ≥ 2 diarrhea, malabsorption syndrome or small bowel resection).\n9. Peripheral vascular disease requiring active therapy or having had surgery < 12 months prior to starting study drug.\n10. Impaired cardiac function or clinically significant heart disease (...)\n\n    * A past medical history of clinically significant ECG abnormalities or a family history of prolonged QT-interval syndrome\n    * Other clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)\n11. Patients who are receiving treatment with medications that are known to be strong inhibitors or inducers of CYP3A4/5 (listed in Protocol Attachment 3) or drugs metabolized by CYP2B6 or CYP2C9 (listed in Protocol Attachment 3) that cannot be discontinued prior to study entry and for the duration of the study. Medications that are strong CYP3A4/5 inhibitors should be discontinued for at least 2 days, and strong CYP3A4/5 inducers for at least 1 week prior to initiating LDE225 dosing.\n12. Patients who have received chemotherapy within a period of time that is < the cycle length used for that treatment (e.g. < 3 weeks for fluorouracil, doxorubicine, epirubicin) prior to starting study drug or who have not recovered from the side effects of such therapy.\n13. Patients who have received biologic therapy (e.g. antibodies) ≤ 4 weeks prior to starting study drug or who have not recovered from the side effects of such therapy.\n14. Patients who have been treated with a small molecule therapeutic ≤ 5 t1/2 or ≤ 4 weeks (whichever is shorter) prior to starting study drug or who have not recovered from the side effects of such therapy.\n15. Patients who have received any other investigational agents ≤ 5 t1/2 or ≤ 4 weeks (whichever is shorter) prior to starting study drug or who have not recovered from the side effects of such therapy.\n16. Patients who have received wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy.\n17. Patients who are currently receiving treatment with therapeutic doses of warfarin sodium (Coumadin) who cannot discontinue this treatment at least 5 days prior to starting study drug.\n18. Patients who are currently receiving immunosuppressive treatment and in whom the treatment cannot be discontinued prior to starting study drug, except in the case of patients with basal cell carcinoma (BCC). Immunosuppressive treatment should be discontinued for at least 1 week prior to initiating LDE225 dosing.\n\n    ...",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. The patient is capable to understand and comply with the protocol and has signed the informed consent document.",
            "criterions": [
                {
                    "exact_snippets": "The patient is capable to understand and comply with the protocol",
                    "criterion": "capability to understand and comply with protocol",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has signed the informed consent document",
                    "criterion": "informed consent document",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Females with histologically confirmed advanced breast cancer.",
            "criterions": [
                {
                    "exact_snippets": "Females",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically confirmed",
                    "criterion": "histological confirmation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced breast cancer",
                    "criterion": "breast cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. TN breast cancer by local laboratory determination. Hormonal Receptor (HR) negative defined as < 1% positive cells by Immunohistochemistry (IHC) for both Estrogen Receptor (ER) and Progesterone Receptor (PgR), and HER2 negative defined as in situ hybridization (ISH) negative or IHC 0 or 1+ in the absence of ISH (Note: patients with IHC 2+ must have an ISH determination in order to confirm the HER2 negativity.",
            "criterions": [
                {
                    "exact_snippets": "TN breast cancer by local laboratory determination",
                    "criterion": "TN breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "determination",
                            "expected_value": "local laboratory"
                        }
                    ]
                },
                {
                    "exact_snippets": "Hormonal Receptor (HR) negative defined as < 1% positive cells by Immunohistochemistry (IHC) for both Estrogen Receptor (ER) and Progesterone Receptor (PgR)",
                    "criterion": "Hormonal Receptor (HR)",
                    "requirements": [
                        {
                            "requirement_type": "negativity",
                            "expected_value": "< 1% positive cells by Immunohistochemistry (IHC) for both Estrogen Receptor (ER) and Progesterone Receptor (PgR)"
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2 negative defined as in situ hybridization (ISH) negative or IHC 0 or 1+ in the absence of ISH",
                    "criterion": "HER2",
                    "requirements": [
                        {
                            "requirement_type": "negativity",
                            "expected_value": [
                                "in situ hybridization (ISH) negative",
                                "IHC 0 or 1+ in the absence of ISH"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with IHC 2+ must have an ISH determination in order to confirm the HER2 negativity",
                    "criterion": "HER2",
                    "requirements": [
                        {
                            "requirement_type": "ISH determination",
                            "expected_value": "required for IHC 2+ to confirm negativity"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Measurable or non-measurable disease according to RECIST 1.1 criteria.",
            "criterions": [
                {
                    "exact_snippets": "Measurable or non-measurable disease according to RECIST 1.1 criteria",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "criteria",
                            "expected_value": "RECIST 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patient is at least 18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "Patient is at least 18 years of age.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. World Health Organization (WHO) Performance Status ≤ 1.",
            "criterions": [
                {
                    "exact_snippets": "World Health Organization (WHO) Performance Status ≤ 1",
                    "criterion": "World Health Organization (WHO) Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Life expectancy ≥ 12 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy ≥ 12 weeks.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Common laboratory values within normal range (...)",
            "criterions": [
                {
                    "exact_snippets": "Common laboratory values within normal range",
                    "criterion": "laboratory values",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "normal range"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. A negative serum pregnancy test ≤ 72 hours before starting study treatment for pre-menopausal women and for women < 1 year from the last menstruation date.",
            "criterions": [
                {
                    "exact_snippets": "A negative serum pregnancy test",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "≤ 72 hours before starting study treatment",
                    "criterion": "time before starting study treatment",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 72,
                                "unit": "hours"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "pre-menopausal women",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "pre-menopausal"
                        }
                    ]
                },
                {
                    "exact_snippets": "women < 1 year from the last menstruation date",
                    "criterion": "time since last menstruation",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "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. Have received more than 3 prior chemotherapy regimens for ABC.",
            "criterions": [
                {
                    "exact_snippets": "received more than 3 prior chemotherapy regimens",
                    "criterion": "prior chemotherapy regimens",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients with untreated brain metastases. However, a patient with Central Nervous System (CNS) metastases may participate in this trial if > 4 weeks from therapy completion (incl. radiation and/or surgery), is clinically stable with respect to the tumor at the time of study entry and is not receiving corticosteroid therapy.",
            "criterions": [
                {
                    "exact_snippets": "untreated brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "Central Nervous System (CNS) metastases ... > 4 weeks from therapy completion (incl. radiation and/or surgery)",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "time since therapy completion",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Central Nervous System (CNS) metastases ... clinically stable with respect to the tumor at the time of study entry",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "clinical stability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Central Nervous System (CNS) metastases ... is not receiving corticosteroid therapy",
                    "criterion": "corticosteroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "receiving status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients with acute or chronic liver or renal disease or pancreatitis.",
            "criterions": [
                {
                    "exact_snippets": "acute or chronic liver ... disease",
                    "criterion": "liver disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "acute or chronic ... renal disease",
                    "criterion": "renal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "pancreatitis",
                    "criterion": "pancreatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients with a second primary malignancy that is clinically detectable at the time of consideration for study enrollment.",
            "criterions": [
                {
                    "exact_snippets": "second primary malignancy that is clinically detectable",
                    "criterion": "second primary malignancy",
                    "requirements": [
                        {
                            "requirement_type": "detectability",
                            "expected_value": "clinically detectable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients unable to swallow tablets.",
            "criterions": [
                {
                    "exact_snippets": "unable to swallow tablets",
                    "criterion": "ability to swallow tablets",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. History of a positive HIV test (HIV testing is not mandatory).",
            "criterions": [
                {
                    "exact_snippets": "History of a positive HIV test",
                    "criterion": "HIV test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. History of a positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result (Hepatitis B or C testing is not mandatory).",
            "criterions": [
                {
                    "exact_snippets": "History of a positive Hepatitis B surface antigen (HBsAg)",
                    "criterion": "Hepatitis B surface antigen (HBsAg)",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "History of a positive ... Hepatitis C test result",
                    "criterion": "Hepatitis C test result",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Impairment of gastrointestinal (GI) function or GI disease (e.g. ulcerative disease, uncontrolled nausea, vomiting, grade ≥ 2 diarrhea, malabsorption syndrome or small bowel resection).",
            "criterions": [
                {
                    "exact_snippets": "Impairment of gastrointestinal (GI) function or GI disease",
                    "criterion": "gastrointestinal function or disease",
                    "requirements": [
                        {
                            "requirement_type": "impairment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ulcerative disease",
                    "criterion": "ulcerative disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled nausea",
                    "criterion": "nausea",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "vomiting",
                    "criterion": "vomiting",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "grade ≥ 2 diarrhea",
                    "criterion": "diarrhea",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "malabsorption syndrome",
                    "criterion": "malabsorption syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "small bowel resection",
                    "criterion": "small bowel resection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Peripheral vascular disease requiring active therapy or having had surgery < 12 months prior to starting study drug.",
            "criterions": [
                {
                    "exact_snippets": "Peripheral vascular disease requiring active therapy",
                    "criterion": "peripheral vascular disease",
                    "requirements": [
                        {
                            "requirement_type": "active therapy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Peripheral vascular disease ... having had surgery < 12 months prior to starting study drug",
                    "criterion": "peripheral vascular disease",
                    "requirements": [
                        {
                            "requirement_type": "surgery",
                            "expected_value": {
                                "operator": "<",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Impaired cardiac function or clinically significant heart disease (...)",
            "criterions": [
                {
                    "exact_snippets": "Impaired cardiac function",
                    "criterion": "cardiac function",
                    "requirements": [
                        {
                            "requirement_type": "impairment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant heart disease",
                    "criterion": "heart disease",
                    "requirements": [
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A past medical history of clinically significant ECG abnormalities or a family history of prolonged QT-interval syndrome",
            "criterions": [
                {
                    "exact_snippets": "A past medical history of clinically significant ECG abnormalities",
                    "criterion": "ECG abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "a family history of prolonged QT-interval syndrome",
                    "criterion": "family history of prolonged QT-interval syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)",
            "criterions": [
                {
                    "exact_snippets": "Other clinically significant heart disease (e.g. congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Other clinically significant heart disease ... uncontrolled hypertension",
                    "criterion": "uncontrolled hypertension",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Other clinically significant heart disease ... history of labile hypertension",
                    "criterion": "history of labile hypertension",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Other clinically significant heart disease ... history of poor compliance with an antihypertensive regimen",
                    "criterion": "history of poor compliance with an antihypertensive regimen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Patients who are receiving treatment with medications that are known to be strong inhibitors or inducers of CYP3A4/5 (listed in Protocol Attachment 3) or drugs metabolized by CYP2B6 or CYP2C9 (listed in Protocol Attachment 3) that cannot be discontinued prior to study entry and for the duration of the study. Medications that are strong CYP3A4/5 inhibitors should be discontinued for at least 2 days, and strong CYP3A4/5 inducers for at least 1 week prior to initiating LDE225 dosing.",
            "criterions": [
                {
                    "exact_snippets": "Patients who are receiving treatment with medications that are known to be strong inhibitors or inducers of CYP3A4/5",
                    "criterion": "treatment with strong inhibitors or inducers of CYP3A4/5",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "drugs metabolized by CYP2B6 or CYP2C9",
                    "criterion": "treatment with drugs metabolized by CYP2B6 or CYP2C9",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Medications that are strong CYP3A4/5 inhibitors should be discontinued for at least 2 days",
                    "criterion": "discontinuation of strong CYP3A4/5 inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "strong CYP3A4/5 inducers for at least 1 week",
                    "criterion": "discontinuation of strong CYP3A4/5 inducers",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Patients who have received chemotherapy within a period of time that is < the cycle length used for that treatment (e.g. < 3 weeks for fluorouracil, doxorubicine, epirubicin) prior to starting study drug or who have not recovered from the side effects of such therapy.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have received chemotherapy within a period of time that is < the cycle length used for that treatment",
                    "criterion": "recent chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last chemotherapy",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "who have not recovered from the side effects of such therapy",
                    "criterion": "recovery from chemotherapy side effects",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Patients who have received biologic therapy (e.g. antibodies) ≤ 4 weeks prior to starting study drug or who have not recovered from the side effects of such therapy.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have received biologic therapy (e.g. antibodies) ≤ 4 weeks prior to starting study drug",
                    "criterion": "biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "who have not recovered from the side effects of such therapy",
                    "criterion": "recovery from side effects of biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Patients who have been treated with a small molecule therapeutic ≤ 5 t1/2 or ≤ 4 weeks (whichever is shorter) prior to starting study drug or who have not recovered from the side effects of such therapy.",
            "criterions": [
                {
                    "exact_snippets": "treated with a small molecule therapeutic ≤ 5 t1/2 or ≤ 4 weeks (whichever is shorter) prior to starting study drug",
                    "criterion": "prior treatment with small molecule therapeutic",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "t1/2"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "who have not recovered from the side effects of such therapy",
                    "criterion": "recovery from side effects of small molecule therapy",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Patients who have received any other investigational agents ≤ 5 t1/2 or ≤ 4 weeks (whichever is shorter) prior to starting study drug or who have not recovered from the side effects of such therapy.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have received any other investigational agents ≤ 5 t1/2 or ≤ 4 weeks (whichever is shorter) prior to starting study drug",
                    "criterion": "prior investigational agent use",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "t1/2"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "who have not recovered from the side effects of such therapy",
                    "criterion": "recovery from side effects of prior investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Patients who are currently receiving treatment with therapeutic doses of warfarin sodium (Coumadin) who cannot discontinue this treatment at least 5 days prior to starting study drug.",
            "criterions": [
                {
                    "exact_snippets": "currently receiving treatment with therapeutic doses of warfarin sodium (Coumadin)",
                    "criterion": "warfarin sodium (Coumadin) treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cannot discontinue this treatment at least 5 days prior to starting study drug",
                    "criterion": "discontinuation of warfarin sodium (Coumadin) treatment",
                    "requirements": [
                        {
                            "requirement_type": "time before starting study drug",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Patients who are currently receiving immunosuppressive treatment and in whom the treatment cannot be discontinued prior to starting study drug, except in the case of patients with basal cell carcinoma (BCC). Immunosuppressive treatment should be discontinued for at least 1 week prior to initiating LDE225 dosing.",
            "criterions": [
                {
                    "exact_snippets": "Patients who are currently receiving immunosuppressive treatment",
                    "criterion": "immunosuppressive treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment cannot be discontinued prior to starting study drug",
                    "criterion": "immunosuppressive treatment discontinuation",
                    "requirements": [
                        {
                            "requirement_type": "possibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Immunosuppressive treatment should be discontinued for at least 1 week prior to initiating LDE225 dosing",
                    "criterion": "immunosuppressive treatment discontinuation duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except in the case of patients with basal cell carcinoma (BCC)",
                    "criterion": "basal cell carcinoma (BCC)",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "16. Patients who have received wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have received wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) ≤ 4 weeks prior to starting study drug",
                    "criterion": "wide field radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "limited field radiation for palliation ≤ 2 weeks prior to starting study drug",
                    "criterion": "limited field radiation for palliation",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "who have not recovered from side effects of such therapy",
                    "criterion": "recovery from side effects of radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "...",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}